In our 2017 post, “Medtronic v. Lohr Has Two Shadows,” we pointed out that the “presumption against preemption” that was the linchpin of that decision’s limited and atextual reading of the FDCA’s express preemption clause for medical devices, 21 U.S.C. §360k(a), was no more. Lohr had justified its specificity gloss on the broad
Last year we reported on Plourde v. Sorin Group USA, Inc., 2021 WL 736153 (D. Mass. 2021), which held that the plaintiff’s failure-to-warn claims were expressly preempted by 21 U.S.C. § 360k(a) because those claims were based on an alleged failure to report adverse events to the FDA and the plaintiff had not shown
In our 2017 post, “Medtronic v. Lohr Has Two Shadows,” we pointed out that the “presumption against preemption” that was the linchpin of that decision’s crabbed and atextual reading of the FDCA’s express preemption clause for medical devices, 21 U.S.C. §360k(a), was no more. Lohr had justified its specificity gloss on the broad
There has been a veritable pandemic of posts about Covid-19 regulations (vaccine mandates, restrictions on indoor gatherings, etc.) on the DDL blog as of late, so we thought we’d take a break from the craziness and report on a good, old-fashioned medical device preemption case. And yet we still found ourselves encountering a loathsome disease
Get a group of experienced lawyers together and it won’t be long before there is a one-upsmanship game of Crazy-Things-Judges-Have-Done. A learned and revered colleague tells the story of how he went to argue before a law and motion judge many years ago and low comedy ensued. Being a diligent sort of fellow, said learned
Today we discuss Sherrod v. Smith & Nephew, Inc., 2021 Tenn. Cir. LEXIS 74 (Tenn. Cir. Ct. 2021), a recent Tennessee trial court decision granting the defendant device manufacturer summary judgment on preemption grounds. Notwithstanding one quibble, there is much to like about the decision.
The plaintiff, who asserted a plethora of product-liability and
We’re not surprised by the preemption ruling in In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, 2021 U.S. Dist. Lexis 100041 (D. Md. May 17, 2021), but that doesn’t makes us any less appalled.
First, here’s what happened.
This latest Birmingham Hip ruling was in preparation for
The Ninth Circuit recently answered a preemption question that we had seen arise intermittently, mostly in food litigation, over the past couple of years. Because the relevant preemption clause closely resembles the language of the Medical Device Amendments (“MDA”), we thought it was worth a look.
In Webb v. Trader Joe’s Co., ___ F.3d
The plaintiff in Vesoulis v. Reshape Lifesciences, 2021 WL 1909725 (E.D. Louisiana May 12, 2021), was a dentist. So if he was complaining about pain and suffering, we’d step back and take notice. (Think of the Steve Martin song from the Little Shop of Horrors musical film.) The plaintiff certainly did have something
Today we report on a recent decision dismissing manufacturing-defect, warranty, and failure-to-warn claims arising from an allegedly defective breast implant. Although the decision, D’Addario v. Johnson & Johnson, 2021 WL 1214896 (D.N.J. 2021), does not stray far from the beaten path, it covers ground worth revisiting. The decision is a useful (if cursory) reminder