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Published by Sean P. Wajert

Mass Tort Defense

Defense of Mass Tort Claims, Class Actions, and Significant Product-Based Litigation

Drug and Device

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Preemption Found in Another Drug MDL

By Sean Wajert on November 28, 2015
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…
Continue Reading Preemption Found in Another Drug MDL

Stay in Amarin Extended

By Sean Wajert on November 7, 2015
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…
Continue Reading Stay in Amarin Extended

Abandonment Issues in an MDL

By Sean Wajert on October 21, 2015
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 October 7, 2015
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 July 27, 2015
Posted in Articles, Class Action, Consumer Fraud, Drug and Device

Class certification was denied — again — in litigation brought by plaintiffs who allege a drug maker misstated the likelihood of withdrawal symptoms…
Continue Reading Drug Class Action Rejected Again

PhRMA Responds to FDA Letter in First Amendment Dispute

By Sean Wajert on June 18, 2015
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…
Continue Reading PhRMA Responds to FDA Letter in First Amendment Dispute

NJ Court Affirms Role of Learned Intermediary Doctrine

By Sean Wajert on May 26, 2015
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 May 5, 2015
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 April 8, 2015
Posted in Articles, Class Action, Drug and Device

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 January 2, 2015
Posted in Articles, Class Action, Consumer Fraud, Drug and Device

A federal court rejected a proposed class action in which plaintiffs alleged that a drug maker misstated the frequency of potential side effects. See …
Continue Reading Class Certification Denied in Drug Case

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Sean P. Wajert
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Fax: 215.278.2594
Email: swajert@shb.com
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Mass Tort Defense Lawyer & Attorney Sean P. Wajert of Shook, Hardy & Bacon LLP, offering services relating to mass torts, product liability, class actions, medical monitoring, pharmaceutical litigation, consumer fraud act defense, complex litigation.

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