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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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Appeals Court Vacates Verdict On Exclusion of Context Evidence

By Sean Wajert on August 16, 2010
Posted in Articles, Drug and Device

Comic Dimitri Martin notes, “I’m sorry” and “I apologize” mean the same thing — unless you are speaking to the widow at a funeral…
Continue Reading Appeals Court Vacates Verdict On Exclusion of Context Evidence

FDA Proposes That Adverse Event Reports Be Submitted Electronically

By Sean Wajert on August 25, 2009
Posted in Articles, Drug and Device

The Food and Drug Administration last week proposed new rules that would require adverse event reports related to approved devices, drugs and biologic…
Continue Reading FDA Proposes That Adverse Event Reports Be Submitted Electronically

State Appellate Accutane Decision Reverses Verdict

By Sean Wajert on March 17, 2009
Posted in Articles, Drug and Device

The New Jersey Superior Court issued an interesting decision in the Accutane litigation last week. See McCarrell v. Hoffman-La Roche, Inc., And Roche …
Continue Reading State Appellate Accutane Decision Reverses Verdict

FDA To Hold Workshop On “Sentinel” Initiative

By Sean Wajert on December 15, 2008
Posted in Articles, Drug and Device

The Food and Drug Administration is holding a public workshop entitled Sentinel Initiative: Structure, Function, and Scope. The workshop is co-sponsor…
Continue Reading FDA To Hold Workshop On “Sentinel” Initiative

FDA Releases First Quarterly Safety Signals Report

By Sean Wajert on September 12, 2008
Posted in Articles, Drug and Device

The U.S. Food and Drug Administration has posted on its website its first quarterly report listing certain drugs that are being evaluated for potentia…
Continue Reading FDA Releases First Quarterly Safety Signals Report

FDA Launches Sentinel Initiative

By Sean Wajert on May 26, 2008
Posted in Articles, Drug and Device

On May 22, 2008, FDA launched the “Sentinel Initiative” – a new program with the goal of creating and implementing the Sentinel Syst…
Continue Reading FDA Launches Sentinel Initiative

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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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