Another year down (and only one more to go for Bexis), and that means, in addition to dreidels, creches, and Santa Claus, it’s time for our annual top ten best prescription medical product liability litigation decisions. As we’ve pointed out before, for an opinion to be eligible for our annual top (or bottom) ten lists, it must: (1) involve a prescription medical product, or an OTC drug, and (2) have a plaintiff asserting liability for something purportedly wrong with that product.
So, before we turn to the best of the best for 2024, we’re going to give passing reference to those non-prescription medical product or non-product liability decisions in 2024 that we think will significantly impact our sandbox in years to come.
First on the list is no surprise, Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024), holding that courts owe no deference to administrative agency interpretations of their own statutory schemes. For us, of course, that primarily means the FDA. We’ve already discussed two opportunities and one defensive strategy that we see arising from Loper Bright. Loper Bright will work in tandem with Corner Post, Inc. v. Board of Governors of Federal Reserve System, 144 S. Ct. 2440 (2024), discussed here, a decision making it much easier to avoid the six-year statute of limitations that the Administrative Procedure Act imposes for challenging the kind of government actions at issue in Loper Bright.
Other non-prescription medical product decisions of significance in 2024 are: FDA v. Alliance for Hippocratic Medicine, 602 U.S. 367 (2024), rejecting, on standing grounds, a frontal assault on the FDA’s authority to approve prescription drugs (here, and here); S.K. v. Obstetrics & Gynecologic Associates of Iowa City & Coralville, P.C., ___ N.W.2d ___, 2024 WL 4714425 (Iowa Nov. 8, 2024), holding that FDA labeling is not proof of medical malpractice in an off-label use case (here); Francisco v. Affiliated Urologists Ltd., 553 P.3d 867 (Ariz. 2024), similarly rejecting FDA regulated labeling as proof of the medical standard of care in an informed consent case involving a boxed warning (here); Politella v. Windham Southeast School Dist., 325 A.3d 88 (Vt. 2024), while Vermont has one of the most liberal high courts, it recognized the full preemptive scope of the PREP Act in a vaccination-related suit (here); Schaffner v. Monsanto Corp., 113 F.4th 364 (3d Cir. 2024), an excellent RoundUp preemption decision, also significant for creating a potentially certworthy circuit split (here); In re Deepwater Horizon Belo Cases, 119 F.4th 937 (11th Cir. 2024), an outstanding Rule 702 general causation case rejecting yet another version of a no minimum exposure level claim (here); Children’s Health Defense v. FDA, 2024 WL 244938 (5th Cir. Jan. 23, 2024), rejecting, on standing grounds, a parent’s challenge to FDA public service pro-vaccine messaging (here); In re Paraquat Products Liability Litigation, 730 F. Supp.3d 793 (S.D. Ill. 2024), a thorough MDL-wide expert exclusion decision faithfully applying the amended Rule 702 standards and holding that subjective “weight of the evidence” opinions were inadmissible (here).
But that doesn’t in any way mean that our top ten decisions aren’t also significant, particularly since they are directly applicable, and not merely analogous, to the arguments we make in defense of our prescription medical product clients. This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. Some excluded bogus expert testimony under Fed. R. Civ. P. 702 (don’t say Daubert), both before and after the new, more muscular version of Rule 702 debuted on December first of 2023. Others applied the learned intermediary rule, another of our favorite defenses. They blew out nuclear verdicts. They rejected novel liability theories and even trimmed large numbers of cases from our increasingly dysfunctional and lawless federal multi-district litigation system (which has grown to nearly 80% of the total federal docket). Some even do more than one of these things. So here they are, our 2024 top ten prescription medical product liability decisions.
- Shears v. Ethicon, Inc., 902 S.E.2d 775 (W. Va. 2024). It’s a little late, since all those pelvic mesh MDLs have run their course, but yes, West Virginia does require a plaintiff to prove an alternative design as an essential element of a strict liability design defect claim. One could also say it’s a little late for this particular case, but that is the nature of MDLs. The Shears case was also a pelvic mesh matter, and it had been pending in one of those MDLs for some seven years, so it was more than a decade old before the necessary elements of the design claim were established. The plaintiff had argued for no alternative at all, while the defendant’s position in Shears was (based in a standard jury instruction) that the alternative design had to eliminate, not merely reduce, the causal risk. Shears did not go quite that far, but confirmed that no West Virginia plaintiff can get to a jury on a design defect claim without proof of the existence of an alternative, feasible design that existed when the product was manufactured. Because product designs in West Virginia must be “reasonably safe” – which is essentially a negligence, rather than a strict liability, standard – the alternative design must not merely be “safer” (the plaintiff’s fall-back position), but must “substantially reduce” the relevant risk. Plaintiff’s “safer” standard, which is also the formulation used in the Third Restatement of Torts §2, was too vague, and thus an “ineffective” basis for jury assessment of the duty of a “reasonably prudent manufacturer.” True enough, the defendant didn’t get the even tougher standard from the jury instruction, but overall we’re more than satisfied, and even a bit jealous, particularly those of us who practice in Pennsylvania. As a state high court decision on a fundamental product liability issue that adopted a liability standard more stringent than the Restatement, Shears qualifies as our best decision of the year. We saluted Shears here.
- Hickey v. Hospira, Inc., 102 F.4th 748 (5th Cir. 2024). The Taxotere MDL has, frankly, been a disaster for plaintiffs. That’s become quite clear for at least the last couple of years or so. While it can’t compete yet with Bone Screw (no equivalent of Buckman), Hickey gets it closer. In Hickey the Fifth Circuit became the first appellate court to recognize extensive federal preemption for medical devices coming to market under 21 U.S.C. §355(b)(2) – the FDA’s successor to so-called “paper NDAs.” Appellate recognition of preemption for a new class of prescription medical products doesn’t happen every day, so Hickey is our number two decision of the year. This type of FDA product approval is intermediate between traditional new drug applications and the abbreviated ANDA for generic drugs. This preemption-friendly result required a number of favorable intermediate steps of its own. First, lack of “newly acquired information” is a separate basis for preemption, apart from the Albrecht (2019+1) “clear evidence standard. Without such evidence, the requirements of the FDA’s preemption determinative “changes being effected” (“CBE”) regulation cannot be satisfied. Second, the CBE regulation requires that such evidence not only be “new” but also “reveal risks of a different type or greater severity or frequency” than material already in the FDA’s possession. Third, plaintiffs offered only “cumulative” information with no significant change in the degree of risk. Fourth, adverse events of the sort plaintiffs alleged proved nothing by themselves because the denominator (number of patients treated) was so large. One minor question – about the interpretation of a particular medical abstract – was remanded, with the appellate court’s express direction that otherwise the defendants were “not liable” on failure to warn claims due to implied preemption. We hailed Hickey here.
- This entry is solely from the Holland & Knight side of the Blog. In re National Prescription Opiate Litigation, ___ N.E.3d ___, 2024 WL 5049302 (Ohio Dec. 10, 2024) (“Trumbull County”). The expansion of public nuisance as a vehicle for shifting governmental costs to private entities has been, well, a nuisance for a while. When it comes to this particular litigation, currently the primary driver of that expansion, however, we have been biting our proverbial collective tongues more than usual. The recent Trumbull County decision, on a certified question from the Sixth Circuit gave one of us a chance to address some of these issues. In our Top Ten posts in each of the last two years, we noted we were watching the appeal following a large plaintiff verdict and then the referral to the Ohio Supreme Court for an answer to the basic question of whether Ohio still has a common-law public nuisance claim based on products claimed to interfere with a public interest. Trumbull County answered that question in the negative. The “unorthodox” product-related public nuisance theory, that Ohio once recognized in a non-prescription medical product liability case, was since completely abrogated by two statutory amendments to the Ohio product liability statute. Thus, a nine-figure MDL verdict should vanish, and future Ohio defendants can breathe easier. Trumbull County’s usefulness is somewhat limited because it concerned the statutory law of one state, but nonetheless it is definitely important given the history of these claims and the breadth of MDL litigation. In terms of that history, the Blog addressed many years ago restrictions from the municipal recovery doctrine (here and later here), issues with governmental outsourcing to contingency fee plaintiff lawyers, and that a trial run with the meth epidemic failed during the Breaking Bad era. All of this foreshadowed years of litigation with the specter of...
