We warned everyone, but there is no sense beating a dead horse (or bear, or whale). So we’re getting right to the unpleasant business of discussing the bottom ten worst prescription medical product liability litigation decisions of 2024. And we stress both “product liability” and “litigation.” Otherwise, we’d have to include Harrington v. Purdue Pharma L.P., 144 S. Ct. 2071 (2024), concerning the scope of bankruptcy releases in a pharmaceutical mass-tort driven Chapter 11 proceeding. While we discussed Harrington here, as defense lawyers we find something abhorrent about considering a defendant’s bankruptcy as part and parcel of prescription medical product liability litigation. Other non-prescription medical product cases that we consider both important and adverse include Davidson v. Sprout Foods, Inc., 106 F.4th 842 (9th Cir. 2024), perpetuating the fiction that a state’s in toto mass adoption of FDCA standards makes their enforcement “state law” for preemption purposes (here); Carson v. Monsanto Co., 92 F.4th 980 (11th Cir. 2024), another adverse preemption decision that we discussed here; and In re Natera Prenatal Testing Litigation, 664 F. Supp.3d 995, 1007-08 (N.D. Cal. 2023), predicting (contrary to Erie principles) a consumer protection exception to the learned intermediary rule (here).
Even without obnoxious decisions like those, there’s more than enough judicial road kill and brain worms out there to complete our disagreeable task of compiling the ten worst prescription medical product liability decisions of the year. We’ve been shoveling the Augean Stables of prescription medical product liability litigation since 2007, assembling this annual list, because who else would do it if we didn’t? Bad decisions, like good ones, should be recognized as such. While it’s always possible that an eleventh-hour holiday horror could arise, as happened here and here, late-breaking adverse precedent has so far been thankfully uncommon.
That’s enough prologue. On to the agony. Coming up are ten decisions that make us say “ow, ow, ow” rather than “ho, ho, ho.” If you were on the receiving end of any of these bad boys, believe us, we sympathize since our own cases have made this list before (see, e.g., 2013-2 and 2021-10). Just keep up the good fight. Lawyers that never lose aren’t trusted with difficult cases. Keep in mind that the pain will go away, since next week we’ll be heralding the top ten best decisions of 2024.
- Gilead Tenofovir Cases, 317 Cal. Rptr.3d 133 (Cal. App. 2024). Our worst case of the year recognized a pernicious “negligence” theory that created liability for the makers of non-defective drugs for not inventing and obtaining FDA approval of different, allegedly “safer” drugs for the same indication. Moreover, it did so in the context of drugs that reduced a diagnosis of AIDS from a death sentence to merely a chronic condition. For those with short memories, before the drug at suit, people were dying of AIDS by the thousands. Tenofovir now holds that its manufacturer can be liable for getting that drug through FDA approval, instead of one not approved until a decade or so later. We can’t imagine how many more people would have died in misery had that been the law at the time. And no state suffered more from the AIDS epidemic than California – talk about biting the hand the feeds (saves) you. Strict liability was a California invention that made proof of a “defective” product easier than negligence. An intermediate appellate panel has stood the law on its head, holding that negligence can impose liability “beyond the duty not to market a defective product.” Tenofovir relied chiefly on a case involving chicken bones in food, rather than California’s extensive precedent involving prescription medical products. We see no way that Tenofovir can possibly be squared with solicitude that the California Supreme Court showed for prescription products in the 1988 Brown case that abolished strict design defect liability for such products. Now no defect is required at all, only “foreseeability” that a later, safer drug would have been approved by the FDA. On a clear day, in California, courts (at least this one) can foresee forever. The decision’s public policy analysis is exemplified by this quotation: “[m]oral blame is typically found when the defendant benefits financially from its conduct.” Making a profit is thus declared immoral in California. This novel “duty to innovate” will do just the opposite – affirmatively impede innovation on both ends of the product cycle. Liability is a form of deterrence, and the liability recognized in Tenofovir will deter product innovation on both ends. At the front end, it deters manufacturers fearful of liability from bringing any “first in its class” product to market, since some later related product might, in hindsight (in Tenovofir, two decades after the fact), turn out possibly to be “safer” for some patients in some respect. On the back end, the same liability will deter manufacturers from releasing improvements that make their products “safer,” because doing so could create hindsight liability for all sales of the original product for whatever injuries the “safer” innovation arguably could have provided. As of now, any defendant who “knows” of an allegedly safer and equally effective design for a product it currently makes will be compelled to replace its existing, non-defective product with the alternative design, or else face a risk of broad liability. Thankfully, the California Supreme Court will review. We trashed Tenovofir here, and tore into it again here.
- In re Fosamax (Alendronate Sodium) Products Liability Litigation, 118 F.4th 322 (3d Cir. 2024). This is the second time that a Third Circuit reversal of a preemption summary judgment holding in the Fosamax MDL has earned the dubious distinction of landing high on our annual worst of the worst list (2017-1). The first Fosamax decision, among other things, found that preemption was a jury question. That decision was unanimously reversed by the Supreme Court in Albrecht (2019+1) and remanded for the trial court to rule on preemption as a matter of law. The trial court did, reviewing a long and detailed FDA administrative record, including the FDA’s view of that record as briefed in the Supreme Court, and once again found preemption (2022+5). Once again, however, the Third Circuit reversed, and its new opinion is equally bizarre. We’ve always thought of the adversary litigation process as an effective way to uncover the truth. This Fosamax opinion utilizes a presumption against preemption – increasingly endangered everywhere else – as a means of avoiding the truth. Fosamax effectively thumbed its judicial nose at the Supreme Court’s Albrecht holding, this time putting said thumb on the scale through that presumption rather than, as in the first time around, through a heightened burden of proof. The Supreme Court held that subsidiary facts relating to the legal question of preemption are determined by the court. That meant a “clearly erroneous” appellate standard of review, which the Third Circuit first recognized, and then disregarded, using the same presumption as grounds for reversal. Further mischaracterizing the Supreme Court’s decision, the Third Circuit panel described it as “emphatically” applying the presumption against preemption, when in fact the opposite was true. No such presumption is mentioned anywhere in Albrecht. Rather, the Supreme Court spent several pages reformulating its earlier Levine decision, pointedly removing all references to that presumption, which had been so prominent in Levine. Having utterly misconstrued Albrecht, the Third Circuit then wielded the presumption against preemption as a sword to cut off, and thus reverse, the district court’s detailed analysis of the FDA’s administrative record. Using the presumption to evade the “clearly erroneous” standard of review, Fosamax held that reliance on the administrative record was simply unnecessary. If the FDA’s formal determinations were “ambiguous” so as to warrant review of this record, the presumption required an anti-preemption result, notwithstanding anything that the FDA had actually done, and even contrary to what the agency had told the Supreme Court it had done in its amicus brief in Albrecht. Thus, instead of using a presumption to simplify the fact-finding process, or to fill in blanks (why presumptions exist in the first place), Fosamax used the presumption to avoid looking at the FDA’s administrative record at all. The presumption controls and actual facts be damned. Fosamax even disinterred an old Supreme Court chestnut from a non-FDCA field preemption case, the courts “have a duty to accept the reading that disfavors pre-emption.” Fosamax concluded by telling FDA-regulated defendants’ tough luck, since the FDA can “take its time” but defendants must “at all times” be held responsible for their labeling, whether the FDA would let them change it or not. That, of course is completely at odds with the Mensing (2011+1) independence principle, but Fosamax also gave Mensing the back of its hand, because generic cases are “different.” They are not, of course, when implied preemption is at issue, but since Fosamax had already disregarded Albrecht, why stop there? We flogged the blatantly result-oriented opinion in Fosamax here and here.
- Himes v. Somatics, LLC, 549 P.3d 916 (Cal. 2024). In Himes, the highest court of the largest state in the country upset decades of settled precedent...
