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Published by Sean P. Wajert

Mass Tort Defense

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

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Important Preemption Decision

By Sean Wajert on December 17, 2015
Posted in Articles

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 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…
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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…
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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…
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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…
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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 …
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New Drug Law in Canada

By Sean Wajert on November 17, 2014
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 August 19, 2014
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 April 23, 2014
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 February 20, 2014
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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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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