You know it's coming. It's unavoidable, but necessary. We don't like it any more than you do, but it's that time of year. Time to recapitulate the worst punishments that the denizens of the you-know-where tort Tartari have inflicted upon our clients and us in 2019. Every year we contemplate our Sisyphean labors facing the arguments over and over again in jurisdictions selected by the other side. We also check the multidistrict Augean Stables, with their own ways of beating our client's swords into settlements, all the while making bad substantive and procedural law. The Stygian litigation depths can also include individual cases where we get hammered in places where we can't reach either the water of dismissal or the fruit of settlement.
While on the subject, this is our unlucky thirteenth year of reviewing the annual bottom ten worst drug/medical device product liability decisions. All we can say is that, at least we don't have two number one worst decisions, unlike 2017, which had two worsts. While 2019 had its share of clunkers, it could be worse − only one, not two, Achilles heels this year (yet).
OK, OK, we'll stop dithering, crank up the Greek chorus of woe and get on with the Herculean task of recounting the ten worst prescription medical product liability litigation decisions of 2019. If any of these legal nemeses is yours, we sympathize, having felt that kind of panic ourselves (see 2013-2). But fear not, next week will be much more jovial, when we review our top ten best decisions.
Here come the Furies:
- Taylor v. Mentor Worldwide LLC, 940 F.3d 582 (11th Cir. 2019). We knew from the moment we first read Taylor that it could be the worst case of the year. Taylor had no redeeming features. For the past five years, at least one pelvic mesh case (sometimes more) has made it onto our bottom-ten cases list: 2018 -2, -3; 2017-2; 2016-2, -7; 2015-7; 2014-7. Unfortunately, 2019 is no exception, and indeed Taylor warrants #1, a first for mesh. Here's why. First, the plaintiff's expert was allowed to ditch his existing opinions, with no prior notice to the defense, and to spout a completely new defect theory at trial. As the dissent complained, the majority in Taylor allowed trial by ambush. The majority barely contested the point, relying instead on one of the most tenuous waiver arguments we've ever seen, an "alternate" relief request in support of a timely objection to the expert's admittedly "evolving" opinions at trial. To us, that's not even the worst part of Taylor. Until Taylor, the Eleventh had been one of the stronger Daubert circuits (Bexis helped with his Seroquel work). Not in Taylor, which allowed a general causation theory lacking any dose-response relationship. Toxic tort cases aren't "different" when, as in Taylor, a plaintiff claims that a medical device emitted a toxic substance. Taylor permitted no-threshold exposure testimony that fails even in asbestos litigation: plaintiff's expert "testified that all [units of the product] degrade and that any [toxic] particles it sheds spark a response" that causes injury. Single molecule causation was foreign to Eleventh Circuit precedent until Taylor. And there's more – punitive damages. Florida follows an "actual knowledge" of " high probability" of harm punitive damages standard, reinforced by a clear and convincing evidentiary standard. What was the "high probability" in Taylor? Maybe as low as none at all, since the plaintiff had only tissue thinning, not the "erosion" to which her scattershot experts testified. Taylor mentioned a "relatively high rate" (which we think fails the "high probability" injury standard ab initio) of complications generally, but those were in "other women," not this plaintiff. Taylor's evidence of a mere "higher risk" simply couldn't support punitive damages under Florida's tough risk enhancement standard. But once again, Taylor trotted out a waiver argument. This appellate disaster fully warrants its place as the worst drug/device decision of 2019. We trashed Taylor here.
- Burningham v. Wright Medical Technology, Inc., 448 P.3d 1283 (Utah 2019). In Burningham, the Utah Supreme Court decided that, while prescription drugs were all protected from strict liability by Restatement §402A comment k, Class II medical devices were not. That's essentially unprecedented, particularly by a state high court. Shortly after this question was certified in Burningham, we did extensive, state-by-state research to see whether any other states treated the two main types of prescription medical products differently for comment k purposes. We found none – until Burningham. Yet Burningham didn't even seem to notice. The opinion discussed none of the previously unanimous nationwide precedent. Instead, Burningham swallowed a bogus Lohr-based argument, metastasized into comment k, and distinguished drugs from medical devices because §510(k) clearance supposedly isn't safety related. We've gone into great detail before why that's simply not so since 1990. So for Class II medical devices – the only ones that really matter (design claims against Class III devices are all preempted) − comment k only applies on a case-by-case basis. Prescription drugs, which the court viewed as subject to more intensive FDA review through new drug applications, remain universally subject to comment k. We bashed Burningham, here.
- A.Y. v. Janssen Pharmaceuticals Inc., ___ A.3d ___, 2019 WL 6317403 (Pa. Super. Nov. 26, 2019). A.Y. is one reason (of several) why Philadelphia deserves ATRA's #1 rating as the worst jurisdiction in the country for defendants. But for a reasonably realistic possibility of further appellate review, A.Y. might have ranked higher. It's that bad. A.Y. was a Risperdal case. The injury in question, gynecomastia, wasn't even considered "serious" by the FDA. Yet A.Y. affirmed a $70 million verdict for a plaintiff with no permanent physical disability. We believe A.Y. to be the largest single-plaintiff personal injury verdict to survive at least one round of appellate review in the history of Pennsylvania. And the damages are all purportedly "compensatory." Another aspect of A.Y. allowed the plaintiff to shoot for punitive damages on remand. Why not? To date, this Philadelphia litigation has only resulted in a paltry $8 billion in punitive damages, so let's have another round, right? We don't think so. A.Y. also rejected the defendant's strong preemption argument. Only the FDA could permit warnings about off-label uses (only later did this drug obtain a juvenile indication), and the regulation at the time only excepted "serious" risks. But as mentioned already, the FDA did not consider this risk to be "serious." That means prior FDA approval of any such warning was required, which means preemption under Mensing's ( 2011+1) "independence principle." A.Y. blew right past FDA pre-approval, never even citing Mensing. Instead it spent page after page on irrelevant discussion of "clear evidence," when the Levine ( 2009-1) CBE exception didn't even apply. Other adverse rulings allowed fraud-on-the-FDA evidence that should have been barred under Buckman, totally misread Tennessee's (yes, A.Y. is one of 86% of the Philadelphia mass tort docket brought by litigation tourists) spoliation exception to its damages cap, and excluded evidence of the minor plaintiff's conduct that made him a good candidate for this drug in the first place. A.Y. was absolutely yucky, as we explained here.
- Painters & Allied Trades Dist. Council 82 Health Care Fund v. Takeda Pharmaceuticals Co., ___ F. Appx. ___, 2019 WL 6498270 (9th Cir. Dec. 3, 2019). RICO should have nothing to do with product liability, but courts allow it in defiance of clear congressional intent that unfortunately did not make the statute's four-corners language. So third-party payor ("TPP") economic losses purportedly caused by false marketing can be trebled and attorney fees recovered. The Supreme Court had largely bottled this genii with strict causation requirements, but Painters ignored them – just as it ignored the role of learned intermediary physicians in prescribing drugs. The result is an indirect, convoluted chain of purported causation in which dumbed-down statistical models substitute "foreseeability" for real world conduct. Foreseeability is another Supreme Court RICO no-no that Painters ignored. Painters thus created the threat of massive liability through a widely-condemned trial-by-formula regime. Indeed, the liability allegations in Painters were particularly offensive because they made a fraud-on-the-FDA theory that, if brought as a state-law claim, would be preempted. Ultimately, Painters was explicitly result oriented: "If ... prescribing physicians' and [benefit managers'] decisions ... sever the chain of proximate cause ..., drug manufacturers would be insulated from liability." We hope the Supreme Court resolves the resulting circuit split. One way to reduce drug prices is to reduce pointless, yet costly, drug litigation. We pummeled Painters here.
- In re Celexa & Lexapro Marketing & Sales Practices Litigation, 915 F.3d 1 (1st Cir. 2019). If the FDA approves a product for a particular use, that means it has found that drug to be safe and effective for that use, right? So how can that same use, before FDA approval, not also be safe and effective? The drugs, the risks, the patient population – all the same. The only thing different is the manufacturer now has a piece of confirming paper. For taking license with science, C&L makes our list. If it were truthful to say the drug was OK for that use afterwards, it was equally truthful before. Thus, C&L approved yet another TPP/RICO "money for nothing" case based on nothing more than truthful off-label promotion (prior to the FDA's belated approval) being supposedly "illegal." No claim was made that the drug was unsafe. While C&L reversed summary judgment and asserted that effectiveness was a "fact issue," that simply can't be right – in its subsequent approval, the FDA decided exactly that (as well as safety) for the use at issue. How can there be any fraud where all patient got exactly what was paid for? How can it be fraud where each TPP knew it was reimbursing an off-label use prescribed by a doctor who believed the use was therapeutically appropriate? No concealment occurred, only a purported FDCA violation that didn't really exist because truthful off-label promotion is protected by the First Amendment. We criticized and lambasted C&L here.
- Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019). In a lot of ways – that you'll hear about next week – Albrecht was a huge win for defendants in preemption cases generally. But unfortunately, the reversed Third Circuit decision was so awful that even ordinarily anti-preemption justices couldn't stomach it. The result was a pro-preemption decision written by anti-preemption justices, and that shows. Those aspects of Albrecht also earn it a place on our bottom ten list. The worst of these was (completely unnecessary to the actual decision) rejiggering of what had been the Levine ( 2009-1) "clear evidence" test. As we've discussed, the test is now more complicated. What is a case "like" Levine? Does "the manufacturer" mean that other sources of final FDA action, such as citizen petitions, can't support preemption? Does the FDA being "fully informed" resurrect "fraud on the FDA" in a limited way as a defense to preemption? How "formal" must an FDA rejection be? While we think most courts will answer these questions consistently with common sense and prior precedent, to have to ask them at all is unfortunate. This aspect of Albrecht could shift more preemption arguments to "changes being effected" prerequisites, such as "newly acquired information," that avoid having to jump through all of these "clear evidence" hoops. But through all this, we remind ourselves that preemption being "legal" (not "factual") means all these questions will be answered by judges (not juries), perhaps with increased input from the FDA itself. We analyzed these aspects of Albrecht here, and undoubtedly will do so often in the future.
- Holley v. Gilead Sciences, Inc., 379 F. Supp.3d 809 (N.D. Cal. 2019). Holley allowed an terrible liability theory – that a defendant can be liable for selling an FDA-approved prescription drug, with its known risks and benefits, simply because the defendant didn't develop what, in hindsight, could be an even "better" drug. What's more, this theory was asserted against the very drugs that reduced AIDS from a death sentence to a treatable chronic condition. To those (like us) who lived through the worst of AIDS epidemic, the Holley stop-selling claim is jaw dropping. The drugs Holley attacked both saved tens of thousands of lives and removed the existential terror from AIDS. The lesson from Bartlett ( 2013+1) is that stop-selling claims inherently conflict with the FDA's authority over drug approval, therefore preemption. That alone should have disposed of this misguided case. The pre- versus post-approval dodge that Holley not only embraced but expanded to warnings can't escape preemption either. "Approval" necessarily turns on the action of the FDA, and thus cannot stand under the Mensing ( 2011+1) independence principle. These factual and legal problems give Holley our booby prize for worst trial court drug/device decision of 2019. We hammered Holley here.
- Schrecengost v. Coloplast Corp., 2019 WL 6465398 (W.D. Pa. Dec. 2, 2019). One of the few bright spots in the otherwise pretty dismal Pennsylvania prescription medical product litigation landscape has been the decades-old preclusion of strict liability claims. Almost a dozen appellate-level Pennsylvania decisions – beginning in 1942 and going through Lance ( 2014-2, on other grounds) all hold, without exception, that strict liability claims (except perhaps manufacturing defects) brought against prescription drugs, devices, and vaccines are barred by Restatement §402A, comment k. Before Schrecengost over two score federal decisions were unanimously in accord, faithfully following the holdings of Pennsylvania state appellate courts. For flimsy reasons – a non-prescription medical product decision that specifically recognized the comment k exception, and a medical device case where the issue had been waived – Schrecengost chose to become the first federal Pennsylvania decision to go the other way. This singular result on substance, combined with the decision's disregard of the limits on federal courts' power to "predict" novel expansions of state-law liability in diversity cases, make Schrecengost worthy of our bottom ten list. We sliced, diced, and pureed Schrecengost here.
- Daley v. Mira, Inc., 2019 WL 499775 (D. Mass. Feb. 8, 2019) ( here). Daley is another example of a federal court improperly expanding state law (here a Massachusetts court making a hash of New York law) in violation of Erie principles. The implant in Daley worked perfectly for nearly three decades. Passage of time evidently caused plaintiff to want a deeper pocket as a defendant, which led to suit against not only the manufacturer but a separate entity that only designed and patented the product all those years ago. The patent-holder had zero dealings with plaintiff. Contrary to almost every other court in the country, including every New York decision, Daley allowed a separate claim for failure to test. But it's worse than that. This device worked for 29 years. How would one even test for such long-term failures? It's not an FDA requirement, and couldn't be one without delaying progress for thirty years. Beyond that, how would a patent holder, that is not a manufacturer, be able to conduct such tests? A profoundly nonsensical and anti-innovation claim. We wondered here if Daley might be Massachusetts' revenge for the Curse of the Bambino.
- Lempa v. Eon Labs, Inc., 2019 WL 1426011 (N.D. Ill. March 29, 2019). Between them, Mensing ( 2011+1) and Bartlett ( 2013+1) recognized preemption of almost all claims against manufacturers of generic drugs. But Lempa didn't get the memo. Even though the risk at issue in Lempa was in the drug's warnings, Lempa permitted plaintiff to pursue an inadequate warming claim – because the defendant allegedly promoted an off-label use. Lempa argued that this was a "parallel" claim recognized by the infamous Bausch case – but Bausch involved medical devices and express preemption – while Lempa was an implied preemption generic drug case. Since express and implied preemption operate independently (e.g., Buckman), Lempa's equating the two was transparently incorrect. Lempa also botched allegations of failure to provide a medication guide directly to the user. The correct response would have been extremely simple – no duty under the learned intermediary rule. But because the warning was allegedly "inadequate," Lempa refused to apply the rule – also obviously wrong. The adequacy (or not) of the warning does not affect who must be warned, only recovery for inadequate warning. We lampooned Lempa's repeated mixing of apples and bricks here.
Ugh! That's our bottom ten. We considered adding In re Avandia Marketing, Sales & Products Liability Litigation, ___ F.3d ___, 2019 WL 6873681 (3d Cir. Dec. 17, 2019), at the last minute, but decided against it. That adverse preemption result was extremely fact-specific, and the decision's most notable legal proposition, that "the FDA, and only the FDA, can determine what information is 'material' to its own decision to approve or reject a labeling change," id. at *6, is something we expect will help our side more often than hurt, since it also excludes opinions by the other side's "regulatory experts."
As for other near misses, we note the string of terrible choice-of-law decisions from the Atrium Mesh MDL – none of them, individually, significant enough to make our list, but collectively raising sufficiently serious legal and jurisprudential questions to warrant mention. A couple of really bad preemption decisions, Rinder v. Merck Sharp & Dohme Corp., 123 N.E.3d 1202 (Ill. App. 2019) ( here), and In re Zofran (Ondansetron) Products Liability Litigation, 368 F. Supp.3d 94 (D. Mass. 2019), might have been bottom-ten candidates, but Albrecht got there first, consigning those two to the legal dustbin. See Rinder v. Merck Sharp & Dohme Corp., 132 N.E.3d 341 (Ill. 2019) (vacating in light of Albrecht); In re Zofran (Ondansetron) Products Liability Litigation, 2019 WL 4980310, at *1 (D. Mass. Oct. 8, 2019) (same).
We need a shower, disinfectant, and a change of clothes after our exposure to this decisional toxic soup, and perhaps some egg nog spiked with Everclear to get our holiday spirit back. But don't worry, we'll be passing around the ambrosia next week, with our review of 2019's top ten best drug/device decisions.
This article is presented for informational purposes only and is not intended to constitute legal advice.