We recently examined one possible beneficial impact of the Supreme Court’s recent landmark decision in Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024) – that it could bring about critical re-examination of the FDA’s questionably supported ban on truthful off-label speech.
Well here’s another one: Medtronic, Inc. v. Lohr, 518 U.S.
If you are of a certain age and are presented with a trio of items, we bet you sometimes add “Oh My” to the end of the list, as in Lions, and Tigers, and Bears-Oh My. Or, you think of other things that come in threes, such as the past and the present
This post is from the non-Butler Snow side of the blog.
When a news article starts with “Florida man…” you know you are in for a bit of crazy. Usually crazy and funny, but in a smack-my-head kinda way.
The lawsuit resulting in the decision in MSP Recovery Claims, Series LLC v. Ethicon Inc.
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Last week, FDA released for comment a draft guidance titled Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers.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 Nonetheless, it addresses a frequent and important problem in our industry.Continue Reading FDA Releases Draft Guidance on Responding to Internet Hogwash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