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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Drug and Device
Stay in Amarin Extended
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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Abandonment Issues in an MDL
The defendant in a medical device MDL recently flagged an important and thorny issue that impacts many if not most MDL’s. And it has to do with bellwe…
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Federal Court Rejects Jurisdiction Over French Manufacturer
A federal court in Mississippi has rejected the assertion of personal jurisdiction over a French medical device company. See Arnoult v. CL Med. Sarl, …
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Drug Class Action Rejected Again
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
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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NJ Court Affirms Role of Learned Intermediary Doctrine
A New Jersey court overseeing the centralized litigation regarding the human tissue product AlloDerm has issued a noteworthy ruling in a bellwether ca…
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Alabama Legislature Enacts Causation in Fact Requirement
There is likely no more fundamental notion in product liability law than the recognition that the defendant’s product must cause the injury complained…
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Federal Court Rejects Off-Label Marketing Class Action
A Pennsylvania federal court recently refused to certify a proposed class action accusing a drugmaker of off-label marketing. See In re: Actiq Sales a…
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Class Certification Denied in Drug Case
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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