Litigation

Recent Posts

Delaware Federal Judge Overturns $2.54 Billion Patent Infringement Verdict For Pharmaceutical Company
Posted on 6 Mar 2018 by Gabriela Nolen

On Feb. 16, 2018 Judge Leonard P. Stark granted a renewed motion by Gilead Sciences Inc. for judgment as a matter of law upon finding that a patent held by Idenix Pharmaceuticals LLC for treating hepatitis C virus (HCV) was invalid due to lack of enablement... Read More

Tags: infringement , Pharmaceutical & Medical Device

William A. Ruskin: Fungal Meningitis Outbreak Spurs FDA Oversight Of Drug Compounders
Posted on 26 Nov 2013 by William A. Ruskin

By William A. Ruskin In 2012, a major outbreak of fungal meningitis was traced to drugs compounded by New England Compounding Centers . The outbreak included approximately 750 confirmed cases and has resulted in 64 deaths to date. Tragedies of this... Read More

Tags: Major Changes in Drug Compounding and Drug Distribution Requirements , New England Compounding Centers , drug compounders , FDA , fungal meningitis , William A. Ruskin , Litigation , Drug Quality and Security Act (H.R. 3204) , Pharmaceutical & Medical Device

Brand-Name Pharmaceutical Companies Can Be Liable to Generic Drug Users for Recklessly Providing Inadequate Warnings on Brand-Name Drugs
Posted on 2 Apr 2018 by Gabriela Nolen

Chief Justice Ralph D. Gants of the Supreme Judicial Court of Massachusetts wrote for the Court on March 16, 2018 that a generic drug user’s negligence claim against Merck had been properly dismissed by the Judge Kenneth J. Fishman of the Middlesex... Read More

Tags: Massachusetts , drug manufacturers , generic drugs , Pharmaceutical & Medical Device

William A. Ruskin: Pharmaceutical Failure to Warn.... On Facebook?
Posted on 19 Mar 2014 by William A. Ruskin

By William A. Ruskin The Facebook page of Switzerland-based drug maker, IBSA Institut Biochimique S.A . (“IBSA”), appeared innocent enough: If you have just been diagnosed with hypothyroidism or are having difficulty controlling your... Read More

Tags: social media guidance , Dr. Freda Lewis-Hall , Sermo , social media , Facebook , Tirosint , blog , FDA , IBSA Institut Biochimique S.A , Twitter , William A. Ruskin , Litigation , Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media fo , fair balance , AskRx Pfizer , torts , Pharmaceutical & Medical Device

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: Physician's Failure To Read Trumps Drug Company's Failure To Warn
Posted on 22 Nov 2013 by William A. Ruskin

By William A. Ruskin When the prescribing physician in a pharmaceutical product liability case admits that at her deposition that she never reviewed the manufacturer’s label before treating her patient and that the label played no role in her... Read More

Tags: James M. Beck , Drug and Device Law blog , pharmaceutical product liability , Warnings' , William A. Ruskin , causation , Litigation , failure to warn , inadequate warnings , Pharmaceutical & Medical Device