Last year we reported on Plourde v. Sorin Group USA, Inc., 2021 WL 736153 (D. Mass. 2021), which held that the plaintiff’s failure-to-warn claims were expressly preempted by 21 U.S.C. § 360k(a) because those claims were based on an alleged failure to report adverse events to the FDA and the plaintiff had not shown
Discovery can be very expensive. Defendants really like to win on motions to dismiss in part because they get to avoid the costs of discovery. We can pile on these shockingly obvious statements with two more. From a defense perspective, a narrow scope of discovery tends to be a good thing. If narrow discovery leads
In a ruling that is contrary to Supreme Court precedent, the district court presiding over the Zostavax MDL recently held that federal law does not preempt a state-law design-defect claim based on the manufacturer’s failure to seek FDA approval of a different, purportedly safer vaccine.
Zostavax, a shingles vaccine, received FDA approval in 2006. The
We’ve commented extensively on COVID–19–related vaccination cases, because vaccines are prescription medical products. We haven’t commented on another aspect of litigation intended to sabotage public health efforts to combat the COVID-19 pandemic – attacks on masking requirements − mostly because masks don’t require prescriptions. The kind of masks involved in
Federal law regulates medical devices differently from pharmaceuticals, and branded drugs differently from generic drugs. Whether a particular state-law tort claim is preempted often depends on whether the claim involves a medical device, a branded drug, or a generic drug. Often but not always. As today’s case illustrates, there is one implied-preemption principle that applies
“You should’ve made a better medicine sooner” sounds like a complaint, but not a legal complaint. The FDA approves drugs if they are safe and effective; they needn’t be the best possible on the fastest schedule. If best-and-fastest were the criteria, the drug approval process would be crazy, sloppy, and frantic. Or maybe it would
Not long ago we pointed out, in our discussion of In re: Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp. ___, 2021 WL 2865869 (S.D. Fla. July 8, 2021), that court’s pithy takedown, in a preemption situation, of plaintiffs’ widespread habit of seizing upon some factual variation and calling it a new “duty” that
We’ll get to the recent Second Circuit decision, Ignacuinos v. Boehringer Ingelheim Pharms., Inc., — F.4th —-, 2021 WL 3438355 (2d Cir. 2021), in due course, but first some background.
One of our top ten decisions in 2018 was Gustavsen v. Alcon Labs., Inc., 903 F.3d 1 (1st Cir. 2018), an important implied-preemption
As we try to keep pace with the unusually fast-moving Zantac MDL, today we review In re: Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp. ___, 2021 WL 2865869 (S.D. Fla. July 8, 2021). As we’ve discussed before, the drug under attack allegedly breaks down naturally into N-Nitrosodimethylamine (“NDMA”), an unfortunately ubiquitous carcinogen.
The Drug and Device Law Rock Climber celebrated her birthday this week by acquiring a companion for the Irascible Rescue Pomeranian (you can read about him here). The new family member is a four-month-old Australian Shepherd mix, pure white with blue eyes. We sense figurative ears perking up at this description, as dog- (and