Last week the Sixth Circuit issued a significant opinion in Yates v. Ortho-McNeil-Janssen Pharmaceuticals Inc., No. 15-3104, 2015 WL 8538119 (6th Cir.
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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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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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Drug Class Action Rejected Again
By Sean Wajert on
Class certification was denied — again — in litigation brought by plaintiffs who allege a drug maker misstated the likelihood of withdrawal symptoms…
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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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Class Certification Denied in Drug Case
By Sean Wajert on
A federal court rejected a proposed class action in which plaintiffs alleged that a drug maker misstated the frequency of potential side effects. See …
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New Drug Law in Canada
By Sean Wajert on
Posted in Articles, Drug and Device
With a tip of the cap to our old friend, Peter Pliszka, north of border: Earlier this month, the so-called Protecting Canadians from Unsafe Drugs Act …
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PhRMA Submits Amicus Brief on First Amendment Issues
By Sean Wajert on
Posted in Articles, Drug and Device
The Pharmaceutical Research and Manufacturers of America recently submitted an amicus brief urging a federal court to dismiss a whistleblower’s False …
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Industry Comments on Draft FDA Guidance
By Sean Wajert on
Posted in Articles, Drug and Device
Several leading drug manufacturers have worked to shed light on serious issues with the social media guidance issued earlier this year by the U.S. Foo…
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FDA Seeks Comments on DTC Study
By Sean Wajert on
Posted in Articles, Drug and Device
The Food and Drug Administration is seeking public comment on its investigation of the impact of communicating risks in direct-to-consumer prescriptio…
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