The Pelvic Mesh MDLs are now all but over, with all but a few stragglers either settled or remanded. But the specious logic used in that litigation to overturn decades of precedent that had recognized compliance with FDA regulatory actions as relevant and admissible evidence, is still afoot to haunt medical device manufacturers. As we've discussed, Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), had nothing to do with evidence or common-law issues. It was a preemption case, and the phrase that was latched upon in that litigation - "the 510(k) process is focused on equivalence, not safety," id. at 493 - isn't even true anymore, as the Supreme Court subsequently recognized in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 349-50 (2001) (§510(k) clearance intended "to ensure . . . that medical devices are reasonably safe and effective"); cf. In re Bard IVC Filters Products Liability Litigation, 969 F.3d 1067, 1074-75 (9th Cir. 2020) (device specific "special controls" imposed through §510(k) process may be preemptive if "relevant" to the claims at issue).
In Pelvic Mesh, this misuse of Lohr nullified state compliance presumption statutes nationwide, since such statutes serve no purpose where design defect claims are preempted and (in Pelvic Mesh) compliance became irrelevant in §510(k) cases. These rulings served to induce settlement, since they ensured that no Pelvic Mesh design defect case would ever be dismissed as a matter of law. To further enable design defect claims, Pelvic Mesh decisions attacked the "unavoidably unsafe" provision of Restatement (Second) of Torts §402A, comment k (1965), which, in a number of states such as California, New York, and Pennsylvania, had been applied across the board to all prescription medical products. See, e.g., Mullins v. Ethicon, Inc., 117 F. Supp.3d 810, 820 (S.D.W. Va. 2015) (calling comment k - which almost every state follows in one form or another - a "useless relic"). Contra Hahn v. Richter, 673 A.2d 888, 891 (Pa. 1996); Brown v. Superior Court, 751 P.2d 470, 481-483 (Cal. 1988); Bravman v. Baxter Healthcare Corp., 984 F.2d 71, 75-76 (2d Cir. 1993) (applying New York law).
The Pelvic Mesh idea that created an all or nothing approach where FDA requirements are either conclusive or irrelevant, with no middle ground, has been rejected in other MDL litigation, but it still persists. Today's case, Taupier v. Davol, Inc., 2020 WL 5665565 (D. Mass. Mag. Sept. 23, 2020), is an example of how Lohr continues to be misused. Massachusetts, like the aforementioned states, has applied although the precedent had been made in prescription drug cases. See Payton v. Abbott Labs, 437 N.E.2d 171, 189 (Mass. 1982) (adopting "policy" of comment k); Burnham v. Wyeth Laboratories, Inc., 348 F. Supp.3d 109, 112 (D. Mass. 2018); Lareau v. Page, 840 F. Supp. 920, 933 (D. Mass. 1993), aff'd 39 F.3d 384 (1st Cir. 1994) (applying Massachusetts law).
Latching onto the Pelvic Mesh decisions however, the magistrate in Taupier decided - without citing a scrap of actual Massachusetts authority - to exempt medical devices from the prior Massachusetts rule that had barred strict liability design defect claims.
Although Massachusetts cases have exempted drugs from breach of warranty liability under comment k, courts in other jurisdictions that have applied comment k to bar strict liability claims for design defects in prescription drugs have distinguished drugs from medical devices based, in part, on the FDA's "more rigorous oversight" of drugs. Therefore, even courts that exempt manufacturers of prescription drugs from strict liability based on comment k have applied a case-by-case analysis to medical devices.
2020 WL 5665565, at *8 (citations omitted). Taupier cited two cases, one of the Pelvic Mesh decisions and Burningham v. Wright Medical Technology, Inc., 448 P.3d 1283, 1290 (Utah 2019). As we pointed out when Burningham was first decided, that decision also relied on the misapplication of Lohr outside of preemption that first gained traction in Pelvic Mesh. Prior to those decisions, there was virtually no precedent for, and massive precedent against, distinguishing between prescription drugs and medical devices in the comment k/"unavoidably unsafe" product context.
That's the bad part of Taupier, and we have to admit, it's pretty bad. Not a mention of the Erie principle that federal courts should not predict expansions of state tort liability. But the decision has some redeeming features. Plaintiff's express warranty claim was dismissed for "fail[ure] to identify any 'affirmation of fact or promise' made by Defendant." 2020 WL 5665565, at *3 (quoting Massachusetts UCC). Plaintiff's warning claims were also dismissed - TwIqballed, to be precise:
While recognizing that Plaintiff has not conducted discovery, he fails to offer any description of the warnings and instructions that Defendant provided or should have provided to his physician. His assertions that he "was not informed of and had no knowledge of the known complications and risks" . . . and that the warnings and instructions were incorrect, inadequate, and incomplete are conclusory and insufficient to state a claim for negligent failure to warn.
2020 WL 5665565, at *11. See Id. at *12 (same result for strict liability warning claim because any difference between negligence and strict liability "has effectively collapsed" in Massachusetts).
While the other rulings in Taupier are nice, they are only a silver lining around a rather dark cloud. Overall, Taupier is yet one more reason why our side needs to find a way to have the Supreme Court re-examine Lohr itself.
This article is presented for informational purposes only and is not intended to constitute legal advice.