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...
