Failure To Warn Pharmaceutical Industry

News & Analysis as of

Guest Post – Failure to Warn Claim Dead on Arrival Without Testimony from Prescribing Physician

This is a guest post from Michael Salimbene, an associate at Reed Smith. It’s about learned intermediary causation, and the need for prescriber testimony. Not infrequently, in mass torts with lots of solicited plaintiffs,...more

Heeding Presumption Only Goes So Far In Post-Sale Warning Case

Devoted as we are to the defense of manufacturers of prescription drugs and medical devices, we have often advocated for the full implication of the fundamental—to us, at least—requirements that warnings claims focus on the...more

Probably the Best Wisconsin Law Decision We’ve Ever Seen

Bexis, who took some lumps in probably the worst Wisconsin product liability decision ever (he filed PLAC’s amicus brief in Thomas v. Mallett, 701 N.W.2d 523 (Wis. 2005)), just read what we believe is the best Wisconsin law...more

Seventh Circuit Holds that FDAAA Does Not Affect Mensing/Bartlett Preemption

When we first set foot on the University of Chicago Law School campus back in 1982, Chicago sports were a mess. But quickly – certainly more quickly than our ability to grasp the Rule in Shelley’s Case, Last Clear Chance, or...more

Proposed New FDA Labeling Rules Would Result in Increased Generic Drug Product Liability Claims

After several years of delay, FDA announced this summer that it expects to publish new rules in April 2017 that will permit generic drug companies to make unilateral changes to their warning labels, even if the brand does...more

11th Circuit Upholds Award of Summary Judgment in Mirena Lawsuit

In March 2014, Jenna Thurmond sued Bayer in the U.S. District Court for the Northern District of Georgia, alleging that her use of the Mirena contraception system caused her to develop pseudotumor cerebri. Her symptoms...more

Product Liability Update: April 2016

Massachusetts Superior Court Rejects “Innovator Liability” Failureto-Warn Claim, Holds Branded Pharmaceutical Manufacturer Owed No Duty to Plaintiff Alleging Injury From Equivalent Generic Drug That Copied Defendant’s...more

New York Decision Not Good For Asbestos, But Not Bad For Drug/Device

The recent decision of the New York Court of Appeals in In re New York City Asbestos Litigation, ___ N.E.3d ___, 2016 WL 3495191 (N.Y. June 28, 2016) (“NYCAL”), was not too good for asbestos defendants – as it permitted,...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

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...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

Product Liability Update: April 2016

United States Supreme Court Permits Class Certification And Proof of Liability Through Statistical Evidence Based on Class Sampling Where Class Was Sufficiently Uniform That Evidence Would Have Been Admissible in Any Class...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

First Circuit Upholds Defense Verdict in Diet Drug Case

Happy Birthday, Eric Clapton. (March 30 is also the birthday of painters Goya and Van Gogh. Is there something about March 30 that breeds people who turn their blues into art?) Clapton has been around so long it is easy to...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

Another Outlier From California On Innovator Liability

We have closely followed the development (or perhaps more accurately, stagnation) of so-called “innovator liability.” It started with the wrongly reasoned and wrongly decided opinion from the California Court of Appeal in...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

The Renaissance of the Learned Intermediary Rule

Our recent “breaking news” post on West Virginia’s statutory restoration of the learned intermediary rule started us thinking about how every state now has pro-learned intermediary precedent. That’s a big change even from...more

Breaking News - West Virginia Statute Adopts Learned Intermediary Rule

The West Virginia legislature has passed, and the governor signed, S.B. 15, adopting the learned intermediary rule on February 26, 2016. ...more

Solid Affirmances: Avandia Summary Judgment, and Westminster

We were not able to make our annual pilgrimage to the Westminster Kennel Club Dog Show this year, so we had to settle for watching the televised portions on the couch with the Drug and Device Law Rescued Ragamuffins. And the...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

Cajun TwIqbal Kiss-off

The Twombly and Iqbal requirement that complaints set forth facts making out a plausible case for liability got a nice workout in the recent case of Guidry v. Janssen Pharmaceuticals, Inc., 2016 WL 633673 (E.D. Louisiana Feb....more

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