Last summer, we gleaned the bitter fields of Davidson v. Sprout Foods, Inc., an opinion in which the Ninth Circuit allowed direct private enforcement of Food, Drug, and Cosmetic Act (FDCA) food labeling requirements because the class plaintiff used the fig leaf of California’s Sherman Act to do so. Our post about the Ninth
The Supreme Court elucidated
Defendant in Beavan v. Allergan U.S.A., Inc., 2014 N.J. Super. Unpub. LEXIS 2898 (N.J. App. Nov. 21, 2024) made two solid arguments for summary judgment – preemption based on the FDCA’s recall regulations and plaintiff’s lack of admissible expert testimony. The trial court rejected both. The appellate court, however, saw the merit in the
Every time we read an order about “pre-approval” defects in prescription drugs, we stop to scratch our heads. It is not because we are easily confused, at least not on most days. No, we pause to ponder what exactly a “pre-approval” defect is and how a company can be held to answer for an alleged
Happy New Year. We are doing that usual January/Janus thing of looking both backwards and forwards. We are gearing up for a massive litigation in 2025, for a couple of trials, and for the January 16 Drug and Device Law webinar on the best and worst cases of 2024. And we’re still finding some 2024
This one seems pretty straightforward to us, but that did not stop plaintiff in Argueta v. Walgreens Company, 2024 WL 5186825 (E.D. Cal. Dec. 20, 2024), from trying to make a claim based on allegations that the product was illegal to sell because it was not FDA approved. No allegation that the product caused
The last time we looked into Bueno v. Merck, it was anything but bueno. Taking the position that, “if there is a cause of action, there must be jurisdiction,” a misguided decision had held that a branded drug manufacturer could be haled to court under an innovator liability claim, despite the defendant having never sold anything to the plaintiff in the state. See Bueno v. Merck & Co., 626 F. Supp.3d 1154 (S.D. Cal. 2022). That decision made our bottom ten list in in 2022.
Two years later – and who knows how many $$$ spent in the interim – the result on the merits was incomparably better. All claims dismissed with prejudice for a variety of excellent reasons. Bueno v. Merck & Co., ___ F. Supp.3d ___, 2024 WL 3974754 (S.D. Cal. Aug. 27, 2024). Ditto for a companion case decided the same day. See Parker v. Merck & Co., 2024 WL 3974764 (S.D. Cal. Aug. 27, 2024).
Here’s what happened.Continue Reading Bueno and More Bueno
Note: There is a table in this post that may be easier to view on a phone than on a computer.
Medical device preemption provides powerful protection from litigation involving Class III devices with premarket approval (or “PMA”).
These devices are a very small subset of FDA-regulated medical devices – around 1% — and they
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
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