He didn’t win, but he sure looked beautiful. Luca, that is. Faithful readers know that our beautiful standard poodle puppy made his show debut last weekend in Massachusetts. He is learning the ropes and settling down – winning will come in time. We can’t express how thrilled we were to be ringside for these first
A potential top-ten case came across our desks the other day, and even better, it comes out of our home state of California. In Amiodarone Cases, No. A161023, 2022 WL 16646728 (Cal. Ct. App. Nov. 3, 2002) (to be published), the California Court of Appeal held that federal law preempts state law failure-to-warn claims alleging that branded and generic drug manufacturers did not ensure that patients received FDA-approved Medication Guides for amiodarone, a heart medicine. Along the way, the Court disabused several harmful misconceptions on California’s learned intermediary doctrine and held that fraud claims based on journal articles and decades-old statements were bunk.
The FDA approved amiodarone in 1985 as a last-resort treatment for ventricular fibrillation, and a few years later—in 1989 and 1992—the agency notified the manufacturer of statements that it considered false and misleading, including purported promotion for an unapproved use. Id. at *1. Fast forward a few decades, and hundreds of plaintiffs in a coordination proceeding in California have alleged that they experienced side effects after their doctors prescribed amiodarone off label. Id. at *2.
You read that correctly. These plaintiffs were reaching back to alleged misstatements made 30 years ago. Moreover, amiodarone has been available in generic forms since 1998, so the plaintiffs ginned up claims against generic manufacturers, too—that all defendants (branded and generic) failed adequately to warn plaintiffs of potential risks because they did not ensure that patients received FDA-approved Medication Guides with their prescriptions.
This is not a new idea. Amiodarone patients in other jurisdictions have made similar Medication Guide/warnings claims, and some have survived challenges to the pleadings, including in Wisconsin and Illinois. You can see our take on these orders here and here. Long story short, we disagreed with those results, especially the short shrift that those orders gave to implied preemption.
Regular readers of the blog know and appreciate our focus (fixation?) on the learned intermediary rule. Not because it is fun to say and makes us feel smart. No, we follow and write on the learned intermediary rule because it is a cornerstone of the law on allegedly inadequate drug and device warnings. It holds
We are trying very hard not to bore everyone silly with endless discussion of our puppy-to-be, almost certainly interesting only to us. But we are failing. So, briefly, we comment that we met the whole spectacular litter last week – eight gorgeous butterballs. Five are white, and three are now black but will probably end
The plaintiff in Salinero v. Johnson & Johnson, __ F.3d __, No. 20-10900, 2021 WL 1681237 (11th Cir. Apr. 29, 2021), tried a new twist to get around the learned intermediary rule—and it did not work. The district court rejected the plaintiff’s attempt to graft a “financial bias” exception onto Florida’s learned intermediary rule,
When we head into a trial against a personal injury plaintiff, our client, the defendant, occupies the right side of the v. We mean that simply as a matter of word placement. It is Plaintiff v. Defendant, not the other way around (though on appeal the parties can be scrambled). By “right” side, we are
Kelly v. Ethicon, Inc., 2020 U.S. Dist. LEXIS 191665 (N.D. Iowa Oct. 16, 2020), is a remanded pelvic mesh case. The complaint included the usual panoply of causes of action for negligence, strict liability, fraud, and breach of warranty. Failure to warn, as usual, was central to the plaintiff’s case.
During the years while
We are certain that profound revelations – scientific, economic, and political – will arise from the Covid-19 crisis. For now, we comment on bits of knowledge we have gained so far. We have learned, spending 24 hours each day with our dogs, that they bark 20 hours each day. We have learned that the concept
This is a quick-hit post bringing you two first-of-their-kind orders on proving causation in cases alleging inadequate drug or medical device warnings. In orders applying Georgia’s and Delaware’s versions of the learned intermediary doctrine, two different federal courts have held that a plaintiff alleging inadequate warnings cannot meet his or her burden of proving causation
We write today about a partial exclusion of a plaintiff expert in the upcoming Taxotere bellwether trial. We have blogged about other aspects of the Taxotere litigation previously. (Here and here, for example.) The case is In re Taxotere (Docetaxel) Prods. Liability Litig., 2019 U.S. Dist. LEXIS 130339 (E.D. La. Aug. 5,