tag:blogger.com,1999:blog-63521441843332448862024-03-13T21:38:57.104-07:00georpan-georgiaChikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comBlogger1000125tag:blogger.com,1999:blog-6352144184333244886.post-66287038505109018242012-09-28T05:00:00.000-07:002012-09-28T07:09:19.669-07:00No Discovery From IRBs in California<span lang="EN"> </span><br /><span lang="EN"><div align="justify" dir="ltr">We’re not comfortable saying much because we have tangential involvement (not on this appeal), but blog readers, particularly in California, might be interested in the recent decision in <u>Pomona Valley Medical Center v. Superior Court</u>, No. B241684, <a href="http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/CabanaIRB.pdf">slip op.</a> (Cal. App. Sept. 24, 2012) (for publication). We haven’t researched it thoroughly, but we believe that <u>Pomona Valley</u> is the first case in California (and maybe the country) to hold an Institutional Review Board ("IRB") exempt from civil discovery under what in most states are considered "peer review" privilege statutes. As the court in <u>Pomona Valley</u> discussed, however, California’s statute is broader than most such statutes.</div></span><br />Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-63731320932087031372012-09-27T05:00:00.000-07:002012-09-28T07:09:19.652-07:00Who Needs TwIqbal?: Round IIThe following is a guest post by <a href="http://www.tuckerellis.com/attorneys/mollie-benedict">Mollie Benedict</a> and <a href="http://www.tuckerellis.com/attorneys/amanda-villalobos">Amanda Villalobos</a>, both of <a href="http://www.tuckerellis.com/">Tucker Ellis</a>, about a recent dismissal they won of one of those all-too-common California "consumer protection" strike suits where nobody's really injured. They get all the credit for the win, and all the blame for this post.<br /><br />*************<br /><br /> In an April 27, 2012 post, “<a href="http://druganddevicelaw.blogspot.com/2012/04/who-needs-twiqbal.html">Who Needs TwIqbal</a>?”,<span style="mso-spacerun: yes;"> </span>John Sullivan examined a putative class action in New Jersey federal court, <u>Young v. Johnson & Johnson</u>. Sullivan credited the defendant for putting a standing argument (usually a bench player) into the starting line-up<span style="mso-spacerun: yes;"> </span>in the case, and both standing and federal preemption came through in the clutch:<span style="mso-spacerun: yes;"> </span>The court dismissed Plaintiff’s claims that he had been misled by representations on the labels of the margarine substitute Benecol Spread, finding both that (1) Plaintiff lacked standing because he had not alleged any injury and (2) his claims were preempted because he sought to impose labeling requirements that were not identical to those imposed by the Federal Food, Drug and Cosmetic Act (FDCA) as amended by the Nutrition Labeling and Education Act (NLEA). <o:p></o:p><br /> <br /><div class="RSBodyText" style="margin: 0in 0in 12pt;"><u>Reid v. Johnson & Johnson</u>, 2012 U.S. Dist. Lexis 133408 (S.D. Cal. Sept, 17, 2012) is a west coast rematch – another putative class action involving Benecol spread, this time in federal court in San Diego.<span style="mso-spacerun: yes;"> </span>As in <u>Young</u>, Plaintiff alleged that the defendants made misleading claims regarding Benecol’s trans fat content and the cholesterol-lowering benefits of Benecol’s key ingredient, plant stanol esters.<span style="mso-spacerun: yes;"> </span>Plaintiff claimed he purchased the product in reliance on these alleged misrepresentations, asserting causes of action under California’s consumer protection statutes, the Unfair Competition Law, the False Advertising Law,<span style="mso-spacerun: yes;"> </span>and the Consumer Legal Remedies Act.</div><div class="RSBodyText" style="margin: 0in 0in 12pt;">Defendants again brought standing off the bench to lead off, arguing that Plaintiff lacked standing because he suffered no injury in fact and, more significantly, because no reasonable consumer was likely to be deceived by Benecol’s label claims, a standing requirement under all three consumer protection statutes.<span style="mso-spacerun: yes;"> </span>Although the court found that Plaintiff had adequately pleaded an injury in fact because he alleged that he “paid more for Benecol, and would have been willing to pay less, or nothing at all, if he had not been misled by the representations and practices”... </div><div class="RSBodyText" style="margin: 0in 0in 12pt;">[Editorial note: This proves that California is even more extreme than New Jersey]</div><div class="RSBodyText" style="margin: 0in 0in 12pt;">...it also found that Plaintiff “has not set forth alleged facts showing that Benecol’s statements may deceive a reasonable consumer.”<span style="mso-spacerun: yes;"> </span>Score another win for standing.</div><div class="RSBodyText" style="margin: 0in 0in 12pt;">But preemption, still waiting on deck, again came to the plate to hog some of the glory.<span style="mso-spacerun: yes;"> </span>As mentioned in Sullivan’s <u>Young</u> post, the NLEA contains a broad express preemption provision prohibiting states from establishing labeling requirements that are not identical to federal regulations.</div><div class="RSBodyText" style="margin: 0in 0in 12pt;">The court concluded that because Benecol’s claims regarding plant stanol esters and their cholesterol-reducing properties were permitted by federal law, Plaintiff’s claims were preempted.<span style="mso-spacerun: yes;"> </span>The court based its preemption analysis on an enforcement discretion letter issued by FDA in 2003.<span style="mso-spacerun: yes;"> </span>The letter advised that, based on new scientific evidence, the agency would relax the content requirements for products eligible to bear the plant stanol ester health claim codified in 21 C.F.R. §101.83.<span style="mso-spacerun: yes;"> </span>While Benecol’s label conformed to the requirements of the 2003 letter, Plaintiff contended the letter did not constitute a final agency action and did not have the force and effect of federal law, so Benecol should be required to, but did not, conform to 21 C.F.R. § 101.83.</div><div class="RSBodyText" style="margin: 0in 0in 12pt;">The court disagreed, finding that “[t]he [2003] letter reflects the FDA’s position” and that “Plaintiff’s plant [stanol] esters claim essentially … seeks to impose a different, outdated interim rule requirement for<span style="mso-spacerun: yes;"> </span>Defendants from that set forth in the 2003 FDA Letter….” <u>Id.</u> at *21-22.</div><div class="RSBodyText" style="margin: 0in 0in 12pt;">[Editorial note: The FDA letter in <u>Reid</u> was not a warning letter, which are <a href="http://druganddevicelaw.blogspot.com/2012/09/the-fda-on-warning-letters-theyre-sure.html">different</a>]</div>The court also found that Plaintiff’s trans fat claims were barred by preemption. According to Plaintiff, Benecol’s “No Trans Fat” and “No Trans Fatty Acids” statements constituted unauthorized nutrient content claims even though the FDA permits the statements “0g trans fat” or “0 grams trans fat” to appear on food labels.<span style="mso-spacerun: yes;"> </span>The court, relying on the doctrine of common sense, disagreed with Plaintiff and noted that an attempt to distinguish the statements “No Trans Fat” and “0 grams trans fat” was unreasonable because the two terms are functionally equivalent.<span style="mso-spacerun: yes;"> </span><o:p></o:p><br /> <br /><div class="RSBodyText" style="margin: 0in 0in 12pt;">Defendants also argued that Plaintiff’s claims should be dismissed based on primary jurisdiction and its closely related cousin, judicial abstention.<span style="mso-spacerun: yes;"> </span>While the court found application of primary jurisdiction to be inappropriate in this case, it declined to rule on the issue of judicial abstention, leaving open the possibility that it too may have been a basis to bar Plaintiff’s claims.</div>Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-90481851991328386892012-09-26T05:00:00.000-07:002012-09-28T07:09:19.697-07:00Breaking Up is Easy to Do<span lang="EN"></span><br /><div align="LEFT" dir="LTR"><span lang="EN">We all know how easy it is to complain about bad decisions. Right now, sports pundits and fans are holding a gripeathon about the National Football League 's replacement referees. There has been more talk about the officiating mistakes than about the athletic performances. A sense of perspective is in order. The comparison baseline is not perfection. It is not as if the regular referees got all their calls right. Does anybody remember <a href="http://en.wikipedia.org/wiki/Ed_Hochuli">Ed Hochuli</a> (actually a very good ref who is also a Phoenix attorney) incorrectly calling a deadball? And who stared at the Steelers-Seahawks Super Bowl in disbelief a couple of years ago, as every call of consequence went against Seattle? Still, there is no denying that the replacement refs have authored an amazing number of egregious errors already in only three weeks of football. The <a href="http://espn.go.com/nfl/story/_/id/8422934/seattle-seahawks-vs-green-bay-packers-disputed-mnf-call-shifted-150-250m-bets">blown call</a> at the end of the Monday night game (it benefitted the Seahawks, so some are saying Karma is at work, though it is hard to see why Karma would hose the Packers) is prompting some fans to call for a boycott. If either Obama or Romney could step up and do something about the referee lockout, he'd probably help his election campaign big time. He would certainly get Wisconsin's electoral votes.</span></div><span lang="EN"><br /><div align="LEFT" dir="LTR"><br /></div><br /><div align="LEFT" dir="LTR">One of the most interesting things about the replacement referee situation is the substitute teacher syndrome. Did you ever have a substitute teacher in elementary school who seemed sort of weak or clueless? Wouldn't the class end up becoming incredibly disruptive? Even the kids who were ordinarily well-behaved started acting like delinquents. We remember back in seventh grade one of the star students hoodwinking a substitute teacher into thinking that his name was <a href="http://en.wikipedia.org/wiki/Billy_Paul">Billy Paul</a>. Billy Paul was an R&B singer . More specifically, he was a practitioner of TSOP -The Sound of Philadelphia. Billy Paul’s big hit was "<a href="http://www.youtube.com/watch?v=mWOTdt9Bovk&feature=related">Me and Mrs. Jones</a>." The teacher was puzzled at how the rest of us howled in laughter when she would scream in exasperation, "Billy Paul, get back in your seat!" "Billy Paul, you leave that girl alone!" After NFL week one, it seemed that many players had sized up the replacement refs as being like bad substitute teachers -- tentative and insecure. Just like 'Billy Paul,' the players took advantage. By 'took advantage,' we mean that the players started perpetrating all sorts of mayhem on their opponents. Things got chippy. One especially devious Ram delivered a nasty shot to a Redskins receiver after a play was over. The aggrieved receiver responded by throwing the ball at the offender. Bad idea. As so often happens, the ref saw the reaction, not the instigation. The receiver drew a penalty and backed his team up. The team's field goal attempt missed. Game over. </div><br /><div align="LEFT" dir="LTR"><br /></div><br /><div align="LEFT" dir="LTR">The substitute teacher syndrome is like the "broken glass" theory of policing. One of the most brilliant minds on governance and policing was <a href="http://www.nytimes.com/2012/03/03/nyregion/james-q-wilson-dies-at-80-originated-broken-windows-policing-strategy.html?pagewanted=all&_moc.semityn.www">James Q. Wilson</a>, who died earlier this year. Some of us were lucky enough to take classes with Wilson, who was a dynamic speaker with an even more dynamic mind. Some labeled Wilson a neocon, but he was really a policy skeptic. He was a political scientist who liked to get his fingernails dirty with data. He wrote about groundbreaking analyses of poverty and bureaucracy. With all that, he was most famous for his writings on crime. Wilson was brilliant on that topic, and he managed to make a difference. Wilson wondered why people commit crimes. Crime is a disease in the body politic. It is an odd disease, because it is a product of human choice. Most people do not choose crime. Some do, they do so repeatedly, and they betray the social contract. Wilson found that people are far more likely to make that destructive choice if they are in an environment that welcomes destruction. If a window was broken in a neighborhood, and was not repaired, that appearance of disorder sent a message that disorder was okay. Crime rates would be higher in such areas. Wilson recommended that cops arrest people for quality-of-life crimes (disorderly conduct, etc.) and help create an appearance of order in the community. That approach, plus a relentless use of statistics (CrimeStat), seemed to play a significant role in reducing crime rates in American cities. (Yes, we know there are other theories about that as well, including the controversial <strong>Freakonomics</strong> argument that increasing abortions led to decreasing crime. We are not touching that one.) </div><br /><div align="LEFT" dir="LTR"><br /></div><br /><div align="LEFT" dir="LTR">We wonder whether the substitute teacher or broken glass theory applies to litigation. If courts permit sloppy, absurd practices, they ineluctably invite more. Our home turf, the Philadelphia Court of Common Please, has been taking a beating for its pro-plaintiff, anti-business court system. We do not agree with all of the criticisms, but it is undeniable that when a judge explicitly invites plaintiffs to engage in litigation tourism, when the court as a matter of course makes nutty venue/forum non conveniens rulings, and when it allows plaintiff lawyers to cobble together multi-plaintiff cases that maximize prejudice against corporate defendants -- well, as Wilson showed, chaos begets chaos. Pretty soon, Philadelphia's City Hall (which houses the Court of Common Pleas civil cases) rang out a clickety-clack of cowboy boots, and if you yelled "Roll Tide!" in the hallways, you'd probably get at least a couple of high-fives. Nevertheless, as an <a href="http://online.wsj.com/article/SB10000872396390444083304578014400849363158.html">article in Monday's</a> <strong>Wall Street Journal</strong> showed, there's a new sheriff in town. Judge Herron has implemented many changes in the Philly courts, including a rule against consolidating plaintiffs in tort cases. That is a welcome reform and it is a big deal. We get how plaintiffs are supposed to be the master of the complaint, but the plaintiff lawyer is not supposed to be the master of the court docket. When plaintiff lawyers self-consolidate multiple plaintiffs into a tort action, they create an artificial case with a perfect plaintiff who gets in every piece of corporate conduct and other evidence -- an array of awfulness that would not come in with a single plaintiff. It stacks the deck and is unfair to defendants. It is also unfair to the courts. The consolidated cases are not only a method of beating defendants into settlements, they are also a method of beating the court out of the extra filing fees for separately filing plaintiff. Courts are noticing all this.</div><br /><div align="LEFT" dir="LTR"><br /></div><br /><div align="LEFT" dir="LTR">So today's post is not a complaint at all. Instead, we celebrate how courts are starting to get things right on joinder and severance issues. Philly has taken a step in the right direction. Other courts are taking similar steps. We offer a tip of the cyber cap to <a href="http://www.cov.com/mimbroscio/">Mike Imbroscio</a> for sending us a recent severance victory in the Accutane MDL. The particular case is called <a href="http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/Aranda.severence.pdf"><em>Aranda v. Hoffman-Laroche, Inc.</em>,</a> No. 8:12-cv-1426-T-30TBM (M.D. Fla. Sept. 20, 2012), and we have written about it <a href="http://druganddevicelaw.blogspot.com/2012/05/new-stuff.html">before</a>. It has, to say the least, a peculiar history. The case was originally filed on behalf of 69 plaintiffs alleging injuries from Accutane. It was filed in a state court with a hellholish reputation as bad as Philly. But after a little fact-checking made clear that the plaintiffs’ effort to stymie diversity was phony, the case ended up in federal court. Post MDL, the defendant moved to sever the plaintiffs. In a refreshing and straightforward opinion, the court granted the motion and severed the cases.</div><br /><div align="LEFT" dir="LTR"><br /></div><br /><div align="LEFT" dir="LTR">First, the plaintiffs’ joinder was flat-out inappropriate under Fed. R. Civ. P. 20(a). The plaintiffs resided in different states, allegedly ingested Accutane at different times, and were allegedly diagnosed with different adverse reactions to Accutane. (Note the word "allegedly." Based on the discovery provided by the plaintiffs, their Accutane use and adverse reactions was by no means established.) Thus, the plaintiffs' claims did not arise "out of the same transaction, occurrence, or series of transactions or occurrences." Fed. R. Civ. P. 20(a). There were different Accutane warnings at different times, which would necessarily have a profound effect on liability issues, and could potentially confuse juries confronted with multiple plaintiffs. Second, the <em>Aranda</em> court emphasized that "[m]any federal courts hold that product liability cases are generally inappropriate for multi-plaintiff joinder because such cases involve highly individualized facts and '[l]iability, causation, and damages will ... be different with each individual plaintiff.'" <em>Aranda,</em> slip op. at 1, quoting <em>In re Prempro Prods. Liab. Litig</em>., 417 F. Supp. 2d 1048, 1059-60 (E.D. Ark. 2006). The <em>Aranda</em> court also cites supporting precedent from the Silica, Diet Drug, Baycol, and Rezulin litigations. Third, the cobbling together of different plaintiffs with different claims and, no matter how much the plaintiff lawyers pretend otherwise, different legal theories, would "likely hamper the orderly, efficient, and expeditious handling of the plaintiffs' claims as the litigation progresses." <em> Tesfaye Abebe v. Takeda Pharmaceuticals (In re Actos Prod. Liab. Litig.),</em> No. 6:11-md-02299 (W.D. La. May 3, 2012 The motion to sever in Aranda was brought under Rule 21, which relates to misjoinder of parties. That rule makes clear that severance can be granted "[o]n motion or on its own, the court may at any time, on just terms add or drop a party." Fed. R. Civ. P. 21. The <em>Aranda</em> court cited both Rule 21 "and the Court's inherent authority to control its own docket." <em>Aranda</em>, slip op. at 2. Fourth, the court ordered that each "severed plaintiff shall also pay a filing fee to the Clerk of the Court." Id. At 3. For some plaintiff lawyers, that last bit hurts the most. </div><br /><div align="LEFT" dir="LTR"> </div><br /><div align="LEFT" dir="LTR">The <em>Aranda</em> severance adds to a growing list of courts that are putting a stop to improper mass tort self-consolidations. As we said earlier, it is easy to complain about bad decisions. It turns out that it is even easier to praise good ones. </div><br /><div align="LEFT" dir="LTR"><br /></div></span>Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-22073444506253042862012-09-25T14:26:00.000-07:002012-09-28T07:09:19.430-07:00Practice Pointer Follow Up<div class="MsoNormal" style="margin: 0in 0in 12pt;"><span lang="EN" style="mso-ansi-language: EN;"><span style="font-family: inherit;"><span style="mso-tab-count: 1;"> </span>First and foremost here at the Drug and Device Law Blog, we like good, strong defense decisions.<span style="mso-spacerun: yes;"> </span>If those decisions contain lessons (or reminders) for our everyday practice – so much the better.<span style="mso-spacerun: yes;"> </span>That’s why we’ve blogged about cases that let us remind you to check publicly available information about plaintiffs, make sure the plaintiff was alive when she filed suit, and search bankruptcy filings to see if plaintiff disclosed her lawsuit.<span style="mso-spacerun: yes;"> </span>We </span><a href="http://druganddevicelaw.blogspot.com/2012/06/practice-pointer-20-bankrupt-plaintiffs.html" target="_blank"><span style="font-family: inherit;">blogged</span></a><span style="font-family: inherit;"> about a bankruptcy discharge case a few months ago out of state court in Massachusetts.<span style="mso-spacerun: yes;"> </span>So, when we stumbled across a recent federal court decision on the issue, we thought we’d pass it along and take a look to see what else was going on in federal court on this issue. <o:p></o:p></span></span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><span style="font-family: inherit;"><span lang="EN" style="mso-ansi-language: EN;"><span style="mso-tab-count: 1;"> </span>The case that prompted this post is a holdout from the Vioxx MDL – <u>In re Vioxx Products Liability Litigation</u>, 2012 WL 4097200 (E.D. La. Sep. 17, 2012).<span style="mso-spacerun: yes;"> </span>Plaintiff Sandra Elliott filed her Vioxx lawsuit in 2006 and later filed for bankruptcy in 2009, but did not disclose to the trustee her claims against Merck.<span style="mso-spacerun: yes;"> </span><u>Id.</u></span><span lang="EN"> </span>at *1.<span style="mso-spacerun: yes;"> </span><span lang="EN" style="mso-ansi-language: EN;">While the bankruptcy was still pending, Merck moved for summary judgment on the grounds of judicial estoppel.<span style="mso-spacerun: yes;"> </span><u>Id.</u><span style="mso-spacerun: yes;"> </span>The fact that the bankruptcy was still pending is one of the things that caught our eye about this case.<span style="mso-spacerun: yes;"> </span>We’re sure you won’t be surprised to learn that plaintiff’s primary argument in opposition to the motion to dismiss was – I’ll just go back and amend my bankruptcy petition and then no harm, no foul.<span style="mso-spacerun: yes;"> </span>The court didn’t see it that way.<o:p></o:p></span></span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><span lang="EN" style="mso-ansi-language: EN;"><span style="font-family: inherit;"><span style="mso-tab-count: 1;"> </span>There are three requirements for judicial estoppel to apply: “(1) [T]he party is judicially estopped only if its position is clearly inconsistent with the previous one; (2) the court must have accepted the previous position; and (3) the non-disclosure must not have been inadvertent.”<span style="mso-spacerun: yes;"> </span><u>Id.</u> at *2 (citation omitted). <span style="mso-spacerun: yes;"> </span>It is the second two factors which are most often at issue in the bankruptcy non-disclosure context.<span style="mso-spacerun: yes;"> </span><o:p></o:p></span></span></div><div class="MsoNormal" style="margin: 0in 0in 12pt; text-indent: 0.5in;"><span style="font-family: inherit;"><span lang="EN" style="mso-ansi-language: EN;">Let’s start with number 3. <span style="mso-spacerun: yes;"> </span>We can imagine that almost every plaintiff when faced with this type of motion to dismiss argues inadvertence.<span style="mso-spacerun: yes;"> </span>The definition of an inadvertent non-disclosure can vary from court to court.<span style="mso-spacerun: yes;"> </span>In the Fifth Circuit “[a] nondisclosure is considered inadvertent only when, in general, the debtor either lacks knowledge of the undisclosed claims or has <i style="mso-bidi-font-style: normal;">no motive</i> for their concealment.”<span style="mso-spacerun: yes;"> </span><u>Id.</u></span> (emphasis added and citation omitted).<span style="mso-spacerun: yes;"> </span>Knowledge and/or motive give “rise to an inference of intent sufficient to satisfy the [bad faith] requirements of judicial estoppel.”<span style="mso-spacerun: yes;"> <u> </u></span><span style="color: black;"><span style="mso-bidi-font-style: italic;"><u>In re Coastal Plains, Inc.</u></span><i>,</i></span><span style="color: black;"> 179 F.3d 197, 210 (5th Cir.1999)</span>.<span style="mso-spacerun: yes;"> </span>The Third, Eighth, Tenth, and Eleventh Circuits have also adopted this reasoning. <span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span><u><span style="mso-bidi-font-style: italic;">See</span></u><span style="mso-bidi-font-style: italic;">, <u>e.g.</u>,<i> </i></span><span style="color: black;"><span style="mso-bidi-font-style: italic;"><u>Eastman v. Union Pac. R.R. Co.</u></span><i>,</i></span><span style="color: black;"> 493 F.3d 1151, 1157 (10th Cir.2007)</span>; <span style="color: black;"><span style="mso-bidi-font-style: italic;"><u>Stallings v. Hussmann Corp.</u></span><i>,</i></span><span style="color: black;"> 447 F.3d 1041, 1048 (8th Cir.2006)</span>; <span style="color: black;"><span style="mso-bidi-font-style: italic;"><u>Barger v. City of Cartersville, Ga.</u></span><i>,</i></span><span style="color: black;"> 348 F.3d 1289, 1294 (11th Cir.2003)</span>; <span style="color: black;"><span style="mso-bidi-font-style: italic;"><u>Ryan Operations G.P. v. Santiam–Midwest Lumber Co.</u></span><i>,</i></span><span style="color: black;"> 81 F.3d 355, 363 (3d Cir.1996)</span>.<span style="mso-spacerun: yes;"> </span></span></div><div class="MsoNormal" style="margin: 0in 0in 12pt; text-indent: 0.5in;"><span style="font-family: inherit;"><span lang="EN" style="mso-ansi-language: EN;">As the Vioxx court explained, at least applying Fifth Circuit law:<span style="mso-spacerun: yes;"> </span>“</span>the motivation sub-element is almost always met if a debtor fails to disclose a claim or possible claim to the bankruptcy court ... because of potential financial benefit resulting from the nondisclosure.”<span style="mso-spacerun: yes;"> </span><u>In re Vioxx</u>, <span lang="EN" style="mso-ansi-language: EN;">2012 WL 4097200 at *3.<span style="mso-spacerun: yes;"> </span>We can’t conceive a situation in which a plaintiff lacks a motive to conceal her claims – the financial motive is strong and always present.<span style="mso-spacerun: yes;"> </span>So at least in the 3<sup>rd</sup>, 5<sup>th</sup>, 8<sup>th</sup>, 10<sup>th</sup> and 11<sup>th</sup> Circuits, if your plaintiff failed to disclose her lawsuit in her bankruptcy proceedings – it wasn’t inadvertent.<span style="mso-spacerun: yes;"> </span><o:p></o:p></span></span></div><div class="MsoNormal" style="margin: 0in 0in 12pt; text-indent: 0.5in;"><span style="font-family: inherit;"><span lang="EN" style="mso-ansi-language: EN;">What about element #2 – the court must have accepted the previous position.<span style="mso-spacerun: yes;"> </span>When a bankruptcy has been discharged, certainly the court has accepted the plaintiff’s statement of her assets and made a ruling based on that.<span style="mso-spacerun: yes;"> </span>But, what about in a situation like Ms. Elliott’s where the bankruptcy proceedings are still open and in response to a summary judgment motion based on judicial estoppel, she seeks leave to amend her bankruptcy petition?<span style="mso-spacerun: yes;"> </span>In the Fifth Circuit it doesn’t matter.<span style="mso-spacerun: yes;"> </span>The Vioxx court explained the recent decision in </span><span><span style="color: black;"><u>Love v. Tyson Foods, Inc.</u>,</span></span><span style="color: black;"> 677 F.3d 258 (5th Cir.2012)</span>:<span style="mso-spacerun: yes;"> </span></span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><blockquote class="tr_bq"><span style="font-family: inherit;">The Fifth Circuit held that the district court did not abuse its discretion when it granted summary judgment, because the plaintiff had not adequately addressed his failure to disclose his claims in his original bankruptcy petition—that is, at the time [plaintiff] failed to meet his disclosure obligations, which is the relevant time frame for the judicial estoppel analysis. The <u>Love</u> Court found it significant that [plaintiff] did state that he would pay his creditors before collecting any money from his claims against [defendant], but he made this assertion only after [defendant] brought his nondisclosure to light. <span style="mso-spacerun: yes;"> </span>On the other hand, [plaintiff’s] disclosure obligations arose long beforehand, and he had not adequately explained why he did not meet those obligations at that time. The court also noted that if a debtor who is caught concealing his claims by an opponent could then disclose his claims in order to fix the problem, there would virtually no incentive for a debtor to disclose his claims until forced to do so by an opponent.<o:p></o:p></span></blockquote></div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><span style="font-family: inherit;"><u><span lang="EN" style="mso-ansi-language: EN;">In re Vioxx</span></u><span lang="EN" style="mso-ansi-language: EN;">, 2012 WL 4097200 at *4.<span style="mso-spacerun: yes;"> </span>“[A]</span> plaintiff may <i>not</i> be permitted to pursue a claim that was omitted from a bankruptcy petition, even if that plaintiff reopens her bankruptcy proceedings and amends her petition.”<span style="mso-spacerun: yes;"> </span><u>Id.</u> at *3.<span style="mso-spacerun: yes;"> </span>Tough love.</span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><span style="font-family: inherit;"><span style="mso-tab-count: 1;"> </span>This hard line by the Fifth Circuit prompted us to poke around and see what some of the other circuits were doing.<span style="mso-spacerun: yes;"> </span>Our research is by no means exhaustive and should only be used as a jumping off point – but we did find a few other decisions worthy of mention.<span style="mso-spacerun: yes;"> </span></span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><span style="font-family: inherit;"><span style="mso-tab-count: 1;"> </span>First, the Fifth Circuit is not alone it is embracing of judicial estoppel for undisclosed claims in bankruptcy:<span style="mso-spacerun: yes;"> </span><u>White v. Wyndham Vacation Ownership, Inc.</u>, 617 F.3d 472, 480 (6th Cir.2010) <span lang="EN" style="mso-ansi-language: EN;">(affirming grant of summary judgment dismissing plaintiff's undisclosed sexual harassment claim); <u>Krystal Cadillac-Oldsmobile GMC Truck, Inc. v. Gen. Motors Corp.</u>, 337 F.3d 314, 325 (3d Cir. 2003) ("Applying a lesser sanction [than judicial estoppel] . . . would reward [plaintiff] for what appears to be duplicitous conduct in the course of its bankruptcy proceeding. [Plaintiff] would still reap the benefit of any recovery . . . . In addition, the integrity of both the bankruptcy process and the judicial process would suffer."), <u>cert. denied</u>, 541 U.S. 1043 (2004); <u>Payless Wholesale Distribs., Inc. v. Alberto Culver, Inc.</u>, 989 F.2d 570, 571-72 (1st Cir.) ("In order to preserve the requisite reliability of disclosure statements and to provide assurances to creditors regarding the finality of plans which they have voted to approve . . . [plaintiff's] failure to announce [its] claim against a creditor precludes it from litigating the cause of action at this time."), <u>cert. denied</u>, 510 U.S. 931 (1993).<o:p></o:p></span></span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><span lang="EN" style="mso-ansi-language: EN;"><span style="font-family: inherit;"><span style="mso-tab-count: 1;"> </span>The Ninth Circuit, however, doesn’t join in.<span style="mso-spacerun: yes;"> </span>Instead, that court has held that rather than invoking judicial estoppel, allowing a plaintiff to remedy his “inconsistent assertions by allowing him to reopen his bankruptcy case, thereby giv[es] the bankruptcy trustee an opportunity to administer the unscheduled claims.” <u>Dunmore v. United States</u>, 358 F.3d 1107, 1113 (9th Cir. 2004).<span style="mso-spacerun: yes;"> </span>So, in the Ninth Circuit, the failure to disclose may be remedied by reopening the bankruptcy case and properly disclosing the claims.<span style="mso-spacerun: yes;"> </span>This then leads to decisions such as <u>Cannata v. Wyndham Worldwide Corp.</u>, 798 F.Supp.2d 1165 (D. Nev. 2011) in which the court denied judicial estoppel in favor of an “alternative equitable solution” that allowed plaintiff to pursue her claims but limited any potential award to “the amount necessary for the repayment of her creditors as determined by the chapter 7 estate trustee. [Plaintiff] will receive nothing.”<span style="mso-spacerun: yes;"> </span><u>Id.</u> at 1176.<span style="mso-spacerun: yes;"> </span>The court reasoned:<span style="mso-spacerun: yes;"> </span>“This solution also serves to discourage others not disclosing assets during bankruptcy proceedings.” <span style="mso-spacerun: yes;"> </span><u>Id.</u><span style="mso-spacerun: yes;"> </span>It certainly discourages that plaintiff from aggressively pursuing her claims. <o:p></o:p></span></span></div><div class="MsoNormal" style="margin: 0in 0in 12pt; text-indent: 0.5in;"><span style="font-family: inherit;">We also found an interesting twist in the Eleventh Circuit.<span style="mso-spacerun: yes;"> </span>The Eleventh Circuit would appear to be a judicial estoppel friendly jurisdicition.<span style="mso-spacerun: yes;"> </span><u>See</u> <u><span lang="EN" style="mso-ansi-language: EN;">Robinson v. Tyson Foods</span></u><span lang="EN" style="mso-ansi-language: EN;">, 595 F.3d 1269, 1276 (11th Cir. 2010) (summary judgment granted on judicial estoppel grounds in employment discrimination action; plaintiff had "motive to conceal her claims in order to keep any settlement proceeds" which made "a mockery of the judicial system").<span style="mso-spacerun: yes;"> </span>Likewise, in an earlier decision, </span><u>Burnes v. Pemco Aeroplex, Inc.</u>, 291 F.3d 1282, 1288 (11th Cir.2002), the court granted defendant’s motion for summary judgment on the ground of judicial estoppel and held that allowing an amendment or re-opening of the bankruptcy proceedings would “diminish the necessary incentive to provide the bankruptcy court with a truthful disclosure of the debtor's assets.” <u>Id.</u> at 1288.<span style="mso-spacerun: yes;"> </span>Two years later, the court called that decision into question in <span lang="EN" style="mso-ansi-language: EN;"><span style="color: black;"><u>Parker v. Wendy's Int'l, Inc.</u>, 365 F.3d 1268, 1272 (11th Cir. 2004)</span></span>:<span style="mso-spacerun: yes;"> </span>“<span lang="EN" style="mso-ansi-language: EN;">it is questionable as to whether judicial estoppel was correctly applied in <u>Burnes</u>. The more appropriate defense in the <u>Burnes</u> case was, instead, that the debtor lacked standing.”<span style="mso-spacerun: yes;"> </span>The difference between the cases – in <u>Parker</u> the bankruptcy trustee intervened and sought to pursue the action on behalf of the estate.<span style="mso-spacerun: yes;"> </span>Finding the trustee wasn’t burdened by the debtor/plaintiff’s non-disclosure, summary judgment was denied.<span style="mso-spacerun: yes;"> </span>Something to watch out for.<o:p></o:p></span></span></div><div class="MsoNormal" style="margin: 0in 0in 12pt; text-indent: 0.5in;"><span style="font-family: inherit;"><span lang="EN" style="mso-ansi-language: EN;">Finally, we refer you to the case of <u>Byrd v. Wyeth</u>, </span>2012 U.S. Dist. LEXIS 18590 (S.D. Miss. Feb. 15, 2012) because we happened upon it.<span style="mso-spacerun: yes;"> </span>It contains a discussion of the difference between a Chapter 7 and a Chapter 13 bankruptcy and why the judicial estoppel analysis may differ.<span style="mso-spacerun: yes;"> </span>We’ll leave that for another day.</span></div>Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-17907469648855021112012-09-25T11:26:00.000-07:002012-09-28T07:09:19.419-07:00Vaccine Act Preemption - Post-BruesewitzBreaking news here. The Ninth Circuit has upheld a preemption-based dismissal of a Vaccine Act case. <u>See</u> <u>Holmes v. Merck & Co.</u>, No. 08-16557, <a href="http://www.ca9.uscourts.gov/datastore/opinions/2012/09/25/08-16557.pdf">slip op.</a> (9th Cir. Sept. 25, 2012). As the docket number indicates, the <u>Holmes</u> appeal has been pending for over about 4 years. It was resubmitted in 2011 after <u>Bruesewitz v. Wyeth</u>, 562 U.S. ___, 131 S. Ct. 1068 (2011).<br /><br /><u>Holmes</u> involved MMR vaccine administered to a one-year-old baby. Plaintiffs claimed that the vaccine caused seizures, brain damage and ultimately death. <a href="http://www.ca9.uscourts.gov/datastore/opinions/2012/09/25/08-16557.pdf">Slip op.</a> at 11794. Plaintiffs sought compensation on the child's behalf through the federal system and received $250,000. <u>Id.</u> Not satisfied with that, they sought to ring the tort bell as well, on their own behalf, filing a wrongful death action in Clark County (Las Vegas) Nevada court. Fortunately, there was diversity of citizenship.<br /><br />The defendant received summary judgment on the basis of Vaccine Act preemption, and plaintiffs appealed. The main issue was whether the parent's could dodge preemption by filing an action in their own behalf while simultaneously taking advantage of the Act's compensation system on behalf of their minor child.<br /><br />Plaintiffs hinged their arguments mostly on the fact that the Vaccine Act only provides compensation and requires exhaustion of administrative remedies to those allegedly (we say allegedly because the Act does not require that causation be proven - as long as the vaccine and injury are on the Act's administrative list) physically injured by vaccines, not to next of kin. Plaintiffs claimed that, by filing a separate wrongful death action on their own behalf, they could in effect double dip, receiving both federal and common-law compensation. <a href="http://www.ca9.uscourts.gov/datastore/opinions/2012/09/25/08-16557.pdf">Slip op.</a> at 11800.<br /><br />In <u>Holmes</u>, the Ninth Circuit said no:<br /><blockquote class="tr_bq">The exhaustion requirement in Section 11 is only a subsection of Congress’s larger statutory scheme to ensure that vaccine manufacturers have an affordable and predictable way of handling injured parties’ compensation claims. Though parents are not bound by Section 11’s exhaustion requirement, they are not free from the Act’s tort liability limitations. Regardless of whether a plaintiff is the vaccine-recipient or the parent of one, Section 22 expressly preempts design-defect claims seeking compensation for injury or death caused by a accine’s unavoidable side effects. §300aa-22(b). Section 22 expressly preempts tort suits based “solely” on the manufacturer’s failure to provide direct warnings to the injured party. §300aa-22(c).</blockquote><br /><a href="http://www.ca9.uscourts.gov/datastore/opinions/2012/09/25/08-16557.pdf">Slip op.</a> at 11800.<br /><br />The Act's triple-barrelled elimination of design claims, imposition of a warning compliance defense and mandating of the learned intermediary rule "indicates that Congress expressly intended to prohibit states from regulating large aspects of tort suits against vaccine manufacturers." <u>Id.</u> at 11802. Thus, technicalities of state law (whether the plaintiff was the injured person or somebody bringing a wrongful death action) did not affect the Act's preemption of substantive claims - the design and warning claims were the same no matter who the plaintiff was:<br /><blockquote class="tr_bq">Given the structure and broad purpose of the Act as a whole, it is most reasonable to apply Section 22 to all design defect and failure to warn claims arising out of a vaccine-related injury or death, not just those that could have first been brought in the Vaccine Court.</blockquote><br /><a href="http://www.ca9.uscourts.gov/datastore/opinions/2012/09/25/08-16557.pdf">Slip op.</a> at 11805. Instead, the Act's preemption clauses apply to "<span style="font-family: Times New Roman;">any civil action for </span><span style="font-family: Times New Roman;">damages arising from a vaccine-related injury" without limiting the identity of the plaintiff. <u>Id.</u> at 11806 (quotation marks omitted). Moreover, to allow different claims for different categories of plaintiff would "<span style="font-family: Times New Roman;">create[] a convoluted trial and liability scenario," since where the vaccine recipient was not dead, both sets of claims would otherwise be tried together. <u>Id.</u> There was no basis for believing that "Congress gave greater rights" to family members than to the injured persons themselves. <u>Id.</u></span></span><br /><span style="font-family: Times New Roman;"><span style="font-family: Times New Roman;"></span></span><br /> To allow parents to bring claims that were otherwise barred by the Vaccine Act also was at war with the broader purposes of the Vaccine Act:<br /><blockquote class="tr_bq"><br />[I]f we were to conclude that the parents of those suffering a vaccine-related injury could bring design defect and failure to warn claims outside of [preemptive] limitations, we would be acting contrary to the statute’s central purpose of managing vaccine manufacturers’ liability because our construction would do little to protect the vaccine manufacturers from suit.</blockquote><span style="font-family: Times New Roman;"></span><br /><span style="font-family: Times New Roman;"><div align="LEFT"> </div><div align="LEFT"><a href="http://www.ca9.uscourts.gov/datastore/opinions/2012/09/25/08-16557.pdf">Slip op.</a> at 11807. Protection from liability, after all was why Congress acted in the first place.</div></span><br />Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-12967689241138618072012-09-24T13:34:00.000-07:002012-09-28T07:09:19.400-07:00So You’re Telling Me There’s a Chance<div class="MsoNormal" style="margin: 0in 0in 12pt;">Anything can happen. You’ve probably heard the claim that a million monkeys in front of a million typewriters would eventually type one of Shakespeare’s sonnets.<span style="mso-spacerun: yes;"> </span>But good luck waiting for the release of “A Monkey’s Immortality Sonnet.”<span style="mso-spacerun: yes;"> </span>In sports, old-time Dodger fans used to say, “Wait’ll next year,” and the next spring they thought, “Anything can happen.”<span style="mso-spacerun: yes;"> </span>That is, until summer passed, and the Brooklyn Bums disappointed them again.<span style="mso-spacerun: yes;"> </span>“Anything can happen” makes for great drama in movies too.<span style="mso-spacerun: yes;"> </span>A barely .500 club fighter from South Philly wins the heavyweight title.<span style="mso-spacerun: yes;"> </span>But it took two movies.<span style="mso-spacerun: yes;"> </span>Bobsledders from tropical Jamaica go to the Winter Olympics.<span style="mso-spacerun: yes;"> </span>Oh, wait, that was real.<span style="mso-spacerun: yes;"> </span>But they didn’t win.<span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;">In musings, sports and entertainment, “anything can happen” can be a source of fun and inspiration.<span style="mso-spacerun: yes;"> </span>Not so much in the courts.<span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><i style="mso-bidi-font-style: normal;">Bonander v. Breg, Inc.</i>, 2012 U.S. Dist. LEXIS 132620 (D. Minn. Sept. 18, 2012), is a summary judgment opinion in a failure to warn pain pump case.<span style="mso-spacerun: yes;"> </span>The doctor who inserted the pain pump in the plaintiff’s shoulder said he never read the product label.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at 5.<span style="mso-spacerun: yes;"> </span>He didn’t listen to sales reps.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i><span style="mso-spacerun: yes;"> </span>He didn’t spend a lot of time reading Dear Doctor Letters and didn’t remember reading one from the defendant.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.<span style="mso-spacerun: yes;"> </span></i>He didn’t expect medical device companies or their sales reps to be the ones who supplied him with information about the risks and benefits of their medical devices.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i><span style="mso-spacerun: yes;"> </span>He relied instead on his training, the literature and his interaction with colleagues.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i><span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;">So the defendant moved for summary judgment: no causation because a different warning from the defendant wouldn’t have mattered to this doctor.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *1.<span style="mso-spacerun: yes;"> </span>He wouldn’t have looked at it, much less considered it.<span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;">Sounds like a winner, right?<span style="mso-spacerun: yes;"> </span>Unfortunately, anything can happen.<span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;">The court denied the motion.<span style="mso-spacerun: yes;"> </span>The reason?<span style="mso-spacerun: yes;"> </span>Four years after the plaintiff’s procedure the doctor stopped using pain pumps for shoulder surgeries after seeing an article in a medical journal that linked pain pumps and the type of injury that the plaintiff had.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *8.<span style="mso-spacerun: yes;"> </span>But that doesn’t undermine the doctor’s testimony that he didn’t consider risks/benefit information coming from medical device companies.<span style="mso-spacerun: yes;"> </span>It underscores it.<span style="mso-spacerun: yes;"> </span>He got this information from a journal.<span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;">The court conceded that the doctor “did not rely on medical device companies to provide such information,” but concluded nonetheless that the doctor “may still have responded to a warning” that was communicated to him.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *11.<span style="mso-spacerun: yes;"> </span>This reasoning has us thinking of Lloyd Christmas: “<a href="http://www.youtube.com/watch?v=wGdhc9k07Ms" target="_blank">So you’re telling me there’s a chance.</a>”<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;">The court also said that the doctor never “foreclosed the possibility” that he would have heeded a warning communicated to him by the defendant.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *7-8.<span style="mso-spacerun: yes;"> </span>But more important, it seems, is that he never opened it.<span style="mso-spacerun: yes;"> </span>We don’t think that summary judgment should be defeated by mere possibilities.<span style="mso-spacerun: yes;"> </span>Inferences must be “reasonable.” <span style="mso-spacerun: yes;"> </span></div><span style="font-family: 'Times New Roman','serif'; font-size: 12pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US;">Remember, this was summary judgment.<span style="mso-spacerun: yes;"> </span>The plaintiff already had discovery and an opportunity to seek evidence and testimony from the doctor.<span style="mso-spacerun: yes;"> </span>It wasn’t early spring in 1951 Brooklyn.<span style="mso-spacerun: yes;"> </span>It was late summer with the Dodgers out of the pennant race.<span style="mso-spacerun: yes;"> </span>Much like all those early Dodger seasons (at least, pre-1955), we think the court should have put an early end to things.</span>Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-34938380905459244552012-09-21T10:37:00.000-07:002012-09-28T07:09:19.458-07:00Returning to a Favorite Spot<div class="MsoNormal" style="margin: 0in 0in 12pt;"><span style="mso-tab-count: 1;"> </span>One member of our blogging team (we’ll let you guess who) recently returned from her (well, that narrows it down a bit) first real camping trip.<span style="mso-spacerun: yes;"> </span>The kind with a tent, sleeping bags, no electricity.<span style="mso-spacerun: yes;"> </span>You get the idea.<span style="mso-spacerun: yes;"> </span>This wasn’t just a step, but rather a huge leap outside this blogger’s comfort zone – which runs more toward poolside bar service somewhere where the view is only obstructed by palm trees.<span style="mso-spacerun: yes;"> </span>Before the trip images of big red welts from mosquito bites, spiders and ticks taking up residence in our hair, and critters of any size wandering around at night left us more than a little disconcerted.<span style="mso-spacerun: yes;"> </span>An ample supply of wine was stowed with the gear.<span style="mso-spacerun: yes;"> </span>A Google maps search had located nearby hotels.<span style="mso-spacerun: yes;"> </span>And the iPhone car charger was packed.<span style="mso-spacerun: yes;"> </span>We were ready for anything.</div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><span style="mso-tab-count: 1;"> </span>Most importantly, as it turns out, we were ready for some fun.<span style="mso-spacerun: yes;"> </span>The weather near the Appalachian Trail in Pennsylvania was almost perfect.<span style="mso-spacerun: yes;"> </span>Sunny and warm during the day.<span style="mso-spacerun: yes;"> </span>Just chilly enough at night to make you want to huddle around the camp fire.<span style="mso-spacerun: yes;"> </span>Perfect weather for hiking, fishing, roasting marshmallows and hot dogs, and telling ghost stories.<span style="mso-spacerun: yes;"> </span>The perfect environment for separating the kids from their DVD players, iPads and assorted other portable electronic devices – something we quickly realized was necessary when, as we drove into the mountains we heard from the back seat:<span style="mso-spacerun: yes;"> </span>Wow, it’s like a real life 3D movie.<span style="mso-spacerun: yes;"> </span>Yikes! (But don’t tell them about the car charger).<span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><span style="mso-tab-count: 1;"> </span>Perhaps best of all was the stillness of the early mornings.<span style="mso-spacerun: yes;"> </span>No alarms going off.<span style="mso-spacerun: yes;"> </span>No sounds of traffic congestion.<span style="mso-spacerun: yes;"> </span>No being bombarded by streaming bad news from all over the world.<span style="mso-spacerun: yes;"> </span>Just big, deep breaths of fresh air.<span style="mso-spacerun: yes;"> </span>It made us think of …well, of camping again.<span style="mso-spacerun: yes;"> </span>Much like the sandy beaches and umbrella drinks (which remain our top destination for relaxing) – when you discover a place you like, you find yourself wanting to return.<span style="mso-spacerun: yes;"> </span>Even on the ride home, you start thinking about the next time.<span style="mso-spacerun: yes;"> </span>Fun places are fun places.<span style="mso-spacerun: yes;"> </span>So, we revisit them with fond memories of the last trip and anticipation that more fun is right around the corner.</div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><span style="mso-tab-count: 1;"> </span>That’s sort of how we feel about the Aredia/Zometa litigation.<span style="mso-spacerun: yes;"> </span>We’ve been there before, we generally like it, and so we go back again.<span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><span style="mso-tab-count: 1;"> </span>This week, the A/Z litigation added to its lengthy string of successes (see prior posts on A/Z cases <a href="http://druganddevicelaw.blogspot.com/search/label/Aredia%2FZometa" target="_blank">here</a>) with a <u>Daubert</u> (<a href="http://druganddevicelaw.net/A-Z%20Daubert%20opinion.pdf" target="_blank">slip op.</a>) and a summary judgment (<a href="http://druganddevicelaw.net/A-Z%20summary%20judgment.pdf" target="_blank">slip op.</a>) win all rolled into one in the case of <u><span style="mso-bidi-font-style: italic;">Conklin v. Novartis Pharmaceuticals Corporation</span></u>, No. 9:11-cv-00178-RC, (E.D. Tex. Sept. 19, 2012). <span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt; text-indent: 0.5in;">While the case was pending in the <u>Aredia/Zometa MDL</u>, the court granted defendant’s motion for summary judgment on plaintiff’s (and 7 other TX residents’) failure to warn claims.<span style="mso-spacerun: yes;"> </span><u>Daubert</u> <u><a href="http://druganddevicelaw.net/A-Z%20Daubert%20opinion.pdf" target="_blank">slip op.</a></u> at 5.<span style="mso-spacerun: yes;"> </span>Shortly after remand, in an attempt to avoid the implications of the MDL court’s ruling, plaintiff notified the remand court that the case would proceed on “design defect under Texas law.”<span style="mso-spacerun: yes;"> </span><u>Id.</u> at 8.<span style="mso-spacerun: yes;"> </span>Plaintiff claimed that Dr. Robert Marx, an oral surgeon and one of plaintiffs’ leading MDL experts, had an alternative design theory that saved her remaining claims.<span style="mso-spacerun: yes;"> </span><u>Id.</u><span style="mso-spacerun: yes;"> </span>As Dr. Marx’s declaration was plaintiff’s sole support for those remaining design defect claims, the court first ruled on defendant’s motion to strike under <u>Daubert</u>.</div><div class="MsoNormal" style="margin: 0in 0in 12pt; text-indent: 0.5in;">Dr. Marx’s opinion was that a decreased dosage and/or frequency of Zometa administration would both reduce the risk of the side effect suffered by plaintiff (ONJ) and still efficaciously treat cancer-related bone damage.<span style="mso-spacerun: yes;"> </span><u>Id.</u> at 16.<span style="mso-spacerun: yes;"> </span>Unfortunately for plaintiff, the court found both that Dr. Marx was unqualified to render such an opinion and that the opinion itself was unsupported.<span style="mso-spacerun: yes;"> </span>First, the court noted that Dr. Marx is neither an oncologist nor pharmacologist and therefore not qualified to offer an opinion on what dosage of Zometa would effectively treat cancer-related bone damage.<span style="mso-spacerun: yes;"> </span>Further, in disqualifying Dr. Marx, the court noted that he “had to rely on studies or opinions of other experts to opine of the efficacy or utility of his ‘safe alternative design.’”<span style="mso-spacerun: yes;"> </span><u>Id.<o:p></o:p></u></div><div class="MsoNormal" style="margin: 0in 0in 12pt; text-indent: 0.5in;">But the court didn’t stop there.<span style="mso-spacerun: yes;"> </span>Delving deeper into the shaky foundation of Dr. Marx’s opinion, the court stated:</div><blockquote class="tr_bq"><div class="MsoNormal" style="margin: 0in 0in 12pt;">The analytical gap, in Dr. Marx’s opinion is demonstrated by setting out his premises and conclusions: </div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><b>Premise</b>: Studies show that a certain regimen of Zometa helps treat cancer-related bone conditions, but may cause ONJ. <span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><b>Premise</b>: Other studies show that less Zometa will result in less ONJ. </div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><b>Conclusion</b>: A regimen using less Zometa will help treat cancer-related bone conditions. </div><div class="MsoNormal" style="margin: 0in 0in 12pt;">This is a classic logical fallacy—an irrelevant conclusion. </div><div class="MsoNormal" style="margin: 0in 0in 12pt;">It is not helpful to the finder of fact for Dr. Marx to state that a drug used to fight cancer related diseases has a particular negative side effect, and that reducing the dosage and/or frequency of that drug will reduce the occurrence of the negative side effect. Rather, Dr. Marx must also provide some factual support that reducing the dosage and/or frequency of that drug will not only reduce the occurrence of the negative side effect, but will also be effective at fighting cancer-related diseases. Unfortunately, Dr. Marx offers no evidence as to the efficacy of a reduced Zometa regimen . . .</div></blockquote><div class="MsoNormal" style="margin: 0in 0in 12pt;"><u>Id.</u> at 18.<span style="mso-spacerun: yes;"> </span>Based upon Dr. Marx’s inability to show that a reduced dose or duration of Zometa treatment would be as efficacious as the FDA-approved dose or duration, Dr. Marx’s “alternative design” opinion was stricken.</div><div class="MsoNormal" style="margin: 0in 0in 12pt;"> The court then turned to defendant’s motion for summary judgment.<span style="mso-spacerun: yes;"> </span>The MDL court having done away with plaintiff’s failure to warn, and by extension her breach of express warranty claims, <u>Summary judgment</u> <u><a href="http://druganddevicelaw.net/A-Z%20summary%20judgment.pdf" target="_blank">slip op.</a></u> at 8, the remand court was left to consider strict liability design defect, negligence per se and breach of implied warranty.<span style="mso-spacerun: yes;"> </span>First, the court quickly recognized that plaintiff’s negligence per se and breach of implied warranty claims were “re-packaged design defect or failure to warn claims.”<span style="mso-spacerun: yes;"> </span><u>Id.</u> <span style="mso-spacerun: yes;"> </span>Since the MDL court had ruled that plaintiff’s failure-to-warn claims were foreclosed, and since plaintiff had offered no admissible evidence of a safer alternative design -- the court granted summary judgment for defendant.<span style="mso-spacerun: yes;"> </span><u>Id.</u> at 9-11.<span style="mso-spacerun: yes;"> </span> Two wins, no waiting.</div><div class="MsoNormal" style="margin: 0in 0in 12pt;"> As you know from our prior posts, the <u><span style="mso-bidi-font-style: italic;">Conklin</span></u> decision is just the latest in a string of defense wins in the Aredia/Zometa litigation.<span style="mso-spacerun: yes;"> </span>But just like a good vacation – we don’t mind revisiting if the trip brings a smile to our face.</div><div class="MsoNormal" style="margin: 0in 0in 12pt;"> <span style="font-family: 'Times New Roman','serif'; font-size: 12pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US;">As always congratulations and thanks to our friend <a href="http://www.hollingsworthllp.com/people.php?PeopleID=43" target="_blank">Joe Hollingsworth</a> for keeping us up to speed on this litigation. </span></div>Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-15010131175902301832012-09-20T12:39:00.000-07:002012-09-28T07:09:19.407-07:00Chantix Daubert Leaves Us Wanting MoreHere's another guest post from <a href="http://www.reedsmith.com/">Reed Smith</a>'s <a href="http://www.reedsmith.com/eric_alexander/">Eric Alexander</a>. Maybe we'll get him his own account next time.<br /><br />************<br /><br />After the overwhelming response to our first post last week – the list of the recipients of those firm holiday cards we never actually send got a bit longer – we agreed to do another this week. We also vowed to make this post more positive than the first. We would not want to get an unfounded reputation for being unduly negative, critical, and crotchety. A well-founded reputation is fine, but we wanted to try to find a case with something to praise. It seems that finding a praiseworthy case some weeks is about as hard as resisting a cheeky alliterative title for our posts. (There sure are some b-words to pair with “bayou” when discussing a Louisiana case.) So, we found a case with some good parts and some bad parts. Like many meals out. On an MDL-wide <u>Daubert</u>, getting a satisfying entrée is sufficiently unlikely that you often have to make sure you enjoy your salad - butter lettuce, pear, blue cheese, and walnuts or pecans is nice, but lay off the raspberry vinaigrette.<br /><br /><br />The decision in <u>In re Chantix Varenicline Prods. Liab. Litig.</u>, MDL No. 2092, 2012 U.S. Dist. LEXIS 130144 (Aug. 21, 2012), is like that. The defendant took a shot at the whole ball of wax - general causation - “whether Chantix [a prescription drug for smoking cessation] is capable of causing the adverse neuropsychiatric events alleged,” as the Court put it. It missed. A definitive “no” on general cause would have pretty much ended the MDL, and MDLs (other than <u>Seroquel</u>) have a way of lasting past <u>Daubert</u> decisions. Similarly, most restaurants tend to like you to order some apps and sides with your entrée, have a few drinks along the way, save room for dessert and a nice aperitif, and maybe offer you a wafer thin slice of beef to finish you off. It is a rare joint that says, in essence, “You really came here for the porterhouse, so have that first and we’ll see if you have any room left after that.” But we digress. The entrée here was not prepared too well. Maybe it was how it was ordered. Maybe it should have been sent back. Maybe it was because the chef/court was confused about what it was preparing/deciding. We’ll get to that. Since we are trying to be positive, we will discuss the tasty part first. <br /><br />The court precluded plaintiffs’ experts – three of them were challenged specifically and addressed in the opinion, but the Conclusion suggests the ruling applies to all of plaintiffs’ experts – from offering testimony about what the defendant knew or that it misled the FDA. For one of the experts, the court said she could not testify to “labeling changes based on that knowledge.” In the Conclusion, the exclusion is of testimony “whether defendant ‘intentionally misled the FDA.’” Since we are still being positive, we will not dwell on the lack of consistency. We will praise something not normally praised – lack of detailed analysis. The court kicks this testimony from the first expert up, Dr. Furberg, with “as such opinions are necessarily based on speculation.” The other two experts challenged for such “opinions” fell without elaboration.<br /><br />There are a bunch of other reasons why an expert should not be able to testify about – or opine about, which is not really the same thing – these subjects, but speculation is a good reason. So, the court stops discussing it. No authority is cited; the case defendant cited <u>In re Rezulin Prods. Liab. Litig.</u>, 309 F. Supp. 2d 531, 543 n. 32, 560 (S.D.N.Y. 2004), is actually brushed aside a few pages earlier. We recall writing the challenge to an expert offering testimony on corporate intent that was granted in <u>In re Diet Drugs (Phentermine, Fenfluramine, Dexfenfluramine) Prods. Liab. Litig.</u>, No. MDL 1203, 2000 WL 876900 (E.D. Pa. June 20, 2000), and later expanded in <u>In re Diet Drugs Prods. Liab. Litig.</u>, MDL No. 1203, 2001 WL 454586 (E.D. Pa. Feb. 1, 2001), and later adopted in said Rezulin opinion – yes, the <u>Rezulin</u> court did preclude the same Dr. Furberg and others from offering testimony on the “intent, motive or state of mind of corporations or regulatory agencies.” Back then, we had to look to a range of non-products cases to cobble together support for a proposition that seemed obvious – an expert in regulatory matters, pharmacology, epidemiology, or whatever should not be allowed to get on the stand and offer up their take on what the drug manufacturer, its employees, FDA, or its employees knew, thought, or intended at a point in time. We used to have spend time in briefs explaining all the reasons why this was so. As courts have fallen in line on this, including, it seems, just about every drug or device MDL court to offer up a <u>Daubert</u> decision on the plaintiffs’ experts since <u>Diet Drugs</u> – because the plaintiffs’ expert keep offering intent testimony – we now have an established proposition the adoption of which required the <u>Chantix</u> court no analysis or citation. Like food – we are just not going to make analogies to smoking – simple can be better than complicated.<br /><br />Taking this same approach on whether the experts can testify FDA was misled is similarly logical and avoids some thorny issues. If an expert is speculating when offering up a testimony on what the company knew, then she is certainly speculating when she says the FDA was misled, which necessarily involves a guess at what FDA knew and thought. Even former FDA officials who become experts do not get to speculate on what another specific FDA official would have done with additional or different information. <u>In re Diet Drugs Prods. Liab. Litig.</u>, 2001 WL 454586, *19 (yeah, did that, too). We do think that the <a href="http://druganddevicelaw.blogspot.com/2009/09/embedded-fraud-on-fda.html">line of cases</a> that exclude evidence, expert or otherwise, offered to show that FDA was misled – starting with <u>Bouchard v. American Home Products</u>, 213 F. Supp.2d 802 (N.D. Ohio 2002) – is right even after Levine. We also see why a court would be hesitant to rely on preemption to exclude evidence in a pharmaceutical products case these days.<br /><br />While the <u>Chantix</u> court excluded the “knew” and “misled” testimony, it hastened to add that the experts could say what the defendant “should have known” and what information it provided to FDA. We will be curious to see how those lines are held at trials, as the veteran testifiers for plaintiffs do have a way of suggesting what they cannot say directly. But “should have known” and therefore “should have” taken some action does not sound like a basis for punitive damages and “knew” and “decided not to” take some action does. Similarly, you feel much better about avoiding punitives when no witness has testified that FDA was “misled” into taking or not taking some regulatory action based on what the company submitted or “failed” to submit. (We would urge that words like “failed,” “chose,” and “decided” are a way that impermissible knowledge and intent testimony actually gets offered by the cagey experts and lawyers.) So, we would take these exclusions, even with the clarifications about what can be offered.<br /><br />That said, the rest of the opinion was grounds for indigestion. Every challenge to opinions from the seven experts at issue on “general causation,” “biological plausibility,” and mechanisms for causation was shot down. In so doing, the court permitted speculation and theories (without any showing of general acceptance) and never identified any study relied upon by the challenged experts that had the hallmarks of reliable evidence of causation, at least as the court explained it . Rule 703 is never mentioned. In general, the court took the opposite approach of the Steve McConnell's Seventh Circuit idol in <u>Rosen v. Ciba-Geigy Corp.</u>, 78 F.3d 316, 319 (7th Cir. 1996) (Posner, J.), ironically another smoking cessation aid case, which famously declared, “But the courtroom is not the place for scientific guesswork, even of the inspired sort. Law lags science; it does not lead it.” The basic approach was to criticize the defendant’s challenge, pump up the expert’s qualifications and number of citations in the expert’s report, and cite caselaw (sometimes miscite) for the propositions that the judge’s gatekeeper role under <u>Daubert</u> does not supplant cross-examination, that most criticisms go to weight, and expert testimony can still be admitted if it fails multiple <u>Daubert</u> factors. It also fundamentally misunderstood the task at hand, often seeming to be rejecting a “no evidence” summary judgment motion rather than a <u>Daubert</u> challenge to specific experts’ testimony.<br /><br />How did this happen? We weren’t there and haven’t read the briefs, but a few things leap out. First, the day before the <u>Daubert</u> hearing, the court issued a partial summary judgment ruling that the Chantix label as changed in 2009 “is sufficient as a matter of law for warnings regarding neuropsychiatric injuries” (and the SOL would start running as of that change) and the court “the court considers the pending motion to exclude certain of plaintiffs’ experts in light of its prior ruling on the label sufficiency.” That had two implications as we read it: 1) that the court thought it was now established that Chantix can cause a range of neuropsychiatric injuries and 2) that the court did not understand – luckily, we do get to speculate on what judges understand – the relationship between labeling and causation. Even if Chantix does have the potential to cause neuropsychiatric injuries, an expert’s opinion that it does may still not be admissible. He may not base his opinion on reliable studies or he may apply an unreliable methodology in evaluating the studies, as by contending that an odds ratio less than 1.0 favors causation. He may have good qualifications in one area, but base his opinion solely on the type of studies he would never come across in his day job (<em>e.g.</em>, a rat study guy trying to rely on epidemiologic studies). The reverse is also true: an expert can have admissible but incorrect opinions that Chantix can cause neuropsychiatric injuries. Here, however, because the court clearly felt Chantix can cause neuropsychiatric injuries, the challenge to each expert was treated as something of an affront and the burden of demonstrating the reliability and admissibility of the expert’s opinions was not placed on the plaintiffs, who should have had it as the proponents of the evidence.<br /><br />In addition, the court seemed to think the fact that warnings in the Chantix label, or in FDA’s communications, became more forceful and prominent over time was important to the analysis of causation. There was no discussion of the well-known disclaimers in labeling regulations that “a causal relationship need not have been definitely established” or various FDA statements that labeling (and reporting of adverse events) should not be viewed as admissions of causation. Although the court discussed whether actions by FDA – its mission is to protect public health, after all – are based standards relevant to consideration of causation evidence under <u>Daubert</u>, its insistence on looking at FDA actions and inconsistency in how it did so was befuddling. Unfortunately, it appears that the defendant may have pushed the court to keep blurring the lines between admissibility under <u>Daubert</u> and what FDA has done/said, as it raised (according to the court) various arguments about how the plaintiffs’ experts interpreted studies or adverse event data different than how FDA did. The record also included defendant’s “Introduction and Statement of Facts Relevant to all Daubert Motions,” 154 exhibits from defendant, plaintiffs’ “Omnibus Memorandum of Facts and Law,” and 215 exhibits from plaintiffs, plus more stuff with the reply. With a dash of hindsight, we can certainly question whether all the background not really relevant to the admissibility of the opinions of the challenged experts ended up distracting the court from the real issues.<br /><br />Second, for whatever reason, after three years of presiding over the <u>Chantix</u> MDL, the judge did not like the defendant or its motions, at least as we read the opinion. When the first sentence in the “Relevant Factual Background” is that “this is a multidistrict product liability action concerning Chantix, <strong><u>touted</u></strong> by defendant to aid in smoking cessation” (emphasis added), you might get a hint at where the court is going. If the court really was “consider[ing] only whether Chantix is capable of cause the adverse neuropsychiatric events alleged,” then marketing conduct does not matter. Nor does how “severe” the events are being alleged, something the court notes several times. The standards for admissibility of expert evidence do not change based on whether defendants marketed aggressively (or misleadingly) or whether the injuries alleged are really bad. As <a href="http://en.wikipedia.org/wiki/Mike_Tomlin">Mike Tomlin</a> says, “The standard is the standard.”<br /><br />We said a “few things” leap out at us to why the portion of the opinion on causation was so bad. We have given two, really three if you count subparts like the Federal Rules of Civil Procedure require. There are more, but to go into them would come across as too negative, which we are resisting. Anyway, we started by saying that the <u>Chantix</u> opinion was like a meal out with some good parts and some bad parts. It was really like a meal that left us nauseated, but we thought back and remembered that we liked the bread. And maybe the butter.Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-15487444755022156422012-09-20T05:00:00.000-07:002012-09-28T07:09:19.411-07:00Basile v. H&R Block - It's Finally Over (and That's a Good Thing)Today's guest post is by <a href="http://www.lambmcerlane.com/lawyer/jcs">Jim Sargent</a>, of <a href="http://www.lambmcerlane.com/">Lamb McErlane</a>, who was one of the winning attorneys in the <u>Basile v. H&R Block</u> decision his post discusses. Way to go Jim (and everybody else on the team)! Bexis and Jim go back a ways, since Bexis wrote PLAC amicus briefs in the <u>Samuel-Bassett</u> case that Jim mentions in this post. As always, the guest blogger gets all the credit/shoulders all the blame for his post (unless the links don't work - that would be Bexis' fault).<br /><br /><u>Basile</u>, although not a drug/device opinion, is an important class certification decision in Pennsylvania.<br /><br />*******************<br /><br />The Pennsylvania Supreme Court’s most recent decision on class actions is in <u>Basile v. H&R Block, Inc.</u>, ___ A.3d ___, 2012 WL 3871504 (Pa. Sept. 7, 2012) ("<u>Basile III</u>"). <u>Basile</u> was a putative class action commenced way back in 1993, claiming that the defendant breached a fiduciary duty to its customers by not sufficiently disclosing that its “rapid refunds” of federal taxes actually were high interest consumer loans. Plaintiffs claimed that the defendant was a "fiduciary" as a way of avoiding reliance and individualized issues that prevent certification of this sort of claim.<br /><br /><br />The class was certified in 1997 by the late Judge Bernard Avellino, based on a “presumption” that an agency relationship existed between the defendant and some 600,000 customers. Over the next 15 years there then ensued 9 separate appeals – the case was before the Superior Court 5 (twice before the court en banc) times and the Supreme Court 4 times – which well may make it the longest appellate record in Pennsylvania history.<br /><br />On the first appeal, the Supreme Court rejected the notion that any agency relationship supported Plaintiffs’ claim that a fiduciary duty existed between the defendant and the class. <u>Basile v. H & R Block, Inc.</u>, 761 A. 2d 1115 (Pa. 2000) ("<u>Basile I</u>"). In its September 7, 2012 opinion the Court reiterated that it meant what it said the first time, rejecting the contention that a “confidential relationship” (the “fiduciary” claim under another name) existed, thus knocking out the remaining foundation for Plaintiffs’ claim.<br /><br />In the course of the 19 year history in <u>Basile</u>, the Supreme Court clarified the law of agency, <u>Basile I</u>, <u>supra</u>, 761 A. 2d 1115, the aggrieved party doctrine (after some Superior Court funny business with appellate issues), <u>Basile v. H & R Block, Inc.</u>, 973 A. 2d 417 (Pa. 2009) ("<u>Basile II</u>"), and now, in this latest opinion, the “confidential relationship” doctrine.<br /><br />Probably most important in the long term, though, is what the Court had to say about the principles governing class certification. . <br /><br />Its September 7 <u>Basile III</u> opinion reversed the Superior Court and affirmed the trial court decertification order. Think about what the Superior Court had done. It had held that that this class <strong><u>had</u></strong> to be certified; that decertification was an abuse of discretion. Writing in a 6-0 decision (Justice Orie-Melvin attended argument but is now suspended from the Court), Justice Saylor disposed of some eighty-year-old dictum, and held that a “confidential relationship” sufficient to give rise to a fiduciary duty is “‘intensely fact-specific,’” 2012 WL 3871504, at *7-8, and not suited to class-certification. The Court therefore held that the class was properly decertified.<br /><br />Justice Saylor’s rulings on class action procedure and his reflections generally on the class action mechanism bear taking specific note. Speaking for a unanimous court, he rejected the Superior Court’s attempt to flip the burden of proof on class certification. Evidence sufficient to defeat summary judgment (where all inferences benefit the plaintiff), does not create grounds for certification of a class (where the plaintiff bears the burden). To support class certification facts must be “properly determined . . . not assumed.” 2012 WL 3871504, at *6. “[D]eferring close consideration of class certification to the time when facts are determined by a jury at trial (namely, in connection with the verdict) is incompatible with the governing procedural rules.” <u>Id.</u><br /><br />Towards the end − after once describing class actions as “collectivized treatment,” <u>id.</u> at *6 − the opinion returns to this theme, stating: “We are cognizant of the tendency toward sanctioning the use of class actions as a convenience to address colorably meritorious claims in an aggregate fashion, where these might not otherwise be capable of being redressed practically on an individual basis.” <u>Id.</u> at *8. However, the Court rejected this temptation, holding that the approach to class treatment reflected in Pennsylvania’s class action rules “stems from limitations inherent in the judicial rulemaking process, the impact of collectivized treatment of individual claims on defendants’ substantive rights,” and “the limited policymaking role of the courts (as compared with the legislative branch) in terms of manipulating substantive law.” <u>Id.</u><br /><br />[Editor's note: On this blog, we refer to the "tendency" that Court rejected in <u>Basile III</u> "judicial triumphalism."]<br /><br />The Court’s rejection of Plaintiffs’ invitation to fashion a judicial solution to a legislative problem should be applauded. In contrast, 9 months earlier in <u>Samuel-Bassett v. Kia Motors America, Inc.</u>, 34 A.3d 1 (Pa. 2011), the same Court approved certification of a class of automobile owners on claims of out-of-pocket expense for brake repairs under an express warranty, where there was no proof that each class member had sustained any (let alone similar) repair expenses. The Court stated: “…a certification proceeding is a preliminary inquiry whose purpose is to establish who the parties to the class action are ‘and nothing more.’” 34 A.3d at 21-22 (quoting Pa. R.C.P. No. 1707 cmt). That plaintiff was not required to prove anything about the defendant’s liability at the certification stage and the trial court was prohibited from factoring the perceived adequacy of the “underlying merits of the class’s claims into the certification decision.” <u>Id.</u> at 22. The Court continued: “By the same token, pre-trial class certification proceedings do not require a mini-trial; the class is not obligated to establish liability during the class certification phase.” <u>Id.</u> (citations omitted). The Court then discounted the importance of individual proof of out-of-pocket costs for each class member: “As our previous analysis shows, [plaintiff] and the class adduced sufficient evidence during certification proceedings to show a common source of liability. Any question regarding individual expenditures resulting from varying attempts to repair the defect was not a ground to reject the commonality found on other issues, to defeat the predominance of common issues and, ultimately, to deny certification of the class at the preliminary stages of trial.” <u>Id.</u> at 28.<br /><br />But less than a year later, the Court is rejecting, unanimously, “assumed facts” and requiring “close consideration of class certification”in the name of “limitations inherent in the judicial rulemaking process” and “the limited policymaking role of the courts” in <u>Basile III</u>.<br /><br />There is no easy explanation for the differences between <u>Samuel-Bassett</u> and <u>Basile III</u>. It may be significant that <u>Samuel-Bassett</u> languished with the Court for 3 1/2 years after argument (during which time <u>Basile II</u> author Justice Greenspan left the bench), whereas <u>Basile III</u> was decided with lightening speed for the Court (4 months from May 8 argument to September 7 decision).<br /><br />Some will always say, most particularly Plaintiff's counsel in <u>Samuel-Bassett</u>, that the two decisions can be distinguished purely on the grounds of "waiver," since the <u>Samuel-Bassett</u> Court concluded that defense trial counsel had waived objection to the molded verdict after trial. But Justice Saylor’s strong dissent in <u>Samuel-Bassett</u> argued that there was no waiver and that <u>Samuel-Bassett</u> would not be cited as a waiver case in the future. 34 A.3d at 64. Moreover, "waiver" usually gives appellate judges a quick exit, and yet Chief Justice Castille wrote an 80-page opinion in <u>Samuel-Bassett</u> that labored hard to justify the result, which certainly didn't conserve judicial resources, and is not convincing.<br /><br />Others will say that the two decisions can't be reconciled. After all, Justice Saylor, who vehemently dissented in <u>Samuel-Bassett</u>, wrote for the unanimous court in <u>Basile III</u>. They will say there are now two alternative sets of policies in Pennsylvania: the "class actions are favored" rationale and acceptance of collectivized proof in <u>Samuel-Bassett</u> and the proscription against using procedural vehicles to change substantive law in <u>Basile III</u> – the second of which appears to line up better with the evolving federal standards articulated in <u><a href="http://druganddevicelaw.blogspot.com/2008/12/happy-new-year-on-class-action-front.html">Hydrogen Peroxide</a></u> and <u><a href="http://druganddevicelaw.blogspot.com/2011/06/whats-in-them-for-us.html">Dukes</a></u>. <br /><br />It may be that, Justice Saylor, who is next in line to be Chief, will usher in a new era. Or perhaps the Court is slowly awakening to the misuse of the class action mechanism in circumstances where the effect is to relieve plaintiffs of the burden of proving all elements of their claims. Philadelphia has earned a reputation nationally for favoring plaintiffs in class actions that might not fly in other jurisdictions. <u>See</u> The City of Unbrotherly Torts, Wall St. J., Dec. 3, 2011 (noting that Philadelphia state court is a “destination of choice” for plaintiff classes due to fewer settlements and higher verdicts); see also Am. Tort Reform Found., <a href="http://www.judicialhellholes.org/2011/12/15/latest-report-names-philadelphia-as-the-worst-of-the-judicial-hellholes-while-courts-in-california-west-virginia-florida-illinois-new-york-and-nevada-also-make-the-list/">Judicial Hellholes 2011-2012</a>, at 3–8 (2011) (listing Philadelphia as the number one “judicial hellhole”); <u>id.</u> at 2 (“Judicial Hellholes have been considered places where judges systematically apply laws and court procedures in an unfair and unbalanced manner.”) (emphasis omitted); <u>id.</u> at 3 (“Of greatest concern is the Complex Litigation Center (CLC) in Philadelphia, where judges have actively sought to attract personal injury lawyers from across the state and the country.”). In <u>Daniel v. Wyeth</u>, Nos. 63-64 EDA 2011, before the Supreme Court from the decision of a panel of the Superior Court overturning the trial court's JNOV on punitive damages, Justice Castille was reported to have remarked that sustaining the award would result in Pennsylvania being labeled a "judicial hellhole." <a href="http://www.law.com/jsp/pa/PubArticlePA.jsp?id=1202570947223&slreturn=20120818110305"> Legal Intelligencer, 9/12/12</a>. Perhaps the Court finally has gotten the message.<br /><br />Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-15613056702397391822012-09-19T05:00:00.000-07:002012-09-28T07:09:19.414-07:00FDA Regulatory Muscles: Ripped and OiledHere's a shocker: your average drug and device law lawyer seldom hoists more weight at any one time than 22 ounces of F.3d or three ounces of The Glenlivet. There is usually a long, nerdy history behind this state of indolence. For example, when we were in high school, we got a varsity letter for being a "Mathlete." Take that in for a moment. That's right, we were on the Math team. The true jocks snickered. But it was not entirely funny to them. They thought we pencil-necked geeks were devaluing their football and track letters. They were probably right. They were also - let's be honest about this - thoroughly repulsed by the more academic types. <br /><br /><br /><br /><br />Let's say two things about that (now that we have the big megaphone of the blog and now that those mesomorphs can no longer menace us at our locker): <br /><br /><br /><br />(1) Who has the last laugh now? When she was in high school, we used to tell the Drug and Device Law Daughter that she should befriend the wonks because some day they might flower into a Bill Gates or Marc Zuckerberg. Did she listen? She did not. And what do you suppose will happen to the hockey player and Goth who captured her young heart? The closest they will come to Microsoft or Facebook will be inputting customer data at a bad retail job or posting a bong as their profile picture. Now she is in college and dating an engineering student. Maybe there's hope. Maybe some day money will flow toward us, not away from us. Maybe we won't have to eat cat food in our dotage. Maybe we should veer away from this digression.<br /><br /><br /><br />(2) That repulsion went both ways. The wrestlers went around on match days incessantly spitting into a cup (kind of like a Texas plaintiff lawyer during a deposition). One guy in our class got into bodybuilding quite early. The movie <a href="http://www.imdb.com/title/tt0076578/">Pumping Iron</a> came out around this time. It was Arnold Schwarzenegger's break-through. Schwarzenegger was remarkable for more than his trolley-car sized biceps. He was also inordinately clever at getting into his competitors' heads. He would give them "<a href="http://www.youtube.com/watch?v=9nHHky2ufDU">the wrong advices</a>" (a preview of Schwarzenegger's charming battles with the English language) whilst crushing their egos. Our classmate emulated Schwarzenegger by carrying a can of protein powder around and occasionally disrobing in class to display his "guns" and "pythons". He is now a self-help maven on the Internet and claims he can uncover your past lives and make them "work for you". Perhaps he takes control over those past lives the same way he took control over things back in 1977: with threats and headlocks. <br /><br /><br /><br />One might have thought that after four years of a fine liberal arts education and then three years of that hazing ritual known as law school, that we would cease to have very much to do with the bodybuilding cult. One would be wrong. We spent a year on a case defending a nutraceutical company accused of making a bad product and phony claims. These folks operate on a wholly different level from companies that manufacture prescription drugs or class III devices. The word "aggressive" does not begin to do them justice. One of our key company witnesses was a champion body-builder who had some sort of Ph.D. We can not remember what the Ph.D was for, but this guy clearly knew a few things. He had taken a hearty dislike of the plaintiff's lawyer. The night before he was to be deposed, he downed a concoction of herbs and other goodies that would render his breath toxic and his gastrointestinal system explosive. It worked. The deposition was extremely unpleasant for the plaintiff lawyer. (As it was for everyone there except, perhaps, the witness.) The deposition did not last very long. <br /><br /><br /><br />As we said, nutraceuticals are different from pharmaceuticals. But they are both regulated by the FDA. And therein lies the tale of today's case, <em>Cytosport, Inc. v. Vital Pharmaceuticals, Inc</em>., 2012 U.S. Dist. LEXIS 126976 (E.D. Cal. Sept. 6, 2012). Cytosport makes Muscle Milk, a ready-to-drink protein shake in an octagonal bottle. Vital Pharmaceuticals makes Muscle Power, a ready-to-drink protein shake in an octagonal bottle. Cytosport sued Vital under the Lanham Act, claiming that the Muscle Power product infringed on its trademark and trade dress for Muscle Milk. Vital counterclaimed, arguing that the Muscle Milk trademark was invalid and deceptive because Muscle Milk contains not a drop of milk. Thus, this is a case concerning intellectual property. Linger on the richness of that. Much of the back-and-forth in the case involves competing surveys, with competing experts opining as to whether consumers were confused. You don't want our opinion on that, do you? <br /><br /><br /><br />Anyway, you ask, what does any of this have to do with drug and device law? First, we don't like your tone of impatience one little bit. This sort of 'roid rage does not become you. Frankly, you're scaring us. Second, relax. The Cytosport case is fun. No heavy lifting required. Vital's counterclaim cited a warning letter sent from the FDA to Cytosport taking issue with the use of the word "Milk." According to Vital, the FDA warning letter should prompt the court to find the "Muscle Milk" trademark to be deceptive and, hence, invalid under 15 U.S.C. section 1125(a). If all this sounds vaguely reminiscent of <em>Pom Wonderful, LLC v. Coca-Cola Co</em>., 679 F.3d 1170 (9th Cir. 2012), it should. The Cytosport court leaned heavily on the <em>Pom Wonderful</em> case, which it characterized as follows: "When the FDA extensively regulates a certain area and does not act to enforce its regulations, the Lanham Act may not be used by a private party to 'usurp, preempt, or undermine FDA authority.'" <em>Cytosport</em>, 2012 U.S. Dist., LEXIS 126976 at *17, quoting <em>Pom Wonderful</em>, 679 F.3d at 1176. Which way does <em>Pom Wonderful</em> cut in this Muscle contest? The <em>Cytosport</em> court says that <em>Pom</em> is not wonderful news for the Vital counterclaim, because "the FDA regulates the use of the term 'milk' on food labels. The FDA is aware of Cytosport's labeling and has not acted." <em>Id.</em> <br /><br /><br /><br />But wait a minute, what about the FDA warning latter? And here, we encounter the same point that we blogged about <a href="http://druganddevicelaw.blogspot.com/2012/09/the-fda-on-warning-letters-theyre-sure.html">yesterday</a>. A warning letter is not a final action. It does not mean anything until it culminates in some final action by the FDA. A warning letter is an invitation to dialogue and compliance. It is almost like that semi-surprising notion in first-year Contracts class about how an advertisement is not in itself an offer, but merely an invitation to the customer to make an offer. Here is how the <em>Cytosport</em> court dealt with the FDA warning letter: "The fact that the FDA sent a warning letter to Cytosport concerning its labeling does not require a different finding. FDA warning letters are informal and advisory, and do not amount to an FDA action." <em>Id</em>. Vital then offered a back-up position: "the Court should defer granting judgment until the FDA issues a final decision on Cytosport's use of 'Muscle Milk.'" <em>Id</em>. at *18. Nice try. The <em>Cytosport </em>refused to defer. The FDA's final decision might end up supporting Cytosport, supporting Vital, or falling somewhere in between. But "the <em>Pom</em> holding is clear that the claims are barred until the FDA issues its decision, not that they are stayed or deferred." <em>Id</em>. <br /><br /><br /><br />That is the part of the case that matters to us. Once again, private causes of action cannot muscle in on the FDA's turf. That is good news for all of us high-minded defense hacks. We put the "clean" in the clean-and-jerk. (Guess who puts in the other part.) Further, an FDA warning is tentative, incomplete, and - ta da - meaningless. More good news. Where it counts, the <em>Cytosport </em>opinion is a strong one for us. Use it. Hold it up. Flex with it. Feel the burn. <br /><br /><br /><br />There are other bits that do not matter as much to us or that we don't understand. For example, Vital also brought "two state law claims which reference the FDA regulations to show that Cytosport's use of the term 'Milk' is inconsistent with FDA regulations." <em>Id</em>. The court holds that these state law claims "are not barred by the ruling in Pom because the FDA specifically permits states to create labeling requirements that are identical to the FDA's and establish independent causes of action for those claims." <em>Id</em>. Sounds like more "parallel claim" Hell to our ears. Also, the court upholds Muscle Power's advertising assertion that it has "600% less sugar and 187% less fat than Muscle Milk."<em> Id</em>. at *37. We agree with Cytosport that there is something mathematically nonsensical about saying that something has "600%" less of something.<br /><br /><br /><br />Once a mathlete, always a mathlete. <br /><br />Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-37920191761492321642012-09-18T05:00:00.000-07:002012-09-28T07:09:19.473-07:00The FDA On Warning Letters - They're Sure Not FinalRemember that case about ear candles? Given the product, we had some fun with it in our <a href="http://druganddevicelaw.blogspot.com/2012/01/ear-candle-suit-snuffed.html">earlier</a> <a href="http://druganddevicelaw.blogspot.com/2011/03/earful-on-daubert.html">posts</a>. Well, it turns out that the ear candling folks are nothing if not persistent. They appealed the second opinion, Holistic Candlers & Consumers Ass’n v. FDA, 664 F.3d 940 (D.C. Cir. 2012), to the Supreme Court. As our post indicated, this opinion turned (in part, but a large part) on the “finality” of an FDA warning letter.<br /><br /><br />The Supreme Court appeal has given the FDA the opportunity to state its formal opinion about how it views the “finality” of warning letters. See Brief for the Respondents [FDA] in Opposition, Holistic Candlers & Consumers Ass’n v. FDA, No. 11-1454, 2012 WL 3991471 (filed Sept. 11, 2012). To put it succinctly, they aren’t final at all.<br /><br />Since it’s Friday and we’re lazy, we’ll simply quote for you some of the FDA’s reasoning on why its warning letters aren’t legal determinations of anything. Here’s what the FDA has told the United States Supreme Court:<br /><br />If FDA believes that a person is violating the FDCA, the agency may issue a warning letter giving the person an opportunity to take voluntary corrective measures before the agency pursues enforcement action. Warning letters are “the agency’s principal means of achieving prompt voluntary compliance with the [FDCA].” FDA, Regulatory Procedures Manual, 4-1-1 (July 2012), http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074330.pdf A warning letter is “informal and advisory”; it “communicates the agency’s position on a matter” but “does not commit FDA to taking enforcement action.” Ibid.<br /><br />FDA Holistic Candlers br. at *5.<br /><br />[T]he warning letters here did not mark the consummation of FDA’s decisionmaking process. As FDA has explained, warning letters give “firms an opportunity to take voluntary and prompt corrective action before [FDA] initiates an enforcement action.” Regulatory Procedures Manual 4-1-1. An enforcement action - typically a seizure or an injunction - is not inevitable, and indeed, most warning letters do not result in enforcement action. See FDA, Enforcement Statistics Summary Fiscal Year 2011 (reporting 1720 Warning Letters, but only 15 seizures and 16 injunctions), http://www.fda.gov/downloads/ICECI/EnforcementActions/UCM285781.pdf. Violations identified in warning letters “may lead to enforcement action if not promptly and adequately corrected.” Regulatory Procedures Manual 4-1-1 (emphasis added). Consistent with the Regulatory Procedures Manual, the warning letters at issue here stated that “FDA will evaluate the information you submit and decide whether your product may be legally marketed.” Pet. App. 43 (quoting FDA warning letter) (emphasis and internal quotation marks omitted). Relatedly, the warning letters were not based on a formal and complete administrative record. At this stage, FDA’s statement that petitioners violated the FDCA was not “final and binding” on the agency or petitioners but rather remained “tentative [and] interlocutory [in] nature.”<br /><br />Id. at *9-10 (emphasis original).<br /><br />Nor did the warning letters finally determine the “rights or obligations” of petitioners with regard to the distribution of ear candles, or trigger “direct and appreciable legal consequences.” Bennett, 520 U.S. at 178. Rather, the letters “request[ed]” that petitioners “take prompt action to correct [the identified] deviations” from the FDCA, and cautioned that “[f]ailure to promptly correct these deviations may result in regulatory action.” Pet. App. 39. The letters served only to communicate FDA's position with regard to ear candles, and to warn recipients about the possibility of future enforcement action. See Regulatory Procedures Manual 4-1-1. The letters nonetheless remained “informal and advisory” and “[did] not commit FDA to taking enforcement action.” Ibid.<br /><br />Id. at *10-11.<br /><br />FDA warning letters trigger no legal consequences and are subject to further agency “evaluat[ion]” based on the recipient’s response. See Pet. App. 47. Such letters do not trigger any enlarged exposure to penalties for noncompliance with the FDCA, nor does their issuance preclude further agency consideration or review. Rather, the letters state FDA’s position on the facts available to it, encourage voluntary compliance with the FDCA, and alert the recipient of possible enforcement action by the FDA. If and when an enforcement action is brought, the agency’s claim is not that the recipient has “violated” the warning letter, but rather that it has violated the underlying requirements of the FDCA.<br /><br />Id. at *14.<br /><br />So there you have it, from the proverbial horse’s mouth. And what should be the consequences of the non-final nature of FDA warning letters. Here are a few − there may well be more, the more we think about this: (1) without enforcement they’re not admissible evidence, being considerably less than a bare criminal indictment; (2) any attempt to give a warning letter binding collateral estoppel effect would be a violation of Due Process, since such letters are not appealable; (3) warning letters are nothing like the enforcement actions mentioned in the concurrence in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), (4) as warning letters are not legally enforceable, they shouldn’t be the basis of an negligence per se action; and (5) being tentative and subject to change at any time, a warning letter should not be the type of evidence reasonably relied upon by experts in the field (assuming there is a “field” as to which expert testimony is permissible in the first instance).<br /><br />Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-80969158345524097812012-09-17T15:06:00.000-07:002012-09-28T07:09:19.692-07:00One Smelly Product, Two Defendants, and Two Different Results<div class="MsoNormal" style="margin: 0in 0in 12pt;">Out of Illinois comes a medical device case with odd and smelly facts.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Smith v. Phoenix Seating Sys. LLC</i>, 2012 U.S. Dist. LEXIS 127865 (S.D. Ill. Sep. 10, 2012).<span style="mso-spacerun: yes;"> </span>The medical device was a wheelchair armrest called the 312G.<span style="mso-spacerun: yes;"> </span>The plaintiffs bought it (and, earlier, the wheelchair) from the defendant, Apria Healthcare Group.<span style="mso-spacerun: yes;"> </span>Plaintiffs installed the armrest themselves.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *2-3.<span style="mso-spacerun: yes;"> </span>But not right away.<span style="mso-spacerun: yes;"> </span>That’s the odd and smelly part.<span style="mso-spacerun: yes;"> </span>Plaintiffs claimed that when they first received the armrest in the mail and opened its box, it smelled.<span style="mso-spacerun: yes;"> </span>How bad?<span style="mso-spacerun: yes;"> </span>So bad that they put it out of the house.<span style="mso-spacerun: yes;"> </span>First they put it in the garage for a week.<span style="mso-spacerun: yes;"> </span>That didn’t work. <span style="mso-spacerun: yes;"> </span>It still smelled. <span style="mso-spacerun: yes;"> </span>So they moved it outside – to the patio – for another 3-4 days to air it out.<span style="mso-spacerun: yes;"> </span>While the opinion doesn’t make it seem as if this worked completely, it apparently worked enough for plaintiffs to install the armrest. <i style="mso-bidi-font-style: normal;">Id.</i> at *3-4.<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;">That didn’t go so well.<span style="mso-spacerun: yes;"> </span>Plaintiffs claimed that each of them then suffered injuries from a toxic combination created by a gel contained in the armrest and the gel’s surface material.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *6, 17-18.<span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;">They sued two defendants.<span style="mso-spacerun: yes;"> </span>One was Apria, whose role appeared to be that of the direct seller.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *29, 30-31. <span style="mso-spacerun: yes;"> </span>Apria faced negligent failure to warn claims.<span style="mso-spacerun: yes;"> </span>The other defendant was Phoenix Seating Systems, who designed the armrest (the extent of their involvement in the design seemed to be in dispute), received the armrest from the manufacturer, repackaged it, applied some identifying labeling, and then sent it to Apria.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *13-14.<span style="mso-spacerun: yes;"> </span>Phoenix faced various strict liability claims.<span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;">Alright, so the facts are a little odd.<span style="mso-spacerun: yes;"> </span>But what about the summary judgment decision?<span style="mso-spacerun: yes;"> </span>Not odd at all.<span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;">Phoenix wanted out because it wasn’t a manufacturer, because there couldn’t be a failure to warn plaintiffs who had such idiosyncratic reactions, and because medical device preemption applied.<span style="mso-spacerun: yes;"> </span>The court rejected all these arguments.<span style="mso-spacerun: yes;"> </span>Illinois product liability actions, according to the court, apply to “all persons in the distributive chain . . . including suppliers, distributors, wholesalers[,] and retailers.” <i style="mso-bidi-font-style: normal;">Id.</i> at *10 (quoting <i>Hammond v. North Am. Asbestos Corp.</i><span style="mso-bidi-font-style: italic;">, 97 Ill. 2d 195 (Ill. 1983<i>)</i></span>.<span style="mso-spacerun: yes;"> </span>So it didn’t matter that Phoenix wasn’t a manufacturer.<span style="mso-spacerun: yes;"> </span>The court also found a fact dispute as to whether the plaintiffs’ reactions were idiosyncratic. <span style="mso-spacerun: yes;"> </span>So that argument didn’t work.<span style="mso-spacerun: yes;"> </span>As to preemption – and take heed here -- the 312G armrest was cleared under §510(k).<span style="mso-spacerun: yes;"> </span>But current law is that preemption only applies to devices approved under the PMA process, not those cleared under §510(k).<span style="mso-spacerun: yes;"> </span>While we’ve argued <a href="http://druganddevicelaw.blogspot.com/2012/08/summer-reading_16.html" target="_blank">here</a> that it’s time for the Supreme Court to reconsider this, it hasn’t done so yet.<span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;">So no preemption, and Phoenix stays in the case.<span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;">The court saw Apria differently.<span style="mso-spacerun: yes;"> </span>There was insufficient evidence in the record to establish that Apria was involved in the manufacture or design of the armrest, or that Apria had reason to know of any problem that needed to be warned about:</div><div class="MsoNormal" style="margin: 0in 0in 12pt 0.5in;">Apria alleges it did not manufacture the 312G, take any part in its design, have knowledge concerning the specific materials contained in the 312G, or have knowledge of complaints similar to plaintiffs’ instant grievances. . . . </div><div class="MsoNormal" style="margin: 0in 0in 12pt 0.5in;">As plaintiffs’ response does not address Apria’s argument concerning its lack of knowledge, plaintiffs do not dispute such allegations. Moreover, plaintiffs’ complaint does not allege Apria had any role in the 312G’s design or manufacture, or knowledge of the 312G’s alleged defective design or manufacture. Similarly, plaintiffs have not instantly offered evidence demonstrating Apria was involved in the 312G’s manufacture or design, or that other complaints or reactions to the 312G have ever been reported.</div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><i style="mso-bidi-font-style: normal;">Id.</i> at *29, *30-31 (record citations omitted).<span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;">Plaintiffs had only negligent failure to warn claims against Apria, and those claims couldn’t survive summary judgment – not on this record.<span style="mso-spacerun: yes;"> </span>Now, just like Phoenix, Apria had a hiccup.<span style="mso-spacerun: yes;"> </span>It claimed to be exempt from liability under a “seller’s exception” to product liability claims, but the statute that contained that exception had been declared unconstitutional years earlier by the Illinois Supreme Court.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *24-45.<span style="mso-spacerun: yes;"> </span>So that argument didn’t work.<span style="mso-spacerun: yes;"> </span>Fortunately for Apria, its other arguments did.<span style="mso-spacerun: yes;"> </span>No duty, no claim – regardless of how bad the armrest smelled.<span style="mso-spacerun: yes;"> </span>So Atria gets out of the case.<span style="mso-spacerun: yes;"> </span></div><span style="font-family: 'Times New Roman','serif'; font-size: 12pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US;">Sometimes odd facts make for ordinary law.</span>Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-21316191950498512772012-09-17T09:34:00.000-07:002012-09-28T07:09:19.427-07:00Conviction on Defrauding Fen-phen SettlementI'm posting this at the behest of our DoJ readers. Congratulations are in order.<br /><br />*********************<br /><br />Please congratulate Paul Shapiro, who, after a one-week trial, successfully prosecuted Dr. Abdur Razzak Tai, convicting him on all 13 counts of mail and wire fraud today. Tai is a physician who specializes in cardiology and who practices medicine in Florida. He was among a number of doctors who agreed to review echocardiogram test results to make determinations as to whether individuals who ingested the diet drug Fen-Phen suffered mitral valve damage to their heart, thereby qualifying them for settlements that averaged approximately $400,000 per person from the trust that had been established here in Philadelphia to pay claims and settle lawsuits from across the United States. Dr. Tai had sought to profit from the $3.5 billion class action settlement of the Fen-Phen litigation by submitting false medical reports attesting that claimants had suffered heart damage when they were, in fact, fine. Tai took the stand and insisted that his medical reports had been forged or altered by the mass-tort lawyer who had hired him and who had paid him on a contingency fee basis. Under cross-examination, the doctor was forced to admit that he had had previously lied under oath about his compensation scheme with the lawyer who had hired him. The jury did not buy his act, and returned its verdicts (and managed to eat lunch) in less than two hours.<br /><br />*********************<br /><br />We would only add that the defendant's allegations about being as an expert on contingent fee are themselves serious. We consider the source, but one those allegations are not necessarily inconsistent with theconviction. We hope that they are being investigated by the approproate authorities.<br /><br /><br />Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-67437415260885056482012-09-14T13:24:00.000-07:002012-09-28T07:09:19.673-07:00Let's Put A Stop To This Right AwayIn <u>Whitener v. PLIVA, Inc.</u>, 2012 WL 3948797, at *4 (E.D. La. Sept. 10, 2012), the court recently allowed “a state-law tort claim based on alleged promotion of [a generic drug] for off-label purposes in violation of federal law” to escape preemption on a motion to dismiss. This claim was presented as a “parallel claim”:<br /><br /><br /><blockquote class="tr_bq">Plaintiffs argue that their complaint involves <strong><u>parallel</u></strong> state law claims − in other words, they claim that Defendants’ violations of federal law also violated Defendants’ state law duties to Plaintiffs.</blockquote><br /><u>Id.</u> at *5 (emphasis original). The only case plaintiff cited in favor of these allegations wasn’t even a generic drug case, but rather a medical device case, <u>Lofton v. McNeil Consumer & Specialty Pharmaceuticals</u>, 672 F.3d 372, 378–79 (5th Cir. 2012) (a very good case for defendants, by the way). 2012 WL 3948797, at *5.<br /><br />The court let the allegation skate, finding it different from <u>Mensing</u> because plaintiffs “allege that Defendants simultaneously violated <strong><u>both</u></strong> state <strong><u>and</u></strong> federal law by actively engaging in off-label promotion despite known risks not listed on the label.” <u>Id.</u> (emphasis original). It wasn’t a particularly strong endorsement, however, as the court stated:<br /><br /><blockquote class="tr_bq">The [<u>Mensing</u>] Court simply did not reach the issue of whether federal regulations preempt state tort claims that are not based on failure to change the label in violation of federal regulations. Furthermore, the parties still have not cited a case on point for this issue. Accordingly, the Court remains “hesitant to hold as a matter of law that there is not a kernel of a viable claim somewhere in Plaintiffs’ allegations.”</blockquote><br /><u>Whitener</u>, 2012 WL 3948797 at *6.<br /><br />Next thing we know, the very next day in fact, we see a routine order in different litigation, concerning amendment of complaints, suggesting that − once again − plaintiffs suing generic drug manufacturers are “asserting off-label promotion“ as a supposedly unpreempted claim. <u>In re Prempro Products Liability Litigation</u>, 2012 WL 3985752, at *1 (E.D. Ark. Sept. 11, 2012).<br /><br />We’d like to see a stop put to such allegations right away, before they gain any real traction. The simple fact is that the idea of a “parallel claim” is a principle of express − that is, medical device preemption − not implied generic drug preemption under <u>PLIVA, Inc. v. Mensing</u>, 131 S. Ct. 2567 (2011). The existence of a preemption exception (assuming for purposes of this post that it exists) for “parallel” claims in medical device cases is based entirely on the specific language of the express preemption clause (21 U.S.C. §360k) concerning medical devices, which preempts state law that is “different from or in addition to” an FDA “requirement“ concerning medical devices. This was made perfectly clear in <u>Lohr</u> itself:<br /><br /><blockquote class="tr_bq">Nothing in <strong><u>§360k</u></strong> denies Florida the right to provide a traditional damages remedy for violations of common-law duties when those duties <strong><u>parallel</u></strong> federal requirements. Even if it may be necessary as a matter of Florida law to prove that those violations were the result of negligent conduct, or that they created an unreasonable hazard for users of the product, such additional elements of the state-law cause of action would make the state requirements narrower, not broader, than the federal requirement. <strong><u>While such a narrower requirement might be “different from” the federal rules in a literal sense, such a difference would surely provide a strange reason for finding pre-emption of a state rule insofar as it duplicates the federal rule. The presence of a damages remedy does not amount to the additional or different “requirement” that is necessary under the statute; rather, it merely provides another reason for manufacturers to comply with identical existing “requirements” under federal law.</u></strong></blockquote><br /><u>Medtronic, Inc. v. Lohr</u>, 518 U.S. 470, 495 (1996) (emphasis added). The dictum in <u>Riegel v. Medtronic, Inc.</u>, 552 U.S. 312 (2008), says the same thing, more succinctly:<br /><br /><blockquote class="tr_bq">State requirements are pre-empted under the MDA only to the extent that they are “different from, or in addition to” the requirements imposed by federal law. §360k(a)(1). Thus, §360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case “parallel,” rather than add to, federal requirements.</blockquote><br /><u>Id.</u> at 330. Essentially, the only reason why a “parallel” claim exception can exist in medical device preemption is the language of the preemption clause − which does not extend to any kind of prescription drug, generic or branded.<br /><br />Preemption in the generic drug context, by contrast, is implied − arising from the impossibility of maintaining “the same” warning if state tort plaintiffs could demand changes in generic labeling independently from the FDA-approved language. These are separate concepts. “[T]he absence of express pre-emption is not a reason to find no <strong><u>conflict</u></strong> pre-emption.” <u>Mensing</u>, 131 S. Ct. at 2577 n.5 (emphasis original); <u>see</u> <u>Buckman Co. v. Plaintiffs Legal Committee</u>, 531 U.S. 341, 352 (2001) (“neither an express pre-emption provision nor a saving clause bars the ordinary working of conflict pre-emption principles”). Under <u>Mensing</u> anything that would “change” the labeling violates this federal “sameness” requirement, and is preempted. <br /><br /><blockquote class="tr_bq">If the Manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law. Taking [plaintiffs’] allegations as true, state law imposed on the Manufacturers a duty to attach a safer label to their generic [drug]. Federal law, however, demanded that generic drug labels be the same at all times as the corresponding brand-name drug labels. Thus, it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.</blockquote><br />131 S. Ct. at 2578.<br /><br />What about the allegations of off-label promotion in <u>Whitener</u>? Without some kind of informationally-based allegation − that is to say that the FDA-approved “same” labeling is inadequate − there is simply no causation. “Promotion” necessarily involves the transmission of information, which means that it concerns what the FDA considers “labeling,” and all generic labeling is subject to the “sameness” requirement that underlies <u>Mensing</u>.<br /><br /><blockquote class="tr_bq">To the extent any investigation, testing, or marketing surveillance would have revealed the dangers of the drug, that knowledge would have been helpful only to the extent it was communicated through labeling − which would not have made any difference as long as the Generic Defendants were following the FDA's labeling regulations. The Generic Defendants could not have unilaterally improved the labeling of the drug any further even if they had wanted to.</blockquote><br /><u>Truddle v. Wyeth, LLC</u>, 2012 WL 3338715, at *4 (N.D. Miss. Aug. 14, 2012). Thus, in order to avoid a “pure” FDCA-based claim (off-label promotion being considered within the FDA’s definition of “labeling”), of the type preempted under <u>Buckman</u>, there must be something inadequate about the label that has to do with the allegedly promoted off-label use. There’s no other way for a manufacturer violate <strong><u>state</u></strong> common law. Off-label promotion is not a state common-law concept. State law theories predicate liability, not on “intended uses,” but only on the inaccuracy or inadequacy of the information itself.<br /><br />You don’t have to take our word for it. Although apparently not before the court in <u>Whitener</u>, a number of cases have recognized that express preemption concepts, such as “parallel” claims, have no place in implied preemption analysis involving generic drugs.<br /><br /><blockquote class="tr_bq">Plaintiff’s focus on decisions involving express preemption is misplaced. Mensing involved conflict preemption, which does not depend on the limitations of the language in a preemption provision. <strong><u>In other words, no parallel state-law claims or alternative theories of liability survive the Supreme Court's ruling in Mensing</u></strong>.</blockquote><br /><u>Guarino v. Wyeth LLC</u>, 823 F. Supp.2d 1289, 1292 (M.D. Fla. 2011) (emphasis added), <u>reconsideration denied</u>, 2012 WL 28810 (M.D. Fla. Jan. 5, 2012). It's hard to get more direct than that.<br /><br />Express preemption concepts such as “parallel” claims cannot be imported into implied preemption cases solely governed by <u>Mensing</u>. “[E]xpress preemption is not applicable here because the Supreme Court [in <u>Mensing</u>] clearly identified the conflict between the LPLA and the FDA labeling rules as a case of conflict or impossibility preemption.” <u>Morris v. Wyeth, Inc.</u>, 2011 WL 4973839, at *2 (W.D. La. Oct. 19, 2011), reconsideration denied, 2012 WL 601455 (W.D. La. Feb. 23, 2012). To argue otherwise is “misguided”:<br /><br /><blockquote class="tr_bq">The Supreme Court very clearly based its decision in <u>Mensing</u> on conflict or impossibility pre-emption, which determines whether the private party could independently do under federal law what state law requires of it. Thus, [plaintiff’s] attempt to analyze the claim under express pre-emption is misguided.</blockquote><br /><u>Del Valle v. PLIVA, Inc.</u>, 2011 WL 7168620, at *6 (Mag. S.D. Tex. Dec. 21, 2011), <u>adopted</u>, 2012 WL 2899406 (S.D. Tex. June 22, 2012).<br /><br />Likewise, in <u>Phelps v. Wyeth, Inc.</u>, ___ F. Supp.2d ___, 2012 WL 1499343 (D. Or. April 24, 2012), the plaintiff sought to assert (among other things) “misbranding” claims alleging FDCA violations to get around <u>Mensing</u> preemption. The court correctly recognized that such claims did not alter the federal “sameness” requirement at the heart of <u>Mensing</u>:<br /><br /><blockquote class="tr_bq">When enacting the FDCA, Congress was explicit that only the federal government may bring an action to enforce its provisions. Consequently, failure to comply with the FDCA cannot form the basis for a state-law claim. Plaintiffs cannot sue to enforce the federal statute. . . . Plaintiffs’ reliance on <u>Hughes v. Boston Scientific Corp.</u>, 631 F.3d 762 (5th Cir. 2011) [a medical device “parallel claim” case] is misplaced. <u>Hughes</u> involved a medical device and whether the plaintiff’s claims were expressly preempted under §360k of the Medical Device Amendments. The court’s holding in <u>Hughes</u> does not change the preemption analysis outlined in <u>Mensing</u>. Here, plaintiffs’ claims are preempted by impossibility; they are not expressly preempted.</blockquote><br /><u>Id.</u> at *9.<br /><br />Thus, there isn’t a “kernel of a viable claim” in a generic drug case alleging off-label promotion. “Parallel” claim analysis is about as useful in a <u>Mensing</u> implied preemption case as a bicycle is to a fish. The generic plaintiffs are still asserting that the label is inadequate − which they simply can’t do under <u>Mensing</u>. They’re only offering a different reason (a claimed FDCA violation) for the inadequacy. Whether or not that creates a “requirement” that’s “different from or in addition to” under <u>Lohr</u> express preemption analysis, such allegations do not change the <u>Mensing</u> requirement of labeling “sameness” one iota . <br /><br />Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-47028029771204288142012-09-13T12:57:00.000-07:002012-09-28T07:09:19.497-07:00Cajun Home Cooking?This is our initial blog post from <a href="http://www.reedsmith.com/eric_alexander/">Eric Alexander</a>, a partner here at <a href="http://www.reedsmith.com/">Reed Smith</a>. We hope we can corral him into more regular contributions, but we have to keep from him just how much of a hassle regular blogging can be until we have him lassoed in. So don't you go telling him.<br /><br />***********<br /><br />As a first time blogger, a brief introduction is in order. I have neither a nickname that borders on copyright infringement - BeckstLaw or something like that - nor did I devote enough attention to television dramas and literature assigned to college sophomores to turn every legal analysis into biting social commentary. I also do not have the habit of referring to myself with plural pronouns. However, I have been representing drug companies in product liability cases for more than fifteen years and device companies for about half as long. Over the years, I have formed some strong views about the laws - as written and as applied- governing such cases. So, when we were asked - see, attempting the plural thing - to author a guest blog entry, we used our fingers on our keyboard to type this up for our readers.<br /><br /><br />We find <u>Caldwell v. Janssen Pharmaceutical, Inc.</u>, 2012 La. App. Lexis 1099 (La. App. Aug. 31, 2012), strangely lacking in detail and analysis, particularly for an appeal of a $330 million judgment. The case is one of many actions by or on behalf of various states against the makers of Risperdal, a prescription medication indicated primarily for the treatment of schizophrenia. Indeed, a <a href="http://druganddevicelaw.blogspot.com/2012/07/news-dismissal-of-pennsylvania.html">similar case in Pennsylvania</a> resulted in a non-suit at trial (no causation as a matter of law) that was affirmed on appeal. But in the <u>Caldwell</u> opinion, you will not find what that drug is used for in the opinion. You actually will not find the word “Risperdal” in the text of the opinion - it is the last word in an earlier footnote explaining what DDMAC stands for - until the 11th page of the slip opinion (*16 on Lexis). More about that later, but the case is about allegedly misleading statements in the marketing of the drug and false claims to the Louisiana medical assistance program funds. After the court had already determined that there was sufficient evidence presented at trial to support the verdict, the reader learns for the first time that the alleged misleading statements concerned drug “safety” (as opposed to its efficacy, price, color, smell, etc.); this comes up when the court is affirming that exclusion of expert testimony that the defendant “did not misrepresent Risperdal’s safety and that Louisiana doctors were not misled by the ‘dear doctor’ letters.” What was the safety issue? The opinion never says. What did the defendant actually say about that unknown issue and why was that representation misleading in light of the information known at the time about the issue? The opinion never says. It does quote the trial court’s oblique reference to “subsequent scientific developments” in affirming exclusion of certain “scientific evidence.” It does not quote any portion of any communication by the defendant about the drug at all.<br /><br />How can there be an opinion affirming a $330 million award - $257 million penalty, $70 million attorney fees, and $3 million costs, exclusive of interest - about how a manufacturer marketed a prescription drug without such basic information presented right up front, or anywhere? When the Louisiana AG, who is the plaintiff here, issued a press release about the opinion, he had no trouble saying the suit was for “serious misrepresentations regarding Risperdal’s link to diabetes in order to obtain funds from Louisiana’s Medicaid program.” Diabetes is not mentioned in the opinion, though. When you look at the <a href="http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/risperdal_uspi[1].pdf">current drug label</a>, in PLR format, you see that information on the risk of diabetes is about half-way through the Warnings and Precautions section. When you run a search on PubMed for “risperidone diabetes,” you get 231 hits for articles over the last 14 years. So, there surely there was plenty of possible evidence about what was known about the risk of diabetes with Risperdal at the relevant time from which to judge whether what the defendant said about it was misleading. The opinion says “a plethora of evidence” was presented to the jury over the course of what it described as a five day trial. Setting aside how you fit a plethora of evidence into a five trial days (especially if openings and closings were included in those days) and whether the court meant to say there was too much evidence presented - which is what plethora really means - the absence of any discussion of what seems like the most relevant evidence makes us suspicious. While the court says “[t]he resolutions of the myriad issues in this case are primarily fact driven,” the opinion is devoid of fact, notwithstanding the repeated incantation of the phrase “[a]fter carefully reviewing the record” before overruling each assignment of error. The determination that the plaintiff’s closing argument did not violate due process by “appeal[ing] to prejudices against out of state corporations” without quoting any portion of the closing itself is particularly mind-numbing.<br /><br />That brings us to the core issue that the appellate court was supposed to be deciding: does the Louisiana Medical Assistance Programs Integrity Law (MAPIL) really provide that the state, represented by outside plaintiff lawyers from Texas, can get per-violation penalties for 35,542 violations for misrepresentations about the safety of a drug without ever having to prove <strong><u>any</u></strong> actual damages were sustained by the state’s medical assistance programs? The trial court, of course, had found that it did. Keep in mind that MAPIL is not a general consumer fraud or unfair trade practices statute, like the one that these same plaintiff lawyers used when worked with the South Carolina AG in another suit over Risperdal marketing. Its name does not hide the ball - it is about making sure people do not defraud the state’s medical assistance programs. In analyzing whether MAPIL could be transformed to a general consumer fraud statute and the requirement that “No action shall be brought under this Section unless the amount of alleged actual damages is one thousand dollars or more” could be ignored, the court endorsed the proposition that the “fundamental question in all cases of statutory interpretation is legislative intent and the ascertainment of the reason or reasons that prompted the Legislature to enact the law.” You would not know it from the opinion, but MAPIL, 437.2, says it was enacted “to combat and prevent fraud and abuse committed by some <strong><u>health care providers participating</u></strong> in the Medical Assistance Programs and by other persons and to negate the adverse effects such activities have on fiscal and programmatic integrity.” The rest of MAPIL reinforces the conclusion that any proceeding under MAPIL has to involve actual damages to MAP. For instance, 437.5 says the AG has to make sure that any settlement covers the “estimated loss sustained by the Medical Assistance Programs” and 438.6 says “actual damages” are calculated based on payments made by the Medical Assistance Programs. We could go on − the Pennsylvania appellate court certainly did, holding that a Risperdal’s manufacturer was not a “provider” under a similar state statute. <u>Commonwealth v. Ortho-McNeil-Janssen Pharms.</u>, ___ A.3d ___, 2012 WL 3030512, at *6 (Pa. Commw. July 26, 2012).<br /><br />The appellate court in <u>Caldwell</u> did not actually decide the correct way to interpret MAPIL, applying only an abuse of discretion standard to the trial court’s interpretation. The trial court, in turn, based its interpretation on a bit of legerdemain by a West Virginia trial court in its own case with an AG seeking damages over marketing of another prescription drug, holding that each time “false or misleading promotional materials than concern health [is used] such promotional materials in and of [themselves] cause harm and injury.” Not only is that complete nonsense, it also came from a case brought under a Consumer Protection Act. Louisiana has its own Unfair Trade Practices and Consumer Protection Law, which is very different from the MAPIL under which Louisiana went after Risperdal. If the appellate court was going to endorse the trial court’s look to West Virginia’s consumer fraud law, it might have bothered to check on whether that law was still good. If it had checked <a href="http://druganddevicelaw.blogspot.com/2010/12/christmas-comes-early-great-result-in.html">this esteemed blog</a> (like any court ever does that), it would have seen that <u>White v. Wyeth</u>, 705 S.E.2d 828 (W. Va. 2010), had determined that the West Virginia consumer protection act “does not extend to prescription drug purchases” and does require reliance.<br /><br />D’oh.<br /><br />Maybe a <em>de novo</em> review of the law, like you usually get on an appeal involving statutory interpretation, would have caught this minor detail. Like the mysterious absence of pertinent facts in the opinion, the facile acceptance of an illogical statement in an irrelevant case as a basis for an unwarranted extension of the law at issue makes us uncomfortable. <br /><br />We would like to think that the trial judge and appellate judges, Louisiana state employees, were not influenced in their decisions by the prospect of $260 million potentially coming to the state coffers at a time when Louisiana’s total debt was steadily climbing to more than $65 billion. We have been around several courts in economically depressed parts of the country - a client GC once called them “economic redistribution centers” - in cases involving one, many, or an entire state’s worth of individuals who claimed physical and/or economic injuries from their use of a prescription drug made by a big out-of-state company. The dynamic in those cases was well explained (and <a href="http://druganddevicelaw.blogspot.com/2007/07/in-defense-of-learned-intermediary-rule.html">noted here</a>) in the concurrence in <u>State ex rel Johnson & Johnson v. Karl</u>, 647 S.E.2d 899 (W. Va. 2007), the infamous decision in which − you guessed it − West Virginia became the only state to reject the learned intermediary doctrine:<br /><br /><blockquote class="tr_bq">Suppose Patient John Doe visits his small-town West Virginia doctor. Further suppose he is prescribed a drug by his doctor that causes him serious injury. Suppose that the drug is one that is heavily advertised. Patient Doe then sues his West Virginia doctor and the drug manufacturer for the injury caused by the drug. If this Court were to adopt the learned intermediary doctrine, the West Virginia doctor would remain in the lawsuit, but the drug manufacturer would not remain in the suit and would not be liable for damages if the drug manufacturer could show that it warned the doctor of the risks of injury associated with the drug. Thus, a small-town West Virginia doctor would become solely responsible for the injury to Patient Doe while an out-of-state multi-million dollar drug manufacturer is off the hook . . . . This result simply would be unfair.</blockquote>647 S.E.2d at 917 (Maynard, J. concurring). In other words, it was fair to take their money because they have plenty and aren’t from around here.<br /><br />Previously, at least, in such jurisdictions, the plaintiffs were claiming that the defendant’s drug had excessive risks, that those risks were not warned of sufficiently, and that they suffered injuries as a result. In those cases, what the risks and warnings were and whether the risks had manifested themselves in legally compensable injuries was openly argued in motions and trials. The judges presiding over those cases may have gotten campaign contributions from the plaintiff lawyers, hunted with them, or generally recognized that a recovery to people residing in or near the county where the case was pending might be a boon to the local economy. However, the judges in those cases did not draw their official paycheck from the same entity that employed plaintiffs’ counsel and the juries always had to find some causal relationship between the actions of the manufacturer - like failing to use an adequate warning about some risk - and tangible harm suffered by plaintiffs before damages could be tallied and awarded. <u>Caldwell</u> required no proof of harm or causation. It allowed a determination of whether a communication about a prescription drug was “misleading” without even admitting evidence of whether the recipients of such communications, the doctors who might prescribe the drug to patients who might have the cost of their drugs paid for by the state Medical Assistance Programs, were ever “mislead.” It allowed recovery of fines for each of 35,542 violations - brushing aside that MAPIL does not require such multiplication - without any requirement that the plaintiff show that a single prescription was paid for by the state Medical Assistance Programs because a doctor saw a misleading statement on Risperdal. Now, we know that this is not a negligence claim, but we learned in law school that Judge (later Justice) Cardozo took care of negligence in the air in <u>Palsgraf</u> in 1928. We hope he would have drawn the same lines had any damages awarded to the Palsgraf plaintiff been payable to retirement fund for the New York Court of Appeals. We also hope that the next court to take a look at Caldwell will pay better attention to the law and evidence used to punish the defendant here - although none of the $330 million tally was for “punitive damages” if you believe the labels.Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-40200738631997657012012-09-12T05:00:00.000-07:002012-09-28T07:09:19.477-07:00Texas Two-step Thwarts Generic and Conte Claims/Conte Comes up Snake-eyes in NevadaDon't expect us to mess with Texas. Some of our best friends live in Texas. You've probably heard the saying, "A good friend will help you move, but a really good friend will help you move a body." If we ever got in a terrible jam, the first friend we'd call lives in Ft. Worth. He's got a way of seeing things straight and lending a hand without hesitation. At the same time, some of our best frenemies also live in Texas. There are Texas plaintiff lawyers with whom we've held marathon mutual clobbering sessions, but who have also earned our respect, trust, and, Heaven help us, affection. There is something undeniably admirable about Texans. Sure, there's the usual stereotype about bigness and brashness, but that isn't what we mean. Everybody we've ever known from Texas tends to announce that things are Right or Wrong, without nuance. There is a pose of certainty that can be either comforting or infuriating. The Texas landscape is devoid of shades of gray. <br /><br /><br />A typical maneuver by a Texas plaintiff lawyer deposing a company witness is to confront the witness with an icky document and then demand an admission that company conduct is "Wrong" -- not inaccurate or illegal, but "Wrong." (We swear we can actually hear the capital W in the question.) For example, the document might seem to evince off-label promotion. "That's Wrong, isn't it?" Well, it might not be scientifically wrong. It might not be morally wrong if it is communicating valuable information that will help heal or save lives. It might not be legally wrong, because of certain exceptions that the FDA has recognized. Heck, it might not be legally wrong because of a little thing called the First Amendment. But once a witness starts hemming and hawing about details or exceptions, it starts to look like an Animal Planet episode on <a href="http://www.youtube.com/watch?v=1V4dPkMA58g&feature=related">weasels in distress</a>. Meanwhile, the plaintiff lawyer comes across as somebody asking good, simple questions. Inquiring minds want to know, etc. You might even get a disarming/smarmy "Can you help the jury please, Ma'am?" A lawyer does not have to hail from Texas to employ this technique, but it helps. Maybe it's the accent. Maybe it's the <a href="http://www.youtube.com/watch?v=4eo0OY8GOuc">Old West gunfighter</a> mythology. Whatever - Texans exude courage and clarity. Let's face it: Texas is the anti-France. <br /><br />Texas judges also have a way of stating things clearly and directly. A recent example is <em>Phares v. Actavis-Elizabeth LLC</em>, 2012 U.S. Dist. LEXIS 123858 (S.D. Texas Aug. 30, 2012). It is yet another good <em>Mensing</em> progeny case where a plaintiff claimed tardive dyskinesia from metoclopramide and where a court held that the claims against generic manufacturers were preempted. We've lately been reporting on such cases with mind-numbing monotony, but <em>Phares</em> is worth a look because it lassoes a couple of goodies together. The plaintiff sued both the generic and brand manufacturers. The claims consisted of the usual menagerie: negligence, negligent misrepresentation, fraud, strict liability, breach of warranties, and deceptive trade practices. Plus, the plaintiff added a claim of suppression of evidence. That last one puzzled the court as much as it puzzles us, and got tossed for the straightforward reason that it does not exist. The court held that all the rest of the claims against the generics were preempted pursuant to <em>Mensing</em>. The plaintiff argued that <em>Mensing</em> applies only against a failure-to-warn claim, but the court had no difficulty concluding that "[n]o matter how she casts her claims" the plaintiff was essentially complaining of a failure to warn. 2012 U.S. Dist. LEXIS 123858 at *15. The plaintiff also cited a variety of cases discussing express preemption, but the court was uninterested because <em>Mensin</em>g preemption (implied/conflict) is different. <br /><br />Further, as many of you know, Texas has a dandy law creating a rebuttable presumption of non-liability in prescription drug suits. If the warnings in question were approved by the FDA, the plaintiff's claim is as doomed as a Dallas Cowboys fan in South Philly. The only exception is if the plaintiff can show that the defendant withheld information from the FDA. As we said in <a href="http://druganddevicelaw.blogspot.com/2012/09/a-better-look-at-preemption-in-new.html">Monday's post</a> (talking about New Jersey law), we think that sort of thing is preempted by<em> Buckman</em>. The Texas federal court pretty much thinks the same thing, except it hung its Stetson hat on <em>Lofton v. McNeil Consumer & Specialty Pharms</em>., 672 F.3d 372, 380 (5th Cir. 2012). Under <em>Lofton</em>, any claim by a plaintiff of fraud-on-the-FDA is preempted unless the FDA itself has found fraud. We have mentioned <em>Lofton</em> <a href="http://druganddevicelaw.blogspot.com/2012/02/fifth-circuit-breaks-buckman-tie.html">before</a>. We like <em>Lofton</em>. We think <em>Lofton</em> is much better than the execrable <a href="http://druganddevicelaw.blogspot.com/2011/07/no-stand-up-comity-in-new-york.html"><em>Desiano</em> </a>case from the Second Circuit, which somehow found a way not to apply Buckman to fraud-on-the-FDA when it is an exception as opposed to a cause of action. Right now, we are thinking much happier thoughts about Texas than New York. Nothing new, really. We'll take brisket over a dirty-water hot dog every day of the week. Anyway, there was no FDA fraud finding in <em>Phares</em>, so adios to the failure-to-warn theory. It is all hat and no cattle. That dog won't hunt. [Now fill in your own overused Southwestern cliché.] Oh by the way, to the extent that the plaintiff was asserting any sort of fraud on anyone, the pleadings did not meet the heightened pleading standard of Fed. R. Civ. P. 9(b). <br /><br />As we mentioned, the plaintiff did not sue only the manufacturer of the generic drug (which she used), but she also sued the manufacturer of the branded drug (which she did not use). The <em>Phares</em> court begins its discussion of these claims by making the (what we would have thought was self-evident) point that this case is a products liability case. That rather elementary classification is a Big Deal because the court makes an "Erie guess" that under Texas law the imposition of product liability is precluded when the defendant did not supply the product that caused the plaintiff's injuries. 2012 U.S. Dist. LEXIS 123858 at *27-28. Good guess, that. The plaintiff was arguing, of course, for <em>Conte</em>-type liability to be applied to the brand manufacturer. But we are in Texas, not California. Nor are we in Vermont (home of Green Mountains, Ben and Jerry's, snowblowers that have more miles on them than the family car, and the abominable <em>Kellogg</em> case). There is simply no way the Texas federal court was going to make an <em>Erie</em> guess that the Texas Supreme Court would embrace the <em>Conte</em> lunacy. The plaintiff argued that <em>Mensing</em> changes the game, presumably based on the notion that if plaintiffs' claims against generics are preempted they must be able to sue someone. Every wrong has a remedy, right? Wrong. As the <em>Phares </em>court observes, "Plaintiff ignores the federal decisions issued post-Mensing that decided Mensing does not affect state law products liability principles." <em>Id</em>. at *30. The Phares court cites a string of federal cases that say <em>Conte</em> is wrong. Check that; <em>Conte </em>is Wrong. Now you can add <em>Phares</em> to that list. <br /><br />We cannot offhand think of any close friends that we have in Nevada, though we've had plenty of good times at a palace there run by some guy named Caesar. We could even imagine your blogging crew as a Legal Rat Pack. Bexis would be Sinatra, Sullivan would be Dino, Yeary would be Shirley MacLaine, leaving your current scribe as … Joey Bishop. Rats, indeed! Anyway, Nevada isn't just fun and games. Yes, there's Vegas, Reno, Tahoe, Hoover Dam, stupid bets on the Iggles to win the Super Bowl, and 3 am visits to the Argentinian Plate-Spinner Revue. But there's also real law being made in Nevada. Very good law was made in the case of <em><a href="http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/Baymiller.pdf">Baymiller v. Ranbaxy Pharmaceuticals, Inc</a></em>., No. 3:11-cv-858-RCJ-VPC (D. Nev. Sept. 6, 2012). The plaintiffs alleged that a woman who took a generic version of Paxil suffered a psychotic episode that caused her to kill her husband and harm herself. The plaintiffs sued the brand and generic manufacturers, as well as the retailers. The causes of action included strict liability, negligence, breach of warranties, misrepresentation, and abuse of an elderly person. There was a stipulation dismissing the generic manufacturers, presumably on Mensing grounds, and the retailers won motions to dismiss. That left Glaxo, which manufactured brand name Paxil, a drug that the woman had not purchased or use. Put another way, the only party left was the one that had absolutely no relationship with the plaintiffs. <br /><br />Glaxo relied on a couple of federal cases that had rejected Conte: (1) <em>Moretti v. Wyeth, Inc</em>., 2009 WL 749532 (D. Nev. 2009); and (2) <em>Foster v. Am. Home Prod. Corp</em>., 29 F.3d 165 (4th Cir. 1994). Foster is a well-reasoned case and was also cited in <em>Phares</em>. <em>Moretti </em>was from a federal court in Nevada, so one would think that it might carry some sway with a federal court in Nevada. <em>Conte</em>, by contrast, is a nutty decision, and it did not grow any less nutty in the wake of <em>Mensing</em>. The only other federal court in the Ninth Circuit to look at the effect (really non-effect) of<em> Mensi</em>ng on <em>Conte</em> and <em>Foster</em> is <em>Phelps v. Wyeth</em>, 2012 WL 1499343 (D. Oregon 2012). The<em> Phelps</em> court was applying Oregon law, but its reasoning was relevant to the Nevada federal court inasmuch as the plaintiff in <em>Baymiller</em> did not really offer any insights on Nevada law. The <em>Baymiller </em>court sorts through all this case law in some detail and we are pleased to report that it arrives at the right result. <em>Conte </em>never makes it across the Nevada border, not even to one of those casinos perched just over the state line. The<em> Baymiller</em> decision is nicely written and thoroughly reasoned, and we commend it to your attention, but its holding boils down to this: if someone was injured by a generic drug, the manufacturer of the brand drug owes no duty to that unfortunate someone. That reasoning applies to claims for strict products liability (did not sell the product), negligence (owes no duty of care), breach of warranty (did not issue a warranty to the plaintiff), or abuse of the elderly (did not have anything to do with the elderly person). <br /><br />We are happy to fire off a salute to Texas and to double-down on Nevada. Especially on the day after our home jurisdiction gets spanked by the Chamber of Commerce for hostile courts, it is nice to read a couple of opinions that get important issues right. <br /><br /><br /><br />Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-42840922444241037192012-09-11T12:25:00.000-07:002012-09-28T07:09:19.488-07:00FDA Enforcement Exclusivity Gets a Boost<div class="MsoNormal" style="margin: 0in 0in 12pt;"><span style="mso-tab-count: 1;"> </span>Yesterday we applauded a preemption decision by the District of Maryland for its well-reasoned analysis which included a focus on the FDA’s exclusive enforcement mechanism created by the Federal Food Drug and Cosmetic Act (“FDCA”).<span style="mso-spacerun: yes;"> </span>The lack of a private cause of action to enforce the FDCA is a fairly predominant theme on this blog, for the obvious reason of it being the cornerstone for preemption of product liability pharmaceutical and medical device litigation.<span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><span style="mso-tab-count: 1;"> </span>Today we decided to draw your attention to a recent case that reaffirms FDA enforcement exclusivity and take the opportunity to remind ourselves of another one of the reasons why that is important<span style="mso-spacerun: yes;"> </span>-- negligence per se.<span style="mso-spacerun: yes;"> </span>First, the case.<span style="mso-spacerun: yes;"> </span>In <u>K-V Pharmaceutical Co. v. FDA</u>, 2012 U.S. Dist. LEXIS 126330 (D.D.C. Sept. 6, 2012), the plaintiff pharmaceutical company brought an action against the FDA seeking to require the FDA to take certain enforcement actions.<span style="mso-spacerun: yes;"> </span>Plaintiff manufacturers the only FDA-approved drug used to treat pregnant women with a history of preterm birth by reducing the risk of another preterm birth.<span style="mso-spacerun: yes;"> </span><u>Id.</u> at *2.<span style="mso-spacerun: yes;"> </span>The drug is considered an “orphan” drug because it is used to treat a rare condition, and therefore, the manufacturer is given exclusivity in the market for 7 years.<span style="mso-spacerun: yes;"> </span><u>Id.</u> at *4-5.<span style="mso-spacerun: yes;"> </span>However, generic versions of the drug are “compounded” by pharmacies (pharmacists combine ingredients to make a customized drug to meet the needs of a particular patient).<span style="mso-spacerun: yes;"> </span><u>Id.</u> at *6.<span style="mso-spacerun: yes;"> </span>In its complaint, plaintiff took issue with the FDA’s decision not to take enforcement action against the compounders for various violations of the FDCA they alleged were occurring.<span style="mso-spacerun: yes;"> </span>Now, plaintiff may have had legitimate concerns about the scope and extent of the compounding and other issues and we don’t express any opinion on the actual circumstances.<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>Our interest in the case is solely as it relates to the court’s recognition that there is no private cause of action to enforce the FDCA.</div><div class="MsoNormal" style="margin: 0in 0in 12pt; text-indent: 0.5in;">That brings us to how this case is important in the product liability arena.<span style="mso-spacerun: yes;"> </span>The court summed up plaintiff’s claims as allegations of “ongoing violations of substantive provisions of the FDCA.”<span style="mso-spacerun: yes;"> </span><u>K-V Pharmaceutical Co.</u>, at *32.<span style="mso-spacerun: yes;"> </span>Sound familiar?<span style="mso-spacerun: yes;"> </span>Sound like our plaintiffs’ negligence per se claims?<span style="mso-spacerun: yes;"> </span>Sure does.<span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt; text-indent: 0.5in;">In granting FDA’s motion to dismiss, the court relied heavily on <u>Heckler v. Chaney</u>, 470 U.S. 821 (1985) (FDCA frees the FDA to pursue whatever remedies the FDA thinks best fit the violation) which had previously held that FDA decisions not to take enforcement action are presumed to be immune from judicial review.<span style="mso-spacerun: yes;"> </span><u>K-V Pharmaceutical Co.</u>, at *28.<span style="mso-spacerun: yes;"> </span>The Supreme Court’s ruling in <u>Chaney</u> turned in large part on the fact that the FDCA’s <span style="mso-spacerun: yes;"> </span>“enforcement provisions . . . commit complete discretion to the Secretary to decide how and when they should be exercised.”<span style="mso-spacerun: yes;"> </span><u>Chaney</u>, 470 U.S. at 835. <span style="mso-spacerun: yes;"> </span>We know this from <u>Buckman</u>.<span style="mso-spacerun: yes;"> </span>The FDCA explicitly precludes private litigants from seeking to prosecute any statutory or regulatory violation:</div><blockquote class="tr_bq">Except as provided in subsection (b) of this section, all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.</blockquote><div class="MsoNormal" style="margin: 0in 0in 12pt;">21 U.S.C. §337(a). So, both in the context of reviewability of enforcement decisions (<u>Chaney</u>) and in products liability (<u>Buckman</u>), the Supreme Court has held that §337(a) “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance.” <u>Buckman Co. v. Plaintiffs’ Legal Committee</u>, 531 U.S. 341, 349 n.4 (2001).</div><div class="MsoNormal" style="margin: 0in 0in 12pt; text-indent: 0.5in;">It is this enforcement exclusivity that led the court to find that plaintiff’s complaint “<span style="mso-fareast-font-family: 'Times New Roman';">is fundamentally an effort to get the Court to direct and oversee the FDA's enforcement activities, and that it cannot do.”<span style="mso-spacerun: yes;"> </span><u>K-V Pharmaceutical Co.</u>, at *32.</span><span style="mso-spacerun: yes;"> </span>We believe the same reasoning holds true for negligence per se claims. If the FDA has chosen not to pursue a particular alleged violation of the FDCA, it is not for the product liability plaintiff or the court to step in and do otherwise.<span style="mso-spacerun: yes;"> </span>By seeking to litigate alleged FDCA violations, plaintiffs ask courts “to get right smack in the middle of agency operations. Directing the FDA to bring a particular sort of enforcement action . . . is directing it how to allocate its finite enforcement resources – a decision that is peculiarly within the agency’s expertise and discretion.” <u>Id.</u> at *38 (citation and quotation marks omitted). <span style="mso-spacerun: yes;"> </span></div><span style="font-family: 'Times New Roman','serif'; font-size: 12pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US;"> We regularly cite to <u>Buckman</u> in our preemption arguments for support that Congress intended the FDCA to be enforced exclusively by the federal government.<span style="mso-spacerun: yes;"> </span>But this point is critical in defending against product liability plaintiffs who attempt private enforcement of the FDCA through negligence per se. <span style="mso-spacerun: yes;"> </span>Only statutes that the legislature (Congress, in the case of the FDCA) intended to be privately enforced can give rise to negligence per se. That’s why we make sure to include cases like <u>K-V Pharmaceutical Co. v. FDA</u> on our blog. While not a products liability case, it’s another decision that illustrates that Congress intended that the FDA be the exclusive enforcer of the FDCA and strengthens the argument that plaintiffs cannot create a private right of action via a back-door negligence <i>per se</i> claim.<span style="mso-spacerun: yes;"> </span>For a more thorough discussion of the defenses to negligence per se claims, including legislative intent, we direct you to our post <a href="http://druganddevicelaw.blogspot.com/2007/01/defenses-to-fdca-based-negligence-per.html" target="_blank">here</a>.<span style="mso-spacerun: yes;"> </span></span>Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-16607931859072639372012-09-11T11:36:00.000-07:002012-09-28T07:09:19.416-07:00More Punitive Damages Preemption, Sixth Circuit Reaffirms GarciaThe following is a guest post by <a href="http://www.reedsmith.com/laura_mastrangelo/">Laura Mastrangelo</a> at <a href="http://www.reedsmith.com/">Reed Smith</a>, who gets all the credit, and takes all the blame, for its contents. Take it away Laura....<br /><br />*********<br /><br />There was a fair amount of preemption action on punitive damage statutes last week, at least with respect to those states that limit punitive damages for FDA approved drugs and devices. John Sullivan provided excellent coverage of <u>Zimmerman v. Novartis Pharmaceutical Corp.</u>, ___ F. Supp. 2d ___, 2012 WL 3848545 (D. Md. Sept. 5, 2012), yesterday <a href="http://druganddevicelaw.blogspot.com/2012/09/a-better-look-at-preemption-in-new.html">here</a>, so I won’t belabor that discussion further. Flying more under the radar, though, the Sixth Circuit issued an opinion in <u>Marsh v. Genentech, Inc.</u>, ___ F.3d ___, 2012 WL 3854780 (6th Cir. Sept. 6, 2012), which dovetails nicely with the District of Maryland’s analysis in <u>Zimmerman</u>. In <u>Marsh</u>, the Sixth Circuit affirmed its previous holding in <u>Garcia v. Wyeth-Ayerst Laboratories</u>, 385 F.3d 961 (6th Cir. 2004), that the fraud exception to Michigan’s bar on products liability suits against drug manufacturers is preempted, even where Plaintiffs haven’t alleged fraud-on-the-FDA in the classical sense.<br /><br />Plaintiffs brought consolidated products-liability actions against drug manufacturers Genentech, Inc. and Xoma (U.S.) LLC (collectively, “Genentech”) to recover for injuries allegedly sustained from use of the psoriasis medication Raptiva, alleging strict products liability under design-defect and failure-to-warn theories, negligence, breach of warranty, and fraud. <u>Id.</u> at *1. The action consolidated four different plaintiffs, but apart from their dates of use and alleged injuries, the allegations for the four were identical. <u>Id.</u>, n.2.<br /><br />Plaintiffs claimed that, both prior to and after FDA approval, Genentech knew of dangerous side effects that it concealed from the public and did not include in the drug’s label. <u>Id.</u> at *1. Specific to the arguments at issue here, Plaintiffs further alleged that Genentech “intentionally and negligently failed to update statement of contraindications, warnings, precautions, and adverse reactions that Defendant affirmatively knew about” and “intentionally and negligently failed to comply with various [FDA disclosure regulations].” <u>Id.</u> <br /><br />Genentech moved to dismiss, and won. The district court held that Genentech was entitled to immunity under the Michigan Products Liability Act (the Act) and that Plaintiffs’ claim that immunity did not apply was preempted by federal law. <u>Id.</u> at *2. Citing <u>Garcia</u>, the district court explained that federal law preempts tort claims premised on the Act’s exceptions absent a finding by the FDA itself that the manufacturer had committed fraud or bribery. <u>Id.</u> The district court concluded that, because Plaintiffs had not alleged that the FDA had found that Genentech committed fraud, their claims were preempted. <u>Id.</u><br /><br />It’s not news that Michigan law is very favorable to drug manufacturers, providing that a drug manufacturer or seller is not liable for injuries caused by the use of its products “if the drug was approved for safety and efficacy by the [FDA], and the drug and its labeling were in compliance with the [FDA’s] approval at the time the drug left the control of the manufacturer or seller.” Mich. Comp. Laws §600.2946(5). <br /><br />Statutory immunity does not apply, however, if the manufacturer or seller: (a) Intentionally withholds from or misrepresents to the FDA information concerning the drug that is required to be submitted under the FDCA, and the drug would not have been approved, or the FDA United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted, or (b) Makes an illegal payment to an official or employee of the United States food and drug administration for the purpose of securing or maintaining approval of the drug. 2012 WL 3854780, at *2-3. The Michigan Supreme Court has described the Act’s immunity provision as “an absolute defense to a products liability claim” premised on the determination that “compliance with federal governmental standards (established by the FDA) is conclusive on the issue of due care for drugs.” <u>Taylor v. Smith-Kline Beecham Corp.</u>, 658 N.W.2d 127, 130-31 (Mich. 2003).<br /><br />Following <u>Buckman Co. v. Plaintiffs’ Legal Committee</u>, 531 U.S. 341 (2001), the Sixth Circuit previously held in <u>Garcia</u> that suits against drug manufacturers under Michigan law in which the Plaintiffs seeks to defeat immunity by invoking the Act’s fraud exceptions are equivalent to fraud-on-the-FDA claims and are thus preempted. 2012 WL 3854780, at *4. Even though, under Michigan law, fraud on the FDA is an exception to a grant of immunity to the manufacturer rather than a stand-alone cause of action, it nonetheless ultimately “requir[es] proof of fraud committed against the FDA” to succeed, and is therefore preempted. <u>Id.</u> “<u>Garcia</u> thus essentially requires treating a plaintiff's fraud arguments against manufacturer immunity as a threshold “claim” that can be preempted.” <u>Id.</u> <br /><br />Here, Plaintiffs attempted to argue that <u>Garcia</u> did not apply because their claims − in what was basically a pleading trick − did not invoke the Act’s fraud exception. <u>Id.</u> Though Plaintiffs’ theory was somewhat unclear, the Court interpreted the argument to be that immunity should not apply because of Genentech’s alleged non-compliance with the terms of the FDA’s approval of Raptiva, in that Genentech failed to comply with the FDA’s post-marketing reporting requirements. <u>Id.</u> However, the purported “non-compliance” was precisely the same fraud on the FDA allegations that the same court had ruled preempted in <u>Garcia</u>.<br /><br />The court noted that Plaintiff’s allegations of non-compliance “do not fit comfortably within the statutory language requiring compliance for immunity to apply,” because the complaint alleged that Genentech did not comply with the terms of the FDA approval by failing to update its application or submit safety reports, not that “the drug and its labeling” did not comply.” <u>Id.</u> at *5. Further, the complaint also did not allege that the dose of Raptiva she received was adulterated or that its label varied from the label that the FDA approved. <u>Id.</u> <br /><br />Thus, the Court considered the allegation of failure to submit reports to the FDA that the FDA requires “to be a species of fraud on the agency under the state Act.” <u>Id.</u> “Indeed, the Michigan Act’s fraud exception specifically encompasses at least some of the misconduct Marsh alleges − a manufacturer “[i]ntentionally withhold[ing] from ... the [FDA] information concerning the drug that is required to be submitted under the [FDCA] ‘when the FDA “would have withdrawn approval for the drug if the information were accurately submitted.’” <u>Id.</u> <br /><br />Further, even if Plaintiffs’ allegations did constitute “non-compliance” (as opposed to fraud on the FDA) within the meaning of the Act, the claim “that immunity does not apply triggers the same concerns that animated <u>Buckman</u> and <u>Garcia</u>[,]” and is therefore preempted. <u>Id.</u> In short, Plaintiffs could not plead around preemption.<br /><br />Plaintiffs claimed that “Genentech failed to submit updated safety information to the FDA as required of all applicants by FDA Form 356h and generally applicable FDA regulations,” and thus they rely on “federal enactments [a]s a critical element in [their] case.” <u>Quoting</u> <u>Buckman</u>, 531 U.S. at 353. Moreover, this alleged wrong was perpetrated upon the agency, and thus implicates the “inherently federal” relationship described in <u>Buckman</u>. <u>Id.</u> at 347. Finally, Plaintiffs’ suit would require a court to rule on the adequacy of Genentech’s post-marketing disclosures to the FDA, which is the kind of “inter-branch[ ]meddling” that concerned the Court in <u>Buckman</u>. <u>See</u> <u>Garcia</u>, 385 F.3d at 966. Having a court determine whether any non-disclosed information “ ‘may reasonably affect the statement of contraindications, warnings, precautions or adverse reactions in the draft labeling,’ “would both usurp the agency's role and go beyond the court's institutional expertise.” <u>Marsh</u>, 2012 WL 3854780, at *5.<br /><br />The Court did not take a position, however, as to whether an allegation of “substantive non-compliance that is unique to the terms of approval of a particular drug or that more directly involves a consumer, such as a chemical variance or an inaccurate label, would be preempted under Garcia,” as the allegations there did not implicate such a holding. <u>Id.</u>, n. 9.<br /><br />As a final note, the Court dismissed Plaintiffs’ other arguments, concluding first that the fact that Plaintiffs’ substantive claims sound in negligence and strict products liability would not enable her to avoid preemption, because so did the claims in <u>Garcia</u>. <u>Id.</u> at *6. Moreover, <u>Wyeth v. Levine</u> did not change the analysis either, because “[a]lthough preemption principles do not foreclose state-law failure-to-warn claims once the FDA has approved a drug, Michigan law does so.” <u>Id.</u> Finally, the Court rejected Plaintiffs’ argument that as an affirmative defense, Defendants bore the burden of establishing compliance with its FDA approval, because the complaint “makes clear that Marsh could not defeat Genentech's arguments for immunity.” <u>Id.</u> at *6-7.Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-78113602657482052952012-09-10T14:07:00.000-07:002012-09-28T07:09:19.689-07:00A Better Look at Preemption in New Jersey<div class="MsoNormal" style="margin: 0in 0in 12pt;">Those of us who practice New Jersey products liability law know <i style="mso-bidi-font-style: normal;">McDarby v. Merck</i>, 401 N.J. Super. 10 (App. Div. 2008).<span style="mso-spacerun: yes;"> </span>It addressed a provision of New Jersey’s Product Liability Act that both granted manufacturers immunity from punitive damages if their product was approved by the FDA and tried to take that immunity away if the manufacturer made knowing misrepresentations to the FDA. Here’s the language of the statute: </div><div class="MsoNormal" style="margin: 0in 30pt 12pt; text-align: justify;"><b style="mso-bidi-font-weight: normal;">Punitive damages shall not be awarded if</b> a drug or device . . . which caused the claimant's harm was <b style="mso-bidi-font-weight: normal;">subject to premarket approval . . . by the federal Food and Drug Administration . . . and</b> <b style="mso-bidi-font-weight: normal;">was approved</b> . . . . <b style="mso-bidi-font-weight: normal;">However, where the product manufacturer knowingly withheld or misrepresented information</b> required to be submitted under the agency's regulations, which information was material and relevant to the harm in question,<b style="mso-bidi-font-weight: normal;"> punitive damages may be awarded</b>. </div><div class="MsoNormal" style="margin: 0in 0in 12pt;">N.J.S.A. 2A:58C-5c (emphasis added).<span style="mso-spacerun: yes;"> </span>We know what you’re thinking: “Wouldn’t that be preempted under <i style="mso-bidi-font-style: normal;">Buckman?</i>” <span style="mso-spacerun: yes;"> </span>Yup.<span style="mso-spacerun: yes;"> </span>And that’s what <i style="mso-bidi-font-style: normal;">McDarby</i> held.<span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;">And, since this decision in 2008, courts applying New Jersey law on this topic generally cite <i style="mso-bidi-font-style: normal;">McDarby</i> and apply its holding.<span style="mso-spacerun: yes;"> </span>But, last week, the court in <i style="mso-bidi-font-style: normal;">Zimmerman v. Novartis Pharm. Corp.</i>, 2012 U.S. Dist. LEXIS 126002 (D. Md. Sep. 5, 2012), did something better.<span style="mso-spacerun: yes;"> </span>It offered a well-reasoned, thoughtful explanation of the law on preemption and <i>Buckman</i>, along with an effective criticism of decisions that (we believe) get <i style="mso-bidi-font-style: normal;">Buckman </i>wrong.<span style="mso-spacerun: yes;"> </span>It’s good stuff, and it provides good quotes for future briefing.<span style="mso-spacerun: yes;"> </span>In fact, you might want to consider citing <i style="mso-bidi-font-style: normal;">McDarby</i> but quoting <i style="mso-bidi-font-style: normal;">Zimmerman</i>.<span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;">Now, <i style="mso-bidi-font-style: normal;">Buckman</i>, even read narrowly, held that tort claims based on a manufacturer withholding information from or misleading the FDA are impliedly preempted because the FDCA grants the power to enforce its provisions to the United States, not private citizens.<span style="mso-spacerun: yes;"> </span>When a federal law such as this creates an inherently federal relationship and exclusive enforcement mechanism, the presumption against implied preemption that ordinarily attaches goes away.<span style="mso-spacerun: yes;"> </span>As the Zimmerman court wrote:<span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt 0.5in;">[I]n <i>Buckman</i>, the Court held that there is no presumption against preemption where a jury is asked to decide whether there has been a material fraud on the FDA during the regulatory process. <span style="mso-spacerun: yes;"> </span>This is because federal law dictated the Defendant’s interactions with and representations to the FDA. Thus, unlike circumstances that implicate “federalism concerns and the historic primacy of state regulation of matters of health and safety,” the relationship between a regulated entity and the FDA is “inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law.” </div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><i style="mso-bidi-font-style: normal;">Id.</i> at *37 (citations omitted).</div><div class="MsoNormal" style="margin: 0in 0in 12pt;">The <i style="mso-bidi-font-style: normal;">Zimmerman </i>court rejected the reasoning of courts that upheld other state statutes that allowed failure to warn claims to go forward if there was a showing of fraud on the FDA.<span style="mso-spacerun: yes;"> </span>One such court reasoned that such statutes “cannot reasonably be characterized as a state’s attempt to police fraud on the FDA” but rather they are a state’s attempt to limit tort claims.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *38 (quoting <i>Desiano v. Warner-Lambert & Co.</i>, 467 F.3d 85, 94 (2d Cir. 2006)).<span style="mso-spacerun: yes;"> </span>But the <i style="mso-bidi-font-style: normal;">Zimmerman</i> court didn’t lose track of the most important point – it’s different when a state tort claim requires determinations about fraud on the FDA:</div><div class="MsoNormal" style="margin: 0in 0in 12pt 0.5in;">Although this Court agrees that the presumption against preemption applies to state tort claims implicating health and safety generally, the Court concludes that such a presumption does not apply to that part of Plaintiff’s claim, which by virtue of New Jersey law, conditions any recovery of punitive damages on a showing that a defendant-drug manufacturer “knowingly withheld or misrepresented information required to be submitted under the [FDA’s] regulations, which information was material and relevant to the harm in question.” [Quoting the N.J. statute]. This conclusion is confirmed by the Court’s analysis in <i>Buckman.</i> There, the Court found that the presumption against preemption did not apply to a specific type of tort claim--a fraud on the FDA claim--even though the presumption against preemption applies to traditional tort claims implicating health and safety matters.</div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><i style="mso-bidi-font-style: normal;">Id.</i> at *39-40 (citation omitted).</div><div class="MsoNormal" style="margin: 0in 0in 12pt;">This is because the key question is not whether the state tort claim seeks to “police” fraud-on-the-FDA, but whether it is an obstacle to FDA regulation.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *42.<span style="mso-spacerun: yes;"> </span>A state statute that hinges compensatory or, more so, punitive damages on a jury’s – more likely, multiple juries’ – determinations of whether the FDA was defrauded raises obstacle after obstacle.<span style="mso-spacerun: yes;"> </span>Companies concerned that juries will see fraud where the FDA doesn’t will understandably respond by providing the FDA with the kitchen sink, causing nothing but greater delay and inefficiency.<span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;">The <i style="mso-bidi-font-style: normal;">Zimmerman </i>court went further, holding that even if a presumption against preemption applied, it is rebutted because the statute requires a jury determine something exclusively left to the FDA.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">Id.</i> at *41-52.<span style="mso-spacerun: yes;"> </span>The court rejected (what we believe is wrong-headed) reasoning by some courts that <i style="mso-bidi-font-style: normal;">Buckman</i> preemption applies only to pure fraud-on-the-FDA claims, not claims in which such fraud is an element of, or gateway to, a broader claim:</div><div class="MsoNormal" style="margin: 0in 0in 12pt 0.5in;">This distinction is meaningless because it is simply not entirely accurate. In <i>Buckman</i>, the plaintiffs not only had to prove the device maker’s non-compliance with FDCA disclosure requirements, which served as the predicate false representation in a common law fraudulent misrepresentation action, but also other common law elements of a fraudulent misrepresentation action such as injury and proximate cause. <span style="mso-spacerun: yes;"> </span>Put another way, the preemption analysis does not change simply because, under New Jersey law, this Plaintiff must prove something in addition to non-compliance with a FDCA disclosure requirement to recover punitive damages.</div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><i style="mso-bidi-font-style: normal;">Id.</i> at *54 (citations omitted).<span style="mso-spacerun: yes;"> </span></div><div class="MsoNormal" style="margin: 0in 0in 12pt;">The <i style="mso-bidi-font-style: normal;">Zimmerman </i><span style="mso-spacerun: yes;"> </span>court was not moved by the argument that the New Jersey statute does not create a fraud-on-the-FDA claim, like in Buckman, but rather only gives plaintiffs the opportunity to rebut a presumption and thereby bring a tort claim under New Jersey common law:</div><div class="MsoNormal" style="margin: 0in 0in 12pt 0.5in;">Once New Jersey passed the statutory immunity provision for punitive damages, the traditional cause of action is no more rooted in common law doctrine than the stand-alone claim in <i>Buckman.</i> This is because, in the post-statutory immunity world, a plaintiff’s punitive damages claim hinges on whether the defendant-drug maker made adequate disclosures to the agency and whether, in the face of these inadequate disclosures, the agency would have approved the drug. In this way, New Jersey’s statutory immunity provision makes fraud on the FDA a “critical element” of every punitive damages claim.</div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><i style="mso-bidi-font-style: normal;">Id.</i> at *55-56 (citation omitted).</div><div class="MsoNormal" style="margin: 0in 0in 12pt;">It really is a simple analysis.<span style="mso-spacerun: yes;"> </span>The statute authorizes juries to dig into the details of regulations and New Drug Applications and make independent determinations of what the FDA should have done or would have done, but didn’t do.<span style="mso-spacerun: yes;"> </span>In other words, precisely what juries can’t do under federal law:</div><div class="MsoNormal" style="margin: 0in 0in 12pt 0.5in;">Simply put, Plaintiff’s claim for punitive damages requires a state fact finder to determine what was required to be submitted to the FDA, whether it was submitted to the FDA and, whether the FDA would have made a different approval decision had it been provided with the correct or missing information. Plaintiff’s claim thus requires a fact finder to make these types of determinations as a matter of state law even though federal law makes such determinations the exclusive province of the FDA. Accordingly, Plaintiff’s claim for punitive damages poses an obstacle to the objectives and purpose of the FDCA, and is therefore preempted by the FDCA.</div><div class="MsoNormal" style="margin: 0in 0in 12pt;"><i style="mso-bidi-font-style: normal;">Id.</i> at *51-52.</div><div class="MsoNormal" style="margin: 0in 0in 12pt;">It doesn’t, and shouldn’t, matter whether this improper determination is an element of a claim, a gateway to a broader claim, or the entirety of the claim.<span style="mso-spacerun: yes;"> </span>Jury after jury deciding what the FDA should have gotten and done about it gets in the way of the FDA doing its job.<span style="mso-spacerun: yes;"> </span>The <i style="mso-bidi-font-style: normal;">Zimmerman</i> court gave a good quotation for this too:</div><div class="MsoNormal" style="margin: 0in 0in 12pt 0.5in;">Allowing state fact finders to second-guess the very decisions that federal law leaves entirely to the agency presents “the same inter-branch-meddling concerns that animated <i>Buckman.</i>” As in <i>Buckman</i>, allowing punitive damages liability here would require applicants to submit a “deluge” of unnecessary information during the approval process, which in turn, delays the approval of new drugs. <span style="mso-spacerun: yes;"> </span>In seeking to comply with various statutory immunity provisions, drug manufacturers would “exert an extraneous pull on the scheme established by Congress.”</div><i style="mso-bidi-font-style: normal;"><span style="font-family: 'Times New Roman','serif'; font-size: 12pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US;">Id.</span></i><span style="font-family: 'Times New Roman','serif'; font-size: 12pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US;"> at *57.<span style="mso-spacerun: yes;"> </span></span><br /><br /><span style="font-family: 'Times New Roman','serif'; font-size: 12pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US;"><span style="mso-spacerun: yes;">We told you that the court's discussion was much better than just, "<em>see</em> <em>McDarby</em>." Keep it handy for future briefs. </span></span>Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-20596695743211079152012-09-07T15:23:00.000-07:002012-09-28T07:09:19.424-07:00More New StuffToday’s post is of the “this and that” variety − dealing with things we’ve come across that we haven’t yet blogged about this week.<br /><br /><br /><div style="text-align: center;"><strong><u>Medical Device Preemption − The Greatest</u></strong></div><br />As defense counsel appreciate, PMA preemption post-<u>Riegel</u> floats like a butterfly and stings like a bee. Anybody representing PMA medical device clients will want to read (and cite) <u>Ali v. Allergan USA, Inc.</u>, 2012 WL 3692396 (E.D. Va. Aug. 23, 2012). <u>Ali</u> involved a “lap band” − a PMA device that restricts the ability of the stomach to expand, used as a last-ditch weight control measure in cases of morbid obesity.<br /><br /><u>Ali</u> involves several preemption issues, and is also good on <u>TwIqbal</u> and the Virginia Consumer Protection Act. On preemption, as usual the battleground was the so-called “parallel claim” exception. 2012 WL 3692396, at *7. Plaintiffs offered only “a series of conclusory allegations that that [defendant] violated federal law.” <u>Id.</u> Not surprisingly, that didn’t cut it. Thus, everything having to do with warnings was dismissed (albeit without prejudice). <u>Id.</u> <br /><br />Plaintiffs contended that they based their negligence and implied warranty claims in a manufacturing defect. Again they faced <u>TwIqbal</u>. “[T]the plaintiff must allege sufficient facts to support both the inference that the defendant manufactured the device in a way that violated federal regulations and the inference that this violation resulted in the defect that caused the plaintiff's injuries.” <u>Id.</u> at *8. The manufacturing defect claim required: (1) that “the plaintiff identif[y] what went wrong in the manufacturing process and cite[] the relevant FDA manufacturing standards that were allegedly violated,” <u>id.,</u> and (2) “sufficient facts to support the inference that the defendant's federal violations resulted in the defect that caused the plaintiff's injuries.” <u>Id.</u> at *9 (citations and quotation marks omitted). The <u>Ali</u> complaint didn’t come close, containing only “information and belief” allegations as to violations and nothing at all about causation. <u>Id.</u> at *10. As to what was violated, alleging “any regulations promulgated pursuant to the Act” somehow didn’t impress the court. <u>Id.</u> Nor do allegations that are nothing more than “simple recitations of regulatory language” enough. <u>Id.</u> at *11. Plaintiff can’t get away with copying sections of the Code of Federal Regulations. That the plaintiff was injured does not mean that an FDCA violation occurred:<br /><br /><blockquote class="tr_bq">[T]he allegation that the [product] eroded does not, by itself, suggest that [defendant] violated federal requirements in manufacturing this device. At the time the [product] obtained PMA, the FDA was aware of [a] risk of erosion and [that it] could cause serious complications. . . . Ultimately, the FDA determined that [this risk] was a rare occurrence and that serious complication resulting from [it] was an even rarer occurrence, and approved the device despite these risks.</blockquote><br />2012 WL 3692396, at *11 (citations omitted).<br /><br />The plaintiff threw in allegations that the defendant’s first try at PMA had been unsuccessful. The court essentially held “so what?” Even if PMA had at first failed, the defendant “obtained PMA more than eight years before it was first implanted in [plaintiff’s] body. <u>Id.</u> at *12. That there had been various recalls of similar models didn’t matter since none of them had involved the device in question or the risk in question. <u>Id.</u><br /><br />To get around TwIqbal, the plaintiffs in <u>Ali</u> trotted out <u>Hofts v. Howmedica Osteonics Corp.</u>, 597 F. Supp.2d 830 (S.D. Ind. 2009), the case <a href="http://druganddevicelaw.blogspot.com/2009/12/top-ten-worst-prescription-drugmedical.html">we love to hate</a>. The judge in <u>Ali</u> hated <u>Hofts</u> almost as much as we do:<br /><br /><blockquote class="tr_bq">This Court respectfully disagrees with the <u>Hofts</u> court’s application of the Rule 8 pleading standard. . . . This Court finds the <u>Hofts</u> court unusually lax in its application of the standard. In assessing the sufficiency of pleadings, district courts should not take conclusory allegations as true but must require factual support for any legal conclusions offered in pleadings. Requiring such factual enhancement does not constitute a heightened pleading standard; it is the basic pleading standard established in Rule 8 as interpreted in [<u>TwIqbal</u>]. Without factual allegations supporting inferences of the defendant’s liability and the plaintiff’s right to relief, pleadings fail to provide adequate notice of the grounds upon which the plaintiff's claim rests. In <u>Hofts</u>, the district court relaxed the facial plausibility standard out of existence with respect to the plaintiff's allegations that the defendant violated federal requirements. This Court declines to adopt that approach in the context of this case.<br /><br />This Court also respectfully disagrees with the <u>Hofts</u> court’s approach to the breach of implied warranty claim, where the court placed the burden on the defendant to show that the claim imposed standards different from applicable federal requirements. Rule 8 places the burden of pleading a plausible claim for relief and the grounds for this claim on the claimant. . . . This Court agrees with the majority of federal courts in holding, post-<u>Riegel</u>, that the facial plausibility standard applies to the pleading of a federal violation in this context and requires facts indicating noncompliance with federal requirements on the manufacture of the device.</blockquote><br />2012 WL 3692396, at *13<br /><br />The plaintiffs in <u>Ali</u> made a premature demand for discovery before meeting their Rule 8 pleading requirements. The court had none of it, finding that request to be “precisely the sort of fishing expedition the Supreme Court [in <u>TwIqbal</u>] sought to avoid in requiring the plaintiff to plead facts demonstrating their entitlement to relief and the defendant's liability.” <u>Id.</u> at *14.<br /><br /><u>Ali</u> also followed the majority rule on preemption of express warranty claims. If they impose duties on the purported warrantor that differ from or add to federal requirements, if they challenge the safety and effectiveness of the PMA device, or if they challenge the manufacturer’s FDA-approved labeling, express warranty claims are preempted. <u>Id.</u> at *15. The only way am express warranty claim survives is when there are allegations “based on representations made by the manufacturer about the device that was not approved by the FDA.” <u>Id.</u> at *16. The plaintiff didn’t plead anything of the sort, so the express warranty claims were also dismissed. <u>Id.</u> <br /><br />We’ve also <a href="http://druganddevicelaw.blogspot.com/2007/07/and-then-there-were-seven.html">collected cases</a> holding that consumer fraud claims involving drugs and medical devices fail under “regulated activity” safe harbor provisions in the relevant state statutes. <u>Ali</u> is another such case:<br /><blockquote class="tr_bq">By its own terms, however, the VCPA does not apply to “[a]ny aspect of a consumer transaction which aspect is authorized under laws or regulations of this Commonwealth or the United States, or the formal advisory opinions of any regulatory body or official of this Commonwealth or the United States.” Va. Code Ann. §59.1-199(A).<br /><br />Plaintiffs’ VCPA claim fails because it challenges conduct that is expressly excluded from the scope of the VCPA. Plaintiffs base their VCPA cause of action on representations made by [defendant] . . . in advertisements and other marketing materials concerning the safety and effectiveness of the device. Representations about the [PMA-approved device] in marketing materials for the device are authorized and regulated by the FDA under federal law. The VCPA, therefore, does not apply to it and therefore no action challenging [defendant’s] marketing practices . . . may be brought under the VCPA.</blockquote>2012 WL 3692396, at *19. Gotta love it. <u>Ali</u> is the greatest.<br /><br /><div style="text-align: center;"><strong><u>Prescription Drugs in Texas − You Can’t Get There from Here</u></strong></div><br />We’re somewhat less enamored with <u>Romero v. Wyeth</u>, C.A. No. 1:03-cv-13467, <a href="http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/Romero.pdf">slip op.</a> (E.D. Tex. Aug. 31, 2012), sent to us by <a href="http://www.tklaw.com/attorneys.cfm?u=DavisJanelleL&action=view&id=99899">Janelle Davis</a> of <a href="http://www.tklaw.com/">Thompson & Knight</a>, although we must admit <u>Romero</u> does have its moments.<br /><br /><u>Romero</u> evaluates a variety of claims purportedly arising under Texas law, in the wake of the <a href="http://druganddevicelaw.blogspot.com/2012/06/news-flash-texas-adopts-learned.html">big win</a> in <u>Centocor, Inc. v. Hamilton</u>, ___ S.W.3d ___, 2012 WL 2052783 (Tex. June 8, 2012). On the good side of the ledger, the court throws out all of the usual bread & butter claims in prescription drug product liability litigation − those involving failure to warn (specifically misrepresentation, fraud, negligence, misrepresentation, gross negligence, and consumer fraud). The Texas statutory presumption of adequacy of FDA-approved warnings controlled, no matter what form the defendant’s information took:<br /><br /><blockquote class="tr_bq">“[I]f a claim is based upon a product’s labeling, its omissions, or inaccuracies, it falls under this purview of the [statutory presumption]. . . . [Plaintiff] seeks to distinguish failure to warn claims based upon a drug manufacturer’s statements in a warning label from those premised on other representations contained, for example, in promotional and marketing materials. . . . Because [plaintiff] cites no other authority [besides the lower court decision reversed in <u>Centocor</u>] for the proposition that [the statute’s] provisions should be so strictly applied, the court declines to make such a determination here. Accordingly, whether [plaintiff’s] failure to warn claims are based on statements made in [defendant’s] labeling or promotional materials, they fall within the purview of [the statutory presumption of adequacy].</blockquote><br /><u>Romero</u>, slip op. at 5.<br /><br />That’s the good part of <u>Romero</u>. The parts responsible for our “you can’t get there from here” comment then follow. For one thing the court allows a naked failure to test claim to continue. <a href="http://druganddevicelaw.blogspot.com/2010/08/duty-to-test-cheat-sheet.html">Abundant precedent</a>, including controlling precedent under Texas law, holds that “failure to test” isn’t a free-standing cause of action. The Texas Supreme Court dealt with such a claim in <u>American Tobacco Co., Inc. v. Grinnell</u>, 951 S.W.2d 420 (Tex. 1997), twice holding “failure to test” to be “inextricably intertwined” with failure to warn, and rising or falling with it:<br /><br /><blockquote class="tr_bq">The [plaintiffs’] negligent testing claim is predicated on [defendant’s] duty to test and ascertain the dangers inherent in its products about which it must warn consumers. Because the negligent testing claim is inextricably intertwined with the [plaintiffs’] negligent failure to warn claim, we hold that summary judgment was also proper on this claim.</blockquote><br /><u>Id.</u> at 437.<br /><br /><blockquote class="tr_bq">The [plaintiffs’] negligent testing claim is also preempted. . . . [Their] negligent testing claim is inextricably intertwined with advertising and promotional materials because the [plaintiffs] allege only that [defendant] should have tested its products to determine the dangerous characteristics about which [defendant] should have warned consumers.</blockquote><br /><u>Id.</u> at 439. Then there’s the Fifth Circuit. In <u>Dow Agrosciences LLC v. Bates</u>, 332 F.3d 323, (5th Cir. 2003), <u>reversed on other grounds</u>, 544 U.S. 431 (2005) (preemption), the court held that, “a negligent testing claim is, as a matter of Texas law, a variation of an action for failure to warn.” <u>Id.</u> at 333. And again, in <u>Skotak v. Tenneco Resins, Inc.</u>, 953 F.2d 909 (5th Cir. 1992):<br /><br /><blockquote class="tr_bq">[N]egligence claims, such as the alleged failure to adequately test [the product], are subsumed within this two-part standard. . . . [Plaintiffs] were required to prove that an inadequate warning was given and that the inadequate warning was the cause of the injury. [Plaintiffs] do not argue otherwise, nor do they assert here an independent, or separate, negligence claim.</blockquote><br /><u>Id.</u> at 912 n.5 (affirming summary judgment).<br /><br />Oh well, so much for appellate precedent. Citing general “reasonable care” negligence cases and an old asbestos case involving failure to warn, <u>Romero</u> concocts some sort of “independent negligence cause of action based upon [defendant’s] failure to test” that no Texas court has ever allowed. Slip op. at 7-8. It may be our favorite legal proposition, and it sure applies here - a federal court sitting in diversity is not supposed to invent new, expansive state-law causes of action. <br /><br /><blockquote class="tr_bq">“[I]n hazarding an <u>Erie</u> guess, our task is to attempt to predict state law, not to create or modify it. The practical effect of adopting an exception like the one [plaintiffs] propose is the creation of a previously nonexistent state law cause of action. Therefore, [plaintiffs] carry a heavy burden to assure us that we would not be making law.</blockquote><u>Memorial Hermann Healthcare System Inc. v. Eurocopter Deutschland, Gm</u>bH, 524 F.3d 676, 678 (5th Cir. 2008) (applying Texas law). We’re sure there’s plenty more where that comes from.<br /><br /><u>Romero</u> also allows a design defect claim, holding that Restatement (Second) of Torts §402A, comment k should be applied on a case by case basis. Slip op. at 11-12. It gets to that result by characterizing comment k as an “affirmative defense” even though no Texas law says so (we reiterate the <u>Erie</u> federalism point) and in <u>Centocor</u> the Texas Supreme Court unanimously and emphatically rejected a similar argument about the learned intermediary rule:<br /><br /><blockquote class="tr_bq">The learned-intermediary doctrine is not an affirmative defense. . . . While the learned intermediary doctrine shifts the manufacturer’s duty to warn the end user to the intermediary, it does not shift the plaintiff’s basic burden of proof. Doing so would create an anomalous situation where, once the defendant prescription-drug manufacturer invokes the learned intermediary doctrine, the plaintiff would be relieved of proving a key burden in any product warning case - that the product warning was inadequate.</blockquote><br />___ S.W.3d ___, 2012 WL 2052783, at *20. With comment k, the analysis is the same, only it involves design rather than warning claims. Several federal courts under Texas law cases have applied comment k to all prescription medical products, not requiring the individualized sort of product by product analysis demanded in <u>Romero</u>. <u>Reyes v. Wyeth Laboratories</u>, 498 F.2d 1264, 1273 (5th Cir. 1974) (vaccine); <u>Woodhouse v. Sanofi-Aventis United States LLC</u>, 2011 WL 3666595, at *3-4 (W.D. Tex. June 23, 2011); <u>Holland v. Hoffman-La Roche, Inc.</u>, 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007); <u>Carter v. Tap Pharmaceuticals, Inc.</u>, 2004 WL 2550593, at *2 (W.D. Tex. Nov. 2, 2004); <u>Hackett v. G.D. Searle & Co.</u>, 246 F. Supp.2d 591, 595 (W.D. Tex. 2002) (applying Texas law). Tellingly, <u>Romero</u> does not cite a single Texas prescription medical product case for its contrary proposition.<br /><br />There’s more we could discuss but for now, suffice it to say that with respect to the non-warning claims, we don’t think <u>Romero</u> can get there from here under what Texas law really is rather than what plaintiffs might want it to be.<br /><br /><div style="text-align: center;"><strong><u>We Think That’s About Right</u></strong></div><br />Finally, from our home turf here in Pennsylvania, we offer the decision in <u>Boeynaems v. LA Fitness International, LLC</u>, ___ F. Supp.2d ___, 2012 WL 3536306 (E.D. Pa. Aug. 16, 2012), which we received internally today. This is not a drug case, but it is a class action in which the plaintiffs were harassing the defendants with massive pre-certification discovery requests. The defendant asked the judge to require the plaintiffs to pay for that discovery themselves, and the court agreed, holding:<br /><br /><blockquote class="tr_bq">[T]he Court mandates cost allocation as fair and appropriate. The Court concludes that where (1) class certification is pending, and (2) the plaintiffs have asked for very extensive discovery, compliance with which will be very expensive, that absent compelling equitable circumstances to the contrary, the plaintiffs should pay for the discovery they seek.</blockquote><br /><u>Id.</u> at *11. The court essentially told the plaintiffs that they had to put up or shut up − no more one-way discovery, at least pre-certification in class actions:<br /><br /><blockquote class="tr_bq">If the plaintiffs have confidence in their contention that the Court should certify the class, then the plaintiffs should have no objection to making an investment. Where the burden of discovery expense is almost entirely on the defendant, principally because the plaintiffs seek class certification, then the plaintiffs should share the costs.</blockquote><br /><u>Id.</u><br /><br />We think that’s just about right. If the class isn’t certified because the claims are bogus, the defendant isn’t going to be able to recoup this sort of massive expense from the class plaintiffs, and the attorneys will try to walk away from the case. If the case is good, then the common fund doctrine will plaintiffs’ counsel recoup their expense. So as Ron Weasley might say, “put your Galleons where your gob is.”Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-64883967321352080442012-09-06T11:29:00.000-07:002012-09-28T07:09:19.655-07:00The Egilman ChroniclesWhen <a href="http://druganddevicelaw.blogspot.com/2010/08/zyprexa-second-circuit-affirms.html">last we looked in</a> on long-time plaintiffs’ expert David Egilman, M.D., in 2010, the Second Circuit in the Zyprexa litigation had affirmed sanctions against one of the lawyers who cooperated with Dr. Egilman in what that court described as a “brazen” disregard of a protective order. <u>Eli Lilly & Co. v. Gottstein</u>, 617 F.3d 186, 188 (2d Cir. 2010). That was the swan song for Dr. Egilman’s involvement that litigation.<br /><br /><div> </div>We also pointed out that Dr. Egilman had previously been involved in a protective order controversy in Colorado: <u>Ballinger v. Brush Wellman, Inc.</u>, 2001 WL 36034524 (Colo. Dist. June 22, 2001), <u>affirmed in part and reversed in part</u>, 2002 WL 2027530 (Colo. App. Sept. 5, 2002) (unpublished). Beyond that, we remember Dr. Egilman from some of our New Jersey <u>Vioxx</u> cases years ago.<br /><div> </div>We hadn’t heard much about Dr. Egilman recently, though, until last week, when a couple of our readers at <a href="http://www.blackwellburke.com/">Blackwell Burke</a>, <a href="http://www.blackwellburke.com/gordon_bio.php">Corey Gordon</a> and <a href="http://www.blackwellburke.com/kenny_bio.php">Brendan Kenny</a>, let us know that Dr. Egilman was involved in still more goings-on stemming from his role as an expert in what we call the “buttered popcorn” litigation.<br /><div> </div>Buttered popcorn?<br /><div> </div>Yeah, that’s right. As weird as it might sound, there are a bunch plaintiffs claiming that they were injured by popcorn. Our old pal Sean Wajert, who writes the <a href="http://www.masstortdefense.com/">Mass Tort Defense Blog</a>, had a significant role in that, so we already knew a little about the popcorn proceedings. Basically, the plaintiffs allege that diacetyl, a flavoring agent used with popcorn, supposedly causes (in extremely large doses − most plaintiffs claim occupational exposures) certain lung problems. Our two readers (who have been in the thick of litigating these cases for years) informed us that Dr. Egilman has been a repeat player in that litigation − particularly in its most questionable aspects, the non-occupational exposure cases.<br /><div> </div>So we took a shot. If we run “Egilman” (fortunately he’s not named “Smith”) in Westlaw since 2010, what do we get?<br /><div> </div>Well, the first case on the list is <u>Watson v. Dillon Cos.</u>, 2012 WL 2060844 (D. Colo. June 7, 2012). It mentions Dr. Egilman, but is really about a <u>Daubert</u> motion (denied) relating to another expert. Looking further we found another opinion in that case, <u>Watson v. Dillon Cos.</u>, 797 F. Supp.2d 1138 (D. Colo. 2011), which was mostly about Dr. Egilman. Apparently Dr. Egilman is one of a small cadre of experts willing to testify that lesser, non-occupational exposures to diacetyl (household use) can cause the same injuries as occupational exposure. Of course, no epidemiology supports this theory (otherwise the plaintiffs wouldn’t need Dr. Egilman) so he relied on the usual bottom-of-the-barrel stuff that we’ve seen so often − animal studies (<u>id.</u> at 1153-54) and a supposed “differential diagnosis” (<u>id.</u> at 1156-57). However, despite the obvious respiratory differences between humans and rats, and Dr. Egilman’s ignoring the plaintiff’s occupational exposure to other lung irritants in his carpet cleaning business, the <u>Watson</u> court, in a very cursory analysis, held Dr. Egilman’s opinions admissible. <u>Id.</u> at 1156 (“[g]iven the evidence and authority discussed above, I conclude that Dr. Egilman’s opinions regarding both general and specific causation, with one exception, employ reliable methods and are based on sufficient, reliable data”).<br /><div> </div>But that’s not so elementary, my dear <u>Watson</u>, at least not anymore. Our correspondents were most pleased to inform us that the court in <u>Watson</u> (actually a different judge to whom the case was reassigned) recently <a href="http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/Watson.recons.pdf">agreed to reconsider</a> that order admitting Dr. Egilman − indicating that under more recent precedent the prior terse analysis that permitted Dr. Egilman’s opinions wasn’t rigorous enough.<br /><div> </div><blockquote class="tr_bq">After reviewing the Tenth Circuit’s recent pronouncement on <u>Daubert</u> challenges and the admissibility of expert testimony at trial, I reexamined pertinent documents in this matter. . . . I find that the <u>Hoffman</u> opinion may impact previous expert witness rulings including, but not limited to, Dr. David Egilman’s opinions.</blockquote><br /><a href="http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/Watson.recons.pdf">Order</a> at 1-2. Thus, the court’s going to take another look in <u>Watson</u>, and hopefully this time get it right. <br /><div> </div>Another development that sparked reconsideration in <u>Watson</u> was the exclusion decision in <u>Newkirk v. ConAgra Foods, Inc.,</u> 727 F. Supp. 2d 1006 (E.D. Wash. 2010), where the court did get it right and tossed almost identical Egilman opinions in another non-occupational exposure popcorn case. The <u>Newkirk</u> opinion contains a detailed indictment of both Egilman’s methods and conclusions (exactly what wasn’t done in <u>Watson</u>). Here are Dr. Egilman’s greatest misses, as stated in the <u>Newkirk</u> opinion:<br /><div> </div><ul><li>The Court notes that Dr. Egilman does not cite to any support for many of his statements. [describing several statements] Each of these preceding statements are important foundational assumptions on which Dr. Egilman relies for the remainder of his analysis. However, without citation to any source, the Court must conclude that those foundational statements are not based on sufficient facts or data. <u>Id.</u> at 1016-17.</li><li>Dr. Egilman’s testimony and reports contain many other examples of conclusions and opinions that he fails to document. . . . In addition to not being supported by sufficient facts or data, Dr. Egilman’s unsupported statements would not assist the fact finder in deciding the material questions in this case and may be misleading or confusing. <u>Id.</u> at 1018.</li><li>Dr. Egilman relies on existing data, mostly in the form of published studies, but draws conclusions far beyond what the study authors concluded, or Dr. Egilman manipulates the data from those studies to reach misleading conclusions of his own. <u>Id.</u></li><li>Dr. Egilman’s underlying methodology for his conclusions regarding [another expert’s] work is not reliable because he provides no basis to extrapolate from [the other expert’s] letter regarding a single patient. . . . Therefore, Dr. Egilman had no identifiable data on which to base his conclusions, and the Court has no means to analyze whether the underlying data is reliable. <u>Id.</u> at 1019.</li><li>Dr. Egilman relies on the findings of [other experts] despite their own reflections that the methodology underlying their work . . . could not support extrapolating to general causation for a broader group of consumers. <u>Id.</u> at 1020.</li><li>Dr. Egilman’s opinions fall below the threshold standard of scientific validity in other ways. . . . Coming to a conclusion first and then doing research to support it is the antithesis of this method. . . . Dr. Egilman’s conclusions . . . preceded his actual estimation of the levels of diacetyl to which [plaintiff]was exposed. <u>Id.</u> at 1021.</li><li>Dr. Egilman also fails to apply reliable scientific methods when he extrapolates from extremely small samplings to make sweeping conclusions. <u>Id.</u> at 1022.</li><li>Dr. Egilman cites no other authority for the analytical step he takes from observing that there is no accepted “safe” level of diacetyl exposure. <u>Id.</u> at 1024.</li><li>Dr. Egilman offers no analytical bridge between the animal studies finding harm from diacetyl exposure to rats and his conclusion that those studies demonstrate that diacetyl exposure causes decreased lung function and [other injuries] in humans. He offers no explanation for how and why the results of those studies can be extrapolated to humans. <u>Id.</u> at 1025-26.</li><li>Dr. Egilman’s characterization of the study as an exposure study when, by its own terms, it is not, indicates that Dr. Egilman did not reliably apply the methodology of that study to the facts of this case. <u>Id.</u> at 1026.</li><li>Dr. Egilman also includes legal conclusions throughout his expert report and affidavits. Yet Dr. Egilman has not presented any credentials to support his qualifications as a legal expert. . . . Dr. Egilman fills his expert report with “opinions” that are actually legal conclusions. <u>Id.</u></li><li>[O]ne illustration of lack of reliable methodology is when the expert has arrived at contradictory conclusions using the same methodology. In his [date] affidavits, Dr. Egilman discounts some of the very studies he relied upon in his [date] report. <u>Id.</u> at 1027.</li><li>Dr. Egilman provides no basis for his confidence in making a conclusion that the authors explicitly stated was premature without additional data. <u>Id.</u></li><li>The bulk of Dr. Egilman’s conclusions do not rise above “subjective belief or unsupported speculation.” <u>Id.</u> at 1029.</li></ul><div> </div>There’s actually more, but it’s too case specific for us to bother with.<br /><div> </div>The plaintiff appealed <u>Newkirk</u>, and last year the Ninth Circuit affirmed in all respects. The Court of Appeals needed only two paragraphs to dispose of Dr. Egilman:<br /><blockquote class="tr_bq">Dr. Egilman did not sufficiently justify his foundational assumption or refute the contrary record evidence. Moreover, as the district court observed, there were problems with Dr. Egilman’s . . . estimates of [plaintiff’s] exposure levels. In light of these concerns, we hold that the district court did not abuse its discretion in concluding that the “analytical gap between the existing data and the opinion Dr. Egilman proffers” was too large.<br /><div> </div>Because Dr. Egilman could not establish that diacetyl in microwave popcorn vapors was generally capable of causing [the lung disease in question], he could not rely on a differential diagnosis to establish that exposure to microwave popcorn had caused [plaintiff’s] medical problems. We therefore affirm the exclusion of all of Dr. Egilman’s testimony.</blockquote><br /> <br /><u>Newkirk v. ConAgra Foods Inc.</u>, 438 Fed.Appx. 607, 609 (9th Cir. 2011).<br /><div> </div>That should have been the end of the matter in <u>Newkirk</u>, but oddly it wasn’t. In addition to the plaintiff appealing in <u>Newkirk</u>, Dr. Egilman <strong><u>himself</u></strong> appealed, purportedly in his own right (we owe thanks to our correspondents for pointing this out; we would never have looked for something like that otherwise). Dr. Egilman claimed, according to the court, “that the district court abused its discretion by using defamatory language in its order.” <u>Egilman v. ConAgra Foods, Inc.</u>, No. 10-35667, <a href="http://www.ca9.uscourts.gov/datastore/memoranda/2012/09/05/10-35667.pdf">slip op.</a> at 2 (9th Cir. Sept. 5, 2012). That argument was, of course, meritless since, as we’ve <a href="http://druganddevicelaw.blogspot.com/2007/04/have-you-ever-sent-opinion-to-your.html">blogged about before</a>, the contents of a judicial opinion can’t be defamatory as a matter of law. <u>See</u> <u>Wolk v. Teledyne Industries, Inc.</u>, 475 F. Supp.2d 491, 510 (E.D. Pa. 2007) (applying Pennsylvania law). But the Ninth Circuit did not have to reach the merits to dispose of Dr. Egilman’s appeal in the <u>Newkirk</u> litigation. Instead, the court held that Dr. Egilman, as a mere retained expert, lacked standing to appeal the exclusion order:<br /><blockquote class="tr_bq">Appellant’s participation in the district court consisted of filing reports in his capacity as an expert. His participation was not akin to party participation. He did not file papers objecting to the order excluding his testimony. He did not argue the legal merits of the motion to exclude his testimony. . . . We conclude that Egilman does not have standing to appeal the district court’s order, that we lack jurisdiction, and that this appeal should be dismissed.</blockquote><br /> <br /><u>Egilman</u>, <a href="http://www.ca9.uscourts.gov/datastore/memoranda/2012/09/05/10-35667.pdf">slip op.</a> at 1-2. We confess, we’ve never had it happen to us, but if an expert ever decides to appeal his own exclusion, separately from the party retaining him/her, we now have some precedent that it can’t be done.<br /><div> </div>To be fair, we need to point out that the same Egilman opinions that were sliced, diced, and pureed in <u>Newkirk</u> were actually admitted in evidence in a Missouri case. <u>See</u> <u>Khoury v. ConAgra Foods, Inc.,</u> 368 S.W.3d 189, 193-94 (Mo. App. 2012) (describing Egilman testimony in another non-occupational popcorn exposure case). However, the jury in <u>Khoury</u> was no more gullilble than the trial and appellate judges in <u>Newkirk</u>. The Show Me State jurors weren’t shown enough because they brought back a defense verdict, <u>id.</u> at 195, so the admission of Dr. Egilman’s testimony wasn’t at issue on the <u>Khoury</u> appeal.<br /><div> </div>So perhaps the reason we haven’t heard much from Dr. Egilman in the drug/device area (not a single Westlaw mention − cases or expert databases, we checked both − in this field in the last two years) is that he’s been busy with the popcorn cases. Extrapolating from the track record we’ve just discussed, however, perhaps that’s likely to change. Since it’s always possible Dr. Egilman may resurface in drug/device litigation, we thought we’d pass along what (with our readers’ help) we’ve been able to find out about what he’s been up to.Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-11739106522633759632012-09-05T05:00:00.000-07:002012-09-28T07:09:19.397-07:00Actos Judge Defends Self (Good), Defends Federal-State Coordination (Great), and Blasts Plaintiff Lawyers (Priceless)Maybe this falls in the category of "people who live in glass houses..." but we think it is silly for lawyers to insult judges. At least when we rip an opinion, we endeavor to do so on sound doctrinal grounds. Further, when we have the temerity to jump on judicial reasoning, it is for a case where we are not involved. So call us fair-minded, cautious, or plain old chicken, but our inner compass and self of sense preservation tell us not to call our judge an oaf or an ogre. Judges can do a whole lot more to us (and our clients) than we can do to them. Mind you, we are talking about a situation where there actually is a legitimate criticism of a judge. Imagine how doltish one would have to be to call out a judge on specious grounds. <br /><br /><br /><br /><br />That is what recently happened in the Actos litigation. The federal MDL judge reached out to a New Mexico state court judge to try to coordinate schedules, and for some reason (we will get to that) that made a couple of plaintiff lawyers boiling mad. They wrote a letter to the federal judge accusing her of improper federal interference with the state court, violating comity, <em>ex parte</em> communications, and prejudicing the state court plaintiffs by delaying their case without proper notice. The answer came in the form of a judicial thunderbolt styled as a Memorandum Response in <em>Dunlavey v. Takeda Pharmaceuticals America</em>, No. 6:12-CV-1162, 2012 WL 3715456 (Aug. 23, 2012). It makes for fascinating reading. We like what the judge did, we like what the judge wrote, and we especially like the feeling of schadenfreude that washed all over us.<br /><br /><br /><br />To begin with, there is absolutely nothing wrong with a federal judge reaching out to coordinate mass proceedings with a state court judge. The whole point of an MDL or any other aggregated proceeding is to increase efficiency. Presumably such efficiency benefits all parties, as well as the judicial system. The judge supplies ample cites from the Manual for Complex Litigation, the Manual for Cooperation between the State and Federal Courts, and many other sources demonstrating that federal-state coordination is "advised, encouraged and welcomed by both the federal and state courts." 2012 WL 3715456 at *2. Clearly, "<strong>Cooperation between state and federal judges is not only advised, it is advised often</strong>." <em>Id</em>. at *1 (emphasis in original). By contrast, the plaintiffs' argument against federal-state coordination is littered with citations that constitute an exercise in "cherry picking".<em> Id</em>. at *9. (We admit it - it is rich to see that term applied against the side that is always lobbing it at us.) <br /><br /><br /><br />Most fundamentally, federal-state coordination does not constitute federal interference with state cases. The plaintiffs cite <em>Younger</em> and the Anti-Injunction Act, but nothing like an injunction was at issue here. As the court says, "this Court has not issued an injunction; this Court has not issued a temporary restraining order; this Court has not halted a legitimate state investigation; this Court has not enjoined a state officer - in short, only in the writers' correspondence do these wholly inapplicable, egregious scenarios exist." <em>Id</em>. at *4. Good stuff, right? Here, have some more: "Again, it is without question, any reference to an injunction exists only in the empty rhetoric and wholly unsupported and inapplicable argument of the writers' correspondence." <em>Id</em>. at *5. It is hard for lawyers to employ such vigorous language and make it work. From a judicial pen (or keyboard), it is powerful and terrifying. <br /><br /><br /><br />We think the judge's ire is well-earned. There is no breach of comity when a federal judge invites a state court to coordinate proceedings. The federal court cannot make the state judge do anything she does not want to do. The Actos federal judge appears to take particular umbrage at the plaintiffs' implication that the state court judge "engaged in judicial misconduct by abdicating her role as a judge of the sovereign state of New Mexico." <em>Id</em>. It turns out that the only thing that that ticks off a judge more than incorrectly attacking that judge is incorrectly attacking a fellow judge. The plaintiffs' accusation against the state court judge is "wholly specious; the facts are nonexistent, and the legal argument is, again, prostituted."<em> Id</em>. at *8. Wow. In any event, if that state judge does something that the plaintiffs think is wrong, the plaintiffs can appeal.<em> Id</em>. at *6. Or do the plaintiffs contend that the federal judge has also assumed control over the state appellate courts? <br /><br /><br /><br />The reality is that most federal and state judges want to coordinate proceedings. It simply makes sense. Good examples of that abound here in Philadelphia, where our local Court of Common Pleas judges have coordinated with federal judges. Not too long ago there was a joint federal-state hearing on admissibility of expert testimony. The lawyers and witnesses appeared at one hearing in front of the federal and state judges. That saved time and money. It does not mean that the federal court somehow hijacked the state proceedings. Indeed, everyone understood that different standards applied (<em>Daubert</em> in the federal court and <em>Frye</em> or <em>Frauber</em>t in the Pennsylvania state court) and that different rulings might result. Moreover, the state judge is fully free to decline to participate or to arrive at a different substantive ruling. Indeed, sometimes it is the state court judge that opens up the dialogue with the federal judge There is nothing wrong with coordination and everything right with it. The Memorandum Response shows that the plaintiffs' griping is wrong on the law, wrong on the facts, and wrong on policy. <br /><br /><br /><br />The plaintiffs complained that the federal judge engaged in a forbidden <em>ex parte</em> communication with the state court judge. But <em>ex parte</em> means that a judge talked with one party without letting the other party in on it. No party was involved in the communication at issue. News flash: judges talk. They are allowed to talk. It is beyond silly for the parties to complain about lack of notice. Since when are judges forbidden from picking the brains of their colleagues without alerting the lawyers? As the Actos federal judge points out, both sides were actively involved in all the hearings where the judges made decisions about management of the cases, including scheduling. <br /><br /><br /><br />The word "specious" repeatedly crops up in the Memorandum Response when referring to the plaintiffs' letter. That might be one of the kinder things the judge says about the plaintiff lawyers. While the plaintiffs lambaste the judge (both the federal and state judges, really) for imaginary ethical improprieties, the federal judge suggests that the plaintiffs are hypocrites of the worst sort. First, the plaintiffs' letter itself "was submitted unsolicited, wholly outside this Court's orders and the Federal Rules of Civil Procedure, and in total contravention to the extensive system set in place by this Court within the MDL for orderly and full interaction with the Court and among parties." <em>Id.</em> at *10. Second, the plaintiffs quoted from <em>In re Palmisano</em>, 70 F.3d 483 (7th Cir. 1995) in accusing the court of an ex parte contact, but the plaintiffs' quote was incomplete. The full quote from <em>Palmisano</em> was that the "federal courts, no less than state courts, forbid ex parte contacts and false accusations that bring the judicial system into disrepute. " 70 F.3d at 487. It was that last part that the plaintiffs omitted, and it was that last part that best describes the plaintiffs' letter.<br /><br /><br /><br />The plaintiffs' criticism of the MDL judge's effort at federal-state coordination is so wrong-headed, such an obvious misstep, that one has to ask what could have prompted it. The court calls it "an attempt to intimidate or manipulate the involved courts." <em>Id</em>. at *9. If so, it does not look like it worked. We certainly hope so, anyway. Sometimes after a court takes a lawyer to task, the court then bends over backwards to be extra nice to that lawyer so as to show no hard feelings. But there isn't any need for that here. That is especially true when we consider the other likely reasons for the plaintiffs' intemperate, inaccurate letter: <br /><br /><br /><br />1. The last thing the plaintiffs want is efficiency. They want multiple, inconsistent rulings, which would afford them the chance to forum-shop and then steer future filings to the courts with the most plaintiff-friendly rulings. It is funny how corporate defendants are always accused of trying to make proceedings unwieldy and expensive, turning litigation into a war of attrition. But we have not heard any in-house corporate lawyer talk that way for at least ten years. Companies are under cost-pressure and they hate litigation expenses. We know - we are an expense. Companies insist on cost reduction, not amplification. By contrast, some plaintiff lawyers act as if the best way to force settlement is to drag companies into multiple jurisdictions, to compel scientists and executives to appear for multiple depositions, and to make the whole litigation process a crazy-quilt mess. When judges from multiple jurisdictions try to coordinate schedules to streamline the process, they are derailing a key plaintiff strategy. Plaintiffs might write nasty letters about it. If we wrote anything, it would be a thank-you note.<br /><br /><br /><br />2. Maybe this is inside baseball and an area where we have less than perfect knowledge, but in some litigations it seems like the most brutal battles are among the various plaintiff lawyers. In an MDL, lead lawyers are appointed. Not surprisingly, those lead lawyers get the most control and, eventually, the most fees. Fees are also affected by a plaintiff lawyer's activity, such as depositions, even if such depositions are pointless or poorly done. If a plaintiff lawyer is not one of the lead lawyers in an MDL, that lawyer might seek to gin up activity in another jurisdiction. It is understandable, but it is not a legitimate reason to prevent federal-state coordination. In such a circumstance, characterizing federal-state coordination as being illegitimate or unethical would not only be wrong and self-destructive, it would be an ugly act of petulance. <br /><br /><br /><br />In the end, the plaintiffs' goals are irrelevant. What is relevant is that the Actos federal judge's commencement of federal-state coordination was correct, will continue to be correct, and, we hope, will continue to be undeterred. <br /><br /><br /><br /><br /><br /><br /><br />Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-61327463507218094442012-09-04T13:21:00.000-07:002012-09-28T07:09:19.640-07:00No Off-Label Promotion In The Air<div class="MsoNormal" style="margin: 12pt 0in;"><span style="mso-tab-count: 1;"> <span style="font-family: inherit;"> </span></span><span style="font-family: inherit;">If yesterday was the unofficial end of summer, for many of us today is the unofficial start of Fall – in other words, back-to-school day.<span style="mso-spacerun: yes;"> </span>Lunches and backpacks packed, pencils sharpened, flip flops traded for sneakers and slick new hair cuts.<span style="mso-spacerun: yes;"> </span>In the Philly/New Jersey area it is a soggy first day of school, but you can feel the excitement nonetheless.<span style="mso-spacerun: yes;"> </span>The kids are excited to see who is in their class and learn what their friends have been up to all summer.<span style="mso-spacerun: yes;"> </span>The parents – well, we all know why we’re excited.<span style="mso-spacerun: yes;"> </span>At least until the first major project is due that our child forgot to tell us about and now it’s Sunday night around eight pm and you’re driving around trying to find a store that is still open that sells glue sticks and poster board.<span style="mso-spacerun: yes;"> </span>But, let’s not get ahead of ourselves.<span style="mso-spacerun: yes;"> </span>Instead, we’ll sit back and wave to our kids as they head for the buses and schoolyards and we’ll bring you a nice piece of news from the District of Oregon.<span style="mso-spacerun: yes;"> </span><span style="font-family: 'Times New Roman','serif'; font-size: 12pt; mso-ansi-language: EN-US; mso-bidi-font-size: 10.0pt; mso-bidi-language: AR-SA; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">Well, it's not all nice and that's why we decided to post about it today -- when we mourn the end of summer but celebrate a new school year.</span></span><br /><br /><span style="font-family: 'Times New Roman','serif'; font-size: 12pt; mso-ansi-language: EN-US; mso-bidi-font-size: 10.0pt; mso-bidi-language: AR-SA; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;"></span><span style="font-family: inherit;"><span style="mso-tab-count: 1;"> </span>The case is <u>Teater v. Pfizer, Inc.</u>, 2012 U.S. Dist. LEXIS 122848 (D. Ore. Jun. 27, 2012) and it involves alleged off-label promotion of the drug Neurontin.<span style="mso-spacerun: yes;"> </span>Plaintiff was prescribed Neurontin for her post-traumatic stress disorder (“PTSD”) which was an off-label use.<span style="mso-spacerun: yes;"> </span>Plaintiff alleged that she suffered a whole host of side effects, including depression and attempted suicide.<span style="mso-spacerun: yes;"> </span><u>Id.</u> at *3-4.<span style="mso-spacerun: yes;"> </span>Plaintiff’s complaint alleged causes of action for: (1) violations of RICO; (2) fraud; (3) violations of the Oregon Unlawful Trade Practices Act (“UTPA”); (4) unjust enrichment; and (5) products liability (breach of warranty, strict liability and negligence) – all based on allegations of off-label promotion.<span style="mso-spacerun: yes;"> </span><u>Id.</u> at *7.<span style="mso-spacerun: yes;"> </span>The court dismissed all but her products liability claims and here is how the court did it.</span></div><div class="MsoNormal" style="margin: 12pt 0in;"><span style="font-family: inherit;"><span style="mso-tab-count: 1;"> </span><i style="mso-bidi-font-style: normal;">RICO</i> – no standing.<span style="mso-spacerun: yes;"> </span>To sustain a RICO claim, plaintiff has to demonstrate an injury to “a specific business or property interest” and “a concrete financial loss.”<span style="mso-spacerun: yes;"> </span><u>Id.</u> at *8.<span style="mso-spacerun: yes;"> </span><span style="font-family: 'Times New Roman','serif'; font-size: 12pt; mso-ansi-language: EN-US; mso-bidi-font-size: 10.0pt; mso-bidi-language: AR-SA; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">Plaintiff Teater alleged that she suffered a business injury when side effects from her use of Nuerontin rendered her unable to make payments on business equipment, which was then auctioned off.</span><span style="mso-spacerun: yes;"> </span><u>Id.</u> at *9-10.<span style="mso-spacerun: yes;"> </span>Not so said the court.<span style="mso-spacerun: yes;"> </span>“Plaintiff has only pled injuries that derive from the alleged psychological side effects and/or emotional distress caused by her consumption of Neurontin.”<span style="mso-spacerun: yes;"> </span><u>Id.</u> at *11-12.<span style="mso-spacerun: yes;"> </span>This is nothing more than standard monetary damages alleged to be the result of side effects of a prescription drug – “hallmark personal injury damages.”<span style="mso-spacerun: yes;"> </span><u>Id.</u> at *11.<span style="mso-spacerun: yes;"> </span>Not a RICO injury.<span style="mso-spacerun: yes;"> </span></span></div><div class="MsoNormal" style="margin: 12pt 0in;"><span style="font-family: inherit;"><span style="mso-tab-count: 1;"> </span><i style="mso-bidi-font-style: normal;">Fraud-based claims</i>—failed to plead with particularity.<span style="mso-spacerun: yes;"> </span>The court dismissed all three of plaintiff’s fraud causes of action – fraud, violations of the UTPA and unjust enrichment – because you can’t allege off-label promotion in the air.<span style="mso-spacerun: yes;"> </span>As the court explained, </span></div><blockquote class="tr_bq"><span style="font-family: inherit;">Plaintiff asserts she justifiably relied upon Defendant's misrepresentations and, accordingly, consumed Neurontin as prescribed by her physicians in the treatment of PTSD, but Plaintiff fails to mention any pharmaceutical representative that called her clinic or when this allegedly took place. Accordingly, Plaintiff's allegations are insufficient to meet the pleading standards for fraud-based claims.</span></blockquote><div class="MsoNormal" style="margin: 12pt 0in;"><span style="font-family: inherit;"><u>Id.</u> at *18-19.<span style="mso-spacerun: yes;"> </span></span></div><div class="MsoNormal" style="margin: 12pt 0in; text-indent: 0.5in;"><span style="font-family: inherit;">It is not enough under Rule 9(b)’s heightened pleading standard to allege that statements were made without also providing “the who, what, when, where, and how of the misconduct charged.”<span style="mso-spacerun: yes;"> </span><u>Id.</u> at *18.<span style="mso-spacerun: yes;"> </span>Applying this standard, with which we wholeheartedly agree, plaintiffs alleging off-label promotion as a basis for fraud can’t get passed the pleadings stage without identifying the pharmaceutical representative who allegedly promoted the drug off-label, what the representative said to plaintiff’s prescriber, when such statements were made and how they impacted the physician’s decision to prescribe the drug to plaintiff.<span style="mso-spacerun: yes;"> </span>All of that was lacking in <u>Teater</u>.<span style="mso-spacerun: yes;"> </span></span></div><div class="MsoNormal" style="margin: 12pt 0in; text-align: justify; text-indent: 0.5in;"><span style="font-family: inherit;">Those same holes in plaintiff’s allegations also led the court to find that plaintiff had failed to sufficiently allege causation to support her UTPA violation claim.<span style="mso-spacerun: yes;"> </span>Plaintiff’s complaint failed to alleged “any connection between Defendants' marketing or advertising campaigns and Plaintiff's unnamed physicians’ decision to prescribe her Neurontin.”<span style="mso-spacerun: yes;"> </span><u>Id.</u> at *24.<span style="mso-spacerun: yes;"> </span></span></div><blockquote class="tr_bq"><span style="font-family: inherit;">Plaintiff does not identify a single statement or misrepresentation by Defendants to which Plaintiff or her prescribing physicians were even exposed, no less relied upon, nor does she allege any facts regarding her healthcare provider's decision to prescribe Neurontin.<span style="mso-spacerun: yes;"> </span>Even accepting Plaintiff's allegations as true, Plaintiff has failed to plead factual content that allows a reasonable inference to be drawn that Defendants are liable for the misconduct alleged. </span></blockquote><div class="MsoNormal" style="margin: 12pt 0in; text-align: justify;"><span style="font-family: inherit;"><u>Id.</u> at *24-25.<span style="mso-spacerun: yes;"> </span></span></div><div class="MsoNormal" style="margin: 12pt 0in; text-align: justify;"><span style="font-family: inherit;"><span style="mso-tab-count: 1;"> </span>Now, we were somewhat disheartened that the court didn’t apply this same rationale to the products liability claims.<span style="mso-spacerun: yes;"> </span>From the allegations cited in the decision, it appears plaintiff’s strict liability, negligence and breach of warranty claims were premised on the same flawed and deficient allegations of off-label promotion.<span style="mso-spacerun: yes;"> </span>If plaintiff failed to allege that her physician relied on statements by defendant in making his prescribing decision – we believe that is likewise fatal to her products claims.<span style="mso-spacerun: yes;"> </span>But, the decision doesn’t contain much of a description of why the court came out the way it did, so we won’t belabor the point.</span></div><div class="MsoNormal" style="margin: 12pt 0in; text-align: justify;"><span style="font-family: inherit;"><span style="mso-tab-count: 1;"> </span>Finally, the court decided to give plaintiff one more try – not surprising given the Ninth Circuit’s extremely liberal amendment policy.<span style="mso-spacerun: yes;"> </span><u>Id.</u> at *27.<span style="mso-spacerun: yes;"> </span><span style="font-family: 'Times New Roman','serif'; font-size: 12pt; mso-ansi-language: EN-US; mso-bidi-font-size: 10.0pt; mso-bidi-language: AR-SA; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">This leads to the other aspect of this case that we weren't particularly happy with -- plaintiff gets the chance to depose a sales rep before she files her amended complaint to presumably see if she can uncover some facts to support her bare bones allegations.<span style="mso-spacerun: yes;"> </span>Wait, isn't that the very definition of a fishing expedition that the Supreme Court said wasn't allowed:</span></span></div><div class="MsoNormal" style="margin: 12pt 0in; text-align: justify;"><span style="font-family: 'Times New Roman','serif'; font-size: 12pt; mso-ansi-language: EN-US; mso-bidi-font-size: 10.0pt; mso-bidi-language: AR-SA; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;"><blockquote class="tr_bq"><span style="font-family: inherit;">We decline respondent’s invitation to relax the pleading requirements on the ground that the Court of Appeals promises petitioners minimally intrusive discovery. . . .<span style="mso-spacerun: yes;"> </span><b><u>Because respondent’s complaint is deficient under Rule 8, he is not entitled to discovery, cabined or otherwise</u></b>.</span></blockquote></span></div><div class="MsoNormal" style="margin: 12pt 0in; text-align: justify;"><span style="font-family: 'Times New Roman','serif'; font-size: 12pt; mso-ansi-language: EN-US; mso-bidi-font-size: 10.0pt; mso-bidi-language: AR-SA; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;"><span style="font-family: inherit;"><span style="font-family: 'Times New Roman','serif'; font-size: 12pt; mso-ansi-language: EN-US; mso-bidi-font-size: 10.0pt; mso-bidi-language: AR-SA; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;"><u>Ashcroft v. Iqbal</u></span><span style="font-family: 'Times New Roman','serif'; font-size: 12pt; mso-ansi-language: EN-US; mso-bidi-font-size: 10.0pt; mso-bidi-language: AR-SA; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">, 129 S. Ct. 1937, 1953-54 (2009) (emphasis added).<span style="mso-spacerun: yes;"> </span>A disappointing shunning of Supreme Court precedent.</span></span></span></div><div class="MsoNormal" style="margin: 12pt 0in; text-align: justify;"><span style="font-family: 'Times New Roman','serif'; font-size: 12pt; mso-ansi-language: EN-US; mso-bidi-font-size: 10.0pt; mso-bidi-language: AR-SA; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;"></span><span style="font-family: inherit;"> Now we know that more often than not, even after the depositions of sales reps and prescribers, it is difficult for plaintiffs to establish that specific statements were relied on in making prescribing decisions for any given plaintiff.<span style="mso-spacerun: yes;"> </span>So, we remain optimistic that the court’s rulings on what is necessary to establish fraud and causation will carry over to an eventual win – either on the amended complaint or at the summary judgment stage.<span style="mso-spacerun: yes;"> </span>If we find out, we’ll let you know.</span></div>Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-4305134764559995962012-08-31T14:43:00.000-07:002012-09-28T07:09:19.491-07:00What Is Buckman?We’re rather tired of the other side, abetted by the flawed reasoning in <u>Desiano v. Warner Lambert & Co.</u>, 467 F.3d 85 (2d Cir. 2006), <u>aff’d by equally divided court</u>, 552 U.S. 440 (2008), attempting to distinguish <u>Buckman Co. v. Plaintiffs Legal Committee</u>, 531 U.S. 341 (2001), into oblivion as relating to nothing more than a “separate, freestanding” claim for “fraud on the FDA.” We’ve argued until we’re blue in the face that <u>Buckman</u> (which was unanimous, but with a concurrence) was so much more than that; specifically an implied preemption case with broad implications. Most courts get it, but enough don’t that we thought we’d investigate a little further. So we’ve asked ourselves the question, What has the Supreme Court itself had to say about <u>Buckman</u> in the decade-plus since it’s been decided?<br /><br /><br />We ran a quick search and found that the Supreme Court has cited its <u>Buckman</u> decision seven times. We’ll look at the drug/device cases first. In <u>PLIVA v. Mensing</u>, 131 S. Ct. 2567 (2011), the Court cited <u>Buckman</u> as a “cf.” (that’s an abbreviation of the Latin “confer” meaning to compare/consult) to the plaintiffs’ “take steps” argument (which the Court rejected) that the manufacturer should have asked the FDA for help. <u>Id.</u> at 2578. Did the <u>Mensing</u> majority limit <u>Buckman</u> to a freestanding count for fraud on the FDA? Hardly. Instead, it described <u>Buckman</u> just the way we do, as “holding that federal drug and medical device laws pre-empted a state tort-law claim based on failure to properly communicate with the FDA.” <u>Id.</u> That’s how <u>Buckman</u> should be read − that any state-law claims purporting to intrude on a defendant’s communications with the FDA are preempted. The quality of a regulated entity’s communications with a federal agency is simply none of state law’s business.<br /><br />That’s one.<br /><br />Then there’s <u>Wyeth v. Levine</u>, 555 U.S. 555 (2009), the case we most love to hate. <u>Levine</u> also discussed <u>Buckman</u>, albeit in dueling footnotes, this time in the context of the “presumption against preemption.” <u>Id.</u> at 565 n.3. <u>Buckman</u> was not, the majority noted, apt precedent for rejecting that presumption entirely in implied preemption cases, because it “involved state-law fraud-on-the-agency claims, and the Court distinguished state regulation of health and safety as matters to which the presumption does apply.” <u>Id.</u> Even in this worst case (which is what <u>Levine</u> is) scenario, the discussion is confined to the scope of a presumption (which later couldn’t muster a majority in <u>Mensing</u>) rather than addressing preemption directly. <u>Levine</u> certainly is not limited to anything about freestanding claims.<br /><br />The Levine dissent, of course, gave <u>Buckman</u> an even broader application:<br /><br /><blockquote class="tr_bq">Petitioner’s dealings with the FDA were prompted by federal law, and the very subject matter of petitioner's statements to the FDA were dictated by federal law. Accordingly − and in contrast to situations implicating federalism concerns and the historic primacy of state regulation of matters of health and safety − no presumption against pre-emption obtains.</blockquote><u>Id.</u> at 624 & n.14 (citation and quotation marks omitted). While we obviously prefer the <u>Levine</u> dissent, there doesn’t seem to be any support − in the <u>Levine</u> majority or dissent − for not applying <u>Buckman</u>’s rationale to any situation implicating the information submitted by a regulated entity to its regulating authority.<br /><br />That’s two − actually call it 2½, since <u>Buckman</u> was string-cited (with no separate discussion) for basically the same presumption-related proposition by the dissent in <u>Altria Group, Inc. v. Good</u>, 555 U.S. 70, 99 (2008) (the majority in <u>Good</u> not mentioning it at all).<br /><br />The Court’s most recent invocations of <u>Buckman</u> are in <u>Arizona v. United States</u>, 132 S.Ct. 2492 (2012), and <u>Chamber of Commerce v. Whiting</u>, 131 S.Ct. 1968 (2011), both involving immigration. In <u>Arizona</u> all but one of the provisions of a state statute were held preempted by federal law. The mere fact that both the majority and the dissent considered <u>Buckman</u> relevant indicates that it can’t be cabined in the manner plaintiffs so often attempt. The majority cited <u>Buckman</u> as authority (albeit “cf.” authority) for the proposition that “[p]ermitting the State to impose its own penalties for the federal offenses here would conflict with the careful framework Congress adopted.” <u>Id.</u> at 2502-03 (describing <u>Buckman</u> holding as “States may not impose their own punishment for fraud on the Food and Drug Administration”). That’s all federal offenses, folks, not just the FDCA. The dissent in <u>Arizona</u> essentially agreed:<br /><br /><blockquote class="tr_bq">In some areas of uniquely federal concern − <em>e.g.</em>, fraud in a federal administrative process . . . this Court has held that a State has no legitimate interest in enforcing a federal scheme.</blockquote><br /><u>Id.</u> at 2518. The dissent in <u>Arizona</u> just didn’t think that “federal alien registration” was as uniquely federal as litigation involving the sanctity of federal administrative proceedings. <u>Id.</u> Again − nothing in either opinion supporting a limitation based upon how a plaintiff chooses to plead such “fraud.”<br /><br />In <u>Whiting</u>, a plurality (this case is split in more ways than are worth describing) distinguished <u>Buckman</u> on grounds similar to the dissent in <u>Arizona</u>. <u>Buckman</u> involved a “uniquely federal area[] of regulation,” specifically “state actions that directly interfered with the operation of a federal program.” 131 S.Ct. at 1983. <u>Buckman</u> was:<br /><br /><blockquote class="tr_bq">[a] determin[ation] that allowing a state tort action would cause applicants before a federal agency to submit a deluge of information that the agency neither wants nor needs, resulting in additional burdens on the agency’s evaluation of an application, and harmful delays in the agency process.</blockquote><br /><u>Id.</u> (citation and quotation marks omitted). Thus, whenever such “interference” − which impacted upon the quality and quantiy of information submitted to a federal agency (notably the Court substituted “agency” for “FDA”) − was present, preemption would exist. <u>Id.</u> The dissent agreed, relying on <u>Buckman</u>’s holding that the “relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law.” <u>Id.</u> at 2006. Thus we find in <u>Whiting</u> (in more than one of its multiple opinions) additional support for a broad reading of <u>Buckman</u> as applicable to all communications with all federal agencies.<br /><br />Finally, <u>Buckman</u> has also been cited solely in dissents and concurrences. In <u>Thompson v. Western States Medical Center</u>, 535 U.S. 357 (2002), Justice Thomas’ dissent cited (“cf.” again) <u>Buckman</u> for an extremely broad proposition − that “flexibility” is “necessary if FDA is to pursue difficult (and often competing) objectives.” <u>Id.</u> at 389. It’s only one justice, but again <u>Buckman</u> is recognized as standing for a proposition much more extensive than what to do with a peculiar type of claim. In <u>Sorrell v. IMS Health Inc.</u>, 131 S.Ct. 2653, 2678 (2011), <u>Buckman</u> was also cited by the dissent (once again as a “cf.”), this time for its discussion of off-label use. That’s a more limited issue, but still one that’s not limited by any particular claim.<br /><br />What we make of all this is that, on several occasions − in <u>Mensing</u>, <u>Whiting</u>, and <u>Arizona</u> for sure, and to a lesser extent in <u>Levine</u> − the Supreme Court has had occasion to comment upon what its holding in <u>Buckman</u> was all about. In those cases, <u>Buckman</u> has been described as relating to state-law-based evaluation of the communication between a regulated person (including but not limited to drug/device manufacturers) and its federal regulating authority (including but not limited to the FDA). In no case has the Supreme Court held, described, or suggested that <u>Buckman</u> is somehow limited to how a plaintiff denominates such a claim in his/her pleadings. In sum, there’s no support in any Supreme Court case for the rationale followed by the Second Circuit in the <u>Desiano</u> case, and only Justice Roberts’ unfortunate recusal prevented the Supreme Court from tossing it then and there.Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.comtag:blogger.com,1999:blog-6352144184333244886.post-74064255705840691082012-08-30T13:08:00.000-07:002012-09-28T07:09:19.680-07:00The Latest From Aredia/ZometaYeah, we know that <a href="http://www.hollingsworthllp.com/people.php?PeopleID=43">Joe Hollingsworth</a> − among his many other talents − likes to publicize his wins (who doesn't, we plead guilty). But that’s okay. When he sends us stuff from the <u>Aredia/Zometa</u> wars that’s worth publicizing, we’ll use it; otherwise, we blog about something else. It just so happens that the latest items we’ve been graced with are worth knowing about.<br /><br /><br />First, there’s what looks like the end of the line for the <u>Hogan</u> case. We’ve been following that one for several years. <u>Hogan</u> was particularly notable because it involved a Rhode Island plaintiff, and there’s just not that much Rhode Island law on anything.<br /><br />Our prior <u>Hogan</u>-related posts:<br /><br />First, the defendant lost a summary judgment motion in the MDL, <u>In re Aredia & Zometa Products Liability Litigation</u>, 2009 WL 2513555 (M.D. Tenn. Aug. 13, 2009), as we <a href="http://druganddevicelaw.blogspot.com/2009/08/from-zyprexa-to-aredia-summary-judgment.html">mentioned here</a>, in the context of keeping score. At that point, we thought that the Zyprexa defense folks were having better luck with their summary judgment motions than the A-Z folks.<br /><br />Then things got better. The next time we <a href="http://druganddevicelaw.blogspot.com/2011/04/hogans-heroic.html">looked in</a>, <u>Hogan</u> had evidently been remanded from the MDL, because a court in New York (the forum choices in A/Z often leave us scratching out heads) took a pro-defense position on subsequent remedial measures − finding them to be “procedural” and thus applying the federal rules (rather than a peculiarly pro-plaintiff Rhode Island state rule). <u>Hogan v. Novartis Pharmaceuticals Corp.</u>, 2011 WL 1336566 (E.D.N.Y. April 6, 2011).<br /><br />We <a href="http://druganddevicelaw.blogspot.com/2011/05/daubert-done-right.html">checked back in</a> not much later for a truly excellent <u>Daubert</u> ruling − excluding the notorious Dr. Parisian and another plaintiff’s expert. <u>Hogan v. Novartis Pharmaceuticals Corp.</u>, 2011 WL 1533467 (E.D.N.Y. April 24, 2011). Unfortunately the court also dodged a prediction of whether Rhode Island would adopt the learned intermediary rule. <u>Id.</u> at *9. That meant Hogan only received an honorable mention in our <a href="http://druganddevicelaw.blogspot.com/2011/12/top-ten-best-prescription-drugmedical.html">2011 top ten list</a>.<br /><br />So fortified, the defense then went out and won the trial. We <a href="http://druganddevicelaw.blogspot.com/2011/05/defense-verdict-in-hogan.html">blogged on that</a>, too, even though verdicts don't usually come with much to blog about, because at trial the court finally predicted − a first we believe − that Rhode Island would adopt the learned intermediary rule. Rhode Island had previously been the only state in the country with no learned intermediary rule precedent at all. We called it “The Closing of the Learned Intermediary Frontier.”<br /><br />Well, now the defense has won the inevitable appeal in <u>Hogan</u>, too. Here’s a <a href="http://www.ca2.uscourts.gov/decisions/isysquery/6e3991c7-4a9b-4a19-b61d-8054515d9a56/21/doc/11-2648_so.pdf#xml=http://www.ca2.uscourts.gov/decisions/isysquery/6e3991c7-4a9b-4a19-b61d-8054515d9a56/21/hilite/">copy of the opinion</a>. Did the plaintiff appeal the subsequent remedial measure ruling? Doesn’t look like it. Did the plaintiff appeal exclusion of Parisian? Again, it’s not even mentioned in the opinion. Finally, did the plaintiff appeal on the learned intermediary rule? Nope.<br /><br />With all these interesting legal issues in the <u>Hogan</u> case, what went up?<br /><br />The only issue the Second Circuit discussed was whether the plaintiff’s screw up in failing to make timely arrangements to obtain the live testimony of one of the treaters. <u>Hogan</u>, <a href="http://www.ca2.uscourts.gov/decisions/isysquery/6e3991c7-4a9b-4a19-b61d-8054515d9a56/21/doc/11-2648_so.pdf#xml=http://www.ca2.uscourts.gov/decisions/isysquery/6e3991c7-4a9b-4a19-b61d-8054515d9a56/21/hilite/">slip op.</a> at 3-4. After all that time and effort, what we’re left with is a discretionary procedural ruling.<br /><br />Bravo Foxtrot Delta.<br /><br />Thus endeth the <u>Hogan</u> litigation, with a whimper not a bang.<br /><br />We get more bang for our blogging buck with the other recent A-Z opinion, <u>Patterson v. Novartis, Inc.</u>, C.A. No. 11-402 ML, <a href="http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/Patterson.pdf">slip op.</a> (D.R.I. Aug. 28, 2012). First of all, <u>Patterson</u> was a statute of limitations dismissal. We don’t usually cover those, because the facts are very case-specific, and the law is very state-specific.<br /><br />But we have exceptions. One of those exceptions is the issue of cross-jurisdictional class action tolling of the statute of limitations. We feel strongly enough about that ill-conceived notion that we devote <a href="http://druganddevicelaw.blogspot.com/2008/08/cross-jurisdictional-class-action.html">one of our scorecards</a> to it.<br /><br />That issue came up in <u>Patterson</u> − but first, the case's rather tortured procedural history:<br /><br /><blockquote class="tr_bq">Plaintiffs initially pursued a claim against Defendant and the generic pharmaceutical drug manufacturers in the United States District Court for the District of Columbia on March 5, 2009. On November 9, 2009, the claims against Novartis were separated from the claims against the generic drug manufacturers by the United States Judicial Panel on Multidistrict Litigation. The claims against Aredia were transferred to the [Aredia/Zometa MDL]. . . . Novartis moved to dismiss Plaintiffs’ claims against it pursuant to Fed. R. Civ. P. 12(c) on the ground that the use of “and/or” to describe the drug manufacturer was insufficient to state a claim for relief against Novartis. Over Plaintiffs’ Objection, the [MDL] Court . . . granted the Motion and dismissed Plaintiffs’ Complaint pursuant to Fed. R. Civ. P. 12(c). Plaintiffs appealed . . . and their appeal was denied. Shortly thereafter, Plaintiffs refiled the case in this District.</blockquote><br /><u>Patterson</u>, <a href="http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/Patterson.pdf">slip op.</a> at 2-3.<br /><br />Basically the <u>Patterson</u> plaintiff failed to identify the defendant as the manufacturer, instead using weasel words “and/or” to muddy up his complaint. Although plaintiffs used to be able to get away with that kind of thing, <u>TwIqbal</u> precludes that kind of vague language – as we discussed in <a href="http://druganddevicelaw.blogspot.com/2009/07/vague-pleading-barred-under-iqbal-andor.html">this post</a>, back in 2009, specifically about "and/or".<br /><br />Only after playing out the string in the MDL did the plaintiff in <u>Patterson</u> bother with filing a new complaint. By that time the statute of limitations had run. It turns out that, despite filing the original complaint in DC, litigating it in Tennessee, and ultimately filing a second action in Rhode Island, plaintiff was really a Massachusetts resident. Again, we have no idea why the plaintiff made some of the tactical choices he did − and apparently neither did the court. <u>Patterson</u>, <a href="http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/Patterson.pdf">slip op.</a> at 11.<br /><br />The plaintiff offered four arguments why he should be allowed to skate under a three-year statute of limitations despite filing the complaint six years after the injury. We don’t care about two of them: the discovery rule (too fact specific), and equitable tolling (too state specific).<br /><br />We care a little about the Massachusetts saving statute argument, but only because that demonstrates that a <u>TwIqbal</u> dismissal is on the merits, and not merely a “matter of form.” “The case law is clear that a dismissal under Rule 12 is a final decision on the merits.” <u>Patterson</u>, <a href="http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/Patterson.pdf">slip op.</a> at 9. A dismissal on the merits cannot be revived by a saving statute.<br /><br />We care a lot about the cross-jurisdictional class action tolling issue. The court (sitting in Rhode Island) refused to become the first court anywhere to predict that Massachusetts would allow an out of state class action (here, in the MDL court in Tennessee) toll its statute of limitations:<br /><br /><blockquote class="tr_bq">Plaintiffs’ cross-jurisdictional class-action tolling argument asks this Court to engage in an exercise of legal gymnastics to save Plaintiffs’ Complaint. In particular, Plaintiffs argue that the filing of an Aredia class action in Tennessee tolled the statute of limitations nationally until such action was dismissed on November 14, 2007. The issue of such tolling is controversial, and Plaintiffs have not identified any Massachusetts cases adopting the theory. Moreover, the case law indicates that “few states” adopt such tolling for class actions filed in another jurisdiction and that “several federal courts have declined to import the doctrine into state law where it did not previously exist.” I decline to apply cross-jurisdictional class action tolling in the present case, since Plaintiffs have not shown that Massachusetts has adopted tolling of this nature, nor that it would. It is not this Court’s role sitting in diversity to create new state law in Massachusetts; thus I reject the arguments advanced by Plaintiffs on these grounds.</blockquote><br /><u>Patterson</u>, <a href="http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/Patterson.pdf">slip op.</a> at 10-11 (citations omitted).<br /><br />Bingo! Not only does <u>Patterson</u> go onto our cross-jurisdictional tolling scorecard as the first Massachusetts decision on the issue, but it warms our blogging hearts to see a federal court refusing to make wildly expansive predictions of state tort law under the <u>Erie</u> doctrine (another proposition we’ve advocated here at DDLaw since the beginning).<br /><br />Thus, we follow <u>Aredia/Zometa</u> not because Joe makes it easy − although that helps − but because (like <u>Bone Screw</u> before it), that litigation raises a host of interesting issues. We wish the defense well as it tackles the difficult task (again, like <u>Bone Screw</u>) of “winning” a mass tort after remand from the MDL.<br />Chikitahttp://www.blogger.com/profile/16207563376987457406noreply@blogger.com