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We all know how important a prescriber’s testimony is in a drug or device case. In many jurisdictions, the testimony of the prescriber is a mandatory requirement if a plaintiff is going to meet his/her burden of proof on a failure to warn claim. That’s because under an ordinary burden of proof, warning claims are dismissed on causation grounds where there is simply no evidence in the record about the prescribing physician’s actions. In other words, without evidence that a different warning would have altered the prescribing physician’s decision to prescribe, plaintiff hasn’t supported his claim.

Of course, this isn’t the case in jurisdictions where a “heeding presumption” puts the onus on the defendant to come up with affirmative proof of lack of causation. So, there are also, unfortunately, several jurisdictions where defendants are quite motivated to secure the prescriber’s testimony as well. We just posted last week about a case where the prescriber testified that he was fully informed of the risks and even if he had received the additional information plaintiff claimed he should have, he would have prescribed anyway. Under the learned intermediary doctrine, that testimony broke the causal chain on a failure to warn claim.

This means in every case, one side or the other (maybe even both) is looking to depose the prescriber. Sometimes that isn’t possible because he/she has died or can’t be found. And sometimes, the federal government simply says no. That happens when the prescriber is an employee of the U.S. Department of Veterans Affairs (the “VA”) and the plaintiff, a veteran, received his treatment, including prescription of the drug or device at issue at a VA hospital/clinic.

Generally, government employees are immune from discovery in private litigation under rules first set out in United States ex rel. Touhy v. Ragen, 340 U.S. 462 (1952). Pursuant to Touhy, a governmental agency can validly issue regulations restricting the availability of its personnel to participate (voluntarily or involuntarily) in private litigation. Id. at 468. Such discovery, the Court held, could easily become unduly burdensome to government operations. The “variety of information” that government employees possess” and “the possibilities of harm from unrestricted disclosure in court,” warrant “centralizing determination” concerning compliance with civil process. Id.

The VA has established its own set of Touhy regulations which can be found at 38 C.F.R. §14.800 et seq. And, if you’ve ever sent a Touhy letter to the VA requesting the deposition of a VA doctor, you’ve most likely received a courteous letter back denying your request and citing those regulations. Sometimes, further discussion can lead to an agreement to conduct a short deposition on a pre-determined set of topics. But, where a compromise with the VA cannot be reached, the issue may need to be litigated in federal court. Which brings us to today’s decision in Brown v. United States Department of Veterans Affairs, 2017 U.S. Dist. LEXIS 134556 (N.D. Ala. Aug. 22, 2017).

In this case, plaintiff was seeking to depose the doctor who had prescribed him Risperdal in connection with his products liability lawsuit pending in California state court. Id. at *1. His efforts to secure this testimony included multiple subpoenas issued by courts in California and Alabama, multiple emails with the Office of General Counsel for the VA, and a formal request for authorization of the deposition to the VA. Id. at *3-4. In its response to plaintiff’s request, the VA offered the following justifications for denying his request: conserving the time of VA employees to perform their official duties; the VA’s non-involvement in the state court case; that pertinent information can be obtained from production of the medical records; and that no advance authorization was sought per VA regulations. Id. at *5.

The court found none of these reasons persuasive. First, the court made clear that Touhy is not a locked door to the discovery of government information:

Application of Touhy regulations . . . is intended only to provide an orderly process by which a government agency may determine whether a demand for information from it is valid and lawful. Such regulations by themselves do not create a privilege or otherwise authorize the withholding of information.

Id. at *6; see also id. at *16-17 (Touhy does not “broadly exempt” the government from providing evidence). In the case of the VA, that process is a list of 15 factors to be considered in determining whether to allow a VA employee to testify. See 38 C.F.R. §14.804. But a list of factors isn’t enough. “There must be a good reason for an agency to withhold its evidence, and absent such a good reason, doing so is arbitrary, capricious, and an abuse of discretion.” Id. at *17. In this case, the court found the reasons the VA provided for withholding evidence simply didn’t make sense in light of the public’s right to obtain “every man’s evidence.” Id.

The VA’s first argument was burden/inconvenience. Section 14.804(a) provides that one consideration is “to conserve the time of VA personnel for conducting their official duties concerning servicing the Nation’s veteran population.” Certainly an honorable and essential service that nobody should be looking to undercut. But the court was perplexed at the VA’s assertion of this factor given that the deposition was limited to three hours, which even with prep time would likely mean no more than 8 hours total for the prescriber. Id. at *11.

[E]ight hours . . . is not a heavy burden of time compared to the need the plaintiff has for the testimony. It is ironic, indeed, that the VA does not consider supplying necessary information to veterans in need of it part of its “servicing of the Nation’s veteran population.”

Id.

The court also disagreed that plaintiff had not made a sufficient request for the testimony. He sent a letter summarizing the testimony that was sought and its importance. Plaintiff sought testimony about the doctor’s prescription of Risperdal to plaintiff and what the doctor knew about the drug when he prescribed it. Id. at *13. As the court acknowledged, what the prescriber knew concerning the risks of the drug is essential evidence for plaintiff’s case. “Only . . . the plaintiff’s treating physician, could provide this factual evidence.” Id. at *14-15. The VA’s argument that the necessary evidence can be obtained from the medical records fails for the same reason:

As mentioned already, under the Learned Intermediary Doctrine, necessary warnings related to drugs and medical devices are made to the treating physician, not the patient. This means that the plaintiff must explore, as a fact, whether [his prescriber] received any warnings or advisories regarding Risperdal, and their contents. Only [his prescriber] can supply this evidence concerning what he was told or read and what he knew about Risperdal when he prescribed it. That information is not likely reflected in medical records.

Id. at *20n.12.

The VA’s final argument was that it had “no direct or substantial interest in the private litigation between the plaintiff and the [drug] manufacturer.” Id. at *15. This lack of interest isn’t explicitly one of the 15 decision factors in §14.804, but could be related to the conservation of resources (already discussed above) or “that his testimony may create the appearance that the VA favors one litigant over another.” Id. On this point, the court repeatedly pointed out that the prescriber is being asked to provide factual testimony only. He is not being asked to serve as an expert or asked for his opinion on medical causation. Id. Moreover, a lack of interest in the litigation doesn’t “absolve” a witness of providing evidence. If it did, we’re sure private practitioners would turn down requests to testify all the time. The VA prescriber is no different than any other neutral, disinterested witness and his testimony is required only to comply with a general duty to provide evidence. Id. at *19-20.

The court’s reasoning would seem to apply to almost any prescribing testimony sought from a VA employee. If appropriately limited in scope to only factual evidence concerning the treatment of the plaintiff, the prescription of the drug, and the doctor’s knowledge of its risks and benefits, the factors for disallowing the deposition do not seem to apply – or are certainly heavily outweighed by the need for the evidence which cannot be obtained from any other source. We haven’t done a search for other Touhy decisions related to prescribers (maybe we will), but we certainly intend to add a cite to this decision to the next Touhy request we send to the VA.

 

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Today’s guest post is by Reed Smith Houston office associate Curtis Waldo.  Given the Noachic weather down there recently, one might ask “where’s Waldo?”  The answer is safe and sound, if not quite high and dry.  Curt is really dedicated – we offered him more time, but he said he didn’t need it.  In this post, Curt is acting the part of our on-the-scene reporter from last week’s Pinnacle Hip mandamus hearing before the Fifth Circuit.  Since things might move rather quickly (weather permitting) we wanted to bring his report to our readers ASAP.  As always our guest posters are 100% responsible for the content of their posts.  Curt deserves all the credit, and any blame, for what follows.

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First, thank you for all the support and well wishes sent to those of us in Southeast Texas riding out Hurricane Harvey.  It is a scary and challenging time, but we will recover.  Two days before Harvey’s arrival, as John Sullivan posted last week, a Fifth Circuit panel in Houston hosted a fascinating oral argument on the writ of mandamus filed by defendants in the Pinnacle hip implant litigation.  As a Reed Smith associate who works three blocks from the courthouse, I was fortunate enough to attend.

The writ has been covered by this blog here and here.  In sum, there are two issues before the court:  (1) did the district court err in holding defendants waived their personal jurisdiction rights?, and (2) if the district court did err, is it the kind of error that warrants the “extraordinary remedy” of a writ of mandamus?  The oral argument was divided about 50-50 between these two questions.  Defendants argue they did not waive their personal jurisdiction rights; plaintiffs argue they did.  Defendants argue a writ of mandamus is appropriate; plaintiffs argue it is not.  The panel was comprised of Judges Jerry Smith, Edith Jones, and Gregg Costa.

First to argue was John Beisner of Skadden Arps for defendants.  Mr. Beisner began with an analogy:  Your acquaintance invites you to dinner once.  You agree.  Your acquaintance invites you to dinner a second time.  You agree.  By agreeing to attend two dinners, have you now agreed to attend all dinners that may be called by the acquaintance in the future?

As tends to happen at oral argument, the judges wasted little time in interrupting.  Judge Smith:  Even if this was error, why a writ of mandamus?  Defendants could wait until the trial concluded and appeal the jurisdiction waiver at that time.

Mr. Beisner’s answer was twofold:  (1) why waste everyone’s time with an unnecessary trial if the appellate court can decide the issue at the outset, and (2) if plaintiff’s waiver theory is believed, defendants have waived their personal jurisdiction rights in 9,300 pending cases, which is exactly the sort of situation that is “not effectively reviewable” by a normal appeal.  As Judge Jones later pointed out, if the plaintiffs and defendants spend $50 million trying cases that are later obviated on appeal, does that $50 million not come straight from the pockets of plaintiffs and defendants, and right into the pockets of lawyers?

While this argument might make sense to anyone who is not a lawyer, Judge Costa pointed out rightly the slippery slope down which that argument might take them—should appellate courts step into district court proceedings at any stage where their input would be dispositive?  One could imagine such a system, but it is not the one we have in the federal courts.  Surely, Judge Costa asked, avoiding expense by itself is not enough to justify mandamus relief?  Mr. Beisner rightly avoided this logical sinkhole and clarified that no, it is not merely the avoidance of expense but also the likelihood of recurrence, which here is profound given the upcoming bellwether trials and thousands of other cases on the horizon where defendants have allegedly waived their constitutional rights.

Moving on to the waiver issue, Mr. Beisner framed the issue as revolving around the interpretation of a single email sent by defendants’ counsel in December 2014.  By agreeing “to allow the Court to select the next round of bellwether cases,” surely defendants were not agreeing to waive their right to object to personal jurisdiction in all 9,300 cases in the MDL and effectively agreeing that all 9,300 cases could be tried in Texas.  This, Mr. Beisner correctly emphasized, was simply not how the MDL process works.  The MDL system is for pre-trial purposes only.

Let us take a moment to consider that in a given day, we may send 100 emails or more, some of which we put more thought into than others.  I have never had one of my emails quoted at length in appellate briefs and dissected by a panel of Fifth Circuit judges, but I can’t imagine it is a good feeling.

Mr. Beisner had to explain why the email at issue referred to “bellwether cases,” and not only the bellwether case that would be tried.  He clarified that the case(s) to be tried in a single bellwether trial came from a larger pool of cases (but still not the 9,300 in the MDL), and it was this slightly larger subset that the email was referring to.  The judges appeared both intrigued and confused at the system used by the district court to select bellwether cases.  I thought Mr. Beisner made his point, but it is hard to say.  In any event, Mr. Beisner came back to his take-home message:  to waive one’s constitutional rights, surely such waiver must be clear and unambiguous, which here it was decidedly not.  Overall, the judges’ questions of Mr. Beisner on the waiver issue were not nearly as hard-hitting as the questions on the propriety of mandamus.

Next it was plaintiffs’ turn, for which plaintiffs turned to Kenneth Starr—former D.C. Circuit judge, solicitor general, law professor, Clinton investigator, and Baylor non-investigator.  Mr. Starr began his argument by quoting the All Writs Act from 1789.  Unsurprisingly, the panel did not let him finish his quote, and Judge Smith injected with the first question, which similar to his first question during Mr. Beisner’s argument cut to the chase:  Just what exactly are plaintiffs saying defendants waived?  Mr. Starr’s response was blunt:  in theory, defendants had waived their right to object to personal jurisdiction in all 9,300 MDL cases.  Mr. Starr hedged by saying this was only in theory, and plaintiffs did not plan to try 9,300 cases in Texas.  In reality, per Mr. Starr, this was only about the two bellwether trials set in the Northern District of Texas.  Despite Mr. Starr’s reassurances, his answer about the scope of the purported waiver seemed to make the panel uncomfortable.

Judge Jones took the opportunity to highlight what was really at stake—the big “M”.  While she did not say so explicitly, what is really “unreviewable” is the shift in momentum that occurs when a big verdict comes in while an appeal is pending.  Mr. Starr fought back:  This isn’t about momentum or settlement; this is about defendants trying to cut in line.  While the law may be under-developed on the issue of what contacts in a direct file case are sufficient to allow for jurisdiction, mandamus is not the proper vehicle to develop the law.  What is at stake, according to Mr. Starr, is our system of permitting trial courts to conduct trials, and leaving appeals for a later, orderly process.

Mr. Starr got out his talking points on his waiver argument, but it was hard to say he made any impact on the judges here.  Perhaps sensing that his stronger point was the impropriety of mandamus, Mr. Starr highlighted that defendants had an adequate remedy (they could appeal!), and the waiver issue was not so “clear and indistinguishable” as to justify mandamus.  Moreover, Mr. Starr brought up (for the first time by anyone) that a trial was actually set to start in September.  Lawyers and witnesses were ready to go, and his clients wanted their day in court.  Judge Jones countered that while plaintiffs may want their day in court, it would do them no good to have their verdict overturned a year later.

Ultimately it was a fascinating hour of argument—the waiver issue appears to revolve around a couple sentences in a CMO and a lawyer’s email from three years ago.  The mandamus issue cuts to the core of what role appeals courts should play in the federal system.  And overriding all of the argument was the judges’ curiosity and at times bafflement at the MDL system.  MDLs are supposed to encourage efficiency and coordination, but how do we achieve them while at the same time serving other purposes of the judiciary such as a deliberative appeals process, consistency, and finality?  What role should the court assign practical litigation considerations such as settlement momentum?  The courtroom was packed with law clerks and at least one district court judge, and the atmosphere of the courtroom had an academic and suspenseful quality.  Given the upcoming trial date, we should expect a decision soon.

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We’ve posted a lot about Plavix recently but all in the context of the Supreme Court’s decision in BMS v. Superior Court on personal jurisdiction. So, we don’t blame you if you forgot that the product at issue in that case was Plavix. The product wasn’t really at the heart of the analysis. Neither the plaintiff nor the defendant having any contacts with or relation to the jurisdiction was where all the action was. But that’s state court. There is also a federal MDL concerning Plavix where the claims of plaintiffs who weren’t trying to be “litigation tourists” are moving forward on the substance. But it doesn’t look like they are moving very far if the recent decision in Armantrout v. Bristol-Myers Squibb, 2017 U.S. Dist. LEXIS 131334 (D.N.J. Aug. 17, 2017) is any indication.

Plavix is an anticoagulant which is approved for prescription alone or in conjunction with aspirin. Because the purpose of an anticoagulant is to prevent the formation of blood clots, it is well known that Plavix carries an increased risk of bleeding. Information about the risk of bleeding has been in the Plavix label since it entered the market. Id. at *4-5. While most of that is probably common knowledge, we thought it warranted repeating given that the crux of the claims in this litigation are for failure to warn. Failure to warn of a risk known by practitioners and most lay persons and that was disclosed in the product’s labeling. If this isn’t an uphill battle for plaintiffs, we don’t know what is.

Plaintiff alleged that he was prescribed and used Plavix in combo-therapy with aspirin following implantation of a stent to treat his acute coronary syndrome. Plaintiff used Plavix and aspirin for 8 years before he was hospitalized with gastrointestinal bleeding. Id. at *7-8. His prescriber testified at his deposition that:

  • He was aware of the risk of bleeding the entire time he prescribed Plavix, id. at *9;
  • He was aware of the increased risk of bleeding when prescribed in combination therapy with aspirin, another anticoagulant, id.;
  • He believed that combo-therapy was medically necessary for the type of stent implanted in plaintiff, id. at *10;
  • In his medical assessment, the benefits of combination therapy outweighed the risks for this plaintiff, id.;
  • “having reviewed all the relevant studies regarding Plavix, he believes – even now – that prescribing Plavix to [plaintiff] was the most appropriate medical therapy.” Id. at *21.

We’ve seen testimony like this before and it simply makes us giddy. It means that there is no causal nexus between any alleged inadequate warning and plaintiff’s injuries. If the prescriber was aware of the risk and prescribed anyway – no causation. If the prescriber, knowing the current state of the scientific information, would still prescribe – no causation. No causation, no causation, no causation. We just love the way that sounds.

But plaintiff wasn’t going down without at least some fight. He proffered an expert opinion on the adequacy of the warning. His expert opined that defendant failed to warn about the lack of studies evaluating the use of Plavix for greater than one year. Id. at *19. But the court found that was sort of like bringing a knife to a gunfight. Defendant wasn’t arguing the sufficiency of the warning but rather whether the prescriber would have prescribed even when provided with the most current research and labeling. Id. at *19-20. So, at oral argument, plaintiff tried to change weapons by arguing that his expert’s report called into question the prescriber’s credibility.

To make this argument, plaintiff relied on an old New York case that held that prescriber testimony similar to the testimony here was insufficient for resolving the issue of proximate cause because the doctor had a been a defendant in the case and since the testimony was not “self-disserving” the doctor’s credibility was in doubt and therefore was an issue for the jury. Id. at *24. But as the court pointed out – the prescriber here wasn’t a defendant. “[W]hen the treating physician is not a defendant, but rather a disinterested witness, the same concern regarding credibility is not present.” Id. at *25. Unfortunately, there are two decisions from the Southern District of New York and the Second Circuit that without explanation extend the concept of “self-disserving” to testimony of treaters who were not defendants. See id. at *22-25. Fortunately, this judge was more thoughtful in her analysis and, like a federal-judge sitting in diversity should be – was unwilling to enlarge state law. The court found no New York cases endorsing the Second Circuit’s decision but found decisions by New York’s highest court granting summary judgment relying on unrebutted doctor testimony. Id. at *27. The court also offered an important observation about the cases relied on by plaintiff:

Importantly, if I were to follow [the Second Circuit], summary judgment would never be granted in these types of cases, because a third-party prescriber’s testimony would always be subject to doubt, unless the prescriber testified he or she would not have prescribed the drug. Such a one-sided result for a disinterested physician’s testimony cannot be correct.

Id. at *25. We agree wholeheartedly.

So, the doctor’s credibility isn’t in question simply because his testimony isn’t “self-disserving.” That left plaintiff to argue that the prescriber wasn’t credible because he didn’t agree with plaintiff’s expert. Plaintiff’s expert opined that defendant should have warned about the lack of long-term safety and efficacy studies and because the prescriber didn’t have such studies while he was prescribing, his testimony wasn’t credible. The court found the argument “wholly without merit.” Id. at *28-29. Most importantly, plaintiff never questioned the prescriber at this deposition on this issue. Id. at *29. Probably because he didn’t think he’d like the answer. The doctor did testify about various studies he read and relied on and each of those studies reported on the duration. So he was both aware of the length of those studies and the lack of any longer studies and that did not change his prescribing decision. Id. at *30.

The bottom line is that plaintiff didn’t refute any of the prescriber’s testimony. In other words, plaintiff did not meet his burden of proving that a different warning would have altered the doctor’s decision to prescribe. In fact, the only evidence in the case is that the doctor was fully aware of the risk when he prescribed and prescribed anyway. Under New York law, the prescriber’s independent knowledge of the risk is an intervening event that precludes manufacturer liability regardless of the adequacy of the warning. Id. at *30-31.

Plaintiff also brought a design defect claim, but the court found it was no different than his failure to warn claim and in addition to failing for all the same reasons, also ruled that under New York law a design defect claim can’t be based on failure to warn alone. Id. at *36.

Summary judgment wins in Plavix cases are hardly anything new. Take a look at our prior posts here and here. But, it’s been a few years since the last wave and maybe Armantrout is the start of another round of dismissals. Given the well-known risk at issue, we wouldn’t be surprised to see more Plavix cases fail under the learned intermediary doctrine based on very similar testimony.

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As we publish this post, lawyers in the Pinnacle Hip Implant MDL are gathering in the Bob Casey Courthouse in Houston or in coffee shops, breakfast cafés or law offices nearby awaiting the argument to come.  At 10:00 a.m., the arguing starts.  The Fifth Circuit will officially begin to consider whether to issue a writ of mandamus telling the Pinnacle Hip Implant MDL Court in Dallas that it cannot exercise personal jurisdiction over the upcoming September bellwether trial involving eight New York plaintiffs. The Fifth Circuit will tackle the substance of the appeal—did defendants waive their personal jurisdiction defense as to those eight cases and, in fact, as to all cases in the MDL when they gave a waiver in connection with the first two bellwether trials? Maybe more important, the Fifth Circuit will tackle procedure—are these the type of rare circumstances that require it to issues a writ of mandamus?

We first posted on this petition to the Fifth Circuit on August 8.  Defendants’ petition argued—fairly convincingly—that the context of their waivers, and the language of the waivers themselves, made clear that they applied only to the cases selected for the previous bellwether trials that were upcoming at the time that the waivers were made, and not to all MDL cases.  (Here is a copy of the petition.)  The defendants’ petition challenged an order issued by the MDL trial holding that the waivers applied more broadly, encompassing all future MDL cases, even (seemingly) those that had not even been filed yet.  (Here is the trial court’s opinion.)

Since our first post, the plaintiffs’ filed an opposition brief, and the defendants have since filed a reply brief.

Plaintiffs’ response brief is confusing at times. It argues (at 19) that MDL courts can exercise the personal jurisdiction necessary to conduct bellwether trials with the consent of the parties. Well, yes. With the consent of the parties. But the existence of consent is the very issue being considered by the Fifth Circuit. Plaintiffs’ response also argues (at 18) that an MDL court’s “direct-file order”—an order that allows plaintiffs to file complaints directly in the MDL court even if the underlying claims have no connection to the state in which the MDL court sits—allows it to exercise personal jurisdiction over those directly-filed cases and to conduct trials. No it doesn’t. Courts can’t create personal jurisdiction that otherwise did not exist simply by issuing an administrative filing order. On “waiver,” at one point plaintiffs’ opposition states (at 5) that defendants had previously explained that their waiver for the second bellwether trial was “in order to allow the court to select the next round of bellwether cases.” Plaintiffs then just let that phrase lie there out in the open, essentially making defendants’ argument for them.

Defendant’s reply brief misses none of this, addressing all these seeming missteps. It also turns some of plaintiffs’ arguments in defendants’ favor. For instance, plaintiffs argue that only two cases address the states’ contacts that should be considered in a direct-file case, claiming that both cases were decided wrongly. Defendants highlight (at 1), however, that this is the precise type of lack of guidance that requires the Fifth Circuit to weigh in. Defendants’ reply brief (at 2) explains that such guidance would assist not only in the upcoming Pinnacle Hip Implant bellwether trials, but also in future Pinnacle bellwether trials and other future MDL proceedings in the Fifth Circuit, as well as dispose of a current Pinnacle appeal. Most important, defendants’ reply brief highlights (at 6) the strict standard for finding a waiver of personal jurisdiction: “a clear and unambiguous showing of a deliberate relinquishment of a known right.” Armstrong v. LaSalle Bank Nat. Assoc., 552 F.3d 613, 615 (7th Cir. 2009). Under this standard, it’s hard to see how the waivers by defendants could ever be reasonably interpreted to apply broadly to all MDL cases.

The Fifth Circuit will test and probe all of these issues and arguments later this morning. It will likely be a fascinating back-and-forth. Now, as with any writ of mandamus, this is a long shot. But personal jurisdiction is a hot button issue right now. And the Fifth Circuit’s decision could affect many cases, as this MDL trial court has a penchant for arranging incredibly large multi-plaintiff bellwether trials. Regardless, one thing that we are reasonably sure of is that the Fifth Circuit will rule quickly. The next bellwether trial is only a couple of weeks away. And so we expect to be posting on the Fifth Circuit’s decision soon.

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It was over 32 years ago that we graduated from the University of Chicago Law School.  The three years in Hyde Park were a punishing experience.  There was one class in particular when Prof. Richard Epstein used the Socratic method to pummel our intellect and ego. By the end of the exercise, we were a puddle of incoherence.  The class was called Advanced Torts.  It is a bit funny that we today practice a form of Advanced Torts, even though Prof. Epstein long ago exposed our idiocy in the field.  But all is forgiven, if not quite forgotten, and we are grudgingly grateful for the hard lessons learned at his feet (from his vigorous kicking away at our preconceptions).  One of the things that Epstein did in that class was rip into the N.Y. Times v. Sullivan decision.  That case is usually thought of as one of the crown jewels of First Amendment jurisprudence, as it furnishes almost absolute protection to the press.  Basically, newspapers and other press media can skate past libel liability, no matter how false their publications, unless the press published with “actual malice” –  knowing the statement was false or acting in reckless disregard.   Epstein’s point was that while it was nice for the press that they would defend against most libel claims successfully, the state of mind inquiry was intrusive and complex, and the stakes involved, which could include punitive damages, were frighteningly high.  Such uncertainty and expense are not in society’s interest.  It sounds like heresy, but a simple standard of falsity, plus a cap on damages, would probably result in better outcomes and would certainly cabin discovery madness.

 

It occurs to us that punitive damages in mass tort cases suffer from the same, ahem, defect. Punitive damages require jurors to read the minds of corporate defendants, looking for bad intent or reckless disregard.  Conduct and documents that would otherwise be out of bounds for discovery and would never be paraded before the jury become fair game if punitive damages are available.  Moreover, due process considerations be damned, courts seem to permit jurors to flip around punitive damage figures in the tens or hundreds of millions of dollars as if they were nickels.  There is no consistency to the process.  One case might get halted by a judge who applies Daubert to preclude junk science, while another judge waves virtually the same case by and a jury socks the defendant with a $110 million verdict.  Or perhaps you have heard of jurors who conclude that the product did no real harm to a plaintiff, but are still sufficiently miffed at the company to award punitive damages.  It isn’t right. It makes no sense.  It probably won’t survive judicial scrutiny.  But the craziness happens.  No wonder our system of civil litigation looks like jackpot justice.  Pull the handle, watch wheels of inconsistent evidentiary rulings, inflammatory arguments, and jury lunacy spin, and see if the result is a shower of money.  If one pull comes up empty, never mind, keep pulling.  Whether or not you think the game is rigged, any rational defendant dragged into the courtroom casino knows it is a sucker’s game.  Better to pay a settlement and find the exit.

 

It turns out that we are hardly the only ones to rue the unfairness of punitive damages in mass torts.  A recent paper from the Cornell Law School  Legal Studies Research Paper Series (No. 17-33) by Cornell Law Professor James A. Henderson, Jr., “The Impropriety of Punitive Damages in Mass Torts,” dissects the issue nicely.   Other academics (think of Kip Viscusi) have exposed the wrongheadedness of punitive damages in mass torts, but Patterson’s paper is particularly compelling and timely.  He shows that punitive damages in mass torts are capricious, unfair, and unpredictable.  The joint justifications for punitive damages are retribution and deterrence.  But the retribution for any limited case at issue loses all sense of scale, and there is zero evidence that mass tort punitive damages actually improve corporate conduct or make anyone safer.  The problem is that the triggers for punitive damages, vague words such as “outrageous” that are meant to suggest “different levels of heinousness,”  are unclear to the point where jurors can do pretty much whatever they want.  That latitude is especially pernicious in the context of mass torts, where aggregation of claims is not just procedural, but substantive.  That is, the mass-ification of torts almost always prejudices the defendant by eroding defenses that would typically make the difference in a one-on-one case.  For certain industries, or whenever the government is involved, the law cheerfully dispenses with such niceties as fault, reliance, and causation.

 

Henderson takes us through some of the newer, non-traditional mass torts, such as asbestos, tobacco, lead paint, firearms, and no-injury economic loss cases where corporate defendants have been stripped of procedural and substantive defenses.  We’ve worked on a couple of these species of cases, and can vouch for the accuracy of Henderson’s analysis.  We’re by no means asbestos lawyers, but we once handled a couple of asbestos cases as a favor to a client.  We still occasionally bolt upright in the middle of the night, sweating from our memories of the asbestos docket call.  The client never manufactured anything with asbestos, but some of its products were later taken by a downstream manufacturer that placed some asbestos into the product before unleashing the products upon the populace.  The downstream manufacturer had shallow pockets, so the asbestos plaintiff lawyers added our client to the latest wave of defendants.  We proved to the plaintiff lawyer that our client had nothing to do with the asbestos, and the plaintiff lawyer shrugged and named some ludicrous figure for us to settle and get out of the case.  Sure – and then we’d be added to the asbestos sucker lists and face never-ending litigation.  We wanted to file a motion, but the insanity of the asbestos litigation “program” was that no defense motions would be considered until trial was only 30 days away.  Who wants to face that kind of brinksmanship?  Have you ever heard of the abomination called “near beer”?  Well, asbestos litigation is “near law.”  In fact, it is hardly law at all.  Rather, it is a system of taxing an unloved industry.

 

Viewing corporate conduct with hindsight, and assuming that corporations know everything and dwell purely on the bottom line, jurors are quick to reach for the spanking paddle.  That spanking means millions of dollars.  Risk averse corporate managers, and insurers worried about bad faith liability for failing to settle within policy limits, more often than not succumb to settlement blackmail.  The possibility of stratospheric punitive damages is simply a risk not worth taking.

 

Here are some other points that Henderson makes about punitive damages in mass tort cases:

 

  • Multiple successive punitive damages awards for the same alleged conduct are unfair to defendants.   (Maybe you could tell the jury that your company was already punished by another jury – but do you really want to do that?)
  • Any retribution is typically suffered by innocent, powerless shareholders, not the faulty managers.  Big surprise: expressing moral outrage toward corporations is unrealistic.
  • Punitive damages can deplete assets to the prejudice of later-filing plaintiffs.
  • Punitive damages are utterly unnecessary.  Large compensatory awards are more predictable and internalize social costs better than random punitive awards.

 

To quote a historical figure who clearly and devilishly believed in punishment, what is to be done?  Henderson mentions some marginal changes.  One idea is to require more specific triggers for punitive damages, such as criminal conduct (with a higher burden of proof).  Another idea, already existing in rare enlightened jurisdictions, is to let judges decide the amount of punitive damages.  It is well past time for courts to limit evidence of harm to that which was actually visited upon the particular plaintiff.  Henderson also discusses the possibility of limiting punitive damages to one case, which then creates a trust fund out of which later plaintiffs take their share.  But all of this is nibbling around the edges.  Henderson alludes to legislative changes, but seems pessimistic that our elected solons will ever risk displeasing a plaintiffs’ bar that is clever and promiscuous when it comes to slinging cash contributions to their favorite candidates.  That leaves the problem in the hands of judges, who will need to toss some troublesome precedents in the dustbin of history and start emphasizing the justice over the jackpot.

 

Henderson’s paper is clearly written and well-argued, and replaces our crankiness with a surfeit of citations.  It is well worth reading.

 

 

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We write this in the first minutes of the eclipse, about 75 minutes from whatever “totality” will be visible here in southeastern Pennsylvania. We have our certified safety glasses at the ready, we have instructed the midday dog-walker to keep the Drug and Device Law Little Shaggy Rescues indoors (lest they unwittingly look skyward), and we have a continuous loop of the Fifth Dimension’s “Age of Aquarius” going around in our head. (Parenthetically, we accidentally typed “Fifth Amendment” just then for the name of the band.) The song has nothing to do with the eclipse, but it talks about the moon. And about Jupiter aligning with Mars. Appropriately thematic, we thought.

And, while “love steering the stars” may be a little strong to describe recent activity in Risperdal litigation, we have been pleased by a recent spate of positive developments. Last week, Bexis reported on two favorable decisions out of federal courts, one a post-BMS personal jurisdiction denial and the second a refusal to consolidate dissimilar cases for trial. Today we round out the triumvirate with a nice summary judgment decision from Pennsylvania’s state court system.

In In re: Risperdal Litigation: P.D. v. Janssen Pharmaceuticals, Inc., 2017 Phila. Ct. Com. Pl. LEXIS 231 (July 26, 2017), the (male) plaintiff allegedly developed gynecomastia – excessive breast tissue – when he was prescribed Risperdal (beginning when he was eight years old). He sued, including claims for design defect, failure to warn, and fraud. The defendant won summary judgment. The published decision occurs in a peculiar posture that is a creature of the Pennsylvania Rules of Appellate Procedure. Under Pa. R.A.P. 1025, when a grant of summary judgment is appealed, the trial judge prepares a written opinion in support of affirmance, arguing that there were adequate grounds for the summary judgment decision.

Design Defect

First, the court addressed the plaintiff’s design defect claims sounding in both strict liability and negligence. Because there were unresolved choice-of-law issues, the court considered these claims under the laws of both North Carolina, where the plaintiff was prescribed Risperdal and developed gynecomastia, and Pennsylvania, the forum state. Both states prohibit strict liability design defect claims against pharmaceutical manufacturers. While Pennsylvania, since Lance v. Wyeth, permits claims for negligent design defect, “a drug manufacturer can shield itself from liability for the design of drugs by including appropriate warnings; however, when it becomes known that a drug should not be used in light of the relative risks, the manufacturer can only avoid liability by removing it from the market.” P.D., 2017 Phila. Ct. Com. Pl. LEXIS 231 at *8-9. Here, the plaintiff did not offer “any evidence that Risperdal was so dangerous no warning could mitigate the relative risk of gynecomastia.” To prevail on a negligent design defect claim under North Carolina law, the plaintiff was required to submit evidence of a safer alternative design, and he had not “even address[ed] this requirement . . . , let alone submit evidence of a safer alternative design for Risperdal.” Id., at *9. As such, the court held, the plaintiff’s negligent design defect claims also failed under either body of applicable law.

Failure to Warn

The court’s dismissal of the plaintiff’s warnings claims rested on a finding that the plaintiff had not met his burden, under either North Carolina law or Pennsylvania law, of proving “warnings causation;” in other words, he had not proven that any alleged inadequacy of the product’s warnings was causally related to the his injury. We love this doctrine, because a successful argument can turn on the opportunistic exploitation of a plaintiff’s lawyer’s failure to ask a single question when deposing the plaintiff’s prescribing physicians.

The plaintiff’s warnings expert opined that the 2006 Risperdal label, in effect when the drug was prescribed for the plaintiff, should have included: 1) a recommendation for physicians to monitor prolactin levels; and 2) an indication that there was a statistically significant association between Risperdal use and gynecomastia. Id. at *12. But, as the court explained, “[a]lthough the parties deposed Plaintiff’s prescribing physicians, neither party elicited any testimony from [the doctors] concerning whether [the expert’s] proposed warnings . . . would have affected their prescribing decision.” Id. And so, the court concluded, “In light of the dearth of testimony from his prescribing physicians that [the expert’s] proposed warnings would have changed their prescribing decision, Plaintiff failed to establish proximate causation.” Id. (citation omitted).

The plaintiff attempted to save his warnings claim by arguing that the defendant engaged in illegal off-label promotion. The court held that, because the plaintiff was in an indicated population and was prescribed the drug for an indicated use, any discussion of off-label promotion was irrelevant to the case.

Fraud

Finally, the plaintiff argued that the court erred in dismissing his fraud claim. Again the court considered this claim under both North Carolina law and Pennsylvania law. Federal courts have interpreted Pennsylvania law as ‘barring [fraud claims]against pharmaceutical manufacturers.” Id. at *18 (citations omitted). Pennsylvania appellate courts have not addressed this issue. North Carolina law permits such claims, but not “where the purported misrepresentation was made solely to a third party.” Id. (citations omitted). “Because . . . neither Plaintiff nor Plaintiff’s mother relied on any representation” from the defendant in deciding whether to use the drug, “Plaintiff’s fraud claim must fail under North Carolina law.” Id.

The parties agreed that, where a true conflict of law existed, North Carolina law would apply, as that state, where the Plaintiff ingested the drug and developed gynecomastia, had a greater interest in the application of its law than did Pennsylvania, the forum state. “Ultimately,” the court held,

[I]t is immaterial whether Pennsylvania law permits a fraud claim in pharmaceutical cases. Assuming, arguendo, that Pennsylvania permits [such a claim], then Pennsylvania law conflicts with North Carolina law and North Carolina law would apply. Conversely, if Pennsylvania law prohibits such a claim, then Pennsylvania law applies. In either scenario, Plaintiff’s fraud claims would be dismissed.

Id. at *19.

We love a good summary judgment decision.  P.D. is sound and well-supported, and we trust that it will be affirmed on appeal. We will keep you posted. In the meantime, the [very cool] eclipse has come and gone. In the words of the Fifth Dimension, “let the sun shine!”

 

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As we discussed at the time, the MDL-wide innovator liability appeals in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), resulted in rulings under more than 20 states’ laws that branded drug manufacturers could not be liable for injuries suffered by plaintiffs who never used their products, but only took competing generic drugs.  Twenty-something states in one opinion.  If that had ever happened before, we remain unaware of it.

Well, it recently happened again, albeit on a smaller scale. See In re Zofran (Ondansetron) Products Liability Litigation, ___ F. Supp.3d ___, 2017 WL 3448548 (D. Mass. Aug. 4, 2017).  The Zofran MDL is like Darvon in that it involves a relatively old drug, approved back in 1991, for prevention of nausea and vomiting in cancer patients undergoing difficult treatments such as chemotherapy. Id. at *1.  Since Bendectin was driven off the market by bogus birth defect litigation, drug companies have been loathe to pursue anything for treating morning sickness (we know of only one), which leaves off-label use.  Id. at *2.  Thus, Zofran and its generic equivalents are frequently used off-label by women (and their physicians) seeking some kind of relief from pregnancy-related morning sickness.

The Zofran litigation is a consequence of this off-label use – anything used during pregnancy becomes the target of birth defect lawsuits.  Plaintiffs make a rather extreme claim, that defendants should be liable for not researching the risks of off-label uses for which they never sought FDA labeling approval.  Id. at *3 (“The crux of all of the claims is that defendants failed to perform an adequate study of the safety of ingesting Zofran during pregnancy”).

When generic drugs get involved, things get even worse. Plaintiffs using generic drugs are barred by preemption from suing those manufacturers (absent unusual situations like failure to update warnings with FDA-ordered changes), id. at *4, but they still want money, so they try to sue the branded manufacturers – innovator liability, in these cases for off-label uses.  Such claims seek to hold manufacturers liable for the risks of someone else’s product used in a manner for which that product was never labeled.

In Zofran, the court was having none of it.  It ordered all generic plaintiffs – 35 plaintiffs from 19 states − alleging innovator liability to justify those allegations.  Id.  Challenged to put up or shut up, most of the generic plaintiffs dropped out, leaving six plaintiffs suing under the laws of six states, those being Georgia, Indiana, Kentucky, Massachusetts, New York, and Oklahoma. Id.

Examining the laws of those six states, the court in Zofran, like the court in Darvocet, concluded that none of them would take the radical step of holding branded drug manufacturers liable for injuries caused by competing generic drugs.  Such liability ran contrary to “the long-settled principle that a manufacturer of a product cannot be held liable for injuries caused by another company’s product.”  Id. at *4.  Instead, plaintiffs alleged that:

As the holders of the New Drug Application (NDA) for Zofran and the patents for Zofran, [innovator] Defendants knew that any generic drug manufacturer would be required by law to use the same labeling as Zofran’s, and that any inadequacies in the labeling of generic ondansetron could be corrected by Defendants only.

Id. at *5.  Thus, the innovator defendants were being held liable not for what they chose to do, but rather for what was “required by law” – how Congress, in amending the FDCA, had chosen to structure the generic drug market.  While plaintiffs claimed this was not “novel,” id., to paraphrase Yogi Berra, “half the lies they tell about [the law] aren’t true.”

The overwhelming majority of courts—including all seven federal circuits to have addressed the issue—have held that the manufacturer of a brand-name drug may not be held liable for injuries caused by ingestion its generic equivalent, regardless of the theory of liability.

Id. at *6 (citations omitted).  The omitted citations, of just the federal appellate decisions, take up half a page of the opinion.  But don’t fret about that.  Our “Innovator Liability at 100” post, which discusses all these decisions, is closing in on 14,000 words.  The precedent rejecting innovator liability is truly “overwhelming.”

The “minority view,” on the other hand, consists of exactly four cases, one of which was “superseded by statute” “within a year” of being decided.  Id. at *8-9 & n. 6.  As for the relevant states in Zofran:

Georgia:  An intermediate state appellate court, the Sixth Circuit in Darvocet, and a federal district court, have all rejected innovator liability.  See PLIVA, Inc. v. Dement, 780 S.E.2d 735, 743 (Ga. App. 2015); Darvocet, 756 F.3d at 943; Swicegood v. Pliva, Inc., 543 F. Supp. 2d 1351, 1353-54 (N.D. Ga. 2008). Zofran, 2017 WL 3448548, at *8-9.  On the other side – zilch.  Actually, Georgia precedent rejecting innovator liability is more extensive than what was mentioned in Zofran.  See our “at 100” post for details.

Indiana:  The Sixth Circuit Darvocet case also rejected innovator liability under Indiana law.  756 F.3d at 845. Zofran, 2017 WL 3448548, at *10-11.  Again, there are several more Indiana law cases also rejecting innovator liability that aren’t mentioned in Zofran – but are in our post.

Kentucky:  Not only is Darvocet again on point, but the Sixth Circuit likewise rejected innovator liability in another Kentucky law case.  Darvocet, 756 F.3d at 945-46; Smith v. Wyeth, Inc., 657 F.3d. 420, 423-24 (6th Cir. 2011).  Zofran, 2017 WL 3448548, at *11.  As our post adds, a couple of Kentucky litigation tourists also got kicked out of court in Missouri on innovator liability grounds.

Massachusetts:  Two Massachusetts trial courts have rejected innovator liability. Rafferty v. Merck & Co., 2016 WL 3064255, at *4-5 (Mass. Super. May 23, 2016); Kelly v. Wyeth-Ayerst Laboratories Co., 2005 WL 4056740, at *2-5 (Mass. Super. May 6, 2005).  Zofran, 2017 WL 3448548, at *12-13.  We provide some more on-point Massachusetts precedent in our post, which never has to cite to a non-Westlaw slip opinion, because Bexis gets all the good ones added.

New York:  Darvocet, again, plus federal and state trial court decisions, all rejecting innovator liability under New York law.  Darvocet, 756 F.3d at 949; Goldych v. Eli Lilly & Co., 2006 WL 2038436, at *3-8 (N.D.N.Y. July 19, 2006); Weese v. Pfizer, Inc., 2013 WL 5691993, at *2 (N.Y. Sup. Oct. 8, 2013).  Zofran, 2017 WL 3448548, at *13-14.  Actually, there’s another recent federal district court decision that agrees, as our post discusses.

Oklahoma:  Not only Darvocet, but another federal appellate decision both reject innovator liability under Oklahoma law. Darvocet, 756 F.3d at 950-51; Schrock v. Wyeth, Inc., 727 F.3d 1273, 1281-84 (10th Cir. 2013).  Zofran, 2017 WL 3448548, at *14.  Our post adds another state trial court opinion applying Oklahoma law in a similar manner (a toughie, but we found it).

Thus, the Zofran decision concludes, as to the merits of innovator liability, that there aren’t any merits, and that contorting state law to impose liability for liability’s sake, without any basis in precedent or policy, isn’t a good idea:

In summary, none of the state supreme courts in any of the six relevant states have ruled on precisely the issues presented here.  Nonetheless, for each of the jurisdictions, there is case law suggesting, often strongly so, that dismissal is appropriate. . . .

It is true that dismissal would appear to leave consumers injured by generic drugs without any form of remedy.  But it is by no means obvious that the minority viewpoint is correct or fair, or even that it is the outcome that best protects consumers.  Just as it may be unfair to leave some injured consumers without a remedy, so too it may be unfair or unwise to require brand-name manufacturers to bear 100% of the liability, when they may have only 10%, or less, of the relevant market.

Id., 2017 WL 3448548, at *14 (citations omitted).

Finally, Zofran rejects what appears to be the new overall strategy of generic plaintiffs peddling innovator liability theories – try to shift the battle from federal to state courts.  Zofran refused to certify the issue to the high courts of the six states in question.  Id. at *15-17.  New York doesn’t even allow certification (an “oops” for plaintiffs).  Id. at *16.  “Clear and recent” appellate authority in every state but Massachusetts, leaves little doubt what the relevant law is.  Id.  As for Massachusetts (and indeed all the states), the question proposed to be certified “involve[d] alleged misrepresentations, none of which are identified by the plaintiff,” leaving the basis for those claims “unclear.”  Id. at *17.  Certification of such a “hypothetical” question would thus be “inadvisable”:

It is therefore entirely possible that the Court could wind up certifying a purely hypothetical question that has no actual relationship to the evidence.  It would be an enormous waste of judicial resources to certify a fact-bound question to the [state high court], only to find that the facts as ultimately proved are different. . . .  Any answer . . . to the proposed question might therefore prove to be entirely advisory.

Id. (footnote omitted).  Courts faced with innovator-liability-related certification requests in the future are likely to be facing similar situations, given how loosely our opponents throw around misrepresentation allegations.  Kudos to Zofran for not taking the easy way out, and declining to kick the decisional can down the road.

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Today’s guest post is by long-time friend-of-the-blog, Dick Dean, of Tucker Ellis.  This post covers the preemption aspects of the recent (after remand from the Third Circuit) aviation decision in Sikkelee v. Avco.  If you’re interested in this issue, we heartily commend the actual decision (which, we warn you, is quite lengthy), since in addition to its many significant legal rulings, it is studded with pungent language, mostly calling out and rejecting plaintiff’s many off-the-wall arguments.  As always our guest poster deserves all the credit (and any blame) for the discussion that follows.

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At times one can tell from the very first paragraph of an opinion that what follows will be an interesting read.  Such is the case with Sikkelee v. Avco Corp., Case. No. 4:07-CV-00886, 2017 WL 3317545(M.D. Pa. Aug. 3, 2017), a case involving the death of a pilot during a crash at take-off:

A weightless innocence so often attends our daydreams of flight. As the American aviator John Gillespie Magee, Jr., loftily described it, pilots “dance [ ] the skies on laughter-silvered wings,” soaring “high in the sunlit silence.”   Sadly, it would seem that Magee’s “high untrespassed sanctity of space” must belong to a universe far away from the dark origins and convoluted history of this case.

Id. at *1. From this ephemeral beginning, we are soon transported to the detailed world of federal aviation regulations and their interaction with design defect and implied preemption.

This case is indeed “convoluted.”  The crash occurred in 2005, and suit was filed in 2007, alleging different legal theories that distill to claims of a poorly designed carburetor.  There were two district court decisions (by two different district judges) dismissing plaintiff’s state law torts claims on grounds of field preemption before the case reached the Third Circuit in 2015.  Field preemption occurs where the subject matter of the law suit is so occupied by the federal government that there is no room for state activity.  It is rarely invoked and hardly ever found. [ed. note: we know of only one FDCA field preemption decision]  The factual underpinnings of field preemption in the aviation field was best summarized in a concurring opinion of Justice Jackson in a tax dispute, quoted by the Sikkelee Court in its recent decision:

As the late Honorable Robert H. Jackson, Associate Justice of the Supreme Court, once remarked, “Planes do not wander about in the sky like vagrant clouds.  They move only by federal permission, subject to federal inspection, in the hands of federally certified personnel and under an intricate system of federal commands.”  Northwest Airlines v. State of Minnesota, 322 U.S. 292, 303 (1944).  Justice Jackson’s observation sprang from “the national responsibility for regulating air commerce” and reinforced the notion that the “air is too precious as an open highway to permit it to be owned” by local interests.  Id.  “Local exactions and barriers to free transit in the air would neutralize its indifference to space and its conquest of time.”  Id.

Id. at *2.

Relying on the breadth of the Third Circuit’s decision in Abdullah v. American Airlines, 181 F.3d 363 (3d Cir. 1999) (holding that federal law preempts the field of aviation safety in the context of federal in-flight seat belt regulations versus state law negligence claims), the Sikkelee Court found preemption first at 731 F. Supp.2d 429 (M.D. Pa. 2010) and most recently at 45 F. Supp. 3d 431 (M.D. Pa. 2014).  The Third Circuit reversed the later decision, finding that state law design claims were not covered by the decision in Abdullah.  Sikkelee v. Precision Automotive Corp., 822 F.3d 680 (3d Cir. 2016).  But it is also observed that the claims might be barred by implied preemption—noting that the design changes advanced by plaintiff necessarily might have required FAA approval and thus would be barred under Pliva, Inc. v. Mensing, 564 U.S. 604 (2011) and Mutual Pharmaceutical Co. v. Bartlett, —U.S.—-, 133 S.Ct. 2466 (2013).  Indeed, it cited Mensing noting that where a party cannot “independently do under federal law what state law requires of it,” the state law claim is preempted.  822 F.3d at 703.  It remanded for consideration of that issue. (See DDLaw April 22, 2016 post discussing the Third Circuit’s suggestion that this claim might be conflict preempted).

On remand, the district court first examined the relevant FAA regulations noting “the FAA has littered the books with a maze of regulations not readily traversed by most laypersons.”  2017 WL 3317545 at *2.  It observed that the first step in production of a new aircraft or aircraft engine is a “type certificate” confirming that the aircraft or its component is properly designed and manufactured.  Id. at *3.  It is an “onerous process requiring numerous submissions that precisely detail the specifications.”  Id.  A type certificate holder may not independently change a type certificate’s design details without first obtaining FAA approval.  Id. at *5-*6 (citing 14 C.F.R. §21.31).  The district court observed that the relevant test was whether federal regulations prevented the defendant from unilaterally doing what state law required, citing the Mensing test of independent action.  The court found that the alternate design theory advocated by plaintiff would have required approval by the FAA and was therefore conflict preempted.  It specifically cited the key language from Mensing establishing that the mere fact that defendant could have asked the agency to change its rules does not defeat preemption.

“To decide these cases,” the PLIVA Court concluded, “it is enough to hold that when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for preemption purposes.”  Id. at 623–24.  Justice Thomas then noted that in regulatory preemption cases such as these, “the possibility of possibility”—that is, the possibility that the agency will approve a requested change—does not defeat conflict preemption.  Id. at 624.

2017 WL 3317545 at *24. More colloquially, if you have to ask, it is preempted.

The Sikkelee Court also made two other points familiar to the readers of this blog.  First, it noted that impossibility conflict preemption may be found even in the absence of express preemption.  Id. at *22.  Second, it recognized that impossibility preemption requires no inquiry into congressional intent.  Id.  The only question is whether there is a conflict between state and federal law.

When Mensing was decided, the first argument of the plaintiffs’ bar (and one that is still run today) was that it was limited to generics.  That was clearly wrong based on the “any party” language of Mensing.  Cases like Yates v. Ortho-McNeil-Janssen Pharmaceutical, Inc., 808 F.3d 281 (6th Cir. 2015) and In re Celexa and Lexapro Marketing and Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015), and many others [ed. note: see our preemption cheat sheet for the citations] have expanded the Mensing test to brand drug manufacturers’ where regulatory approval was a predicate of the claim alleged.  Now the Mensing test has been appropriately applied to the federal aviation context.  With this decision, it can be said that Mensing applies generally—not just to generic drugs, or even just drugs at all.  In Mensing and Bartlett, “[c]onflict preemption did not turn on a drug maker’s status as a brand-name or generic manufacturer per se.”  Sikkelee, 2017 WL 3317545 at *31 n.26.  That is not a surprising conclusion, since this is how implied preemption is supposed to work, but it is nice to have this solid opinion building upon the Third Circuit’s observations actually finding implied preemption in the aviation context.  Going forward, one needs to read any complaint involving relevant federal regulations with an eye on preemption: if the relief sought could not be undertaken unilaterally by the defendant in light of federal law or regulations the claim is preempted.

[Ed. note: we’d like to add one final point – about proximate cause. Sikkelee also recognized something we’ve observed about design changes too “minor” to require FDA pre-approval:  that such changes can’t be causal in a product liability action. The same is true of “minor” design changes under the FAA:

If the alleged omission was a minor one, then by definition, it had no effect on the aircraft engine’s structural strength, reliability, operational characteristics, or airworthiness. . . .  [T]he underlying claims are nothing more than state law tort actions, which require proximate causation.  If the alleged breach of duty had no appreciable effect on the engine’s reliability, airworthiness, structure, or operation, then proximate cause cannot be met.

2017 WL 3317545 at *28 . Likewise, design changes too “minor” to affect a product’s safety and effectiveness (the corresponding FDA standard), could not possibly be causal in a product liability action.]

 

 

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If not yet dead, the medical monitoring claim itself is hooked up to monitors and the prognosis is not good. It’s dying from a self-inflicted injury, which paradoxically is its lack of injury. Class action plaintiffs’ lawyers, the lawyers who have largely filed these claims, despise physical injuries. Physical injuries come with differences, and differences defeat class certification. On the other hand, they love financial damages, like those needed to implement a medical monitoring program. Financial damages come with sameness, and sameness increases the chances of class certification. This is the conundrum for medical-monitoring class action plaintiffs’ lawyers. They have struggled mightily to allege the financial damages that they so want while trying not to allege the physical injury that will kill their chances of certifying a class.

Cure v. Intuitive Surgical Inc., 2017 WL 3381848 (11th Cir. 2017), illustrates how this struggle is killing medical monitoring claims. In Cure, the plaintiffs claimed that, during heart surgery, instruments manufactured by the defendants shed small metallic particles that were later found in plaintiffs’ brains. Plaintiffs’ lawyers brought a medical monitoring claim, asking the court to set aside funds for monitoring plaintiffs, and those similarly situated, so that doctors could identify anything bad that might happen in the future.

But that’s where things go wrong. Plaintiffs could not allege that anything had actually gone bad. Not yet. So they hoped that the presence of small metal particles in their bodies would qualify. It doesn’t. The mere “presence of metal shavings in the plaintiffs’ brains does not, under Georgia law [applicable here], constitute a legally recognizable injury in itself.” Id. at *2. The metal particles had to have “caused or would eventually cause actual disease, pain, or impairment of some kind to support a finding that they suffered an injury.” Id. (quoting Boyd v. Orkin Exterminating Co., 381 S.E.2d 295 (Ga. Ct. App. 1989) (applying Georgia law), overruled on other grounds by Hanna v. McWilliams, 446 S.E.2d 741 (Ga. Ct. App. 1994)).

But the plaintiffs’ lawyers didn’t want to allege anything of the sort. Once they allege a disease, pain or impairment, they have entered the world of physical injury, which brings with it issues of causation, alternative causes, risk factors, predisposition and so many other things that wreck sameness and defeat class certification.

And so plaintiffs struggled mightily to avoid these class-killing problems by piecing together purported injuries that weren’t really injuries. They claimed that they “suffered and will continue to suffer physical, neurological, and mental effects.” Id. But those “vague, conclusory statements” weren’t nearly enough to satisfy the TwIqbal pleading standard. Id. They alleged that they would suffer future medical costs and lost wages. But, again, they were unable to tether these allegations to any explicit symptoms or conditions or how they would interfere with the plaintiffs’ work. Id.

In effect, plaintiffs’ claims had achieved sameness. They all had the same lack of injury. And, for that very reason, the district court dismissed plaintiffs’ medical monitoring claims, as had so many courts before it.  And, with its decision in Cure, the Eleventh Circuit upheld that dismissal. Id. at *3.

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Risperdal, an antipsychotic drug prescribed to treat serious mental conditions – schizophrenia, manic depression, and autism – allegedly causes some male users to develop abnormal breast tissue growth. Particularly when compared to the consequences of the conditions Risperdal is indicated to treat, that seems like a relatively minor risk.  It isn’t fatal.  It isn’t a long-term disability.  It doesn’t prevent one from making a living.  Thus, Risperdal litigation is a prime example of low-value cases that only exist because of the mass-tort system that has saddled the country for so long.

Thus, it is hardly surprising that Risperdal cases are on the front lines of the battle to rein in our long national mass-tort nightmare.

Just last week we learned of these two decisions:

(1) Covington v. Janssen Pharmaceuticals, Inc., 2017 WL 3433611 (E.D. Mo. Aug. 10, 2017).  Covington was one of the ridiculously misjoined multi-plaintiff complaints that mashed together residents from all over the country.  Before Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017) (“BMS”), Missouri federal courts routinely remanded these atrocities to the St. Louis litigation cesspool because there was always at least one diversity-destroying non-Missouri plaintiff, as well as one jurisdiction establishing Missouri plaintiff in the bunch.  Covington, 2017 WL 3433611, at *2 (“Historically − and especially in this district − courts generally have addressed subject matter jurisdiction first”).

Not anymore.

Covington is typical of the multi-plaintiff complaint genre – 54 plaintiffs from 26 different states.  2017 WL 3433611, at *1.  “Only one plaintiff” alleged injury from use of the drug “in the state of Missouri.  Id.  As for the rest:

The Non-Missouri plaintiffs, or those who do not have any connection to the state of Missouri, do not allege that they were prescribed Risperdal or any of its variants in Missouri, ingested the same in Missouri, or were injured in Missouri.

Id.

With BMS, the personal jurisdiction issues involving litigation tourism of this sort were largely resolved.  With no fixed “jurisdiction hierarchy,” it was now logical to take up this “more straightforward issue first. ” Id. at *2.

However, these [contrary] cases were decided before [BMS] and State ex rel. Norfolk S. Ry. Co. v. Dolan, 512 S.W.3d 41 (Mo. 2017) (en banc) [our post on Dolan is here].  These decisions make the personal jurisdiction issue in this case much easier to decide. . . .  Further, analyzing the challenge to personal jurisdiction first avoids any issues relating to fraudulent joinder.  Personal jurisdiction is now the more straightforward inquiry and should be addressed first as it is in the interests of judicial economy and expeditiousness.

Id. (citations and quotation marks omitted).

The personal jurisdiction question was easy.  There could be no general jurisdiction.  “[N]o defendant is incorporated in Missouri nor has its principal place of business in Missouri.”  Id. at *4.  ‘Nuff said.  Nor was there specific personal jurisdiction for all but one of the plaintiffs – thus removing the planted plaintiffs from the defendants’ home states.

[B]esides the Missouri plaintiff, no other plaintiff allege that they, or a child or incapacitated person whom they represent as next friend, were prescribed or purchased Risperdal in this state, suffered an injury from Risperdal in this state, or received treatment for an injury from Risperdal in this state.

Id.  The “mere fact that other plaintiffs were prescribed, obtained, and ingested [the drug in Missouri] − and allegedly sustained the same injuries as did the nonresidents − does not allow the State to assert specific jurisdiction over the nonresidents’ claims.”  Id. at *4 (quoting BMS).  Thus 53 of the 54 plaintiffs were dismissed (without prejudice, and with the laws of their home states determining whether an unsuccessful litigation tourism jaunt tolled their statutes of limitations).  A single plaintiff’s low-value case thus remained in Missouri federal court.  Id. at *5.  It probably won’t last long, since the March 8, 2017 filing date was more than a dozen years after 2004, when that plaintiff admits discovering the supposed injury.  Id. at *6.

Plaintiffs mounted unsuccessful rearguard actions in Covington.  They sought a stay – claiming “prejudice” from the need to sort out a supposed jurisdictional morass that they, themselves, created.  That went nowhere.  Id. at *3 (“A motion to stay should not be abused by a party to dictate which motion is first addressed by the Court.”).  They also sought “jurisdictional discovery” – a fishing expedition to search for Risperdal/Missouri contacts.  Covington likewise saw that request for what it was:

Here, the plaintiffs do not plead any specific facts that support their contention that this Court has personal jurisdiction over all of the plaintiffs’ claims. Alleging that facts might be discovered during a jurisdictional discovery expedition will not allow plaintiffs to survive a 12(b)(2) motion to dismiss.

Id. at *5.

Summing up, Covington observed:

Unfortunately for the plaintiffs, [BMS], under the facts of this case, made personal jurisdiction the more straightforward issue and therefore more proper to be analyzed first.  Further, [BMS] held that forums, like Missouri in this action, do not have specific personal jurisdiction over non-resident corporations when the plaintiffs do not allege any specific connection between the forum and the specific claims at issue.

Neither this Court nor the state court in which this action was removed can exercise personal jurisdiction − whether general or specific − over the defendants for the claims brought by the 53 non-Missouri plaintiffs.

Id. at *6.

That’s one.

(2) West v. Janssen Pharmaceuticals, Inc., 2017 U.S. Dist. Lexis 124276 (Mag. M.D. Ala. Aug. 4, 2017).  West is something of the obverse of Covington.  In Covington the plaintiffs joined together in an attempt to manufacture jurisdiction for a horde of weak cases, whereas in West, jurisdiction already existed, so the plaintiffs were trying to join their weak cases together to prejudice the defendant at trial.  Once again, the court wasn’t buying the consolidation.  West involved two plaintiffs, Harper and West, treated at one point by the same prescribing physician, both alleging the same injury from the same drug.  Id. at *2, 11.

But that was as far as the similarities went.

The two plaintiffs were of much different ages; one a minor, the other not. One involved off-label use; the other not.  One involved innovator liability (being filed during the few Weeks window when that theory was allowed in Alabama); the other not.  There were various other differences as well, such as duration of use, and when the drug was prescribed (affecting the relevant warnings), and the age at which the risk allegedly manifested.  Id. at *13-15.

The dissimilarities in the Plaintiffs’ claims have be-come more apparent as discovery and expert testimony have developed.  Harper began taking Risperdal as a five or six-year old and was always a minor while taking the medication.  In contrast, West did not begin taking the medication until he was almost eighteen years old and was physiologically an adult.  The significance of this difference is highlighted by the expert causation testimony. . . .  Further, the consequence of Risperdal not being approved for pediatric use takes on a much different meaning in the two cases.

Id. at *12-13.

These differences precluded a joint trial under Fed. R. Civ. P. 20.  “The critical differences between the claims asserted by Plaintiffs outweigh the similarities between the cases, and the court finds trying the cases together would thus be inefficient and confusing for both the Court and the jury.”  Id. at *14.  The presence of an innovator liability claim in one of the cases demonstrated their legal as well as factual disparity.  Id. at *15-16.  Further, “West and Harper were prescribed multiple prescriptions, written at different times by different physicians and in different doses at different physiological stages of their lives.”  Id. at *16.

Thus, two disparate plaintiffs could not claim injury “from the same series of transactions” as required by Rule 20. Id. at *17.  No consolidation synergies for these two weak cases.

*          *          *          *

Two Risperdal cases; two different jurisdictions; two attempts by plaintiffs to manipulate joinder to the disadvantage of defendants defeated.  We look forward to similar rulings in the future.

 

 

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