Long ago, a senior partner told us that clear writing flows from clear thinking. That might be so, but clear thinking and clear writing do not necessarily produce the correct result. For example, you’d have a tough time finding a legal opinion written more clearly than Calchi v. Topco Assocs., LLC, 2024 U.S. Dist.
Preemption
Has Albrecht Been Undone?
We do not mean the German Renaissance painter and thinker Albrecht Dürer. His work, while a poor cousin to that of some famous contemporaries to the south, remains as is. We mean the Supreme Court’s decision in Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019), which has been touted for the…
Loper Bright Likely Lays Lohr Low
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.
Another Pretty Potent Painkiller Preemption Decision
Even though lawyers who bill for their time defending product liability cases might favor those cases sticking around and plaintiffs getting many chances before inevitable dismissals with prejudice, we have been clear that we think plaintiffs should not get to re-plead around preemption once courts have defined the preempted path. There seems to be an…
Another Preemption Win Involving An Economic Loss Class Action And An OTC Drug
As regular blog readers know, we love a clean grant of a motion to dismiss on preemption grounds. They are relatively common, so it sometimes puzzles us that the plaintiffs’ bar keeps filing plainly preempted claims.
Perhaps some of these plainly preempted lawsuits get filed because the express preemption provision of the FDCA related to…
Hip, Hip … Meh? N.D. Cal. Issues Mixed Bag of Rulings on Hip Implant Claim
We have often characterized judicial options as mixed bags, and a recent example of such a mixed bag can be found in Muldoon v. DePuy Orthopaedics, Inc., 2024 U.S. Dist. LEXIS 130020 (N.D. Cal. July 23, 2024). The plaintiff claimed injuries from a ceramic-on-metal hip implant. He alleged that friction and wear caused the…
In Important First, Claims Implicating Class II Medical Device that Received De Novo Classification Held Expressly Preempted
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…
Constitutional Challenge To The Vaccine Act Misses The Mark
In simpler times for those of us of a certain age, what we learned in elementary school was often supplemented during Saturday mornings watching cartoons. While you could pick up some information watching Super Friends or Captain Caveman, the catchy songs and minimalist animation of Schoolhouse Rock! really helped to teach children a range…
100% Preemption Dismissal
No one can argue with that title because Bruno v. Bluetriton Brands, Inc., was most definitely dismissed completely on preemption grounds. 2024 U.S.Dist. LEXIS 98451 (C.D. Cal. May 6, 2024). In so ruling, the court handed class action plaintiffs a significant defeat on of their latest litigation endeavors: “microplastics” in water. It’s not a…
Bartlett Pairs – “Failure To Recall” As a “Stop-Selling” Variant
We recently discussed how “failure-to-recall” claims essentially don’t exist – outside of a couple of limited fact patterns that plaintiffs asserting such claims in litigation involving FDA-regulated products can almost never allege. Today’s post adds the constitutional defense of preemption to good, old-fashioned state-law failure to state a claim.Continue Reading Bartlett Pairs – “Failure To Recall” As a “Stop-Selling” Variant