Welcome to our annual Elysium tour, in which we electronically acknowledge the sweet nectar of victory flowing from the top ten drug/device product liability decisions of the year. It’s time to salute those fortunate decisions that brought the judicial Midas touch to our clients’ cases. We echo what we said last year: “we’re looking for nothing but pleasant news . . . [a]nd make no mistake about it, there’s plenty to celebrate this year.”
Occasionally, a court will do something decidedly anti-Dionysian, with an eleventh-hour awful decision (the infamous Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), was decided two days before Christmas), but barring that, we’re expecting pleasant dithyrambs from 2019’s paragons of judicial reasoning.
Before the Great Panathenaia begins, we remind readers that our scope of coverage is limited. Our top (and bottom) ten lists are limited to cases involving prescription medical product liability litigation (relatively broadly defined). Cases are decided each year that significantly impact what we do, even though not involving prescription medical products. So, we’ll tip our collective pilei to In re Amendments to the Florida Evidence Code, 278 So.3d 551 (Fla. 2019) (discussed here), not really a “case” at all, but a monumental step forward for Florida law – adopting a Daubert-based standard for admissibility of expert witnesses. Kudos also to two talc wins, State ex rel. Johnson & Johnson v. Burlison, 567 S.W.3d 168 (Mo. 2019) (discussed here), granting mandamus to disapprove venue abuse in St. Louis; and Johnson & Johnson Talcum Powder Cases (Echeverria), 249 Cal. Rptr. 3d 642 (Cal. App. 2019) (discussed here), j.n.o.v.ing several parts (including punitive damages) of an absurd $400+ million verdict and granting a new trial as to the rest due to inadequate causation evidence. Also noteworthy is Fitzpatrick v. Wendy’s Old Fashioned Hamburgers, ___ N.E.3d ___, 2019 WL 5792847 (Mass. App. Nov. 7, 2019) (discussed here), the first express appellate condemnation of plaintiff-side “reptile” tactics. Finally, we recognize American Beverage Ass’n v. City & County of San Francisco, 916 F.3d 749 (9th Cir. 2019) (en banc) (discussed here), for holding that the First Amendment precludes governmental mandate of a controversial “safety” statement in product advertising.
Enough with the introductions. Now, let’s proceed with the panegyrics.
- Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019). Even though Albrecht has enough aspects we don’t like to be named simultaneously as our sixth worst case, the Court’s disposition of the core preemption issues promises to be so beneficial to all defendants that Albrecht is also our number one best case for 2019. Already, it wiped out our worst case of 2017, as well as two decisions that otherwise might have made this year’s bottom ten. The impact of Albrecht’s holding that preemption is always a question of law for the court – including resolution of any subsidiary factual disputes – should have numerous beneficial effects. The Third Circuit’s ill-fated “clear and convincing evidence” standard likewise vanished with the “question of fact” misnomer, and with no facts for juries to decide, the summary judgment “most favorable to nonmovant” standard for viewing facts also drops out (it hasn’t applied in analogous patent litigation). Albrecht thus removed pro-plaintiff thumbs from the evidentiary scale in preemption cases. In 95% of preemption cases (at least), we think defendants have the better side of the regulatory record, thus we should win most straight-up preemption arguments. Courts can no longer cop out, or kick the can down the road, with the excuse of “disputed” facts. Since expert testimony on questions of law is improper, obfuscation of preemption issues by paid “FDA experts” should lessen. Also, with preemption as a discrete legal issue, separate from trial, arguments for interlocutory review of adverse preemption decisions improve (although judicial factual determinations, where present, may well get appellate “clearly erroneous” deference). These points improve defense chances in all preemption cases, implied or express, since a level playing field should also greatly assist defeating FDCA intensive “parallel violation” claims in PMA preemption cases. Other useful points include the Court’s first discussion of “overwarning” as a policy concern. Albrecht omitting any “presumption” about preemption in its extensive Levine (2009-1) discussion, instead using only the older “assumption” language. The last vestiges of the so-called “presumption against preemption” are now in doubt. Albrecht also doubled down on the FDA changes-being-effected (“CBE”) regulation defining Levine’s safe harbor against impossibility preemption, which creates preemption arguments for everything that CBE doesn’t cover. Even the reformulated FDA “fully informed” gloss on Levine “clear evidence” opens the door to the FDA itself answering that question (see the above 95% reference). Likewise, the decision’s discussion of “force of law” also cuts both ways, and should restrict plaintiffs’ ability to rely on warning letters and other FDA actions lacking the required legal status. Since preemption is the strongest defense our side has, all these favorable holdings and implications make Albrecht our number one decision for 2019. We analyzed Albrecht on multiple occasions, most notably here and here, and will undoubtedly do so again.
- Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699 (2d Cir. 2019). Gibbons is a two-fer. Its preemption ruling is extremely helpful – affirming in all respects the district court’s extensive and expansive preemption rulings based, not on Levine (2009-1) clear evidence, but on the “newly acquired information” limitation in the FDA’s CBE regulation. Those rulings showed the strength of “newly acquired evidence” as a separate preemption basis, enough to be our top district court decision in 2017. Gibbons also confirmed that Mensing (2011+1)/Bartlett (2013+1) preemption is indeed of universal applicability, and not limited (as plaintiffs argued) to generic drug cases. Thus, whenever FDA pre-approval is required for a given alteration in the design or warning of a drug (or device), the Mensing independence principle mandates preemption. Gibbons also confirms the value of TwIqbal in preemption cases, upholding preemption where plaintiffs failed to plead any “newly acquired information” that could get them into Levine’s CBE preemption safe harbor. Gibbons demonstrates the power of preemption – an entire MDL went down to defeat. That’s one. The second part of Gibbons strongly confirmed that defendants can properly remove cases to federal court before service of process on a “forum defendant” that would otherwise prevent removal. That’s what the statute said, so that’s what defendants can do. Litigation tourist plaintiffs have exploited the archaic “forum defendant rule” to create mass torts in their favored locales, even though their target defendant is otherwise diverse and would be exposed to pro-plaintiff “home cooking” in such places. For handing defendants wins in both preemption and removal, Gibbons comes in second only to a Supreme Court decision. We goggled over Gibbons here.
- Weber v. Allergan, Inc., 940 F.3d 1106 (9th Cir. 2019). Preemption, again. Hey, it’s our strongest defense. In this pre-market approval case, the plaintiff sought to prove the FDCA violation necessary to support a “parallel violation” claim on what amounted to res ipsa loquitur – asserting that a device malfunction allows the inference, not just of a product defect, but of a regulatory violation (but don’t ask the plaintiff what it was). Weber became the first appellate court to hold that plaintiffs can’t do that. Res ipsa loquitur may allow inference of a product defect, but not a violation of any particular regulation. Instead, to avoid preemption, a plaintiff must show that the defendant device deviated from the device’s pre-market approval requirements or some other applicable FDA standard. The FDA approves devices knowing they can malfunction. Since full compliance can’t eliminate malfunctions, no inference of regulatory violation from a mere malfunction is possible. A secondary, and helpful, ruling in Weber was that a factual description of clinical trial results did not create any express warranty that every device would always perform within that description. Such a mandatory guarantee was “different from” applicable FDA requirements, and thus also preempted. We welcomed Weber here.
- In re 3M Bair Hugger Litigation, 924 N.W.2d 16 (Minn. App. 2019). The appellate decision that put an end to the Bair Hugger litigation rates as our best state-court decision of 2019. The opinion described what we called the “Dostoyevskian” origins of the litigation, stirred up by the jilted inventor of the device, who left the company under a legal cloud, invented a competing device, and then tried to use this product liability litigation as a tool either to obtain a competitive edge or to force the defendant to buy his company. Suffice it to say, that it did not end well for plaintiffs – particularly since the FDA disagreed with the inventor’s supposed “scientific” study of comparative device safety. Of course, the thrice-jilted inventor also served as plaintiffs’ expert in the litigation. Minnesota doesn’t follow Daubert, but in Bair Hugger that hardly mattered. The novel scientific theory touted by plaintiffs and their expert wasn’t generally accepted, so all the Bair Hugger claims failed on causation grounds. The best legal ruling in Bair Hugger was that the Frye test (Minnesota’s version, anyway) applied to both methods and to ultimate opinions. In other words, even when an expert is devious enough to manipulate accepted methods to reach a crazy result, the craziness of the result is sufficient to require exclusion. We gave Bair Hugger a big hug here.
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