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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

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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

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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

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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