The FDA recently published its Final Guidance on REMS programs for prescription drugs, which we thought might interest our readers. The document is formally called “Format and Content of a REMS Document: Guidance for Industry” and you can download and review the Final Guidance here. You might be thinking two things at this moment:
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.
We are always delighted to find a case that bars a claim based on FDA preemption, but Nexus Pharms., Inc. v. IntegraDose Compounding Servs., LLC, 2022 Minn. Dist. LEXIS 1734 (Minn. 4th Dist. May 24, 2022), is unusual. It is not a product liability case. Rather, a pharmaceutical company sued a compounder for fraudulently
We offer a different take on preemption today. We have discussed on any number of occasions how the FDA’s regulation of drug warnings preempts (or should preempt) state-law tort claims purporting to impose different or additional warnings. But what if the alleged state-law duty is based on a public referendum or statute? Does that make
This post is from the non-Reed Smith side of the blog.
This blog has repeatedly lamented the tendency of MDL courts to flout federal pleading standards when assessing the sufficiency of master complaints. All too often MDL courts disregard Rule 8(a), which—as authoritatively interpreted by the Supreme Court in Twombly and Iqbal—requires plaintiffs to
A Vaudeville act is supposed to leave the audience wanting more. Not so a judicial decision. But that is what we have today: a decision whose result—the dismissal of Lanham Act claims brought by a device manufacturer against a competitor—is underexplained.
The plaintiff in Impact Applications, Inc., v. Concussion Management, LLC, 2021 WL 978823
We have blogged about class actions; we have blogged about preemption; we have blogged about social media; we have blogged about alleged economic loss; and we have blogged about alleged product defects—endlessly. Rarely, however, have we blogged on all of these topics in a single post.
Today is the day, and the topic is an
As we round the clubhouse turn and head into the home stretch of this annus horribilis, our nominee for the word of 2020 is “doom-scrolling.“ We’ve sacrificed entire nights of sleep to our iPads, pursuing the latest news (real, fake, or hybrid) of infectious diseases of both the body and the body politic. Three
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