This post is from the non-Reed Smith side of the Blog.
Breaking new ground, a court has for the first time held that the Medical Device Amendments to the Food, Drug, and Cosmetic Act expressly preempt product-liability claims implicating a Class II medical device brought to market through the “de novo” classification process. This is
Last week, FDA released for comment a draft guidance titled Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers. FDA guidances are nonbinding recommendations without force of law, and this is only a draft. Nonetheless, it addresses a frequent and important problem in our industry.Continue Reading FDA Releases Draft Guidance on Responding to Internet Hogwash
It is hard to imagine a less qualified expert witness than the one retained by plaintiff in Krom v. Smith & Nephew, Inc., 2024 U.S. Dist. LEXIS 121618 (N.D.N.Y Jul. 11, 2024). And since truth is often stranger than fiction, we are just going to give it to you straight.
Plaintiff, a 73-year-old, morbidly
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
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.
It’s a short week, so we are going to do a short post about a short decision on a product that lasted a long time.
An inferior vena cava (“IVC”) filter was implanted in plaintiff in 2004. Some years later she experienced a complication, not identified in the decision, which led her to file a
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
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
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
We have lost track of how many times we have written on pelvic mesh cases as they have gone through a number of district courts on remand and occasionally up on appeal to circuit courts. One theme we have seen play out over and over is that plaintiff lawyers who took on more cases than