United States: The Lows − Mourning The Worst Prescription Drug/Medical Device Decisions Of 2017

Last Updated: December 27 2017
Article by James Beck

The second most successful college basketball coach of all time (in terms of NCAA Division 1 national championships) has said "All of life is peaks and valleys. Don't let the peaks get too high and the valleys too low." We're remembering that today because, frankly, dealing with all the lows at once can get depressing. That, however, is the purpose of today's post. We're looking at the bottom ten worst prescription medical product liability litigation decisions of 2017.

All these lumps of coal in our defense-oriented stockings is enough to give us all a case of seasonal depression. These cases, while hardly candidates for a Hallelujah Chorus, do remind us of a different sort of Hallelujah – the kind we want over with as soon as possible. So let's get on with it already. If you were on the receiving end any of these cases atrocities, we feel your pain. We've been there (see 2013 -2), and we know what you went through. That said, we'll feel better next week, when we welcome the New Year with the our best decisions, after having taken this week's purgative.

So let's start purging:

  1. In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017). It's hard to screw up the our most important defense – preemption − law in more different ways in one case than Fosamax did. The MDL court had found preemption because the FDA had actually considered the risk in question, several times, after obtaining classwide information, leading to a detailed section on that risk in 2011. Plaintiffs, as always demanded more, a causal warning that the FDA had rejected. They lost, under Levine's ( 2009-1) "clear evidence preemption standard, back in 2014, and scores of claims were dismissed. Typical of the muddle that MDLs make of litigation these days, an appeal took three years to decide. Definitely not worth the wait. To avoid preemption on facts where the FDA had actually rejected the warning the plaintiff wanted, the Third Circuit did two things. First, ignoring prior Supreme Court precedent, the Third Circuit created an unprecedented heightened evidentiary standard for implied preemption, converting Levine's requirement of "clear evidence" into a requirement for "clear and convincing" evidence. In eight years since Levine, no court had gone there (and no court has since). Second, to make things even worse, after putting a thumb on the evidentiary scale, the court then declared preemption – the determination that the FDA "would have" rejected a label change – was a question of fact, not law. That's right, juries get to speculate, after hearing both side's warring FDA "experts" (current FDA employees can't be called as witnesses without the Agency's consent) about what the FDA might have done. That ruling goes beyond unprecedented, since it flies in the face of more supposedly binding Third Circuit precedent than we have fingers. Nor could anything be more destructive of FDA authority than to let juries speculate about what the agency might have done with hypothetical warnings, and reach differing conclusions about the same drug in different cases. Under Fosamax, summary judgment on preemption is possible only when "no reasonable juror could conclude that it is anything less than highly probable that the FDA would have rejected Plaintiff's proposed . . . warning." In other words, never – since the FDA had, in fact, rejected it. We decried this "lawless" result here. In addition, we cheered on the defendant's certiorari petition and supporting amicus briefs, while pointing out other courts that rejected the Third Circuit's misguided reasoning. And there is a glimmer of hope. The Supreme Court has asked for the Solicitor General's views on the case, which tells us that this appeal has a pretty decent chance of being granted.
  2. Eghnayem v. Boston Scientific Corp., 873 F.3d 1304 (11th Cir. 2017). Eghnayem is the year's outstanding example of MDL abuse. Leery of MDL "bellwether" cases turning into Stalinist show trials, featuring multi-plaintiff consolidation and punitive damages, the defendant declined to waive its Lexecon rights limiting MDL trials. Didn't work. Shades of Stalin chasing Trotsky to Mexico: the MDL judge chased the defendant back to Florida, obtained a temporary commission and tried the case there – with four plaintiffs, punitive damages claims, and all of the adverse evidentiary rulings that have come to characterize that MDL. All four plaintiffs won nearly identical (two exactly $6,722,222) verdicts of over $6 million apiece. We have pointed out elsewhere at length how multi-plaintiff consolidations are inherently prejudicial to defendants, hence their use in MDLs as a means of pressuring defendants to pay big bucks to settle. In Eghnayem, the Eleventh Circuit let it stand – despite the almost identical verdicts that should be a red flag demonstrating that the jury abandoned any effort to consider the cases separately. "Confusing or not," it was not an abuse of discretion to consolidate product liability cases (including warning claims, which change over time) involving similar injuries from similar products. Contrary to almost every other case, even "identical damage awards" "are not sufficient evidence of juror confusion." Nor did admission of otherwise inadmissible warning (state of the art) and damages evidence preclude consolidation. It's a terrible appellate precedent, we think the first allowing product liability consolidation outside of asbestos. Compared to that, the court's affirmance of exclusion of §510k clearance evidence – another unfortunate hallmark of this litigation, although virtually unheard-of previously – is secondary. We excoriated Eghnayem here, and recommended changes to the MDL statute to prevent such abuses here.
  3. Barron v. Abbott Laboratories, Inc., 529 S.W.3d 795 (Mo. 2017). The intermediate appellate decision in this case alone was enough to make #3 on our bottom ten list last year. But for a couple of colossal federal appellate screw ups, affirmance of the $38 million ($23 million in punitives) verdict by the Missouri Supreme Court would have moved up a notch or two. The big problem was venue and joinder – the trick of Missouri forum shopping that allowed a Minnesota plaintiff to have her case tried in St. Louis. The Missouri Supreme Court dodged the issue holding that any error "by either failing to transfer venue or failing to sever the claims" was harmless because no "prejudice" from trial in St. Louis was shown. How one would ever show prejudice, short of a lynch mob at the door, is unclear. Rulings like this are what keep plaintiffs coming back to certain jurisdictions for more. On warnings, the court held that because the defendant did not trash its own product as being riskier than other similar products, the warning wasn't "accurate." As to punitive damages, the court held that a "black box warning is not relevant" because all contrary evidence is to be "disregarded" in evaluating the verdict. Incredible – millions in punitives for a risk with a boxed warning. We blasted Barron here as a poster child for why Missouri needs tort reform to put an end to blatant forum shopping. That didn't happen, but something else did (wait till next week) that has made a big differenct.
  4. Cottrell v. Alcon Laboratories, 874 F.3d 154 (3d Cir. 2017). Two Third Circuit cases are in the bottom five this year, and sure enough, the composition of the panels, here and in Fosamax, overlapped substantially. The question in Cottrell was standing, specifically whether an otherwise uninjured consumer of a product could sue because the product wasn't made and priced in a way that the consumer thought would be better or cheaper. The same theory had been called "absurd" in a prior Third Circuit (unfortunately nonprecedential) opinion, but this panel never found a novel tort theory it couldn't adopt. Creating a circuit split, Cottrell allowed a would-be class action (all these ridiculous cases start as class actions) alleged "injury in fact" because the claims arose from consumer protection statutes. That the claim made no practical or economic sense, because consumers can't force manufacturers to make different products, was irrelevant because when considering standing the merits didn't matter. TwIqbal, what TwIqbal? Calling the defendant's actions "unfair" was enough. When we started writing this blog, the Third Circuit had strong standing requirements that barred no-injury class actions; after Cottrell, the court has fallen to the bottom. At least in this case, unlike Fosamax, there was a dissent. We castigated Cottrell here.
  5. Taylor v. Intuitive Surgical, Inc., 389 P.3d 517 (Wash. 2017). The learned intermediary rule means that the duty of the manufacturer is to provide an adequate warning to the plaintiff's treating physicians, right? Not if you're the Washington Supreme Court. In an unprecedented ruling, Taylor opens up an entirely new front in prescription medical product litigation by ruling that, despite the rule, there exists a separate duty to provide warnings to a hospital, where the product actually was sold to the hospital, which many drugs and devices are. This ruling potentially opens up hospitals to claims that they failed to stop doctors from using/prescribing products, and creates a second chain of warning causation that now must be negated. On top of that, Taylor deviated from what had been consistent Washington precedent applying comment k to all prescription drugs and medical devices (Bexis filed an unsuccessful amicus brief on this issue), and held that strict liability can apply anytime a plaintiff asserts that warnings were inadequate. We trashed Taylor here.
  6. In re Accutane Litigation, 165 A.3d 832 (N.J. App. Div. 2017). At 15 years, Accutane litigation may well be the second longest running mass tort (after asbestos, of course) in New Jersey. For a long time that was due a certain one-woman wrecking crew in Atlantic County. She was kicked upstairs shortly after the defendant in Accutane sought recusal, and the mass tort has outlived her. However her ghost haunts Accutane still, as Accutane (particularly footnotes 5 and 9) demonstrates. New Jersey's approach to expert evidence has sometimes been called "relaxed." However, Accutane goes from relaxed to supine. Plaintiffs' experts were allowed to avoid and discount multiple epidemiologic studies finding no statistically increased risk at all. Far from the law lagging science, as is the case (at least rhetorically) with Daubert in the federal courts, Accutane declared that "legal decision making in toxic tort and similar cases may vary from scientific decision making." It disregarded the usual hierarchy of scientific evidence, putting animal studies and single-patient case reports on the same level as statistically significant epidemiology. Where did "general acceptance" go? Everywhere else but New Jersey, Accutane cases alleging intestinal issues have been dismissed as a matter of law for lack of scientific basis. Here, some two thousand cases have been resuscitated. We abhorred the Accutane result here, and praised the defense appellate arguments here. Now, as with Fosamax there is hope. Earlier this month the New Jersey Supreme Court granted the defendant's appeal and will decide the scientific issues in Accutane for itself.
  7. Christiansen v. Wright Medical Technology, Inc., 851 F.3d 1203 (11th Cir. 2017). Christiansen is another example of the problems with bellwether trials in MDL litigation, illustrating how trial and appellate courts will bend over backwards to obtain and affirm plaintiff verdicts. In Christiansen the jury initially returned a defense verdict. That was not the result the MDL judge wanted, so he told the jurors that perhaps they did not "fully understand" the case and instructed them to try again, because a no defect finding was supposedly "inconsistent" with a finding of misrepresentation. Duly admonished, the jury changed its mind and returned a verdict for the plaintiff. Amazingly, the Eleventh Circuit let that second verdict stand. In and of itself, that would be bad, but probably too much of a one-off situation to warrant the bottom ten. However, the Eleventh Circuit went on to disregard the across-the-board application of comment k decreed by the relevant state's (Utah) highest court. Comment k only applies to drugs, not medical devices (or at least 510k medical devices) because only drugs are "approved." No Utah – indeed no court anywhere – has ever distinguished between prescription drugs and prescription medical devices in this fashion. Utah law had never even required proof of FDA approval of anything for comment k to apply. This kind of liability-enhancing, Erie-ignoring ruling on state law is, we believe, a consequence of the bellwether system, which causes disproportionate investment of time and effort in particular trials, which in turn pressures appellate courts to find some way to affirm, so that investment is not wasted. We chastised Christiansen here.
  8. Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017). A terrible trifecta for the Eleventh Circuit. Shades of Bush v. Gore – this time Mink thinks that it knows more about Florida law than the Florida state courts do. As a general proposition, the Florida Supreme Court has required, for over two decades, that before any use of negligence per se, such use must be consistent with legislative intent. That means, as a matter of state law, FDCA-based negligence per se claims fail, because the FDCA famously included §337(a), which expressly provides for exclusive government enforcement. This legislative intent requirement further means that "parallel claims" of FDCA violations do not exist in Florida, and so an unbroken string of state and federal decisions had held. Until Mink. The court's reasoning was bluntly result oriented. Florida law could not be that way, Mink declared, because otherwise plaintiffs suing over allegedly defective PMA medical devices would be out of court. That's true, but as the Supreme Court noted in Riegel, that is precisely what preemption does. For taking a blunt instrument to a long-standing requirement of state law for no reason other than to preserve an exception to preemption that this particular state has chosen not to recognize, Mink belongs in this list. We skinned Mink here.
  9. Wendell v. GlaxoSmithKline, LLC, 858 F.3d 1227 (9th Cir. 2017). In an ugly decision, the Ninth Circuit reversed a Daubert exclusion in Wendell. Given the appellate abuse of discretion standard applicable to Daubert decisions, that amounts to a decree that this type of expert testimony must be admitted. What type of opinion was it? It was litigation-driven, without a scrap of independent research. It was unsupported by epidemiology, or even animal studies. Even the "science" cited by the excluded experts did not address the drug combination plaintiff had used. Nor had the experts excluded, as a possible cause, the underlying condition that the drug was used to treat. Instead of science, Wendell was blinded by the supposed "highly qualified" credentials of the experts. Qualification and methodology are supposed to be separate inquiries under Daubert. Linus Pauling, for example, won two Nobel prizes, but as to cancer cures he was a quack. Ditto William Shockley and eugenics. Further, the "differential diagnosis" technique is notoriously lax, and Wendell was far to credulous about what a proper differential diagnosis must include – and exclude. The worst Daubert decision of the year in our sandbox. We whacked Wendell here.
  10. Dunson v. Cordis Corp., 854 F.3d 551 (9th Cir. 2017). Back in 2014, we awarded a Ninth Circuit en banc decision, Corber v. Xanodyne, our #4 best case rating. Corber held that a California request for "coordination" triggered CAFA's mass action provision and supported removal to federal court. Unfortunately, with Dunson, Corber has now been distinguished into seeming oblivion. Apparently en banc doesn't matter much in the Ninth Circuit. It certainly didn't in Dunson. Request for "pre-trial" consolidation – no CAFA. Request for bellwether trials – no CAFA unless the result would be "binding" on the other cases, which is vanishingly rare. Basing the bellwether request on need to avoid inconsistent results? Not specific enough. After Dunson, we wonder how much is left of Corber. Form appears to be triumphing over substance. We derided Dunson here.

So that's the bottom ten. Unfortunately, the other side did better than usual this year – this is the first time in blog history that every one of the dregs cases has been an appellate decision. As for the near misses, we'd put United States ex rel. Campie v. Gilead Sciences, Inc., 862 F.3d 890 (9th Cir. 2017), at the top of the list, since it allowed fraud on the FDA theories in False Claims Act cases, and we hate cases that purport to give private plaintiffs ways to get around Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).

That's quite enough, thank you. We're ready to bring this exercise in the gnashing of teeth and rending of clothes to a close. Stay tuned, however. Next week, we take the litigation roller coaster up rather than down when we review the ten best drug/device decisions of 2017.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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James Beck
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