Last week we discussed the Jacob v. Mentor Worldwide, LLC case, in which a pro se plaintiff alleged injuries from breast implants and complained that the manufacturer had inadequately warned of the risks. The claim boiled down to an attack on the FDA-approved labeling of a class III medical device, and that meant it was
No writer made as strong an impression on us in high school as Albert Camus. The opening of The Stranger is arresting: “Mother died today. Or maybe it was yesterday, I don’t know.” Our teacher pronounced The Plague to be an even better book, and he often quoted the bit about how we had “to
In Tinkler v. Mentor Worldwide, LLC, 2019 WL 7291239 (S.D. Fla. Dec. 30, 2019), the plaintiff claimed that a breast implant leached chemicals into her tissue, causing a constellation of symptoms known as Breast Implant Illness. Her lawsuit alleged that the manufacturer knew of this danger but failed to warn the implanting surgeon who,
We had to shake our heads at the recent 360 story entitled, “Allergan Breast Implant Risk MDL Heading to New Jersey” – the link is here for those of you with a subscription.
The idea of a “risk” MDL seems bizarre. The story involves a particular type of cancer, and states that “four proposed class
Did you remember that there can be express preemption for over-the-counter drugs? We sometimes forget too, but there are really good reasons for that. The Food Drug and Cosmetic Act includes the following provision:
[N]o State or political subdivision of a State may establish or continue in effect any requirement – (1) that relates to
Offhand, we cannot think of opinions we have blogged on that pleased us more than today’s cases, Jacob v. Mentor Worldwide, LLC, et al., 2019 WL 3500325 (C.D. Cal. Aug. 1, 2019) and Vieira v. Mentor Worldwide, LLC, et al., 2019 WL 3500331 (Aug. 1, 2019). The two decisions are virtually identical and
We have taken a daily multivitamin ever since our doctor told us that we were chronically deficient in a particular vitamin, the one you can get from being out in the sun. Given our chosen line of work, we should not be surprised that we don’t get enough sunlight. We should also not be surprised
We understand that we write a lot about federal preemption. You might even be rolling your eyes at yet another post on this most powerful of defenses, but we just can’t help ourselves. Federal regulation runs deep in the drug and medical device world, and the possibility that federal law might preempt state-law claims is
We have made it no secret that we think the Ninth Circuit wrongly decided Stengel v. Medtronic. That is the case where the Ninth Circuit reversed express preemption of claims involving a pre-market approved medical device by divining a “parallel” state-law duty to report adverse events to the FDA. As we have said here
Last year’s list of the Ten Worst DDL cases was remarkable because all ten decisions came from appellate courts. Yikes. And it is not as if the bad appellate decisions were spread around. Two came from our home circuit, the Third. Two came from the reliably problematic Ninth Circuit. But the ‘winner’ was the Eleventh