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
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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Abandonment Issues in an MDL
By Sean Wajert on
Posted in Articles, Drug and Device
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
By Sean Wajert on
Posted in Articles, Drug and Device
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
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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NJ Court Affirms Role of Learned Intermediary Doctrine
By Sean Wajert on
Posted in Articles, Drug and Device
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
By Sean Wajert on
Posted in Articles, Drug and Device
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
By Sean Wajert on
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
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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