We cannot offer any additional commentary because the Firm was part of the team representing defendant, but we wanted to commend to our readers the recent decision, In re Zofran (Ondansetron) Prod. Liab. Litig., 57 F.4th 327 (1st Cir. 2023). The case arises in the MDL related to the FDA-approved drug Zofran, and plaintiffs’ allegations
FDA
FDA Settles Amarin First Amendment Challenge
By Sean Wajert on
Posted in Drug and Device
Amarin Pharma and the FDA recently announced a widely expected settlement of First Amendment litigation over restrictions on the company’s promotion of its Vascepa product.
Readers may recall that this was one of several recent challenges to the FDA’s attempt to restrict off-label promotion of prescription products, even if that speech is truthful and not…
Preemption Found in Another Drug MDL
By Sean Wajert on
Posted in Articles, Drug and Device
Implied preemption makes complete sense when it is evident that the FDA would not have permitted label changes that plaintiffs in private litigation s…
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FDA Seeks Comment on “Natural” Labels
By Sean Wajert on
Readers will recall our many posts about the “all natural” litigation and the spate of cases plaintiff firms have brought challenging such l…
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Stay in Amarin Extended
By Sean Wajert on
Posted in Articles, Drug and Device
The court recently extended its stay of the proceedings in Amarin Pharma Inc.’s suit against the FDA challenging threatened agency action concerning t…
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Proposed Class Action Stayed Pending FDA Guidance
By Sean Wajert on
A California recently indicated he would stay a putative class action raising allegations about labeling of “evaporated cane juice” pendin…
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PhRMA Responds to FDA Letter in First Amendment Dispute
By Sean Wajert on
Posted in Articles, Drug and Device
The Pharmaceutical Research and Manufacturers of America last week submitted an amicus brief relating to the FDA’s response to a drug company’s suit c…
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Chocolate Class Action Dismissed
By Sean Wajert on
A California federal court recently rejected a putative consumer class action alleging the defendant somehow misled customers about antioxidants in it…
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Tea Class Action Dumped Overboard
By Sean Wajert on
A federal court rejected a putative class action against tea maker Twinings North America, Inc. over antioxidant labeling. See Craig v. Twinings N. Am…
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Expert Panel Confirms Safety of BPA Use
By Sean Wajert on
We have posted before about the BPA “controversy” egged on by lawyers seeking their next mass tort. Now comes yet another report on BPA, fro…
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