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When we tell people what we do, we often get a response, from lawyers and non-lawyers alike, to the effect of, “so you do class actions.”  The somewhat canned response is that “serial product liability litigations” or “mass torts” rarely involve certified classes other than settlement classes because individual factors in personal injury cases almost

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Local counsel in one of our cases made it clear that unless we wanted to broadcast that we were from out of state, we needed to pronounce Oregon as “Or-gun” not “Or-ah-gone”, and we have tried to remember that tip ever since.  But today’s District of Oregon case, Glover v. Avanos Med., Inc., No.

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The FDA has taken recent steps that may, or may not, affect product liability litigation.  We’re discussing the “may” aspect.  For purely regulatory analysis, plenty of other commentary is available.

These actions occurred on September 7, 2023, and involve three “draft guidances” bearing on the “§510(k)” substantial equivalence clearance process for medical devices.  Any litigator with even passing knowledge of medical device preemption knows that this − more properly, a prior (1982) version − is the process that the Supreme Court stated, was “focused on equivalence, not safety” in Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996) (emphasis original).Continue Reading Tort-Related Implications of Recent FDA Device Draft Guidances

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Listen to your gut.  Follow your instincts.  Trust your intuition.  Great advice in many situations.  Like deciding whether to buy skinny jeans or whether to buy your forever home.  Or, when things seem “off” or feel “dangerous.”  Or, when your body is trying to tell you something about your health.  These are all times to

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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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As evidenced by our PMA Preemption Score Card, on which today’s case became the 651st entry, defendant manufacturers of FDA-approved Class III medical devices generally do pretty well with preemption motions.  But plaintiffs keep filing PMA medical device complaints, so we’ll keep posting about them. 

Which brings us to today’s case, Arnold v.

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It’s unusual when the same defendant wins two unrelated cases involving the same product in the same week – and on the same issue.  But it does happen, and recently, in both Benn v. Medtronic, Inc., 2023 WL 3966000 (D.N.J. June 13, 2023), and Warmoth v. Medtronic, Inc., 2023 WL 3938464 (W.D. Okla. June 9, 2023), express medical device preemption carried the day, in decisions issued only four days apart.

That’s worth a blogpost – and two cheers.  Hip hip!Continue Reading A Preemption Two-Fer