News & Analysis as of

Failure To Warn Pharmaceutical Industry

SDNY Rejects Innovator Liability

by Reed Smith on

May 10 is an important day in the history of the law. On this date, way back in 1893, the Supreme Court ruled that the tomato is a vegetable, not a fruit. The case was called Nix v. Hedden, 149 U.S. 304 (1893). The issue...more

The Cheese Runneth Over...Into Illinois

by Reed Smith on

Last September we expressed our curiosity over Wisconsin cheese curd and our distaste for an order from the Western District of Wisconsin rejecting implied preemption in an amiodarone case. As we explained then, the district...more

Smoke Screens & Side Shows

by Reed Smith on

We confess, we can’t think of any good reason for admitting evidence concerning product risks that the plaintiff in a particular case never actually encountered – yet plaintiffs try it with a straight face all the time. It’s...more

WDNY Holds that Tysabri Warnings are Adequate as Matter of Law and that Product Liability Claims are Preempted

by Reed Smith on

However a drug/device product liability is styled, it will almost always be focused on a claim of failure to warn. Why do plaintiffs insist on inserting a cause of action for manufacturing liability when there is not a whiff...more

Product Liability Update: April 2017

by Foley Hoag LLP on

Massachusetts Federal Court In Prescription Drug Case Holds “Learned Intermediary” Rule Requiring Warnings Only To Prescribing Physician Applied Even Though Patient and Caregiver Were Physicians, But Experts’ Affidavits of...more

Sixth Circuit Affirms Branded Drug Preemption and Trial Win

by Reed Smith on

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a...more

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

by Reed Smith on

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

by Reed Smith on

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

by Reed Smith on

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

by Reed Smith on

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

by Foley Hoag LLP on

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

by Reed Smith on

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

by Reed Smith on

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

by Reed Smith on

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

by Reed Smith on

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

by Latham & Watkins LLP on

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

by Reed Smith on

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

by Foley Hoag LLP on

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

by Reed Smith on

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

by Reed Smith on

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

by Reed Smith on

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

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