Friday, June 29, 2012

Why Are Sales Reps In The Operating Room?

Especially with preemption driving plaintiffs towards new and unusual causes of action, we've seen more cases making allegations about our clients' sales representatives being in the operating room.  We've (Michelle) blogged about this topic before.  We just spotted in interesting on-line piece in Becker's Spine Review that interviewed seven prominent spine surgeons on what exactly sales reps do as a practical matter when they're in the OR, and how helpful they are to the medical team.  Since the article demonstrates (to us anyway) beyond doubt that their presence is a good thing, we thought we'd pass it along to our colleagues as background reading on the medical rationale for having reps present during surgery:

It's called "Seven Spine Surgeons on Implant Reps in the Operating Room."

Here's part of one of the seven responses (don't want to publish an entire probably copyrighted article):

Sometimes there are issues with case sterilization, or even with instrument failure, and the rep is able to get the needed implants to the room (usually faster) than the OR nurse.

Especially with new technologies, the OR staff is probably not accustomed to the implants or hardware. The rep is able to instruct the team in steps required.

As a surgeon, I do not depend on having a rep in the room. But as far as ensuring quality care, I feel that there is an important role for the instrument rep in helping the scrub tech prepare for the intraoperative requirements of the surgery.

The rest of the article is here.

Practice Pointer 2.0: Bankrupt Plaintiffs

Not too long ago we advised that it’s a good idea to check whether your plaintiffs were actually alive when they filed their suits.  We’d like to amend that to add that it’s also a good idea to check whether your plaintiffs were financially alive as well.

By that, we mean plaintiffs should be checked for bankruptcy filings.  The quite lengthy and well-reasoned opinion in Fair v. Biogen IDEC, Inc., 2012 WL 2417722, slip op. (Mass. Super. June 13, 2012), explains why.  If a plaintiff has an accrued but unfiled personal injury claim and does not list it as an “asset” in a personal bankruptcy, then it passes to the bankruptcy estate as property and the plaintiff loses standing to assert it.  Fair, slip op. at 12-13.  In addition, or in the alternative, to the no-standing rule, a plaintiff who omits an unfiled personal injury claim from his/her list of assets in bankruptcy is judicially estopped from pursuing it following discharge in bankruptcy.  Id. at 14.

[N]otwithstanding that she may have some form of personal stake in the outcome of this litigation, [plaintiff’s] failure to disclose to the bankruptcy court nevertheless extinguishes her standing to pursue personal compensation.

[I]n reaching this conclusion to apply judicial estoppel in this case this court is acting in accordance with the doctrine’s primary purpose to protect the integrity of the bankruptcy process and to promote finality of confirmed reorganization orders.

Id. at 15 (findings 4 and 5).

As the numerous case citations in Fair indicate, the preclusive effect of a plaintiff’s bankruptcy on accrued but unfiled personal injury claims is the general rule.  There’s lots of law out there, for almost any jurisdiction, for the proposition that plaintiffs can’t hide claims during bankruptcy and then pursue them afterwards.  We recall filing similar motions in both the Bone Screw and Diet Drug mass torts − we even had templates prepared.  So, if you don’t already have “plaintiff bankruptcy” on your to do list with respect to mass tort (indeed, any) plaintiffs, we’d recommend adding it.

Finally, we’d like to thank Joe Blute, of Mintz Levin, a member of Biogen’s defense team, for passing along the win.

Thursday, June 28, 2012

Canadian Class Action Win

Since we follow developments in Canada, and in particular Canadian class action litigation, we thought our readers would like to know about the significant defense win in Andersen v. St. Jude Medical, Inc., 2012 ONSC 3660, slip op. (Ont. Super. June 26, 2012).

However, because of ReedSmith’s involvement in the litigation, we’re limited to telling you what happened.  Then again, since they write opinions differently in Canada − Andersen weighs in at a whopping 215 pages (with a glossary) − maybe that’s not such a bad thing, for you or for us.

Andersen is significant because there are not many instances where a Canadian class action (about 1100 members) has been dismissed outright after a full trial (and we do mean full − 39 witnesses and 140 trial days over the course of nearly 1½ years).  The case involved a medical device, a type of heart valve, and at bottom the class simply alleged negligence.  The plaintiffs sought compensatory and punitive damages, medical monitoring, disgorgement of profits, and provincial insurers’ health care costs, and of course attorneys’ fees for eleven years of litigation.  What was that that Robert Harper said about the XYZ affair?

Proceeding under different, and more liberal, class action standards than in the United States, the Andersen opinion addressed the following “common” issues:

(1) Negligent design/testing/marketing (broken into two parts, pre- and post-marketing)

(2) General causation

(3) Increased risk of medical complications

(4) Medical monitoring

(5) Spoliation

(6) Disgorgement/waiver of tort

(7) Punitive damages (note, our issue numbering is different than the court’s).

Here are the results that the court reached on those issues:

(1a) The evidence did not establish negligence in the device’s pre-market design and testing.  A balance of foreseeable risks and harms favored the defense.  Andersen, slip op. at 20-63.  Plaintiffs’ claim of regulatory fraud was rejected.  Id. at 59-62.

An interesting holding, that lack of testing has no legal significance unless the test results would have made selling the product “unreasonable,” appears on page 42.  This is a Canadian variant of the argument underlying our duty to test cheat sheet − that failure to test by itself is not a separate cause of action.

(1b) The evidence did not establish negligence in the device’s post-market surveillance or failure to recall the device sooner. Andersen, slip op. at 64-76.

(2) Plaintiffs’ evidence of toxicity neither satisfied the Canadian version of Daubert, nor sufficed to establish general causation. Andersen, slip op. at 15-19; 76-107; 110-26.

A case series was insufficient scientific evidence to support a causation opinion.  Id. at 125-26.

(3) The design of the device increased the risk of one condition (paravavular leak within specific post-implant periods), that was not seriously disputed.  Evidence (epidemiology; the court declined to perform a Bradford-Hill analysis) failed to establish any material increased risk of any other condition, those being all the ones in dispute.  Id. at 127-93.

Doubling of risk (relative risk of 2.0) is the legal standard of materiality in toxic tort cases, but as a presumption, not an absolute bar.  Id. at 178-85.

(4) Since general causation was unproven, plaintiffs were not entitled to medical monitoring.  Id. at 193.

(5) There was no intentional spoliation of evidence that could give rise to an adverse inference.  Id. at 107-10.

(6) A theory of “waiver of tort,” basically a cause of action for negligence without proof of causation, was not adopted, because such a change is more proper for the legislature than the courts.  Id. at 193-201.

(7) Without separate discussion, punitive damages are denied.  Id. at 202.

Obviously, we’ve left out a lot of details.   That’s why you have a link to the 215 − page Andersen opinion.

Wednesday, June 27, 2012

This Just In … NJ Win on Innovator Liability

We direct your attention to Coundouris v. Wyeth, et al. No. ATL-L-1940-10, 2012 WL 2401776 (N.J. Super. Jun. 26, 2012).  It’s a Reglan decision (actually a decision that applies to 8 Reglan cases) that Dechert was directly involved in – so we can’t say much.  But we can tell it is worth a read :

·         NJ resident plaintiffs who ingested generic metoclopramide sued the manufacturers of brand name Reglan for failure to warn – what we and others have dubbed, innovator liability.
·         The Court granted the brand manufacturers’ motion to dismiss finding:
o   the claims were governed by New Jersey’s Products Liability Act, slip op. at 4;
o   under which liability is limited to “specific parties – namely the manufacturer or seller of a product,” slip op. at 6 -- hence, no brand liability without brand product usage;
o   the Supreme Court’s Mensing decision did not address or impact the issue of innovator liability under NJ law. 


Vioxx Consumer Fraud Action gets Booted

We've been watching more soccer lately -- which is to say that we've been watching any soccer at all. The Euro 2012 competition is heating up, with an all-Iberian tilt today, and a battle tomorrow between members of the original, more scary Axis-of-Evil. We do not know a whole lot about futbol, but our unschooled eyes tell us that Spain will meet Germany in the final. Not that we have much of a rooting interest, especially with Ireland and Poland making early exits. Let's face it, we just want an excuse for a party with tapas, brats, sangria, and beer. The Phillies stink this year, so we have to redirect our sports fanaticism somewhere else, even if it is for a sport with not enough scoring and too many fake injuries.

One phrase that keeps coming up in the broadcasts is "the 50-50 ball." (We googled "50-50 ball" and found a Jeff Koons work of art called "Three Ball 50-50 Tank," consisting of three partially submerged basketballs in a fish-tank. It was sold for almost half a million dollars. Is it any wonder that the rich Western countries are the object of so much contempt?) Sometimes a soccer ball will be propelled toward two opposing players with the same opportunity to get it -- thus, the 50-50 aspect. The player who earns possession is the one who is better or who simply wants the ball more. A whole team can go on a run of winning virtually every 50-50 ball. The same thing occasionally happens in hockey games, though we have not yet heard of the "50-50 puck."

That got us to thinking about 50-50 cases. There are many issues in our little playing field where the outcome is, or should be, clear and one-sided. Buckman preemption comes to mind. But there are some issues where the outcome is like a 50-50 ball, where either side could win. That is not necessarily because the merits of the two opposing positions are roughly equal. Would you really expect us ever to say that?! No, it's just that there are certain issues where, as we read the advance slips, it looks like courts are perfectly capable of going either way. Maybe it comes down to political predilections or life experiences, but courts can be as biased or results-oriented as a talking head on Fox news or MSNBC. Maybe better lawyering really can make a difference. Think of parallel violations claims as a means of trying to circumvent preemption. Or think of Daubert challenges when doctors stray beyond their board certifications or rely upon adverse events, case studies, or iffy epidemiology. Or think of consumer fraud actions brought by plaintiffs whose claimed injuries dance with sophistry. We've seen courts go both ways on all these issues. Those cases form a litmus test of sorts, either intellectual or ideological.

Consumer fraud actions are particularly vexing. Used aggressively and interpreted broadly, they threaten to permit plaintiff lawyers to cobble together claims that are bereft of reliance, causation, or injury, that cannot possibly earn their "clients" anything more than nominal relief, yet are an effective means of extortion via inflated attorney fees and costs. Not to put too fine a point on it, but these cases are crap. They are an embarrassment. They make as much sense as a basketball partly submerged in a fish-tank. There is plenty of blame to go around everywhere, including legislators, judges, and lawyers. We've written about some bad outcomes in this area here, for example. And we’ve written about some good outcomes in this area here and here, for example.

The Vioxx litigation recently furnished a good outcome. In re Vioxx, 2012 U.S. Dist. LEXIS 81637 (June 13, 2012). Judge Fallon's opinion offers clear, rigorous reasoning that will be useful for future defense lawyers trying to win the 50-50 ball in consumer fraud actions. First, Judge Fallon reminds us that the Vioxx MDL began way back in 2005. 2012 U.S. Dist. LEXIS 81637 at *4. Time sure goes by when you're having … never mind. That same year, plaintiff Walker filed a Vioxx suit under the District of Columbia False Claims Act, and the case was filed under seal. He later amended the complaint to assert a separate claim under the D.C. Consumer Protection Procedure Act (the "CPPA"). The false claims act claim was dismissed for lack of standing. Now the CPPA claim was being attacked on the same theory. The court agreed with Merck and concluded that the plaintiff had failed to assert either an economic or statutory injury.  By the way, there was absolutely no dispute on this score:  the plaintiff suffered no physical injury.  Vioxx worked.  Why are we here?

Judge Fallon tells us that it "is abcedarian" that Article III jurisdiction reaches only justiciable cases and controversies. 2012 U.S. Dist LEXIS 81637 at *8. Wow. Great word. We had to look it up. The first definition is "of or pertaining to the alphabet." Yes, we did notice that "abc" and tardy "d" thing going on there. The second definition is "arranged in alphabetical order." Yawn. That is not really what we have here. We could imagine someone super-clever like Judge Kozinski managing to write an opinion where all the words are in alphabetical order, at least if the case involved zymurgy. But the third definition is in action here: "rudimentary, elementary." Bingo. We pity our poor friends who for the next week will have to listen to us persistently pooh-pooh other people's ideas as "abcedarian." Anyway, the abcedarian issue in the Vioxx case was whether the plaintiff had alleged an invasion of any legally protected interest for which the plaintiff had standing to sue. Under the case law, which Judge Fallon accurately describes as "fact-intensive and somewhat difficult to reconcile" (2012 U.S. Dist. LEXIS 81637 at *9), the plaintiff must allege an injury to either an economic or statutory interest.

The plaintiff argued that he alleged an economic injury from paying more out of pocket for Vioxx than he would have if Merck had not misrepresented its safety profile. The plaintiff cited some cases in support because, frankly, there really are cases going both ways in this area. One of the plaintiff's favorite cases was Shaw v. Marriott International, 605 F.3d 1039, 390 U.S. App. D.C. 422 (D.C. Cir. 2010). Shaw matters a lot because it included an interpretation of the CPPA. Judge Fallon does a nice job of distinguishing Shaw as involving "a much more obvious economic injury; in that case, the defendant misrepresented the price of a hotel room and as a result the plaintiffs paid 18% more than they thought they would pay." 2012 U.S. Dist. LEXIS 81637 at * 18. That is clearly a concrete, particularized economic injury. By contrast, in the Vioxx case, the plaintiff "thought he was purchasing a medication that would relieve his pain without causing him personal injury (other than that warned of in the FDA-approved label), and that is what he received. There is no obvious, quantifiable pecuniary loss that Plaintiff incurred from purchasing a drug that worked for him and did not cause him any harm" Id. Talk about abcedarian! Judge Fallon found more useful authority in Rivera v. Wyeth-Ayerst Laboratories, 283 F.3d 315 (5th Cir. 2002), "at least with respect to the question of whether he has alleged a concrete and particularized economic injury; '[m]erely asking for money does not establish an injury or fact.' Id. quoting Rivera, 283 F.2d at 310. Consequently, the Vioxx court concludes "that merely purchasing a drug-which in fact helped Plaintiff-does not generate an economic injury giving rise to Article III standing and Plaintiff has no alleged a concrete particularized injury in fact to his economic interests." Id. at *20.

Without any economic injury, the plaintiff falls back on arguing that he suffered some sort of statutory injury. Here, the plaintiff argued "that Merck's violation of 'his statutory right to 'the disclosure of information regarding Defendant's dangerous misrepresentations' suffices to establish a statutory injury that creates Article III standing." Id. at *20-21. Once again, the plaintiff relied on the Shaw case. Once again, the court analyzed the Shaw case carefully and distinguished it effectively. Under the Shaw statutory injury analysis, the plaintiff must be "in the class of individuals protected by the CPPA." Id. at *21, quoting Shaw, 605 F.3d at 1042. This analysis turns on the substantive law of the CPPA and whether the factual allegations in the Second Amended Complaint, taken as true, state a claim for violation of Plaintiff's individual rights under the CPPA by Merck.

It turns out that Merck had a few cases to cite in support of its position, including the recent Third Circuit opinion in In re Schering Plough Corp. Intron/Temodar Consumer Class Action, F.3d, 2012 U.S. App. LEXIS 9832, 2012 Wt. 1700836 (3rd Cir. May 16, 2012). We discussed that case here. The Third Circuit dismissed that consumer fraud action because the plaintiff failed to "present a plausible allegation actually linking [plaintiff's] injuries to any type of miscommunication or false claim about the drugs that were actually prescribed to her." In re Schering Plough, 2012 U.S. App. LEXIS 9832 [WI] at 16. Similarly, in the Vioxx case, "when it comes to connecting that conduct to himself, Plaintiff only alleges in general terms that those communications were directed towards consumers in the District of Columbia and that he was a resident of the District of Columbia." In re Vioxx, 2012 U.S. Dist. LEXIS 81637 at *25. And now, fellow soccer fans, we are in TwIqbal country. All that the plaintiff supplies are generalized and conclusory allegations, none of which suffices to show any plausible nexus or causation between Merck's conduct and the plaintiff as an individual. For example, the Second Amended Complaint "is devoid of any allegation that Plaintiff or his doctor personally received any misleading communications regarding Vioxx." Id. at *26.

The plaintiff grudgingly offers "one concrete fact regarding the Vioxx he personally took." Id. The plaintiff alleged that his "initial Vioxx pills came as sample packages he received from his doctor, which he alleges "demonstrates that Merck representative had visited" his doctor. Id. But, according to Judge Fallon, "this piles speculation upon speculation; not only does it require an inference that the samples were delivered directly from a Merck representative to Plaintiff's doctor, it requires the additional conjectural leap that such a meeting included some of the allegedly violative misrepresentations." Id. Thus, "[w]hether the deficiency is characterized as missing 'causal connection between the injury and the conduct complained of,' or a failure to allege that Merck's conduct had an effect on Plaintiff such the Plaintiff's personal rights under the CPPA were invaded, the pleading fails. Amendment would be futile. " Id. at 27 (citations omitted).

Maybe this is an obvious, even abcedarian thing to say, but we love it when a 50-50 ball goes the right way.

Tuesday, June 26, 2012

Nipping It in the Bud (or Don't Build It and They Won't Come)

There’s an awful lot of consolidated treatment of product liability cases these days.  So when the plaintiffs in Jones v. Wright Medical Technology, No. 11-14432 (E.D. MI. June 19, 2012), argued that their case should be consolidated (under FRCP 42(a) and a local rule) with another that involved a “similar defect in the identically defective medical device, installed by the same surgeon at the same hospital, within a very short time of each other,” we half-expected the court to go along.

But, lo and behold, it didn’t.  While the plaintiffs focused on a few similarities, the defendant pointed out the important differences:

Two different Plaintiffs, with different lifestyles, different ages, different heights and weights, implanted with two different products, with alleged injuries occurring nearly 1.5 years apart, in different states, treated by different doctors, in different hospitals.  The evidence at trial will be vastly different.

Slip op. at 4-5.  Also, the Jones case had a loss of consortium plaintiff, while the other case did not.  The Court was swayed by these differences:

Here, the allegations are that two different devices, manufactured in different lots, broke in different ways. . . . Proving these claims will not require substantially similar evidence.  It will require different evidence.  (Likewise, proving the loss of consortium claims of Mrs. Jones will require establishing a set of facts wholly distinct from those relevant to the [plaintiff in the other case]).

Slip op. at 6 (quotation marks omitted). 

These evidentiary differences are important in litigations and trials.  They are often the difference between defeat and victory.  As we all know, it matters that the product is different, that the plaintiffs are vastly different, that their injuries and circumstances are different. 

Sure, plaintiffs want to consolidate the cases nonetheless.  It will cut their costs and create an atmosphere that blurs the differences and hides the detail.  For discovery, it usually means more.  For trial, it means that evidence that isn’t admissible against one plaintiff comes in anyway because it’s admissible against the other.  Juries may reach a verdict for one plaintiff based on evidence relevant only to the other.  And juries are more likely to feel something must have been wrong because more than one person is complaining.  And so the risk of undue prejudice to the defendant rises along with the chances of a plaintiff victory.  We’ve posted about these problems before.  

Possibly most important, the very existence of a consolidated proceeding encourages more cases.  People will come, Ray.  People will most definitely come.  And so the point at which there are just a few cases and consolidation is requested can be critical.  It can mean the difference between a few generally unrelated cases and a consolidated docket-full of cases.  If you build it, they will come.  And suddenly something that never really was, and never should have been, is created. 

Or instead, like here, the court spots the differences and nips it in the bud.

Monday, June 25, 2012

Don't You Just Hate It When....

The other side provides expert "disclosures" that are so vague and generic that they provide no substantive information about what the bases for the expert's opinions (or even the opinions themselves) are?

So do we.

So we're glad to call your attention to the recent decision in Ingram v. Novartis Pharmaceuticals Corp., ___ F.R.D. ___, 2012 WL 2354451 (W.D. Okla. Jun. 19, 2012), where the court slammed the practice and granted a defense motion to compel "disclosures" that were worthy of that description.

Ingram was another Aredia/Zometa case.  Instead of complying with the expert disclosure provisions in Rule 26 (that's Rule 26(a)(2)(B) for retained experts and 26(a)(2)(c) for non-retained (usually treating physician) experts), the plaintiff submitted boilerplate, identical in each instance that:  (1) each retained expert would testify in accordance with prior depositions and their reports; and (2) each non-retained expert would testify in accordance with medical records and depositions.  Ingram, 2012 WL 2354451, at *1.

Wow, that's helpful.

So the defense moves to compel, because such generic garbage blatantly disregarded what Rule 26 disclosures are intended to accomplish.  Fortunately, the court agreed.  As to the retained experts, the court held:
While . . . there may be some logical and practical appeal to plaintiff's mere incorporation of these experts' previous reports or testimony in other venues, the court ultimately concludes that this practice fails to comply with Rule 26's clear terms requiring written disclosures of expert testimony.  For retained experts, the written report itself must contain, among other things, a complete statement of all opinions the witness will express and the basis and reasons for them.  The court finds that reference to other testimony, without providing the complete statement of opinions and basis therefor in a self-contained document is not only insufficient under Rule 26, but is unworkable. The court is not aware of any local practice that would replace this clear requirement of a written report for retained experts, particularly over another party's objection.  In considering this matter, the court agrees with defendant that to allow such a broad designation would require not only the defendant, but also potentially the court, to review and evaluate the previous trial, deposition, and hearing transcripts involving these witnesses in an attempt to learn the basis of the testimony of the named witnesses to see if it conforms to their testimony in this case.  However, the burden of designation is on the plaintiff, not the defendant or the court.

Ingram, 2012 WL 2354451, at *2 (emphasis added).

As to non-retained experts, the court held essentially the same thing:
[E]xpert witnesses who are not required to give written reports must nevertheless provide disclosures which must include the subject matter on which the witness is expected to present evidence. The disclosure must also state a summary of the facts and opinions to which the witness is expected to testify. Again, mere reference to unspecified testimony is insufficient under this standard. Therefore, the court also finds that it would be appropriate for plaintiff to provide a proper disclosure of the expected testimony,

While the Ingram opinion isn't very long, it concerns a recurrent issue that can use the explication.  Therefore, we (and maybe others) sought its publication, which we're pleased to say will happen.

Congrats again to Joe Hollingsworth and his crew - this time for successfully grappling with a problem common to all of us.

Friday, June 22, 2012

Breaking News - Bartlett Goes Nowhere In Darvocet

We've just learned from our friends at Skadden that the plaintiffs attempt to obtain reconsideration of the Mensing preemption dismissals in the Darvocet MDL have come to naught.  See In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, MDL No. 2226, slip op. (E.D. Ky. June 22, 2012).  Here's what the court had to say about Bartlett's "just remove it from the market" rationale:

Having reviewed the Bartlett decision, the Court agrees with the Generic Defendants.  In Bartlett, the First Circuit adopted the “failure-to-withdraw” argument previously rejected by this Court and others.  This argument — which failed to persuade either the Supreme Court or the Eighth Circuit on remand in Mensing, and the Sixth Circuit in Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir. 2011) — is no more availing now.  Moreover, the First Circuit offered little explanation for accepting it, noting simply that the Mensing opinion had not specifically addressed design-defect claims.
Darvocet, slip op. at 4-5 (other citations omitted).

As we observed before, Bartlett is little more than the First Circuit jabbing a sharp stick in the eye of the Supreme Court because the lower court doesn't like Mensing.  It allowed a theory (take generic drugs off the market altogether) that conflicts even more strongly with Hatch-Waxman than the warning theory preempted in Mensing.  We didn't think that other courts would be taken in, and so far they haven't.

Bessemer Process Yields Stainless Steel

Id. at *1.
We mentioned last Friday that the defense win in the Bessemer Aredia case had been affirmed.  We didn’t have time to gloat then, but we do now − at least a little.  The affirmance, which won’t be published, is now online here:  Bessemer v. Novartis Pharmaceuticals Corp., 2012 WL 2120777 (N.J. Super .A.D. June 13, 2012) (per curiam).  There isn’t much to this opinion; it’s basically an appellate endorsement of two of the trial court’s (Judge Jessica Mayer) opinions:
[W]e affirm substantially on the basis of the well-considered and thorough opinions of Judge Mayer, which are well supported by the evidence and legal precedent.

The two prior opinions in question are:  Bessemer v. Novartis Pharmaceuticals Corp., 2010 WL 6052544 (N.J. Super. L.D. Nov. 12, 2010) (denying post trial motions), and Bessemer v. Novartis Pharmaceuticals Corp., 2010 WL 6257855 (N.J. Super. L.D. April 30, 2010) (granting partial summary judgment).  Now that they’ve been confirmed as "well-considered and thorough," what we’d most like to see is these two opinions (particularly the summary judgment order) get published in the A.2d reporter − so Westlaw would give them page numbers, for one thing.

So what exactly did the Appellate Division endorse last week? Here’s a synopsis:

The post-trial motion decision (2010 WL 6052544) in Bessemer held:
  • The testimony by plaintiff’s prescribing oncologist at trial that called causation into question was in response to plaintiff’s own question, and plaintiff, having asked the question, had to live with the answer.

  • Plaintiff failed to place other objections to videotape deposition testimony on the record, and thus waived them.

  • If plaintiff did not like the prescriber’s videotape testimony, she could have called him as a live witness, but failed to do so.

  • The jury was told that the defendant paid the travel expenses for the treating physician who testified that plaintiff likely didn’t have the disease condition she claimed she did.

  • The court acted properly in letting both sides speak informally to plaintiff’s treating physicians.

  • The total number of patients with similar conditions (at least to what plaintiff claimed she had) was properly excluded as irrelevant and prejudicial, and in any event the jury never reached causation, having found for the defendant on defect.
    If we had page numbers, we’d use them, but we don’t so we can’t.

    Except for the informal interviews point − to which the Appellate Division spoke in its recent decision in the mesh litigation − these issues are very case specific and, frankly, seem rather makeweight.
    The more important of the two Bessemer trial court decisions was its summary judgment decision (2010 WL 6257855). That opinion held:
    • Plaintiff presented enough evidence of her warning theory to survive summary judgment (that’s why there was a trial).

    • Defendant was under no obligation to warn a non-prescribing physician in a different field (dentistry) of the risks of what was a drug prescribed in the treatment of cancer.

    • Plaintiff presented enough evidence of causation for her warning theory to survive summary judgment.

    • Aredia was FDA approved, so punitive damages could not be assessed.

    • Plaintiff failed to establish a design defect claim.

    • There is no independent cause of action for implied warranty.
      Of these rulings, the most important concern warnings to non-prescribing physicians in other fields and punitive damages. While we don’t like everything in this opinion, we think it deserves to be published.

      Thursday, June 21, 2012

      Odd Facts Should Not Make Bad Law

      When we saw the first one we thought, that’s odd, but it’s mostly a malpractice claim pretty far from our sweet spot.  When we saw the second one, we thought, maybe we should blog about this now….  But the result was mostly unfavorable, and other, more significant things were happening.  But now that we’ve seen a third one, well we think we finally have to comment.  We don’t want the odd facts that the plaintiff pleaded (we have some difficulty believing their truth) in Schiff v. Hurwitz to mess up Pennsylvania law − any worse than it already is, that is.

      First, some legal propositions:

      Proposition one − No separate duty to test theory exists under Pennsylvania product liability law − period.  The relevant cases, all in our duty to test cheat sheet, are:  Lance v. Wyeth, 4 A.3d 160, 168-69 (Pa. Super. 2010), appeal granted, 15 A.3d 429 (Pa. 2011); Viguers v. Philip Morris USA, Inc., 837 A.2d 534, 541 (Pa. Super. 2003), aff’d, 881 A.2d 1262 (Pa. 2005) (per curiam); Oddi v. Ford Motor Co., 234 F.3d 136, 143-44 (3d Cir. 2000); Wolfe v. McNeil-PPC, Inc., 773 F. Supp.2d 561, 570 (E.D. Pa. 2011); Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289, 318 n.32 (E.D. Pa. 2007); Stitt v. Philip Morris, Inc., 245 F. Supp.2d 686, 694 (W.D. Pa. 2002).

      Proposition two − The Food, Drug & Cosmetic Act (“FDCA”) does not give private persons a right of action to enforce it.  Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 352 (2001); In re Orthopedic Bone Screw Products Liability Litigation, 193 F.3d 781, 791 (3d Cir. 1999); Gile v. Optical Radiation Corp., 22 F.3d 540, 544 (3d Cir. 1994); Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 231 (3d Cir. 1990); Green v. Dolsky, 685 A.2d 110, 115 (Pa. 1996); 21 U.S.C. §337(a).

      Proposition three − Strict liability does not lie against the maker of a prescription medical product under Pennsylvania law − not for any type of defect (except possibly manufacturing).  Hahn v. Richter, 673 A.2d 888, 889-90 (Pa. 1996); Baldino v. Castagna, 478 A.2d 807, 810 (1984); Incollingo v. Ewing, 282 A.2d 206, 219-20 & n.8 (Pa. 1971), Lance, 4 A.3d at 164-65; Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. 2006); Sykes, 484 F. Supp.2d at 318 & n.31; Soufflas v. Zimmer, Inc., 474 F. Supp.2d 737, 750 (E.D. Pa. 2001).

      Proposition four − Strict liability does not lie against health care providers in Pennsylvania.  Cafazzo v. Central Medical Health Services, Inc., 668 A.2d 521, 537-38 (Pa. 1995); Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1386 (Pa. 1991); Kelly v. St. Mary Hospital, 694 A.2d 355, 358 (Pa. Super. 1997); Podrat v. Codman-Shurtleff, Inc., 558 A.2d 895, 897 (Pa. Super. 1989); Makripodis v. Richardson-Merrell, Inc., 523 A.2d 374, 378 (Pa. Super. 1987); Flynn v. Langfitt, 710 F. Supp. 150, 152 (E.D. Pa. 1989); Eby v. Milton S. Hershey Medical Center, 31 Pa. D. & C.4th 121, 125 (Pa. C.P. 1996).

      Proposition five − Strict liability cannot be reimported into prescription medical products/health care services under the guise of a consumer fraud claim brought under the Pennsylvania Unfair Trade Practices & Consumer Protection law (“UTPCPL”), because the act is inapplicable to medically-related activities.  Walter v. Magee-Women’s Hospital, 876 A.2d 400, 407-08 (Pa. Super. 2005), aff’d, 906 A.2d 1194 (Pa. 2006); Foflygen v. Zemel, 615 A.2d 1345, 1354 (Pa. Super. 1992); Gatten v. Merzi, 579 A.2d 974, 976 (Pa. Super. 1990), Kee v. Zimmer, Inc., 2012 WL 1758618, at *4 (E.D. Pa. May 17, 2012); Zafarana v. Pfizer, Inc., 724 F. Supp.2d 545, 557 (E.D. Pa. 2010); Smith v. Bristol-Myers Squibb Co., 2009 WL 5216982, at *5-6 (D.N.J. Dec. 30, 2009) (applying Pennsylvania law); Heindel v. Pfizer, Inc., 381 F. Supp.2d 364, 374 (D.N.J. 2005) (applying Pennsylvania law); Kester v. Zimmer Holdings, Inc., 2010 WL 2696467, at *14 (W.D. Pa. June 16, 2010); Albertson v. Wyeth, Inc., 63 D. & C.4th 514, 538-39 (Pa. C.P. 2003); Crossen v. Peretz, 2002 WL 34576549 (Pa. C.P. Oct. 17, 2002); Luke v. American Home Products Corp., 1998 WL 1781624, at *8 (Pa. C.P. Nov. 18, 1998); see Beyers v. Richmond, 937 A.2d 1082, 1088 (Pa. 2007) (favorably citing and applying medical professional UTPCPL precedent to hold that lawyers were also not within the scope of the UTPCPL).

      Proposition six − Hospitals have no common-law obligation to obtain informed consent to medical procedures from patients.  Valles v. Albert Einstein Medical Center, 805 A.2d 1232, 1239 (Pa. 2002); Watkins v. Hospital of the University of Pa., 737 A.2d 263, 268-69 (Pa. Super. 1999); Friter v. Iolab Corp., 607 A.2d 1111, 1114 (Pa. Super. 1992).

      Proposition seven − In Pennsylvania the informed consent doctrine is not unlimited.  It extends only to the risks and benefits of surgery, specifically not including any obligation to explain the FDA regulatory status of prescription medical products to patients.  Southard v. Temple University Hospital, 781 A.2d 101, 107 (Pa. 2001).  Nor does the informed consent doctrine require disclosure of a physician’s financial interests.  Duttry v. Patterson, 771 A.2d 1255, 1259 n.2 (Pa. 2001); Corrigan v. Methodist Hospital, 874 F. Supp. 657, 659 (E.D. Pa. 1995).

      Proposition eight − and probably the most important for present purposes − federal judges exercising diversity jurisdiction have no business “predicting” novel expansions of state-law liability.  They follow, and do not lead, state courts.  Day & Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4 (1975); Sheridan v. NGK Metals Corp., 609 F.3d 239, 253 (3d Cir. 2010); Travelers Indemnity Co. v. Dammann & Co., 594 F.3d 238, 253 (3d Cir. 2010); City of Philadelphia v. Beretta U.S.A. Corp., 277 F.3d 415, 421 (3d Cir. 2002) Camden County Board of Chosen Freeholders v. Beretta, 273 F.3d 536, 541 (3d Cir. 2001); Leo v. Kerr-McGee Chemical Corp., 37 F.3d 96, 101 (3d Cir. 1994); City of Philadelphia v. Lead Industries Ass’n, 994 F.2d 112, 123 (3d Cir. 1993).

      Second, we’ll take a look at the facts in Schiff v. Hurwitz, 2012 WL 1971320 (W.D. Pa. June 1, 2012) (hospital institutional review board’s (“IRB) motion) (“Schiff III”); Schiff v. Hurwitz, 2012 WL 1828035 (E.D. Pa. May 18, 2012) (medical device manufacturer’s motion) (“Schiff II”); and Schiff v. Hurwitz, 2012 WL 1355613 (W.D. Pa. April 18, 2012) (doctor’s motion) (“Schiff I”), as they’re pleaded. That’s all we have to go on since all three Schiff opinions decide Rule 12 motions to dismiss.  Maybe these weird allegations will become less beguiling when the pleadings can be pierced.  Here's hoping, anyway.

      The plaintiff’s allegations in Schiff − which we have a hard time believing − are that the defendant medical device manufacturer sold a Class II device (that means no preemption under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)) called “Invasix” that the FDA had cleared for marketing and labeling for certain uses.  The plaintiff, however, allegedly did not use the device for any of those labeled uses.  Instead, the plaintiff alleges that she was provided the device in the context of some sort of underground, non-FDA authorized clinical trial of a new use.  This underground trial purportedly was conducted like a clinical trial, in that her surgeon was an “investigator” and the trial was carried out under the auspices of the defendant hospital IRB.  In accordance with the usual trappings of a clinical trial, the plaintiff signed a written agreement under which she was to receive money for participating in the trial and any medical expenses from adverse events suffered in what amounted to a medical experiment would be paid for.  Plaintiff alleged that the manufacturer defendant, in order to avoid the FDA's clinical trial requirements, falsely represented (it's not clear to whom) that the new use had no safety issues.  The plaintiff further claims that she was not informed of any safety risks by anyone − in particular that the defendant surgeon’s informed consent discussion omitted mention that she didn’t fit within the trial’s protocol and didn’t mention any safety risks.  Then, of course (since this is a product liability action), plaintiff suffered injury from those risks.  Plaintiff also claimed she wasn’t informed that the defendant surgeon “was a paid investigator.”  Schiff I, 2012 WL 1355613, at *1-2; Schiff II, 2012 WL 1828035, at *1-2; Schiff III, 2012 WL 1971320, at *1-2.  We’ve seen a lot of claims in several decades of practice, but we've never encountered allegations of an under-the-table or off-the-books clinical trial before.  That's the source of our skepticism about whether the pleaded facts in Schiff are true, or even could be true.  But there’s always a first time….

      On these purported facts, the plaintiff in Schiff alleged (at least) the following general theories:  (1) against the treating surgeon:  UTPCPL violations; (2) Against the manufacturer (Invasix): negligence, strict liability, breach of warranty, and misrepresentation; (3) against the hospital IRB:  UTPCPL violations and intentional infliction of emotional distress.  Plaintiff may well assert other claims − these are just what was discussed in the Schiff set of opinions.

      Third, and the whole point of this post, here is why we’re bothered by what’s been going on in Schiff.

      From our perspective, it appears that these weird FDA/clinical investigation allegations have mesmerized the court, at least as far as the pleadings are concerned.  By that we mean that these allegations have induced a federal judge into permitting causes of action − for strict liability, for negligence, and under the UTPCPL − that have at best never been recognized under Pennsylvania law, and at worst are flatly rejected by controlling precedent.

      It’s no isolated occasion. Precedentially unconstrained rulings typify the three Schiff opinions.

      Let’s dispel the haze, shall we?

      We will assume for purposes of this argument − although the Pennsylvania Supreme Court has never spoken on the subject − that under some circumstances, Pennsylvania would allow a negligence per se-type cause of action for at least some violations of the FDCA.

      But not these.


      Start with legal Propositions 1 and 2 − Pennsylvania recognizes no duty to test, and there exists no private FDCA cause of action.  A clinical trial, whether FDA approved or not, is simply a very formal a method of testing a product for safety and effectiveness.  Pennsylvania courts have said over and over again, that unless a product is otherwise defective, it doesn’t matter whether it was properly tested, or indeed tested at all.  If one assumes the rather fantastic allegations in Schiff that a surreptitious clinical trial of an experimental use was being conducted, that’s just an elaborate attack on the testing (or lack of same) of the product.

      But plaintiff's argument that the purported clinical trial should have been conducted under FDA auspices is simply an claim that the defendants violated the FDCA.  As a private individual seeking damages, plaintiff simply can’t do that − not unless the claim resembles a recognized, pre-existing tort.  That’s been looked at over and over again in medical device preemption cases (we’re not arguing preemption here because it’s a class II device), and the lack of an FDCA private right of action restricts plaintiffs to FDCA-related claims that “parallel” state law.  We’ve done lots of posts on parallel claims, and most of our medical device preemption scorecard is devoted to what is or isn’t a “parallel” claim, so we won’t delve deeply into that here.

      Since a duty to test doesn’t exist under Pennsylvania law, the FDCA violation claims in Schiff can’t possibly be parallel to any recognized Pennslyvania product liability claim.  The defendant manufacturer might have violated the FDCA from here to kingdom come (or at least to Israel, where it’s based) but that’s for the FDA to sort out.  As we’ve recently posted, private plaintiffs simply don’t have standing to raise FDCA violations that don’t also amount to traditional common-law claims − and the underground clinical trial allegations here aren't even in the vicinity.

      So the FDCA regulatory haze in Schiff is just that − a smokescreen of basically irrelevant allegations that do nothing but confuse and obfuscate the plaintiff’s common-law causes of action − or lack of same.

      One of those other causes of action would seem to be informed consent.  If, as plaintiff Schiff claims, she was not told the underlying medical risks and benefits of the surgery in question, then that would support a traditional informed consent action against the surgeon.  Moreover, if the procedure in question was really “experimental” − in the sense that its risks and benefits were unknown − then the law requires patients to be told this fact.  See Proposition 7.  However, as the Pennsylvania Supreme Court has pointed out “the doctrine of informed consent is a limited one.”  Valles, 805 A.2d at 1240 (quoting Duttry, 771 A.2d at 1258).  Informed consent obligations are owed only by doctors, not by hospitals, and certainly not by manufacturers.  See Proposition 6.  The learned intermediary rule, at the heart of most of the cases in Proposition 3, limits a manufacturer’s informational obligations to warning the treating physicians.  If those choose not to pass along information, that’s both their prerogative and their responsibility.

      Thus, the apparent holding in Schiff III, 2012 WL 1971320, at *3, that some sort of “negligence” based warning claim (exactly what is never articulated) exists against the hospital IRB is simply contrary to Pennsylvania law governing the informed consent obligations of hospitals.  The only negligence theory (we'll put aside that "informed consent" in Pennsylvania sounds in battery, not negligence) that might even arguably exist to impose liability on a hospital for inadequate patient information would be under Friter, supra − that a hospital voluntarily agreeing to participate in an FDA-regulated clinical trial voluntarily assumes, and must perform reasonably, the informed consent obligations stated in FDA regulations.  But the allegations in Schiff are antithetical to any Friter-based cause of action, since plaintiff asserts that the defendants sought to circumvent FDA clinical trial regulations, not follow them.  Again, we’re left with a bare allegation that the hospital (and its IRB) should have complied with the FDCA, which must fail since it’s not “parallel” to any liability Pennsylvania law has ever recognized against a hospital.

      Could there be a claim against the hospital in Schiff?  It’s hard to tell, and we don’t have a lot of experience in this area, but IRBs are supposed to supervise clinical trials.  To the extent plaintiff claims that she fell outside of the alleged study’s alleged protocol, well, at least compliance with protocol sounds like something that’s within the scope of an IRB’s supervisory duty.  So maybe.

      The departures from established Pennsylvania law are even worse in Schiff II, with its holding that the alleged FDCA violations somehow provide an informational claim that can bypass the learned intermediary rule, see 2012 WL 1828035 at *6 (“defendant was negligent for failing to follow FDA regulations regarding investigative devices and failing to properly test the . . . device”).  We've already dealt with the non-existent "duty to test."  As for the rest, let’s be blunt.  Once a physician/patient relationship is in place, for forty years Pennsylvania has not recognized any exception to the learned intermediary rule, not for pharmacists, not for contraceptives, and certainly not for clinical trials.  Once again, there is no “parallel” direct-to-patient warning duty in Pennsylvania.  It’s a bare FDCA violation claim that the plaintiff in Schiff has no standing to pursue.

      What could conceivably be pursued, buried beneath all the FDA-related dross in the Schiff complaint, is a claim that the manufacturer withheld information about safety and effectiveness (or the lack of data supporting same) from the prescribing surgeon.  That would state a claim under Pennsylvania law, but Schiff II wanders so far afield from anything recognizable as a Pennsylvania cause of action, that its hard to tell if a normal claim is even being alleged.  Also, the plaintiff in Schiff asserts a breach of contract claim, that the manufacturer agreed to pay for certain things, and then didn’t.  That could also be a viable claim, assuming the accuracy of the pleading (which is questionable).

      Likewise, Schiff II purports to tease some sort of “strict liability” claim from the plaintiff’s FDCA-related allegations:

      Plaintiff argues that, because the strict liability claim is based on more than a failure to warn theory, the claim is permitted to go forward.  Plaintiff argues that the “risk of thermal injury rendered the device unsafe, defective and dangerous as well as [defendant manufacturer’s] failure to consider the factors set forth in the FDA Guidance Document on RF medical devices” also permits for recovery for strict liability.  At the Motion to Dismiss phase, this Court finds that plaintiff has adequately pled a claim for strict liability.

      2012 WL 1828035, at *5.  We've read this quote several times, and it’s still so vague and garbled that we can’t even figure out what kind of strict liability (design, warning, manufacturing?) is at issue.  Schiff II doesn't mention design.  It doesn't mention manufacturing.  But it nevertheless states that there's something "more than a failure to warn."  But the only thing mentioned aside from an inherent risk (which can only be warned about - see Viguers, supra, for the proposition that inherent risks aren't design defects), is the purported FDCA violation.

      We do know this − Propositions 3 and 4.  Strict liability does not exist in Pennsylvania in the context of medical procedures involving prescription medical products.  That’s been the law, without exception (where the bar to strict liability has been asserted; we know a couple of cases where it wasn't) in Pennsylvania since Incollingo in 1971.  The absence of strict liability has been reaffirmed regularly by appellate courts applying Pennsylvania law.  Indeed, the most significant pending controversy in prescription medical product liability litigation in Pennsylvania is whether a negligence claim exists for design defect.  Even the very pro-plaintiff Lance decision (now before the Pennsylvania Supreme Court) agreed that no strict liability claim of any sort exists.  The fight in Lance is solely over negligence.

      And then there’s fraud/UTPCPL.  As the abundant precedent cited in support of Proposition 5 holds, the Pennsylvania consumer fraud statute doesn’t apply to medical procedures of any sort or in product liability actions involving prescription medical products that physicians use in such procedures.  But in all three Schiff decisions allow novel UTPCPL or fraud causes of action to proceed against persons against whom that such claims have never before been allowed − and once again, the bizarre FDCA violation claims are at the heart of the allegations. In Schiff I:

      Here, [plaintiff] avers that confusion and deceptive conduct surrounded the affiliation, connection, and association [defendant surgeon] had with the [defendant manufacturer] and the “BodyTite Procedure” as well as Plaintiff’s lack of knowledge of the clinical trial involving the Invasix device.  Furthermore . . . [the surgeon] allegedly failed to warn [plaintiff] of the potential dangers of the Invasix Device and, critically, allegedly misrepresented that the FDA approved, or was at least involved in the clinical trial, of the Invasix Device.

      2012 WL 1355613, at *4 (emphasis added).  The “critical” UTPCPL allegations − indeed the only facts actually cited − all have to do with the purported non-FDA clinical trial.

      In Schiff II, instead of the UTPCPL, plaintiff alleged, and the opinion allowed, a “misrepresentation” claim where “some of the alleged misrepresentations were made regarding the classification of the device.”  2012 WL 1828035, at *7.  There's the FDA again.  Once again, however, this claim is completely incompatible with controlling Pennsylvania law − our supreme court’s unanimous Southard decision cited in Proposition 7 above.  There the court held:

      [T]he FDA labels given to a medical device do not speak directly to the medical issues surrounding a particular surgery. The category into which the FDA places the device for marketing and labeling purposes simply does not enlighten the patient as to the nature or seriousness of the proposed operation, the organs of the body involved, the disease sought to be cured, or the possible results.  The FDA administrative label does not constitute a material fact, risk, complication or alternative to a surgical procedure. It follows that a physician need not disclose a device’s FDA classification to the patient in order to ensure that the patient has been fully informed.

      781 A.2d at 107 (emphasis added).

      Not material....

      Need not be disclosed to the patient....

      It's safe to say that, as a matter of controlling Pennsylvania law, the supposed FDA “classification” of a regulated product “does not constitute a material risk” and “need not [be] disclose[d].”  It’s hard to get clearer than Southard that "misrepresentations . . . regarding the classification of the device" are immaterial and cannot possibly be the subject of any viable fraud claim, since such information doesn't have to be disclosed in the first place.

      In Schiff III, once again, the UTPCPL allegations deemed most important are those involving the purported FDCA violations:

      The Complaint further avers that [the IRB] engaged in unfair trade practices because the FDA had not given prior approval for [these] devices in . . . plastic surgery procedures.  These facts, in addition to others in the Complaint, are sufficient to state a claim for unfair trade practices and negligence.

      2012 WL 1971320, at *4.

      But yet these FDCA violation allegation have no analogy in any legal claim recognized in Pennsylvania, given Proposition 5 − that the UTPCPL simply doesn’t apply to medical providers.  Here, in a slightly different guise, we have the same bare FDCA regulatory violation (that private plaintiffs can’t pursue, Proposition 2) being passed off as something else, this time the violation of another statute.  Plaintiff can’t do that either − it’s been tried.  As the Third Circuit has held:

      [Plaintiff’s] position would require us to usurp administrative agencies’ responsibility for interpreting and enforcing potentially ambiguous regulations.  Jurisdiction for the regulation of OTC drug marketing is vested jointly and exhaustively in the FDA and the FTC. . . . and what the FD & C Act and the FTC Act do not create directly, the Lanham Act [a federal statute] does not create indirectly.

      Sandoz Pharmaceuticals, 902 F.2d at 231 (cited in Proposition 2).  In this respect, the UTPCPL as alleged in Schiff is no different than the Lanham Act claim alleged in Sandoz − both try to create forbidden private FDCA violation claims “indirectly” under cover of another statute.

      So as we see it the FDCA-related allegations in the Schiff litigation about the purported surreptitious conduct of a clinical trial are both, (1) irrelevant, since there’s no FDCA-based cause of action paralleling any recognized claim under Pennsylvania law, and (2) immaterial, since the Pennsylvania Supreme Court has already held that FDA regulatory status is not information that need be disclosed to patients at all.

      More fundamentally we believe that the repeated allowance of novel and often already-rejected supposed “Pennsylvania law” causes of action in Schiff needs to stop.  That’s Proposition 8.  Schiff is merely diversity-jurisdiction-based state-law litigation.  The Supreme Court and the Third Circuit have repeatedly and vehemently held that federal courts just cannot do what’s been going on in Schiff − allowing novel theories of liability that state courts have not recognized.
      [A] federal court is not free to apply a different rule however desirable it may believe it to be, and even though it may think that the state Supreme Court may establish a different rule in some future litigation.

      Hicks v. Feiock, 485 U.S. 624, 630 n.3 (1988).

      A federal court in diversity is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.

      Day & Zimmerman, 423 U.S. at 4 (1975).

       Unlike our role in interpreting federal law, we may not act as a judicial pioneer in a diversity case. 

      Sheridan , 609 F.3d at 253.
      As a federal court sitting in diversity, we are charged with predicting how another court – in this case, the [relevant state] Supreme Court – would rule on the record presented to us. . . .  [I]n reaching our conclusion we have exercised restraint in accordance with the well-established principle that “where two competing yet sensible interpretations” of state law exist, “we should opt for the interpretation that restricts liability, rather than expands it, until the Supreme Court of [the state] decides differently.”  To hold here, as [plaintiff] urges. . . would undoubtedly subject manufacturers and dealers to greater liability. . . .  Given the muddled state of [state] law on this point, we must decline [plaintiff’s] invitation.

      Travelers Indemnity, 594 F.3d 238, 253 (3d Cir. 2010) (quoting Werwinski v. Ford Motor Co., 286 F.3d 661, 680 (3d Cir. 2002)).

      [I]t is not the role of a federal court to expand state law in ways not foreshadowed by state precedent.  Instead, a federal court follows the precedents of the state’s highest court and predicts how that court would decide the issue presented.

      City of Philadelphia v. Beretta U.S.A. Corp., 277 F.3d 415, 421 (3d Cir. 2002).

      In a diversity case . . . federal courts may not engage in judicial activism. Federalism concerns require that we permit state courts to decide whether and to what extent they will expand state common law. . . . Our role is to apply the current law of the jurisdiction, and leave it undisturbed.

      Leo v. Kerr-McGee Chemical Corp., 37 F.3d 96, 101 (3d Cir. 1994) (quoting City of Philadelphia v. Lead Industries Ass’n, 994 F.2d 112, 123 (3d Cir. 1993)).

      At bottom, Schiff doesn’t strike us as that hard or complicated of a case.  There’s a question of whether the defendant adequately warned the prescribing surgeon of the risk (or perhaps of it's unknown nature) that the plaintiff encountered.  If not, did the surgeon already know the risk from his own clinical experience or elsewhere?   Did the surgeon adequately pass along the relevant risks to the plaintiff as part of his informed consent discussion?  If some sort of experimental surgery was involved, was plaintiff adequately informed by the surgeon that the relevant risks could not be accurately estimated on the basis of what was known?  And if there was some sort of protocol-based investigation going on (whether FDA-authorized or not), did the defendant surgeon follow the protocol and inform the patient that she was being enrolled in such a study − and did the defendant IRB adequately ensure that study protocols were being followed?  That’s it.  That sounds like what Schiff was (or should be) about.  The rest, all the regulatory brouhaha, is a smokescreen at best and an invitation to error at worst.  Right now, it unfortunately appears that the invitation is being accepted.  We hope that changes.

      Wednesday, June 20, 2012

      You Only Live Twice

      Now where were we? Oh, that's right, we were at another firm and were handing out farewells. Our Long Goodbye was apparently so maudlin and overwrought that some readers thought it signaled full-on retirement or a fatal disease. It turns out that our temporary exit from blogging was prompted by nothing more dramatic than a change of firms and an impending trial. Now Bexis has traipsed off to the same firm (coincidence - or so he says) and the trial settled on the courthouse steps. As Pacino says in the one good line in Godfather III, "Just when I thought I was out, they pull me back in." We are treating this reentry into the blogosphere as a second chance. It is an opportunity to do better. In our former stint, we ladled on a little too much fluff and low-brow silliness. Looking back, it is almost embarrassing how we seized upon any slender excuse for connecting legal developments with our pop culture obsessions. Shame on us for pretending to derive doctrinal learning from the likes of Star Wars or George Harrison or the film criticism of Pauline Kael. We hereby resolve to keep things on a higher, more serious plane.

      So let's talk about that Mad Men season 5 finale. It was called "The Phantom," a reference to a couple of dead guys and an unrealistic career choice. The reviews of the episode have been mixed, and at least one esteemed critic showcased a delightfully euphonious word we had not heard before: "anvilicious" -- as in, the themes of the finale were as subtle as an anvil dropped on the audience's tender noggin. There is truth to that. It is not exactly subtle for the ghost of Don Draper's brother to glide into a dentist's office and inform a nitrous-oxidized Don that it's not just his tooth that is rotten. Nevertheless, to our mind, the finale was a perfectly serviceable way to wrap up a transitional season, and to put an exclamation point at the end of a string of motifs of double-ness and appearance vs. reality. It is arguable where Mad Men ranks in the Big Four of recent great cable tv dramas (along with The Sopranos, The Wire, and Breaking Bad), but it is clearly the most relevant for most of us. Putting aside some of our more aggressive plaintiff lawyer friends, not many of us can identify with folks dealing in extortion and brutality. But we all play the game of trying to get others to buy what we have to sell. Not too long ago we worked with an incredibly successful trial lawyer who loved to remind us that what goes on in front of the jury is more a play than a recitation of real life. We understand what that means, but, frankly, that sort of thing makes us a little squeamish. Maybe it's a product of some particularly admirable role model or too many Frank Capra movies, but we are viscerally attached to the image of ourselves as being scrupulously honest. Note the word "image." There is always that gap between who we are and who we want to be.

      Don Draper is literally not who he pretends to be. Who is he pretending to be? A war hero. A loving husband. And James Bond. In an earlier episode, we catch Don reading From Russia With Love. In the season 5 finale, there is a double reference to Bond. Don plops down next to Peggy [if you buy the definition of the main character as the one who undergoes the biggest change, Peggy is the main character of Mad Men] in a movie theater to watch Casino Royale, a sloppily, self-indulgent unfunny comedy that came out in early 1967 (not to be confused with the recent, very fine Daniel Craig version). Then, at the end of the episode, we get the best three minutes of the show so far, putting aside "The Wheel" and "The Suitcase." Don walks off a soundstage, strides alone in the dark, ambles up to a bar, orders an Old Fashioned, and then a Heather Graham look-alike asks him if he is alone. His eyes narrow, he turns, and he offers that old serial-canoodler Draper smile, oozing bad intentions. The screen goes black. Season 5 was about second chances (e.g., Don's second marriage) and dealing with inner duality. Is Don alone? Will he stay that way? Will Don backslide and bid adieu to fidelity? By the way, what do you think 1968, that awful year of assassinations, the Tet offensive, Chicago riots, and Nixon, has in store for our morally challenged Mad Men characters? (Which is to say, all of them.)

      That marvelous three minute ending to season 5 begins with deep orchestral maneuvers, followed by piercing string notes. Wait a minute - is that really the song they are going to play? Yes, and it is so perfect that you have to believe that show runner Matt Weiner knew all along he would use it. He was just waiting for 1967 to arrive. The song was "You Only Live Twice," sung by Nancy Sinatra for the Bond movie of the same name. Sinatra's singing is a bit uncertain (nepotism is another theme in season 5 of Mad Men), but the opening lines ring clear: "You only live twice/or so it seems/ one life for yourself/and one for your dreams." We get good Bond and bad Bond. Good Don and bad Don. And we get a whole cast of characters trying to reconcile inner ideals with outer, scurvy selves. As the credits rolled, we thought of that over-used Karl Marx quote from "The Eighteenth Brumaire of Louis Napoleon," about how history repeats itself, "first as tragedy, then as farce." Not too long ago, we wrote a couple of posts about sequels, and how things usually get worse, not better. "You drift through the years/and life seems tame/then one dream appears/and love is its name." And then you screw that up. The people who most plea for second chances are most likely to squander them. It's hardly an uplifting theme, but, as with The Sopranos, it is as if the writers want to make clear that bad people deserve bad consequences.

      But good people deserve a second chance. So do good lawyers. "You Only Live Twice" was a good movie and a great song, but as a life lesson it is a bit pessimistic. (By the way, as a shout-out to one of our loyal readers, we also acknowledge that "You Only Live Twice" is inartfully phrased. Somewhere in the great fly-over resides one of the three or four best product liability lawyers in the country. He is frighteningly smart. So smart, in fact, that he already knows this parenthetical is about him. Many years ago, he wrote a little pamphlet for associates about how to write. Strike that: it was really about how not to write. It, along with DDL blogger emeritus Mark Herrmann's Curmudgeon's Guide, is the best primer on legal writing we have ever seen. Anyway, one of our friend's pet peeves was the misplaced "only." "Only" should go right in front of the word it is modifying. So it should be "You Live Only Twice." Got it?)

      Two weeks ago we wrote about Ray v. Allergan, 2012 WL 1979226 (E.D. Va. June 1, 2012), where excellent defense-lawyering earned a defendant a second chance -- a new trial. The court overturned a $12 million verdict and held that the plaintiff had impermissibly argued that the Botox label should have come with a boxed warning. The judge held that such an argument was preempted. You might remember the really weird thing about the Ray case: the defense lawyers obtained the courtroom security video, which showed that during closing argument the plaintiff lawyer used hand gestures to describe a box warning. Those were not empty gestures. They were prejudicial. They misled the jury into thinking that liability could be imposed for failure to include a boxed warning. Ray I was a good opinion. Ah, if there is a Ray I, there must be a Ray II, right? (It reminds us of an Encyclopedia Brown story, where the teenaged detective deduces that a purported civil war sword is phony because its inscription says that the sword was presented to the Confederate General immediately after the victory at the First Battle of Bull Run. How would they know there would be a Second Bull Run? Plus, the South called it Manassas, not Bull Run. But we digress.)

      In granting the motion for a new trial, the Ray court did not address the defendant's Mensing argument. Instead, that would be 'explained elsewhere." Bexis went on to speculate what that Mensing argument was. And, as usual when it comes to conjuring up smart defense arguments, Bexis got it right. Under Mensing, drug and device manufacturers should not be on the hook for not taking steps when it is not clear what the FDA would have done in reaction to those steps. Rather, the issue should be what the manufacturer could have made happen independently. We said that "we look forward to seeing what happens next in Ray." Mark that as a monument to our prescience. We are not sure how many of you read the comments to our posts, but they are usually worthwhile (putting aside the spambots that occasionally litter the comment field with oddly inappropriate sales pitches). This time, one of our faithful readers had the temerity to disagree with Bexis, pointing out that Mensing was about generics who could not approach the FDA to suggest label changes. By contrast, the defendant in Ray was the name brand manufacturer. That is a good point, as far as it goes. But Bexis offered a rejoinder, demonstrating that the point did not go far enough. "The point of Mensing is that the FDA might or might not do something at some indefinite future time, whereas the state requirement of an 'adequate' warning (or design, or whatever) is immediate. If the defendant can't independently act immediately, then it can't comply with both requirements and there's impossibility preemption."

      As we said, Bexis can devise a logical argument. But Bexis cannot always predict what an illogical court might do. Now we have the Ray court's ruling on the Mensing issue. Ray v. Allergan, Inc., 2012 WL 2120018 (E.D. Va. June 1, 2012). As for the debate between the commenter and Bexis, let's just say that Bexis came in second place. The court ended up holding that whatever the underlying logic behind Mensing and its takes-steps vs. acting-independently analysis, Mensing applies only to generics. If you are not in Mensing-land, you are in Wyeth v. Levine-land, where preemption is but a fond dream. It's not even a close call, according to the Ray court. We know we're headed to a bad place when the court tells us up front how preemption is disfavored. Ray, 2012 WL 2120018 at *2. We know we are headed to a very bad place when the Ray court gratuitously calls the 2006 FDA pro-preemption preamble "remarkably arrogant." Id. at *3 n. 1. The Ray court holds "that Mensing simply does not apply here and that it does not change the fundamental principles announced two years earlier in Wyeth, a decision that the Supreme Court actually cited with approval in its decision in Mensing." Id. at *5. The Ray court declined "to do what the Supreme Court did not do, extend the rationale of Mensing to brand name drugs." Id. at *7. Thus, while federal regulations control what must be in a black box warning and, therefore, "any theory based on a black box warning as a requirement of state law would be preempted," "nothing in the regulations that govern Allergan's duties at issue precluded using bold type or some other way of emphasizing and making prominent language respecting the information that was in its possession. Moreover, nothing in Mensing precludes Allergan, as distinct from a generic manufacturer, from sending a Dear Doctor letter." Id.

      Talk about empty gestures! A plaintiff lawyer cannot say box warning and cannot draw a box with his or her hands, but it sounds like pretty much everything else is fair game. We are not quite calling Ray II a farce. In fact, lots of other courts might come out the same way. Pity, that. Marx was always talking about the "contradictions" he spotted everywhere, and how they would inevitably produce some new synthesis. There is, at a minimum, some tension between Levine and Mensing, and it will be interesting to see how it will play out, either in the legislative or judicial arena. Granted, it would take a gutsy court to follow the logic of Mensing along the lines Bexis suggested. But we cannot help mourn the missed opportunity.

      Anyway, that is why Ray II made us think of the Mad Men season 5 finale. We are looking forward to season 6 even more than Bexis looked forward to Ray II. We trust that we will not be similarly disappointed.

      It is good to be back.

      Tuesday, June 19, 2012

      Groundhog Day in Illinois in June

                  Sometimes we feel just like Phil Connors when he said:  I told you. I wake up every day, right here, right in Punxsutawney, and it's always February 2nd, and there's nothing I can do about it.   That about sums up our feelings about the Yasmin/Yaz MDLWe wake up, right here in Southern District of Illinois, and it’s always pharmacist liability and fraudulent joinder, and there’s nothing we can do about it.  We thought the Seventh Circuit had put this issue to bed in Walton v. Bayer Corp., 643 F.3d 994 (7th Cir. 2011).  But, here we are one year later – and plaintiffs continue to file claims against pharmacies/pharmacists in the Yasmin/Yaz MDL in the hopes of beating diversity and having their cases remain in the South Illinois judicial hellholes (St. Clair County in this case).  Like Phil Connors, plaintiffs seem determined to re-live the same issue over and over again.  Like Phil Connors, plaintiffs make small changes to their argument each time in hope that the result will turn out differently.  But, unlike Phil Connors, we don’t see plaintiffs breaking out of this loop – the issue has been decided and it’s time to move on.

                  The most recent case on pharmacy/pharmacist liability and fraudulent joinder is Martin v. Moody’s Pharmacy, 2012 U.S. Dist. LEXIS 80863 (S.D. Ill. Jun. 12, 2012).  And, since this is a repeat performance by plaintiffs, it is somewhat of a repeat performance for us as well.  You can see our prior posts on Walton and pharmacy liability in the Yasmin/Yaz MDL here and here.  In fact, it’s only been a few weeks since the last Yasmin/Yaz pharmacy liability/fraudulent joinder decision.  So we’ll dispose of the basic issues quickly.
            Plaintiff’s failure to warn claim is premised on the allegation that defendants failed to warn about the risks of taking YAZ for someone suffering from arteriovenous malformation (AVM) (a vascular condition which includes a heightened risk of hermorrhage).  Id. at *4.  In addition to suing the manufacturer, plaintiff sued her non-diverse pharmacy and pharmacists.  On that claim, plaintiff Martin, like plaintiffs in the prior cases, tried to rely on a narrow exception to pharmacy non-liability in Illinois where the pharmacist has actual, subjective knowledge of a reason why a particular drug is contraindicated in a particular patient.  Happel v. Wal-Mart Stores, Inc., 766 N.E.2d 1118 (Ill. 2002) See Martin, 2012 U.S. Dist. LEXIS at *18-20 (discussing Happel).  In deciding plaintiff’s motion to remand and the pharmacy defendants’ motion to dismiss, the court found that plaintiff missed the mark on the “actual knowledge” requirement:

      the allegations of this most artfully crafted complaint do not specify that [the pharmacy] or The Pharmacist defendants had actual knowledge of the decedent’s AVM condition. There is no allegation that anyone had specifically advised the non-diverse defendants of the decedent’s condition, or that the pharmacy had previously filled prescriptions related to the decedent’s AVM condition, or that the pharmacy had asked about any complicating factors. All that is alleged is that the non-diverse defendants should have known of the risks inherent in YAZ for a person with AVM.

      Id. at *10.  And, that’s not enough. 

                  But, plaintiff here did try an additional argument that we thought warranted bringing this otherwise been-there, done-that case to our readers' attention.  And it’s about another issue that really sticks in our craw – prohibition of ex-parte, informal defense interviews with treating physicians of plaintiffs in personal injury cases.  Yes, Illinois is one of those states in which defense counsel don’t have equal rights with plaintiffs for informal discussions with treating doctors. 

      [W]hen an ex parte communication has taken place between defense counsel and a treating physician, . . . sanctions may be imposed upon the defendant, including reversal of the judgment in favor of  the defendant and the award of a new trial.

      Id. at *23-24 (citations and quotation marks omitted) (discussing Petrillo v. Syntex Labs, Inc., 499 N.E.2d 952 (Ill. App. Ct. 1986)).  

      We’ve blogged numerous times about the importance of both sides in personal injury litigation – and especially drug/medical device product liability litigation involving the learned intermediary rule – having equal rights to talk to treating/prescribing physicians.  Here is yet another reason – plaintiff’s attempt to extend a ban on informal interviews with treating physicians to pharmacists and thus to prevent defendants from establishing fraudulent joinder.

      Plaintiff’s position in Martin is even more absurd given that the pharmacists were themselves defendants, but we’ll get to that in a minute.  First, just a quick reminder of why this issue gets us riled up.  It is not because defendants don’t get to conduct informal interviews of plaintiff’s treating physicians, but rather because we don’t and plaintiffs do.  All we want is for both sides to have to play by the same set of rules.  If that means instituting certain procedural safeguards (like authorizations or notice to opposing counsel) before informal interviews can be conducted – so be it.  As long as those restrictions apply to both plaintiff and defense counsel. This has worked just fine in mass tort litigation in states where defense informal interviews are allowed, like New York and In re Bausch & Lomb Contact Lens Solution Product Liability Litigation, Index No. 766000/2007 (N.Y. Sup.).  See also Arons v. Jutkowitz, 880 N.E.2d 831, 837 (N.Y. 2007) (informal interviews with plaintiffs’ treaters are allowed, subject to notice and filling out some forms).

      Unfortunately, a defense ban on informal interviews, such as Illinois’, allows plaintiffs to do whatever they want, while the defendants are stuck having to play solely by the rules of formal discovery.  The type of formal discovery not available at the time of removal -- which takes us off our soapbox and back to Martin. 

      In support of the removal petition, the manufacturer-defendant included affidavits from the pharmacist-defendants establishing their lack of knowledge of plaintiff’s medical condition.  Martin, 2012 U.S. Dist. LEXIS 80863 at *25-26.  Plaintiff attempted to exclude the affidavits arguing that they were obtained via improper ex-parte communications with plaintiff’s pharmacists.  Id. at *23.   Plaintiff further argued that because the pharmacy/pharmacists had not entered their appearances in the case, the manufacturer-defendant couldn’t obtain discovery from them.  Like we said, one-sided litigation practices encourage plaintiff trickery.  If the court had favored plaintiff’s argument, plaintiff could put in her own affidavit to support her allegations about conversations with the pharmacists (see discussion of plaintiff affidavit, id. at *27-28) but defendants would be left out in the cold – no formal discovery, no informal discovery, no evidence.

      Fortunately, the court readily dismissed plaintiff’s argument on two grounds – the pharmacists were parties to the lawsuit and the ban on communications with treating physicians did not extend to pharmacists:

      The Court notes that despite plaintiff's assertion to the contrary, the non-diverse defendants were not required to file an entry of appearance in Illinois courts before consenting to removal in this Court. Nor is there a pharmacist-patient privilege extension of the Petrillo doctrine applicable in this case. To apply plaintiff's logic would be to effectively prohibit defendants joined by a plaintiff to a cause of action from communicating about their defense, a scenario not warranted by Petrillo.

      Id. at *24-25.  Moreover, the manufacturer obtained the affidavits through the pharmacists’ counsel, so there was no ex-parte communication.  Id. at *24. 

                  If the Yasmin/Yaz MDL is our Groundhog Day, we’re OK watching remand get denied over and over -- at least it’s not February in western Pennsylvania and we aren’t waking up to “I’ve Got You Babe” every morning.