Express Preemption

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Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted.  After all, PMA “is in no sense an exemption from federal safety review − it is federal safety review.”  Id. at 323.  Thus, by a 7-2 margin the Court held, per Justice Scalia, that all state-law liability claims before it – “strict liability; breach of implied warranty; and negligence in the [product’s] design, testing, inspection, distribution, labeling, marketing, and sale,” id. at 320 – were expressly preempted:Continue Reading PMA Preemption Decision Slides to the Bottom of the “Parallel Claim” Slippery Slope

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Kulkarni v. Generics, 2023 U.S.Dist.LEXIS 160730 (S.D.N.Y. Sept. 8, 2023), is an interesting generic preemption (mostly) dismissal involving an “old” (pre-1962) drug.  A pro se plaintiff sued five affiliated pharmaceutical companies alleging that a course of generic prednisone caused her to develop functional myoclonus.  The plaintiff’s theory of the case was that the drug label failed…

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We know this is the Drug and Device Law Blog, but the similarities between food labeling preemption and medical device preemption are just too strong for us to pass up.  In both contexts, the FDCA has express preemption provisions.  The Medical Device Amendments to the FDCA, prohibit any state law or regulation “which is different…

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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).Continue Reading Thinking About the FDA’s Alternative Summary Reporting Program

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If a court tells you your only non-preempted claim is one based on a theory that your labeling does not comply with the Federal Food, Drug & Cosmetic Act (“FDCA”), it’s probably a good idea for your expert so opine.  Opting instead for expert testimony based on a consumer’s perspective is risky and likely problematic. …

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As we’ve discussed before, the United States Supreme Court, in Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115 (2016), sent the presumption against preemption, in express preemption cases anyway, into the dustbin of history.

[B]ecause the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.

Id. at 125 (citations and quotation marks omitted).Continue Reading On the Erstwhile Presumption Against Preemption, the Third Circuit Sticks Out Like a Sore Thumb

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Over-the-counter (“OTC”) drugs are protected from civil liability by an express preemption provision that is even stronger than the medical device preemption clause interpreted in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  That provision is:

Except as provided in subsection . . . (e) . . ., no State or political subdivision of a State may establish

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We do not often see state court opinions strongly endorsing federal preemption, or even weakly endorsing federal preemption.  That is why we took notice last week when the California Supreme Court ruled unanimously that the Medicare Act expressly preempted state common-law and statutory claims against a health maintenance organization and a healthcare plan administrator.  Most…

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