We have been to Montana only once. Through various life events, we have traveled by highway from the San Francisco Bay Area to the Midwest multiple times, so we are somewhat familiar with the mountains of Utah, western railroad towns like Cheyenne and North Platte, and the long rolling expanse known as Nebraska. We never
We knew as soon as we read the Supreme Court’s opinion in Mutual Pharma v. Bartlett that its reasoning should extend beyond generic drugs and would support implied preemption in generic and innovator products alike. We were generally correct. Bartlett held that federal law preempted state law design defect claims involving a generic drug because
Our best college era summer job was working as a staffer for the New Jersey State Senate. The Abscam investigation was ongoing, and it seemed that every week there’d be another empty seat in the Senate chamber courtesy of the FBI. Good times. We doubt we personally performed any services that were useful for Garden
We have been monitoring litigation involving tenofovir-based HIV medication for some time now. We reported a few weeks ago on oral argument in the California Court of Appeal, where the parties debated a novel “duty to innovate” under California law. We also gave you our view on the 2019 order that many say kickstarted these
Thirteen years litigating the same case is a looooong time. Absurdly long. Long enough for an attorney working on the case to go from an associate learning to coax a newborn to sleep, to a partner juggling teen school and soccer commitments. Long enough for lawyers to migrate from Blackberrys and voicemail, to smart phones
Today we report on Farson v. Coopersurgical, Inc., 2023 WL 5002818 (N.D. Ohio 2023), a product-liability decision that dismissed all claims against all defendants based on lack of personal jurisdiction, preemption, and Twombly.
Claiming that she was injured when an implantable medical device migrated in her body, the plaintiff brought suit in Ohio
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
We reported nearly two years ago on a California trial court that dismissed claims against generic over-the-counter drug manufacturers under California’s notorious Proposition 65, on the basis that federal law preempted those claims. You can read that post here, and you will see that we said at the end that an appeal was likely.
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. Continue Reading California Appellate Court Reaffirms Federal Preemption, Learned Intermediary Doctrine in Amiodarone Cases