Few medical treatments suffer from an image problem as bad as electroconvulsive therapy (ECT). We remember when it was called electro shock therapy. We also remember its gruesome depiction in One Flew Over the Cuckoo’s Nest. But modern medicine has redeemed ECT. It can be a genuinely effective treatment for maladies such as depression
Express Preemption
Another Attack On A Contraceptive Is Dismissed (For Now)
We are not the only ones who have pointed out that every new contraceptive for the last fifty years or so has been the subject of litigation and that it is not hard to see how the burden associated with such litigation, even if the manufacturer does well, discourages the development of new options. This…
Federal District Court Turns Prep Act On Its Head
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…
D. Nevada Dismisses Gardasil Vaccine Lawsuit
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.…
Twombly and Iqbal Taken Seriously: Express-Preemption Dismissal
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.
Mostly Good Preemption Decision Out of the District of Columbia
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…
Preemption and Humanitarian Medical Devices
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
…
Federal Law Expressly Preempts State-Law Misbranding Claims Predicated on Labeling Statements Approved By A Federal Agency
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…
Fifth Circuit Affirms Dismissals and Summary Judgment in Defibrillator Case out of the Eastern District of Louisiana
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…
FDCA Expressly Preempts State-Law Claim Challenging Labeling Statement Authorized By FDA Regulations
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…