Trick Or Treat? The Ghost Of Pelvic Mesh Haunts Medical Device Litigation

• Published date: 20 October 2020
• Law Firm: Reed Smith
• Author: Mr James Beck

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"). ContraHahn 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...