We’ve always hated the Ninth Circuit’s decision in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (applying Arizona law), holding that allegations of failure to provide adverse event reports (“AERs”) to the FDA created a viable, and unpreempted, state law claim. Now our #2 worst case of 2013 is effectively gone. Kaput.
Today we have another guest post by long-time friend of the blog, Dick Dean, and his colleague at Tucker, Ellis, Mike Ruttinger. Regular readers will recall, that right after Sikkelee v. Precision Airmotive Corp., ___ F.3d ___, 2018 WL 5289702 (3d. Cir. Oct. 25, 2018), was decided, we blogged about the
Not terribly long ago, we had a series of posts—too many to link—that recounted court decisions rejecting efforts to impose liability on a generic manufacturer for the standard design and labeling claims and/or on an NDA holder for injuries allegedly caused by the use of the generic version of its drug. When the conjunctive
Failure to warn claims premised on a failure to report incidents to a federal governing agency are preempted in the Third Circuit. Sikkelee v. Precision Airmotive Corporation, — F.3d –, 2018 WL 5289702 (3d. Cir. Oct. 25, 2018). And this would be a DDL Blog drop the mic moment if the ruling had come
Next week, under pressure from the Drug and Device Law Lifelong Best Friend, we are participating in a “murder mystery dinner theatre” in the “conservatory” of a local cemetery. (We didn’t know cemeteries had “conservatories.”) It is a Halloween-themed event, with costumes encouraged, and we may or may not wear our eerily-lifelike Standard Poodle mask/hood.
The toughest thing about defending product liability cases is the occasional immersion in human misery. Securities and antitrust cases pose intellectual challenges but they are, in the end, pretty much about money. By contrast, the plaintiffs in our cases are claiming injuries to their bodies, not just their wallets. Sometimes those alleged injuries are phony
Recently, the Enviably Youthful Drug and Device Law Mother has been pushing us to plan a mother/daughter vacation. Her longtime companion no longer enjoys travel, and few of her friends share her sense of adventure. So we set about finding a suitable trip for next spring. Threshold categorical decisions proved troublesome. Our normal instinct, given
Today’s guest post is by frequent contributor Dick Dean of the Tucker Ellis firm. This time, Dick is sharing some insights on Wyeth v. Levine, 555 U.S. 555 (2009), which we consider the single worst prescription medical product decision since we started blogging. Not surprisingly, Dick shares our views of Levine. We agree
We confess – when we first considered the spate of eye drop class actions a few years ago, we had trouble taking them seriously. It was tough to get excited about penny-ante allegations that the size of eye drops warranted the attention of federal courts, or warranted class action status. We were not alone in
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