Failure To Warn Preemption

News & Analysis as of

Causation Issues in Failure-To-Report Cases – Post-Stengel Precedent

As we blogged at the time, we believe that the Ninth Circuit made a historic error in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc), when it equated routine product liability inadequate warning claims...more

Another Make Work Project In New Jersey – Duty To Update Claims

The United States Supreme Court has said it – the test for implied preemption under 21 U.S.C. §337(a) (the FDCA’s no-private-enforcement provision) is whether the purported state-law cause of action would exist even in the...more

A Banner Week For Buckman Preemption

There used to be a TV show called “That Was the Week That Was.” It was a satirical look at the news of the prior week, but perhaps it’s most lasting accomplishment was to launch David Frost’s career. Without an ounce of...more

Environmental Litigation and Toxic Torts Update – Mountain West Coast Case Law Highlights

COLORADO CITY FRACKING BANS PREEMPTED BY STATE LAW - City of Longmont v. Colo. Oil and Gas Ass’n, 369 P.3d 573 (Colo. 2016), 2016 Colo. LEXIS 442; City of Fort Collins v. Colo. Oil and Gas Ass’n, 369 P.3d 586 (Colo....more

Mixed and Matched Hip Components Equal Express Preemption

If a surgeon combines a PMA device with a 510k device, what does that do to federal preemption? We ask this question because one of the more fascinating aspects of the medical device world is modularity. We have heard of...more

Federal Court Dismisses Essure Complaint

A couple of weeks ago we reported on our visit to the Women’s Health Litigation Conference. One of the conference panels discussed the most interesting ongoing litigations involving women’s health products. Essure, a...more

A One-Two Punch Case With An Off-Label Twist

When we were young(er), we had a pretty good memory. It is not bad now, as far as we recall, particularly when it comes to pulling up bits of esoteric nonsense. For more important stuff, we find qualifiers like “vague” and...more

Something Went Right In Brazil

Zika virus, Olympic unpreparedness, economic collapse, presidential impeachment - a lot of things have gone wrong in Brazil lately. But we’re not here to talk about any of that. Here’s something that went right: Brazil v....more

Another Prescription Drug Warnings Preemption Decision

Not that our readers are dying for a glimpse behind the curtain into the making of the sausage (and mixed metaphors) of the blog, but we do try to first figure out what decisions may be blogworthy before we start writing up...more

Generic vs. Branded Liability: Mensing Holds Sway Until FDA Completes Rulemaking

FDA’s delay on the final version of generic labelling rules until April 2017 means both branded and generic drug manufacturers face continued uncertainty. The U.S. Food and Drug Administration (FDA) recently announced it...more

Some Case-by-Case Comment K Mixed with Some Insufficient Pleading of Fraud

In Hawaii, from whence today’s case comes, tourists are encouraged to try poi, mashed up taro root, which looks like purple wallpaper paste and tastes like, well, purple wallpaper paste. The term is also used as a friendly...more

C.D. Cal. Dismisses Infusion Pump Complaint

The plaintiff in Frere v. Medtronic, Inc., 2016 WL 1533524 (C.D. Cal. April 6, 2014), was an 80 year-old woman who had an infusion pump implanted to treat her chronic low-back pain. According to the plaintiff, the device...more

Federal Preemption Claims: Clear Evidence and an Unclear Standard

Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. Cerveny v. Aventis, Inc., 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016). The...more

Silence Would Have Been Golden: Unnecessary Illogical Preemption Decision in Motrin SJS/TENS Summary Judgment Victory

We sat through The Revenant again this weekend, at the plaintive (not plaintiff) request of a Drug and Device Law Friend who had yet to see it. Last time, we barely stayed awake. This time, we lost the battle. We have heard...more

Preemption And Causation Do Away With Contraception Lawsuit

With Spring Training well underway, we took notice of the solid base hit delivered last month by the Northern District of California in La Paz v. Bayer Healthcare LLC, No. C 15-03995, 2016 U.S. Dist. LEXIS 13058 (N.D. Cal....more

Liability for Brand Drug Manufacturers All But Clear

Earlier this month, a federal district court in Illinois denied GlaxoSmithKline’s (GSK) renewed summary judgment motion based on federal preemption of failure-to-warn claims in an opinion setting tough standards for brand...more

Seventh Circuit Knocks Out Claims Against Generic Manufacturer on Preemption Grounds

It is not often that we get the opportunity to discuss an opinion from a panel of judges including two former professors from our law school. Diane Wood is the Chief Judge of the 7th Circuit and taught us Civil Procedure at...more

Learned Intermediary: Arizona Supreme Court Restores Order in the Desert

We recently brought you the breaking news that the Arizona Supreme Court has adopted the learned intermediary doctrine in prescription drug cases. The case is Watts v. Medicis Pharmaceutical Corp., No. cv-15-0065-PR, 2016 WL...more

Wyeth v. Levine’s ‘Clear Evidence' Language: Clearly Misunderstood

In 2009, the United States Supreme Court in Wyeth v. Levine affirmed a judgment rejecting a prescription drug manufacturer’s contention that plaintiff’s claim that the manufacturer should have strengthened its U.S. Food and...more

The New One-Two Is Back

A couple of years ago the one-two punch was all the rage in prescription drug cases. “One-two punch” has been our moniker for decisions where plaintiffs ingested only generic drugs, but tried to hedge their bets, given the...more

“May the Odds Be Ever in Your Favor” – The Ten Best Prescription Drug/Medical Device Decisions of 2015

The iconic Hunger Games line, “may the odds be ever in your favor” pretty much sums up how we feel about our top ten best decisions of 2015. These are results that put the “happy” in Happy New Year – which we wish all our...more

N.D. Mississippi Invokes Buckman in Rejecting Plaintiff Efforts to Screw Up Product Liability Law

We are determined not to end 2015 on a bad note. Thus, we turn, as we do with surprising frequency (and as we did last week), to a federal court decision out of Mississippi for a heaping helping of solid legal reasoning. ...more

Sixth Circuit Sweeps State-Law Design Defect Claims Under the Rug of Impossibility Preemption

Last week, the Sixth Circuit Court of Appeals issued a groundbreaking opinion in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc. that could change the liability landscape for brand-name drug manufacturers. No. 15-3104...more

ANDA Update - October 2015

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Philly Court Applies Michigan Law to Dismiss Risperdal Cases

Delve into the crime stories of Elmore Leonard, whether in the form of the books, movies, or television shows, and you are likely to spend considerable time in Michigan and Florida. True, Justified was set in Kentucky. But...more

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