Bexis has been updating the preemption chapter of his treatise on drug/device product liability litigation. He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting” (“ASR”) system that the agency operated for about 20 years, “from 1997 through June 2019.” FDA, “Medical Device Reporting (MDR): How to Report Medical Device Problems,” at MDR Data Files, Alternative Summary Reports (available here). Bexis came across preemption cases mentioning ASR reporting with respect to surgical staplers, Bell v. Covidien LP, 2023 WL 3006175, at *2 (D. Mass. April 19, 2023), breast implants, e.g., Gravitt v. Mentor Worldwide, LLC, ___ F. Supp.3d ___, 2022 WL 17668486, at *3 (N.D. Ill. Dec. 14, 2022); D’Addario v. Johnson & Johnson, 2021 WL 1214896, at *3 (D.N.J. March 31, 2021), and contraceptive devices. McLaughlin v. Bayer Essure Inc., 2019 WL 3764658, at *1 (E.D. Pa. May 9, 2019). It appears that plaintiffs are attempting to turn various defendants’ use of this FDA-created and authorized program into a tort (variously described as warning defect or a variant of a misrepresentation claim).
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