Every time we read an order about “pre-approval” defects in prescription drugs, we stop to scratch our heads. It is not because we are easily confused, at least not on most days. No, we pause to ponder what exactly a “pre-approval” defect is and how a company can be held to answer for an alleged
implied preemption
No Private Right of Action Under the FDCA in Big Sky Country

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…
This Is Why Federal Law Preempts “Pre-Approval” Design Defect Claims

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…
N.D. Cal. Sees No Standing or Merit in Eye Cosmetic Claims

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…
California Court Again Embraces Hindsight Claims

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…
What A Difference A Decade+ Makes

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…
A Dismissal Trifecta: Personal Jurisdiction, Preemption, and Twombly Doom Product-Liability Claims in the Northern District of Ohio

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…
Mixed Bag of Holdings from EDNY in Class II Non-invasive Facelift Device Case

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…
California Court Affirms Preemption Of Prop 65 Claims For OTC Drugs

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. …
FDA Finalizes Guidance on Prescription Drug REMS

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: …