We scratched our heads last year when the Third Circuit misconstrued the federal PREP Act to allow a state-law negligence claim arising from an alleged COVID-related death, in direct contravention of the Act’s express preemption. See Maglioli v. Alliance HC Holdings LLC, 16 F. 4th 393 (3d Cir. 2021). The other shoe dropped the
Happy Star Wars Day. May the Fourth be with you.
If all FDA approved medicines enjoyed the preemption protection that vaccines do, the DDL product liability litigation landscape would be leaner and less nonsensical. Flores v. Merck & Co., 2022 U.S. Dist. LEXIS 46442 (D. Nev. March 16, 2022), shows why that is so.
Defendants love and plaintiffs hate Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S. 662 (2009), which together stand for the proposition that to state a claim and avoid dismissal a plaintiff must allege facts that plausibly suggest that the defendant is liable. Today’s case, Poozhikala v.
We write on a gorgeous spring day in suburban Philadelphia, with Passover imminent for us and Easter for many we love. Today’s decision contains more than enough “good” to sustain the positive vibe. Ward v. Zoll Lifevest Holdings LLC, 2021 WL 7907066 (D.D.C. Sept. 20, 2021) is a D.C. District case from last September
We had occasion recently to reread Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and here’s what the Court said about why the “reasonable assurance of safety and effectiveness” standard is preemptive of personal injury claims:
[The FDA] may thus approve devices that present great risks if they nonetheless offer great benefits in light
Today we report on Thornton v. Tyson Foods, Inc., — F.4th —-, 2022 WL 727628 (10th Cir. 2022)—a favorable express-preemption decision under the Federal Meat Inspection Act (FMIA), 21 U.S.C. §§ 601–695, that is directly applicable to medical-device cases. Although decided under a different statute, Thornton makes clear that the FDCA bars state-law claims
This post is from the non-Winston & Strawn side of the blog.
As we write today, we are nine days from an event, two years in the planning, that we have mentioned in these pages before. We are taking the Drug and Device Law Dowager Countess (nearly 88) and her slightly younger sister to see
A few weeks ago, we reported on Chong v. Kind LLC, 2022 WL 464149 (N.D. Cal. 2022), a decision holding that 21 U.S.C. § 337(a) as construed in Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), impliedly preempts claims based on California’s Sherman Act, which adopts the FDCA as state law. As
As we write this, our firm’s “return to office” date is less than two weeks away. We will be delighted to see, hug, and collaborate in person with colleagues we’ve missed for two long years (computer visages notwithstanding), though we confess to panic at the prospect of “real clothes.” And shoes. It’s all a bit
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