Friday, August 31, 2012

What Is Buckman?

We’re rather tired of the other side, abetted by the flawed reasoning in Desiano v. Warner Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d by equally divided court, 552 U.S. 440 (2008), attempting to distinguish Buckman Co. v. Plaintiffs Legal Committee, 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 Buckman (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 Buckman in the decade-plus since it’s been decided?

We ran a quick search and found that the Supreme Court has cited its Buckman decision seven times.  We’ll look at the drug/device cases first.  In PLIVA v. Mensing, 131 S. Ct. 2567 (2011), the Court cited Buckman 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.  Id. at 2578.  Did the Mensing majority limit Buckman to a freestanding count for fraud on the FDA?  Hardly.  Instead, it described Buckman 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.”  Id.  That’s how Buckman 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.

That’s one.

Then there’s Wyeth v. Levine, 555 U.S. 555 (2009), the case we most love to hate.  Levine also discussed Buckman, albeit in dueling footnotes, this time in the context of the “presumption against preemption.” Id. at 565 n.3.  Buckman 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.”  Id.  Even in this worst case (which is what Levine is) scenario, the discussion is confined to the scope of a presumption (which later couldn’t muster a majority in Mensing) rather than addressing preemption directly.  Levine certainly is not limited to anything about freestanding claims.

The Levine dissent, of course, gave Buckman an even broader application:

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.
Id. at 624 & n.14 (citation and quotation marks omitted).  While we obviously prefer the Levine dissent, there doesn’t seem to be any support − in the Levine majority or dissent − for not applying Buckman’s rationale to any situation implicating the information submitted by a regulated entity to its regulating authority.

That’s two − actually call it 2½, since Buckman was string-cited (with no separate discussion) for basically the same presumption-related proposition by the dissent in Altria Group, Inc. v. Good, 555 U.S. 70, 99 (2008) (the majority in Good not mentioning it at all).

The Court’s most recent invocations of Buckman are in Arizona v. United States, 132 S.Ct. 2492 (2012), and Chamber of Commerce v. Whiting, 131 S.Ct. 1968 (2011), both involving immigration.  In Arizona 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 Buckman relevant indicates that it can’t be cabined in the manner plaintiffs so often attempt.  The majority cited Buckman 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.”  Id. at 2502-03 (describing Buckman 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 Arizona essentially agreed:

In some areas of uniquely federal concern − e.g., fraud in a federal administrative process . . . this Court has held that a State has no legitimate interest in enforcing a federal scheme.

Id. at 2518.  The dissent in Arizona just didn’t think that “federal alien registration” was as uniquely federal as litigation involving the sanctity of federal administrative proceedings.  Id.  Again − nothing in either opinion supporting a limitation based upon how a plaintiff chooses to plead such “fraud.”

In Whiting, a plurality (this case is split in more ways than are worth describing) distinguished Buckman on grounds similar to the dissent in ArizonaBuckman 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.  Buckman was:

[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.

Id. (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.  Id.  The dissent agreed, relying on Buckman’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.”  Id. at 2006.  Thus we find in Whiting (in more than one of its multiple opinions) additional support for a broad reading of Buckman as applicable to all communications with all federal agencies.

Finally, Buckman has also been cited solely in dissents and concurrences.  In Thompson v. Western States Medical Center, 535 U.S. 357 (2002), Justice Thomas’ dissent cited (“cf.” again) Buckman for an extremely broad proposition − that “flexibility” is “necessary if FDA is to pursue difficult (and often competing) objectives.”  Id. at 389.  It’s only one justice, but again Buckman is recognized as standing for a proposition much more extensive than what to do with a peculiar type of claim.  In Sorrell v. IMS Health Inc., 131 S.Ct. 2653, 2678 (2011), Buckman 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.

What we make of all this is that, on several occasions − in Mensing, Whiting, and Arizona for sure, and to a lesser extent in Levine − the Supreme Court has had occasion to comment upon what its holding in Buckman was all about.  In those cases, Buckman 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 Buckman 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 Desiano case, and only Justice Roberts’ unfortunate recusal prevented the Supreme Court from tossing it then and there.

Thursday, August 30, 2012

The Latest From Aredia/Zometa

Yeah, we know that Joe Hollingsworth − 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 Aredia/Zometa 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.

First, there’s what looks like the end of the line for the Hogan case.  We’ve been following that one for several years.  Hogan was particularly notable because it involved a Rhode Island plaintiff, and there’s just not that much Rhode Island law on anything.

Our prior Hogan-related posts:

First, the defendant lost a summary judgment motion in the MDL, In re Aredia & Zometa Products Liability Litigation, 2009 WL 2513555 (M.D. Tenn. Aug. 13, 2009), as we mentioned here, 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.

Then things got better.  The next time we looked in, Hogan 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).  Hogan v. Novartis Pharmaceuticals Corp., 2011 WL 1336566 (E.D.N.Y. April 6, 2011).

We checked back in not much later for a truly excellent Daubert ruling − excluding the notorious Dr. Parisian and another plaintiff’s expert.  Hogan v. Novartis Pharmaceuticals Corp., 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.  Id. at *9.  That meant Hogan only received an honorable mention in our 2011 top ten list.

So fortified, the defense then went out and won the trial.  We blogged on that, 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.”

Well, now the defense has won the inevitable appeal in Hogan, too.  Here’s a copy of the opinion.  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.

With all these interesting legal issues in the Hogan case, what went up?

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.  Hogan, slip op. at 3-4.  After all that time and effort, what we’re left with is a discretionary procedural ruling.

Bravo Foxtrot Delta.

Thus endeth the Hogan litigation, with a whimper not a bang.

We get more bang for our blogging buck with the other recent A-Z opinion, Patterson v. Novartis, Inc., C.A. No. 11-402 ML, slip op. (D.R.I. Aug. 28, 2012).  First of all, Patterson 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.

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 one of our scorecards to it.

That issue came up in Patterson − but first, the case's rather tortured procedural history:

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.

Patterson, slip op. at 2-3.

Basically the Patterson 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, TwIqbal precludes that kind of vague language – as we discussed in this post, back in 2009, specifically about "and/or".

Only after playing out the string in the MDL did the plaintiff in Patterson 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.  Patterson, slip op. at 11.

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).

We care a little about the Massachusetts saving statute argument, but only because that demonstrates that a TwIqbal 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.”  Patterson, slip op. at 9.  A dismissal on the merits cannot be revived by a saving statute.

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:

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.

Patterson, slip op. at 10-11 (citations omitted).

Bingo!  Not only does Patterson 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 Erie doctrine (another proposition we’ve advocated here at DDLaw since the beginning).

Thus, we follow Aredia/Zometa not because Joe makes it easy − although that helps − but because (like Bone Screw before it), that litigation raises a host of interesting issues.  We wish the defense well as it tackles the difficult task (again, like Bone Screw) of “winning” a mass tort after remand from the MDL.

Wednesday, August 29, 2012

More Mensing, More Mensa

This makes two Wednesdays in a row where we have the pleasure of discussing courts that applied Mensing in a clear-headed manner.  To review the bidding:  the Supreme Court decided in Mensing that claims against generic drug manufacturers for failing to disclose risks are preempted because generic manufacturers are powerless to deviate from the FDA-approved brand label.  That straightforward rule has not prevented plaintiffs from pursuing some clever, though mostly not-so-clever, paths around preemption.  We cannot blame plaintiffs for their efforts, but we certainly can blame those courts that reward such efforts. 

Last week we reviewed the Truddle case, where a Mississippi federal judge followed Mensing and bounced claims against a generic manufacturer.  This week, we have a well-reasoned, well-written opinion from the Eastern District of Louisiana in Jacobsen v. Wyeth LLC, No. 2:2010 cv 00823, 2012 U.S. Dist. LEXIS 116887 (E.D. La August 20, 2012).  Is common sense suddenly breaking out all across the land?  What next?  Will telephone customer service center operators stop asking us for our account number after we have just punched it in?  Will the Phillies drop Jimmy Rollins (with an on-base percentage under .300) from the lead-off spot?  Will the Republican and Democratic conventions quit with the phony "spontaneous" floor celebrations?  Doubtless we are hoping for too much.  But cases like Jacobsen give rise to optimism. 

In Jacobsen, the plaintiff claimed injuries from metoclopramide, the generic form of brand-name drug Reglan.  The plaintiff alleged that the defendants were liable for their alleged failure to monitor the drug, because the design was unreasonably dangerous, because (big surprise) the defendants failed to warn of certain risks, and because the drug did not conform to an express warranty.  The generic defendants moved to dismiss the case in its entirety on the ground of Mensing preemption.  The plaintiff sought to evade preemption with a series of arguments that have secured purchase in some courts.  Perhaps as the crystalline logic of Truddle, Jacobsen, and, indeed, Mensing itself, prevails, those few courts buying the plaintiff arguments will be exposed as the rogues that they are.  The plaintiff's arguments in Jacobsen were rejected efficiently and elegantly:

* Failure to Monitor

The only point of monitoring is if it would "necessarily result in warnings to patients and physicians."  2012 U.S. Dist. LEXIS 116887 at *36.  Mensing precludes warnings claims.  Accordingly, the monitoring claim is gone.  (And, as Marcellus says in Pulp Fiction, it better "stay gone.")

* Design Defect

The only alternative design suggested by the plaintiffs was "unit of use" packaging, which would limit the amount of drug dispensed and which would provide warning information directly to the patient.  There is that W-word again.  Moreover, if you are talking about packaging, you are ineluctably talking about failure to warn.  As Blofeld would say, "Goodbye Mr. Bond!"  As David Spade would say, "Buh bye."  Or, as an Article III judge would say, "Dismissed."

* Failure to Warn

As in many other cases, the plaintiffs argued that the generic manufacturer should have worked toward changing the label, engaged in non-label communications (including Dear Doctor letters), or even gone so far as to withdraw the drug from the market.  But Mensing explicitly forecloses the first option, the majority of the judges in Mensing made reasonably clear that the second option is a no-go, and the underlying logic of Mensing rules out the third.  The Jacobsen court observes that "[t]o require a generic manufacturer to remove a drug from the market would repudiate the label approved by the FDA."  Id. at * 42.  That reasoning is unanswerable, and should drive errors like the Bartlett opinion into the dustbin of history. The plaintiff in Jacobsen offered another argument that some courts have smiled upon - that the generic manufacturer did not update its label as fast as it should have.  But that argument in Jacobsen was merely a post hac rationalization to keep the case alive.  The claim was nowhere in the complaint, nor had the plaintiff ever moved to amend the complaint.  Some courts either hate preemption or love plaintiffs so much that they would have permitted a tardy amendment.  Not the Jacobsen court.  

* Express Warranty

Claims for express warranty often seem like afterthoughts lobbed into complaints, almost as a matter of rote.  It looks like that here.  The plaintiff's complaint never identified any express warranties by the defendants "beyond the allegedly false statements contained in the package insert."  Id. at *45.  "Specifically, Plaintiff has not alleged that Defendants advertised their products, detailed their products to doctors, or made any other forms of communication regarding the drug."  Id.  To make matters worse for the plaintiff, her opposition to the summary judgment motion asserted that the defendants "never provided Plaintiff or her physicians with ANY warning or other information with respect to metoclopramide."  Id.   That fact is presumably a bad thing, right?  Well, it is really bad for the plaintiff's warranty claim.   It refutes it.

The reasoning in Jacobsen is so clear and compelling that it makes all the usual plaintiff maneuverings around Mensing seem utterly specious.  The plaintiff's arguments in Jacobsen were rightly greeted with dismissal.  We would like to see that become commonplace.  Maybe in the not-too-distant future, as cases like Truddle and Jacobsen build up momentum, plaintiff efforts to circumvent Mensing will be greeted with more and more dismissals ... and yawns.  As a current book on the science of sleep (Dreamland) reminds us, yawns are contagious.    

Tuesday, August 28, 2012

Off-label Promotion in California – Same Facts, Same Law, Different Results

            This post is solely on behalf of the Dechert half of the Blog.  The Reed Smith half is involved in these cases and they ain’t saying a word (not out loud, anyway).

            As litigators, we are all too familiar with the adage “you win some, you lose some.”  Unless and until an issue is decided by the Supreme Court (and all too often not even then), the law is subject to interpretation by judges, who after all are just people with their own outlooks and biases.  Hence, we often report on cases with very similar facts but very different results –often leaving us scratching our heads.  And that’s what happened in two recent California cases involving the same spinal fusion product.  Both plaintiffs alleged unlawful off-label promotion.  One court found the claims preempted, the other did not.  Go ahead, scratch away – we can’t figure out the difference either – other than one court got it wrong.

            You can guess which we think that was.

            First, we’ve said it before and we’ll say it again:  Off-label promotion is not a tort.  Courts have so held repeatedly, here’s just a sampler.  So while in some instances off-label promotion is not permitted by the FDA, “[t]he FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.”  Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341, 349 n.4 (2001).  This statute (21 U.S.C. §337(a)) is “clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government.”  Id. at 352.  The California exemptions from §337(a) − see 21 C.F.R. §808.55 − have nothing to do with these cases or this device. 

            That brings us to the court that got it right:  Coleman v. Medtronic, 2012 WL 2335532 (Cal. Super. Jun. 13, 2012).  Under Riegel, that court had previously tossed plaintiff’s claims but  allowed plaintiff to continue to try and state a non-preempted claim by allowing leave to amend on two occasions. Plaintiff there focused on a “warning” claim alleging off-label promotion.  On motion to dismiss #2, the court took a second look at permitting the warning/off-label claim based mostly on dicta from a case in Minnesota.  Moving away from the dicta and looking at the totality of implied preemption law, the Coleman court concluded, properly, that plaintiff’s off-label promotion claims were “impliedly preempted because they would involve imposing a state requirement that is different from or in addition to the federal requirement and therefore preempted.”  Coleman, 2012 WL 2335532. 

The next court, in Cabana v. Stryker Biotech, LLC, slip op., (Cal. Super. Aug. 20, 2012), didn’t agree.  Before tackling the unfortunate preemption ruling, we should point out how little’s left of that case.  In response to defendant’s motion for summary judgment, plaintiff gave up strict liability manufacturing, design defect and failure to warn claims and her implied warranty claims.  Slip op. at 4.  That's 90%+ of most product liability cases.  All that’s left is general negligence, express warranty (which invariably vanishes the moment a plaintiff has to put up or shut up about what the warranty actually was) and fraud.  Plaintiff definitely has only a small playing field left. 

As to preemption – hey wait, we thought this was summary judgment − where are the actual facts?  For some reason, the court focused almost exclusively on mere allegations in the complaint, slip op. at 2-4, and not on whether plaintiff had any evidence to support those allegations, particularly as they concern off-label promotion.  Summary judgment, however, is supposed to pierce the pleadings; bare allegations are not sufficient:
Plaintiffs cannot simply incant the magic words that Defendants violated FDA regulations in order to avoid preemption.  Moreover, the nonmovant may not defeat a properly focused motion for summary judgment by relying on mere allegations without introducing definite and competent evidence.
Carrelo v. Advanced Neuromodulation Systems, 777 F. Supp.2d 303, 313 (D.P.R. 2011), citing, Maldonado-Denis v. Castillo-Rodriguez, 23 F.3d 576, 581 (1st Cir. 1994); Horowitz v. Stryker Corp., 613 F.Supp.2d 271, 282 (E.D.N.Y. 2009); In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F.Supp.2d 1147, 1158 (D. Minn. 2009), aff’d 623 F.3d 1200 (8th Cir. 2010).  We could cite a lot more, but we think the point’s been made.

Too bad for the defense in Cabana, though; that plaintiff skated.

Reading Cabana as a whole, the court seems to hold that all a plaintiff needs to do is allege a violation of federal law – in this case off-label promotion – and that’s enough to create a triable issue of fact.  We call this a “magic words” approach.  Even though we don’t like all of the recent Cornett case (see last week’s post here), the New Jersey Supreme Court at least required facts to go forward.  Off-label promotion cases must not:
  • be nothing more than a private action to enforce FDA statutes and regulations;
  • be nothing more than a challenge to the approval of the device or label;
  • require proof of fraud on the FDA; or
  • involve off-label promotional activities that are legal under FDA guidelines.
Cornett v. Johnson & Johnson, ___ N.J. ___, ___ A.3d ___, 2012 WL 3210943, at *14 (N.J. Aug. 9, 2012).  The Cornett court sent the plaintiff back with an admonition to come up with the right evidence, otherwise “defendants may move for summary judgment, and the trial court should not hesitate to grant such relief.”  Id.

Not so in Cabana.  That court didn’t care what the state law cause of action was – if the complaint alleged the magic words -- “violation of federal law” – preemption simply disappears.  Ignoring the state-law side of “parallel” was the only way the court distinguished a wealth of cases strongly in favor of preemption.  For instance, as to Riegel v. Medtronic, 552 U.S. 312 (2008), which established express preemption, the court said:
Here . . . plaintiff’s claim is not based on allegations that Medtronic’s device violated state tort law notwithstanding compliance with the relevant federal requirements.  In contrast, plaintiff here is alleging that Medtronic promoted the use of its device in violation of federal requirements.  Accordingly, Riegel is not authority that plaintiff’s claims against Medtronic are preempted here. 
Cabana, slip op. at 4-5 (citations omitted).  That’s almost a textbook definition of a purely federal cause of action barred under Buckman and §337(a).  Heck, even Riegel involved off-label use.  552 U.S. at 320 (physician use was contraindicated by the labeling).  Likewise, the court dismissed California appellate law, McGuan v. Endovascular Technologies, Inc., 182 Cal.App.4th 974 (Cal. App. 2010), as inapplicable, because in McGuan the plaintiff’s state law claims focused on “defects in the design, testing, and manufacture of the . . . [d]evice, the failure to warn . . ., and the fraudulent concealment of the dangers and defects of the product.”  Slip op at 5.  Oh really?  That looks no different than plaintiff’s failure to warn and fraud claims in Cabana.   If the point was to distinguish Cabana from McGuan by saying that plaintiff Cabana is bringing a claim for violation of a federal regulation, not a state law tort claim -- well, we direct your attention back to square one:  the United States, not private litigants, enforces the FDCA and FDA regulations.  Hmmm….  What should we use to make the point this time?  How about something recent?
Even if a plaintiff does properly plead facts demonstrating the defendant’s failure to satisfy federal regulations, there is no private cause of action against a device manufacturer under the FDCA.  Only the federal government may file suits against manufacturers that do not comply with federal regulations.  Although the Supreme Court acknowledged in Riegel that parallel claims based on violations of federal regulations would escape express preemption under §360k, §337(a) has been held to impliedly preempt private claims against device manufacturers for failure to comply with federal regulations.  As a result, Riegel and Buckman create a narrow gap through which a plaintiff's state-law claim must fit if it is to escape express or implied preemption.
Gross v. Stryker Corp., ___ F. Supp.2d ___, 2012 WL 876719, at *19 (W.D. Pa. March 14, 2012).

The Cabana court was also unpersuaded by defendant’s argument that this was not a parallel violation claim because plaintiff has no evidence that any of the off-label promotion she alleges in her complaint actually violated a federal regulation. A “parallel” claim can’t be “parallel” to nothing.  We discussed this issue last week in our post on Cornett.  While Cabana cites to Cornett, at least Cornett (1) recognized the safe harbor provisions adopted by the FDA regarding off-label promotion, and (2) demanded real evidence of the purported promotion (Cornett was a legitimate pleadings-based case).  Now Cornett didn’t get it exactly either (as we alluded above), because it overlooks the fact that just because off-label promotion may fall outside the safe harbor doesn’t mean it’s tortious off-label promotion.  It’s only potentially “illegal,” and that’s up to the FDA, and the FDA only, to determine.  Cabana misses this point too.

Finally, we are left wondering how plaintiff’s off-label promotion allegations in Cabana support a failure to warn claim.  In the end, if plaintiff is basing her claim solely on allegations that defendant promoted its device for off-label purposes – then we’re in Buckman-land.  Rather, plaintiff must base her cause of action on some other recognized legal claim.  But promotion and warnings are two different things.  By definition, a failure to warn claim requires two things: a warning and causation.

As to the warning, either the risk of an off-label use is the same as that of the labeled use or it isn’t.  If it is, then the label already warns about it, and if it doesn’t, well the plaintiff is asking for something “different from or in addition to” the FDA-approved labeling.  That’s preempted.  If the risk of the off-label use isn’t shared with the labeled use, then … well, it’s the same result, isn’t it − only worse.  This sort of claim creates the potential of a finding that state law would require the defendant to add a warning uniquely related to off-label promotion.  That’s way “different from or in addition to” the approved label. 

Then there’s causation − that whatever the “known” risk (California is a state-of-the-art state) the defendant allegedly failed to warn about  was unknown to the physician using the product, that the physician actually received and relied on the allegedly inadequate information, etc….  There’s none of that in Cabana.  These additional tort requirements (required under Buckman) have nothing to do with if or how the product was supposedly promoted for off-label use.  Promotion allegations, in the end, can’t save a failure to warn claim, negligent or otherwise.  Only the FDA can require a warning about an off-label use.

All in all, we are once again wondering how two courts in the same state, governed by the same law could come to two so disparate conclusions.  While the plaintiff skirted preemption in Cabana, she still hasn’t provided the slightest indication that she actually has facts that could prove her claims – those few that remain.  On that note, we are also very familiar with the adage:  lose the battle, but win the war.   We understand from other reports on this case, there is more discovery to be done and another opportunity to have the judge in Cabana to get it right.  Here’s hoping we can report on a favorable overall outcome in Cabana in the months to come.

Monday, August 27, 2012

Another Decision Leveling the Playing Field

We recently saw another decision allowing defendants in mass tort litigation to retain as defense experts doctors who also treated plaintiffs.  In Re: Zimmer NexGen Knee Implant Prods. Liab. Litig., 2012 U.S. Dist. LEXIS 117238 (N. D. Ill. Aug. 16, 2012).  The NexGen MDL court rejected some of plaintiffs’ familiar arguments, including that defendants would improperly influence the doctors’ testimony as fact witnesses in their own patients’ cases and that treaters serving as defense experts somehow violate fiduciary obligations to the patient.  Id. at *31, 34. 

The court was influenced, instead, by the defendants’ proposed order, which set out the circumstances under which the defense could retain treaters as experts:

Defendants propose that their contact with Plaintiffs’ treating physicians should be permitted, subject to an order limiting contact with prospective expert witnesses who are also treating physicians of individual plaintiffs as follows:

   1. Zimmer’s counsel will not communicate with physician-expert about any of his or her patients who are plaintiffs in this MDL.
   2. Zimmer and its counsel may not use a physician as a consulting or testifying expert in a case where that physician’s present or former patient is a plaintiff in that particular case.
   3. Before having any substantive communication with a prospective physician-expert, Zimmer’s counsel will provide the treating physician with this Order and will secure the treating physician’s written acknowledgment that he or she has read the attached Memorandum to Physicians [not attached to the opinion], except that [an] expert[ ] retained as of the date of this Order shall be provided with this Order within thirty (30) days, and shall provide written acknowledgment that he or she has read the attached Memorandum to Physicians.

Id. at *10-11. 

We should note that the court also rejected a key (and incorrect) argument often made by plaintiffs – that the defense’s access to treating doctors for ex parte informal discovery is restricted to some extent by the physician-patient privilege.  It is not.  That privilege is waived the moment plaintiff files suit.  The MDL court sided with courts holding that state privilege law doesn’t apply and neither does state-law restricting the defense conducting ex parte treater discovery.  It’s not a privilege issue.  It’s about available methods of discovery under federal law:

These courts recognize that a state’s law of privilege applies in diversity actions, but they conclude that a plaintiff waives the physician-patient privilege as to all matters relevant to the case by putting his or her medical condition at issue.  Thus, state law banning ex parte communications between defense counsel and a plaintiff’s treating physician merely governs the method of discovery, not the operation of the privilege. . . .

The ex parte rule shares certain public policy goals with the law of privilege, but [any state] rule [banning ex parte discovery] operates by imposing restrictions on the methods of discovery--traditionally a matter within the broad discretion of the district court.  The Federal Rules of Civil Procedure do not directly address the matter of ex parte contacts at issue in this case, but those rules do empower the court to “regulate practice in any manner consistent with federal law, rules adopted under 28 U.S.C. §§ 2072 and 2075, and the district’s local rules.”

Id. at *18-21.  The court used that power to allow the defense to retain treaters as experts.

Now, we think that decision was an easy one.  There would be no semblance of fairness in allowing Plaintiffs in mass torts to have potential access to the entire pool of the most active and involved experts while restricting the defense’s access. 

But maybe more important is that plaintiffs’ attorneys should not have the advantage of one-sided access to treating doctors before their fact depositions or trial testimony.  For those of us who have taken treater depositions after the doctor had an ex parte “meeting” with plaintiff’s lawyer, we know the usefulness that such a meeting can have and the unfairness it can create if only one side has the opportunity to request such a meeting. 

While this wasn’t at issue in the NexGen decision, the court’s opinion nonetheless offered helpful language that could apply.  Plaintiff argued that the evidence or testimony given by a treater as to her or his patient might be unfairly influenced by the defense if the defense had also hired that treater as an expert.  In other words, the plaintiffs – who have no restrictions on access to treaters – wanted the treaters for themselves.  The court rejected this reasoning:

As a general proposition . . . no party to litigation has anything resembling a proprietary right to any witness’s evidence.  Absent a privilege no party is entitled to restrict any opponent’s access to a witness, however partial or important to him, by insisting on some notion of allegiance. . . . Unless impeded by privilege an adversary may inquire, in advance of trial, by any lawful manner to learn what any witness knows . . . . [W]hile the Federal Rules of Civil Procedure have provided certain specific formal methods of acquiring evidence from recalcitrant sources by compulsion, they have never been thought to preclude the use of such venerable, if informal, discovery techniques as the ex parte interview of a witness who is willing to speak. 

Id. at *31-32 (quoting Doe v. Eli Lilly & Co, 99 F.R.D. 126, 128 (D.D.C. 1983)).

Similarly, the court addressed the notion that a treater serving as an expert witness for the defense would somehow violate a fiduciary duty to her patient/plaintiff, a duty that supposedly involved assisting the plaintiff in litigation.  Id. at * 34.  If you recall, New Jersey’s Appellate Division recently rejected this very same argument.  We wrote about it here.  The NexGen MDL court rejected it too.  The treater’s duty in litigation is not to help one side.  It’s to tell the truth: “[A]s imposed by law, the physician’s duties in litigation are to cooperate procedurally when called upon and to provide truthful information.”  Id. at * 36 (citing In re Pelvic Mesh/Gynecare Litig., 426 N.J. Super. 167, 188 (App. Div. 2012). 

We think these points support more than allowing the defense to retain treaters as experts.  They help establish that when doctor-patient privilege is not an issue – and it clearly isn’t in these types of mass torts – one side of the litigation shouldn’t have a unilateral right to informal discovery from key witnesses.  Both sides should have such access. 

Friday, August 24, 2012

Procedural Notes

This week we came across a couple of cases dealing with procedural issues that we don’t see every day, but which have annoyed us in the past.  Since we don’t like being annoyed, we thought we’d pass them along.  While neither of these involves anything like complete research, they would provide easy starting points in the event that either issue has to be briefed in the future.

In the first case, Sherfey v. Johnson & Johnson, 2012 U.S. Dist. Lexis 116283 (E.D. Pa. Aug. 17, 2012), the defendant removed the matter, which involved an alleged drug overdose, to federal court.  So far so good.  The interesting procedural aspect of the case had to do with the use of a “related case” designation in the forms used to initiate the case in federal court:

[T]he defendants designated this action as related, under Local Rule 40.1, to two actions before the undersigned, one recently dismissed and one pending. . . .  As a result of that designation, this action was assigned to the undersigned.

2012 U.S. Dist. Lexis 116283, at *3.

While Sherfey involved a defendant’s use of a “related case” designation, we’ve heard stories for years of plaintiffs engaging in “related case” judge-shopping, particularly where novel industry-wide product liability theories against cigarette and firearm manufacturers were involved.  Thus, we were interested in anything that discussed the limits on such designations.  If you were involved in this litigation, you know what we're talking about.  Sherfey didn’t disappoint.  Just because the same active ingredient is involved doesn’t make for a “related case” − differing products (infant’s vs. children’s strength), purchase dates, sales locations, and damages all mitigate against the matters being considered "related" for purposes of assignment to the same judge.

[T]he general facts giving rise to the claims in the MDL, [another case], and this case are similar and may well require similar proof.  That this case is a wrongful death suit, however, ensures that factual issues relating to the plaintiffs’ pre-injury behavior, injury, and causation will be distinct. . . .  The plaintiffs in this action allege the purchase of a different medicine on a different date and from a different retailer than those in [the other personal injury case], and they set forth a categorically different injury than that [economic loss] alleged by the plaintiffs in the MDL.

2012 U.S. Dist. Lexis 116283, at *7.  The court observed that “related case” designations “should be applied sparingly because the policies underpinning the system of random assignment encourage transparency, fairness, and avoiding the appearance of arbitrariness.”  Id.

Anyway, while Sherfey isn’t particularly lengthy, it does cite some cases − providing a quick start to research in this arcane area, should it arise again.  Since plaintiffs, by definition since they file first, have far more opportunities for judge-shopping than defendants, we want to keep Sherfey in mind. What better way to do that than with a blogpost?

The second case, In re Asbestos Products Liability Litigation, MDL 875, 2012 U.S. Dist. Lexis 106515 (E.D. Pa. July 31, 2012), obviously doesn’t involve prescription medical products at all.  It does, however, address another annoying plaintiff procedural tactic − misuse of corporate designee depositions under Rule 30(b)(6) as fishing expeditions.  In Asbestos, the plaintiffs issued deposition notices on scads of defendants − to “all counsel of record” for the 40 defendants sued.  2012 U.S. Dist. Lexis 106515, at *6-7.  “The information sought related to ‘any asbestos-containing products or materials dating from 1940 through the date of this notice.’”  Id. at *7.

Thankfully, the magistrate judge was not about to let plaintiffs get away with rummaging through decades of product information without some showing of good cause.  Rather, the court required an independent showing of exposure to each defendant’s products:

[T]here is no evidence that the decedent was directly exposed to any asbestos-containing product of these Defendants.  Plaintiffs are not entitled to testimony of a corporate representative without some evidence to connect a particular product/products of Defendants to the decedent's alleged asbestos exposure.  Noticing a 30(b)(6) deposition to obtain testimony from a defendant identifying all asbestos products it supplied, sold or distributed over a sixty plus year period is not proper.

2012 U.S. Dist. Lexis 106515, at *10.

Since our clients are corporations, and most plaintiffs are not, Rule 30(b)(6) is another avenue for plaintiffs to engage in asymmetrical discovery in order to drive up our client's costs, and for other vexatious purposes.  Again, while not on our agenda at the moment, Rule 30(b)(6) has been before and probably will be again.  Asbestos al;so cites some case law (although not as much), so it’s another easy avenue for starting research, if and when it might be needed.  So we pass it along.

FDA - The First Amendment Closes In

The DC Circuit today held 2-1 that the FDA's proposed graphic labeling for cigarettes is unconstitutional under the First Amendment.  R.J. Reynolds Co. v. FDA, No 11-5332, slip op. (D.C. Cir. Aug. 24, 2012).  While it's a much different analysis than restrictions on truthful off-label promotion, the FDA's regulation fell under the Central Hudson test usually applied to commercial speech.  Slip op. at 28-30.  We think that the court's discussion of the second Central Hudson prong - the "direct advancement" test - id. at 24- has some relevance to the Agency's off-label speech prohibition.  The court required proof of "direct cause" to satisfy that prong, and we doubt that the FDA has any more evidence of such cause to support its off-label ban than it did for its graphic warnings.  The agency's characterization of data as "suggestive" was only another way of saying it was "mere speculation and conjecture."  Id. at 26.

Nor can the FDA define for itself the "effectiveness" of its speech restrictions:
Allowing FDA to define “effectiveness” however it sees fit would not only render Central Hudson’s “substantial interest” requirement a complete nullity, but it would also eviscerate the requirement that any restriction “directly advance” that interest.
  Slip op. at 29.  And there, at the end, lurks Sorrell:  “[t]hat the [government] finds expression too persuasive does not permit it to quiet the speech or to burden its messengers.”  Slip op. at 30 (quoting Sorrell, 131 S.Ct. at 2671).

Off-label use is probably more prevalent than smoking these days. The most plausible argument for the FDA is that discouraging off-label promotion encourages submission of such uses to the Agency. That doesn't seem to have worked much, if at all. "FDA cannot get around the First Amendment by pleading incompetence or futility." Slip op. at 28-29.

Ouch.  The First Amendment is coming.

Thursday, August 23, 2012

A Couple Of Interesting New Cases Forwarded By Our Readers

We like it when our readers contact us, even when it’s only to tell us that we made a mistake.  At least they’re paying attention.  But we like it most when our readers send us new opinions of interest − especially good ones.  The rapid exchange of information helpful to the defense of prescription drug and medical device product liability litigation is what the DDLaw blog is all about.

But once we receive good new cases, it becomes our responsibility to get the word out, and that’s what we’re doing today, even if we feel we’ve been a mite slow about it.

Eckhardt v. Qualitest

Two readers (Quinton Urquhart of Irwin, Fritchie, and Rachel Passaretti-Wu of Skadden) both sent us, in response to our “Conte Rejected Again” post, Eckhardt v. Qualitest Pharmaceuticals, Inc., C.A. No. M-11-235, slip op. (S.D. Tex. Aug. 9, 2012).  Eckhardt − guess what? − also rejected the notorious Conte theory that brand-name manufacturers could be liable for allegedly inadequate warnings accompanying competing generic drug products that they never sold.

Eckhardt is the latest of a number of cases to reject brand-name liability under Texas law.  As indicated in our Branded/Generic liability scorecard, Eckhardt builds on Finnicum v. Wyeth, Inc., 708 F. Supp.2d 616, 620-22 (E.D. Tex. 2010); Cousins v. Wyeth Pharmaceutical, Inc., 2009 WL 648703, at *2 (N.D. Tex. March 10, 2009); Hardy v. Wyeth, Inc., 2010 WL 1049588, at *2-5 (Mag. E.D. Tex. March 8, 2010), adopted, 2010 WL 1222183 (E.D. Tex. Mar. 29, 2010); Burke v. Wyeth, Inc., 2009 WL 3698480, at *2-3 (S.D. Tex. Oct. 29, 2009); Pustejovsky v. Wyeth, Inc., 2008 WL 1314902, at *2 (N.D. Tex. April 3, 2008), aff’d on other grounds, 623 F.3d 271 (5th Cir. 2010); Block v. Wyeth, Inc., 2003 WL 203067, at *2 (N.D. Tex. Jan. 28, 2003) and Negron v. Teva Pharmaceuticals USA, Inc., 2010 WL 8357563, slip op. at 1-2 (Tex. Dist. Dallas Co. May 7, 2010), in hewing to the traditional product liability axiom that manufacturers are the only ones that can be liable for their products.

We make that point because we were somewhat disturbed to read the Eckhardt court expressing “disappointment” with the quality of the briefing on both sides.  Slip op. at 2-3.  While we expect the other side to do things like throw in “two several-hundred-page depositions” without page citations, id., we’re not accustomed to seeing our side criticized for citing “cases that have no nexus with” relevant law.  Id.
That’s precisely what we try to avoid with our branded/generic scorecard.  If as is the case in Eckhardt, the jurisdiction in question has a statutory product liability scheme (like Texas, or Tennessee, Kentucky, and New Jersey to name a few), we try to note in our case summary.  That way we try to make it easy for defense counsel everywhere to cite to the most relevant cases, whether inside or outside any particular jurisdiction.

Anyway, the rest of Eckhardt is good.  It’s a “one-two punch” case − by that we mean (as is apparent from our Generic Preemption scorecard) that the generic defendants have also been dismissed on preemption grounds.  Eckhardt v. Qualitest Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2012 WL 1511817 (S.D. Tex. April 30, 2012).  Thus, the one-two punch of preemption and product identification has effectively ended the case.

Eckhardt makes the following holdings that might be useful in future cases:
  • The tenuous relationship of branded products to generic labeling was not sufficient to justify liability under any Texas product liability theory.  Slip op. at 4-5.
  • Fraud and similar claims satisfy the statutory definition of “products liability” claims.  Id. at 6-7.
  • Breach of warranty and consumer protection claims fail where the defendant did not make the product.  Id. at 8-9.
  • Negligence and negligent misrepresentation fail because a non-manufacturer owes no recognized duty to persons using competing products.  Id. at 10-11.
Baker v. APP Pharmaceuticals

We thank old colleague Will Sachse of Dechert for sending along Baker v. APP Pharmaceuticals LLP, C.A. No. 09-05725 (JAP), slip op. (D.N.J. Aug. 21, 2012).  Baker contains an excellent description of the New Jersey presumption of adequacy of FDA-approved warnings:
In failure to warn cases involving prescription drugs, “[i]f the warning or instruction given in connection with a drug . . . has been approved or prescribed by the federal Food and Drug Administration under the ‘Federal Food, Drug, and Cosmetic Act,’” there is a rebuttable presumption that the warning is adequate.  This is no ordinary rebuttable presumption.  “Compliance with FDA regulations” gives rise to “what can be denominated as a super-presumption[.]”  “[C]ompliance with FDA standards should be virtually dispositive of such claims.”  Indeed, the PLA’s presumption that an FDA-approved prescription drug label is adequate “is stronger and of greater evidentiary weight than the customary presumption referenced in [New Jersey Rule of Evidence] 301.”

Baker, slip op. at 12-13 (citations, but not quotation marks, omitted).

The New Jersey presumption suffers from ill-advised, judicially-created exceptions to the broad legislative mandate, but Baker held that neither of those applied.  There can’t be “deliberate concealment” of information that’s “publicly available in published scientific and medical literature.”  Slip op. at 9-10.  Moreover, the plaintiffs weren’t being honest with the court.  The information in question was, in fact, disclosed to the FDA.  Id. at 10-11.  (The concealment claim was also a preempted fraud on the FDA claim, but the court didn’t have to discuss that.)  Also, for case-specific reasons (after-the-fact timing, and the information involving a different drug), the court found no manipulation, “intentional” or otherwise, of FDA post-marketing regulatory processes.  Id. at 12-14.  Thus the FDA-approved warning was as a matter of law.

Of equal interest, the court in Baker held that, even if the warning had been inadequate, it couldn’t have caused any injury.  This is important, because there hasn’t been all that much New Jersey law on warning causation.  There’s Strumph v. Schering Corp., 606 A.2d 1140, 1148-49 (N.J. Super. App. Div. 1993) (dissenting opinion), rev’d, 626 A.2d 1090 (N.J. 1993) (adopting dissenting opinion below), which establishes the warning causation principle in New Jersey.  There’s also Appleby v. Glaxo Wellcome, Inc., 2005 WL 3440440, at *5-6 (D.N.J. Dec. 13, 2005).  These are both cases where the prescribing physician already knew the information and didn’t read the warning.  Two favorable opinions for a jurisdiction with as much learned intermediary rule litigation as New Jersey strikes us as a little thin.

Baker’s now a third case in that category.  First of all the court took out the lamentable “heeding presumption.”  “The heeding presumption is rebutted, however, if the plaintiff’s physician was aware of the risks of the drug that he prescribed, and having conducted a risk-benefit analysis, nonetheless determined its use to be warranted.”  Slip op. at 14-15 (citation and quotation marks omitted):
Moreover, a manufacturer who fails to warn the medical community of a particular risk may nonetheless be relieved of liability under the learned intermediary doctrine if the prescribing physician either did not read the warning at all, or if the physician was aware of the risk from other sources and considered the risk in prescribing the product.  In that case, the physician’s conduct is the superseding or intervening cause that breaks the chain of liability between the manufacturer and the plaintiff.
Id. at 15 (citations, quotation marks, and footnote omitted).  That happened in Baker.  Not only did the prescriber know of the alleged heparin-related risk, but he “stood by his decision to administer heparin” under the facts of the case.  Id. at 15-16.  Further blocking any causal inference was the physician’s failure to read labels for “frequently” prescribed drugs with which he was familiar:
[The prescriber] testified in his deposition that he does not read the label of drugs he prescribes often, which includes heparin.  Moreover, Plaintiffs concede that [the prescriber] never testified that he would have consulted a black box warning or “Dear Doctor” letter, or that he ever reviewed the Physician’s Desk Reference when prescribing heparin.  Therefore, a different warning would not have made a difference in [plaintiff’s] treatment or outcome because [the prescriber] would not have reviewed it.
Baker, slip op. at 16 (citation omitted).

There was also a case-specific superseding cause − the “fail[ure]” of the nursing staff “to follow its own heparin treatment protocol” and monitor the drug level in the plaintiff’s blood.  Id. at 16-17.
Therefore, Plaintiffs have failed to raise a genuine issue of material fact that it was the heparin labeling, as opposed to the failure of the hospital to follow its treatment protocol, that was a substantial factor in causing or exacerbating [plaintiff’s] injuries.
Baker, slip op. at 17.

Thus, Baker is a nice causation triple play (prior knowledge, failure to read, and third-party superseding cause) in a jurisdiction where such precedent is most welcome.

Thanks to everyone who sends us cases − and keep them coming.

Wednesday, August 22, 2012

A Truddle, not a Muddle, through Mensing and Buckman

The scope of Mensing is one of the hotter issues in drug and device law these days. (The Bartlett appeal is one example.) To our defense-hack eyes, Mensing seems perfectly straightforward: a claim is preempted to the extent it alleges that the risks of a generic drug were not adequately disclosed. But the doctrinal landscape has quickly grown messy and treacherous. There is already a lot of legal kudzu out there, courtesy of plaintiff-lawyer ingenuity or judicial discontent with Mensing. Some attorneys and judges do not like preemption at all. Some do not smile upon the differential treatment between brandeds and generics. Accordingly, we get clever arguments and brittle analyses that limp along the page, proudly indifferent to the manner in which they manage to muck things up. It reminds us of what must surely be one of the most cynical observations of all time, when Thomas Hobbes wrote that "Reason scouts and spies for the passions." Nice (in the sense of being foolish) distinctions are drawn to preserve bogus claims.

Still, every once in a while Reason seems to stand up quite well for itself. That is the case with Truddle v. Wyeth, LLC et al., 2012 WL 338715 (N.D. Miss. Aug. 14, 2012), where the court dealt with Mensing in as clean and fair and straightforward a fashion as could be expected. The case is sad. A nineteen year old man was treated for gastritis. The doctor prescribed metoclapramide. The young man began suffering from hallucinations, extreme restlessness (akathisia), and suicidal impulses. He eventually took his own life. His parents filed suit against both brand-name and generic manufacturers, alleging negligence, strict liability, breach of warranties, misrepresentation, fraud, and negligence per se, all grounded upon an alleged failure to warn of the risks of side effects. The plaintiffs' counsel withdrew from the case (the opinion does not tell us why, prompting us to engage in all sorts of pointless speculation), the case was removed to federal court, and the generic defendants filed a motion to dismiss the case because of Mensing preemption.

The generic defendants argued exactly what we would expect them to argue -- that Mensing governed the entire case because all of claims, no matter what the styling, were predicated on an alleged failure to warn, and the generic defendants lacked any power to add warnings. The generic defendants "anticipate[d] that the Plaintiffs would argue that the Generic Defendants should have used an additional means of communicating warnings to physicians, such as letters to health care providers, and suspended sales of the drug until the brandeds were changed." Truddle, 2012 WL 3338715 at *3. The defendants also anticipated that the plaintiffs might try to assert "design defect or other legal theories to escape the preemptive reach of Mensing." That's certainly a lot of anticipation, especially against a pro se plaintiff. Maybe it is smart to trot out, and then knock down, the other side's arguments, rather than wait for the court to endeavor to help out the pro se plaintiffs. In any event, the battle-lines are pretty well drawn in Mensing cases. The potential avenues for circumventing Mensing no longer arrive as a surprise.

The Truddle court granted the generic defendants' motion and dismissed all claims on the grounds of Mensing preemption. Even though the plaintiffs asserted various theories of recovery, "all theories stem from the Generic Defendants' alleged failure to warn of the side effects of the drug." Truddle, 2012 WL 3338715 at *4. Even when the plaintiff complained of activities that might at first blush seem different from disclosing risks on the label, such as failure to investigate or test, any knowledge that would have been acquired from such investigation or testing "would have been helpful" only insofar as it would have been "communicated through labeling - which would not have made any difference as long as the Generic Defendants were following the FDA's labeling regulations." Id. The generic defendants could not have unilaterally improved the labeling even if they wanted to -- that is the point of Mensing. The Truddle judge offers a healthy dose of clear-thinking, and we wouldn't mind seeing that spread to other courts, including a couple we can walk to in ten minutes.

That ends that. Or at least, it could. But the plaintiffs' fraud and misrepresentation claims attacked the defendants for fraud on the FDA, and the Truddle court seized the opportunity to bring some additional clarity on that issue. There was a need for clarity, because a couple of Fifth Circuit cases introduced some unnecessary puzzlement into the Buckman issue. In the first case, which we would like to call the "Bad case," but which the official reporter calls Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), the Fifth Circuit held that a state tort claim for negligence "that attempted to prove breach of a state law duty by asserting a violation of FDA regulations was not a fraud-on-the-FDA claim that would be preempted by Buckman." Truddle, 2012 WL 3338715 at *6. The negligence claim in Hughes was predicated on the manufacturer's failure to comply with the applicable federal statutes and regulations. Well, if there is no private right of action under the federal laws (and there isn't) what exactly are we talking about in Hughes? The negligence claim, pled under Mississippi law, charged, inter alia, that the defendant manufactured and distributed the product inconsistently with its FDA PMA approval by failing to report serious injuries and malfunctions of the device as required by MDR regulations. The Hughes court said that this theory was different from a fraud-on-the-FDA theory that would be preempted under Buckman. Maybe - but that does not make it a valid action under state law. Hughes looks like sheer nonsense, but it is Fifth Circuit nonsense, so the Truddle court had to navigate around it.

The Truddle court did so by holding fast to another case, which we like to call the "Good case," but which you will want to cite as Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012). In Lofton, the Fifth Circuit applied Buckman preemption, in contrast to the Hughes court's unconvincing effort to dodge it. The plaintiff in Lofton alleged that the manufacturer of Motrin had not warned consumers of the risk of autoimmune reactions to the drug. The failure to warn claim was brought under Texas law, which establishes a rebuttable presumption that a drug manufacturer is not liable for failure to warn if the FDA approved the warnings in question. Texas law is specific that such a presumption can be rebutted if the defendant withheld information from the FDA. The issue is whether that fraud-on-the-FDA exception was preempted by Buckman. Sound familiar? We've written about this issue before, discussing another pair of cases, with the good one being Garcia v. Wyeth-Ayerst Labs., 585 F.3d 361 (6th Cir. 2004), and the bad one (wretched, awful, horrible, etc - we're tempted to unload the thesaurus on this one) is Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff'd by an equally divided court sub nom. Warner-Lambert Co. LLC v. Kent, 552 U.S. 440 (2008). Desiano seems nutty in calling off Buckman preemption when fraud-on-the-FDA is part of an exception instead of the cause of action itself, and we would hate to see other courts latch onto the Desiano rationale. Mercifully, the Lofton court did not do so. In Lofton, the Fifth Circuit applied Buckman preemption because the relationship between the manufacturer and the federal regulator was central to the matter at issue.

The Truddle court, after being confronted with the sloppiness of Hughes and the sanity of Lofton, divined a unifying Buckman principle that it believed compelled preemption in the Truddle case: "It is likely that the Plaintiffs' fraud-on-the-FDA theory would be preempted under Buckman, as the theory concerns the 'inherently federal' relationship between the FDA and the Generic Defendants, which are entities regulated by the FDA." Truddle, 2012 WL 3338715 at *7. Now it may be that the Truddle court simply (and rightly)  preferred the interpretation of Buckman in Lofton, but it didn't have to go there because Mensing answered the question.  Lofton versus Hughes made no difference since, in either case (or in neither case) where a generic product is involved the statutory "sameness" rationale of Mensing controls (neither Hughes nor Lofton involved generics).  Clearly, the Truddle court did not merely use reason to scout and spy for a preordained result. It returned to first principles. Those first principles result in more vigorous applications of Mensing and Buckman.

Tuesday, August 21, 2012

Foreseeability in the Evergreen State -- An Unfortunate Development

The last time we blogged about an asbestos case it was to bring you the good news about O’Neil v. Crane Co., 266 P.3d 987 (Cal. 2012) from the California Supreme Court – and our hope that it spelled the beginning of the end for Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008) (see here for our clear distaste for Conte).  Unfortunately, earlier this month, the Washington Supreme Court zigged where California zagged and Macias v.  Saberhagen Holdings, Inc., 2012 Wash. LEXIS 543 (Wash. Aug. 9, 2012) is the result.

Plaintiff Macias allegedly developed mesothelioma from cleaning respirators worn by shipyard workers to filter out asbestos, welding and paint fumes, and dust.  Id. at *2-3.  Plaintiff brought suit against the respirator manufacturers alleging that although the respirators themselves contained no asbestos, it was “foreseeable” that the respirators would be used with asbestos to which he would then be exposed when he cleaned them.  The trial court denied defendants’ motion for summary judgment, but the appellate court reversed holding that the manufacturers had no duty to warn “because they did not manufacture the asbestos-containing products that were the source of the asbestos to which [plaintiff] was exposed.”  Id. at *2.    

In a 5-4 decision, the Washington Supreme Court overturned that summary judgment order finding that “the duty at issue is to warn of the danger of asbestos exposure inherent in the use and maintenance of the defendant manufacturers’ own products, the respirators.”  Id. at *2.  But, the respirators don’t contain asbestos and they don’t have to be used with asbestos – it is only foreseeable that they might be.  This is precisely the argument rejected in O’Neil.

A quick refresher on O’Neil helps to set the stage.   Plaintiff O’Neil, an aircraft carrier worker, sued the manufacturer of the carrier’s propulsion system alleging that while the propulsion system contained no asbestos at all, it was manufactured to specifications that required the addition of asbestos insulation from other sources and it was “foreseeable” that asbestos would be used in conjunction with their products.  The California Supreme Court, citing the appellate court’s decision in Macias, said no:  “California law does not impose a duty to warn about dangers arising entirely from another manufacturer’s product, even if it is foreseeable that the products will be used together.”  O’Neil, 266 P.2d at 1004.   Just like Mr. Macias, Mr. O’Neil did not allege that he was exposed to asbestos from any products actually sold by the defendants.  So how are the results in these cases so different?

Well, O’Neil is a California decision and therefore not controlling in Washington.  But Simonetta v. Viad Corp., 197 P.3d 127 (Wash. 2008) and Braaten v. Saberhagen Holdings, 198 P.3d 493 (Wash. 2008) are.  And they are virtually identical to O’Neil.  Non-asbestos containing pumps/valves on Navy ships were insulated with asbestos.  When workers had to repair or perform maintenance on the pumps/valves, they were exposed to the asbestos insulation.  They sued the pump/valve manufacturers for asbestos-related injuries.  Macias, at *16.   In those cases the Washington Supreme Court held that “to find strict liability in a product liability case, the manufacturer must be in the chain of distribution”  Id. at *10.  Applying that principle to the facts of Simonetta and Braaten, the court found:
that the manufacturers were not in the chain of distribution of the asbestos insulating products and therefore had no duty to warn of the danger of exposure to asbestos during servicing, and it makes no difference whether the manufacturers knew that their products would be used in conjunction with asbestos insulation.
Id. at *17 (emphasis added).   We wholeheartedly agree with this conclusion and its premise that a manufacturer is not required to warn users of risks inherent in another’s product.  Id. at *11.  We also highlight the portion that says foreseeability doesn’t matter – because that is where the Macias court seems to have made its biggest u-turn.

            While the court acknowledged its ruling in Simonetta that “foreseeability of injury, does not in and of itself, create a duty to warn,” id. at *22, it then undertook a risk-benefit analysis with foreseeability at its core.  Id. at *22-26.  And while the Washington Product Liability Act does look in part to foreseeability of the harm in order to determine whether a product is unsafe – that’s not the question before the court.  As the court itself said: “The only issue before us is whether as a matter of law the manufacturers are entitled to summary judgment on the basis that they had no duty to warn of the danger of exposure to asbestos when their respirators were cleaned and maintained for reuse because these manufacturers were not in the chain of distribution of the asbestos-containing products themselves.”  Id. at *10.  So, “whether the defendant is in the chain of distribution of the relevant product is a threshold matter that must be determined before considering whether the product is reasonably safe.”  Id. at *36 (dissent).  Clearly a case of the cart before the horse.

The Macias court also focused on the fact that there are exceptions to the general “chain of distribution” rule – such as “assembler liability” for defective component parts or where two non-defective products are combined and create a dangerous condition.  Id. at *12-14. But then the court goes onto say that neither exception applies to the current case.  Id. at *15.   So, if the exceptions don’t apply, shouldn’t the general rule stand? 

In fact, plaintiff’s argument in Macias might be even more of a stretch than in O’Neil.  In O’Neil, defendant’s products were required to be used with insulation and the only insulation meeting Navy specifications was asbestos.  Id. at *22 n.4.    As the Macias dissent points out:
In contrast, these respirators were complete upon sale and did not require the addition of an asbestos-containing component. Moreover, these respirators were intended to protect against a number of different contaminants, including welding fumes, paint fumes, and various types of dust. The manufacturers should not be expected to warn of the dangers of every contaminant a user could conceivably encounter. Imposing such an obligation would render all the warnings given virtually meaningless. 
Id. at *35 (dissent).  It is difficult to imagine the length and breadth of the warning that would be required by this decision?

Since all four cases involve maintenance performed on products that post-manufacture and post-sale come into contact with another maufacturer's product that contains asbestos, we find it extremely difficult to understand how Macias could have come down any differently than O’Neil, Simonetta or Braaten.  And we think the court must have struggled with this too, because their ultimate holding is frankly ponderous.  To fit within the general rule that a manufacturer is only liable for harm caused by its own product, the court ruled that the respirators are “the very products that posed the risk to [plaintiff]” and “[i]t does not matter that the respirator manufacturers were not in the chain of distribution of products containing asbestos when manufactured.”  Id. at *18-19.  Wait a minute. That’s a direct contradiction of the very general rule the court claims to be applying.  If the respirator manufacturers’ products don’t contain asbestos, they shouldn’t be liable for plaintiff’s alleged exposure to asbestos.  Plaintiff wasn’t harmed by the respirator itself, but by asbestos that the respirators came in contact with.  If the respirators had been used somewhere where there was no asbestos – also very foreseeable – plaintiff wouldn’t have been injured.  There is no claim for injury without the asbestos and the defendants didn’t manufacture the asbestos-containing products. 

We also need to point out the serious flaw in the court’s analogies.  The court likens the respirators to blenders or table saws – that while sitting dormant in their boxes pose no real risk.  Rather “[i]t is only when the product is put to use at some point in the future that the hazards inherent in swiftly turning blades exist.” Id. at *24.  That’s right – the risk is from the blades.  The blades are part of the product – they were designed by, manufactured by, and sold by the maker of the blender or table saw.  Not true of the asbestos that allegedly caused injury to Mr. Macias.  And a gas stove doesn’t work without gas – respirators work without asbestos.  That analogy doesn’t hold water either.  It is just a further example of how far the court had to stretch to find a cause of action against the non-manufacturer defendants.  

 It’s just this type of stretch that makes us nervous about where a court is heading.  The court could easily have decided that this case was governed by Simonetta and Braaten and held that the respirator manufacturers owed no duty to warn about asbestos because they were not in the chain of distribution of the asbestos-containing products.  Having gone out of its way to distinguish its prior rulings, we can only wonder what’s next in the Evergreen State.

Thank you to one of our faithful readers, Brendan M. Kenny of Blackwell Burke PA for brining this important, although unfortunate, decision to our attention.