We posted earlier this year about the failure to warn causation decision from the California Supreme Court in Himes v. Somatics, 549 P.3d 916 (Cal. 2024), and the potential parade of horribles that might ensue. Here comes the grand marshal of the parade.Continue Reading California District Court Punts on Learned Intermediary Causation Post-Himes
We have a couple of updates on the learned intermediary rule in California. We reported to you three months ago on the California Supreme Court’s tweaking of the learned intermediary rule in Himes v. Somatics, and the tweaks were not good. As we wrote back then, the Court did not make any fundamental
The California Supreme Court issued its widely anticipated opinion on the learned intermediary rule the other day, and the opinion is worth the wait. Based on the oral argument (which we reported on here), we did not expect the Supreme Court to enact a fundamental change to the learned intermediary doctrine, and the Court
We observed oral argument the other day before the California Supreme Court in Himes v. Somatics, a case that places California’s learned intermediary doctrine squarely in the spotlight. A learned intermediary case before the California Supreme Court? For your ever-vigilant DDL bloggers, that is like Thanksgiving and Christmas wrapped into one!
Who will be
For readers noticing the new byline, let me introduce myself. I am Susanna Moldoveanu, and I practice with Butler Snow LLP’s Pharmaceutical, Medical Device and Healthcare group. I am excited to join the Drug & Device Law Blogging Team. The best group of legal wonks there is.
Today we discuss the Western District of Washington’s recent summary judgment order in Dearinger v. Eli Lilly & Co., 2023 WL 8717570 (W.D. Wash. Dec. 18, 2023). A prior opinion in this case earned the top spot on the Blog’s Ten Best Prescription Drug/Medical Device Decisions of 2022. This opinion is short and sweet, but a good one too.Continue Reading W.D. Wash. Nixes Failure to Warn Claim Under Learned Intermediary Doctrine
Plaintiffs love sales representatives. They love to use them to try to keep cases in state court—naming them as non-diverse defendants. They love to try to use them to get around preemption—claiming a direct duty from the rep to the plaintiff. And they certainly love making sales representative statements and conduct a focal point of
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. Continue Reading California Appellate Court Reaffirms Federal Preemption, Learned Intermediary Doctrine in Amiodarone Cases
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