Litigation

Recent Posts

Ex-GSK General Counsel Acquitted By Judge Of Obstructing FDA Investigation
Posted on 10 May 2011 by Tom Moylan

GREENBELT, Md. - (Mealey's) Former GlaxoSmithKline vice president and associate general counsel Lauren Stevens was acquitted by directed verdict May 10 of charges of obstructing a Food and Drug Administration investigation into the off-label promotion... Read More

Tags: drug Wellbutrin , Lauren Stevens , (United States of America v. Lauren Stevens , off-label promotion , Food and Drug Administration , FDA , Litigation , GlaxoSmithKline , verdict , antidepressant

Texas Risperdal Trial Ends When Janssen Settles For $158 Million, Company Says
Posted on 19 Jan 2012 by Tom Moylan

AUSTIN, Texas -- Johnson & Johnson subsidiary Janssen LLP said Jan. 19 that it has agreed to pay $158 million to settle claims by Texas that it defrauded the Medicaid program through its off-label promotion of the atypical antipsychotic drug Risperdal... Read More

Tags: Travis County District Court , Risperdal , off-label promotion , State of Texas v. Janssen LP , Johnson , Medicaid , Litigation , Settlement , Janssen LLP , Texas , Johnson &amp , antipsychotic drug

William A. Ruskin: New Draft FDA Guidance On Off-label Uses Raises Concerns
Posted on 28 Mar 2014 by William A. Ruskin

By William A. Ruskin | On March 3, 2014, FDA made available for comment a revised draft of its " Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices ". The revised guidance... Read More

Tags: unapproved new uses , off-label promotion , draft guidance , product liability , Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses--Reco , misbranding , FDA , William A. Ruskin , unapproved uses , FDCA , product label , u.s. v. caronia , Litigation , First Amendment , torts , Pharmaceutical & Medical Device

William A. Ruskin: First Amendment Bars Pharmaceutical Company Prosecution
Posted on 14 Dec 2012 by William A. Ruskin

By William A. Ruskin The Second Circuit [on Dec. 3] rendered its much-anticipated decision in United States v. Caronia [ enhanced version available to lexis.com subscribers ], the most important Food Drug and Cosmetics Act enforcement case pending... Read More

Tags: False Claims Act , Second Circuit , off-label promotion , Drug & Medical Device , misbranding , Stuart Gerson , William A. Ruskin , FDCA , Litigation , Food Drug and Cosmetics Act , United States v Caronia , qui tam , First Amendment