LexisNexis® Legal Newsroom
William A. Ruskin: Physician's Failure To Read Trumps Drug Company's Failure To Warn

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 decision to prescribe the drug, plaintiff’s...

William A. Ruskin: Fungal Meningitis Outbreak Spurs FDA Oversight Of Drug Compounders

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 scale have often been the impetus for major changes...

William A. Ruskin: Pharmaceutical Failure to Warn.... On Facebook?

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 levothyroxine blood levels, talk to your doctor about...

William A. Ruskin: New Draft FDA Guidance On Off-label Uses Raises Concerns

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 seeks to clarify and expand upon FDA's 2009 draft...

Delaware Federal Judge Overturns $2.54 Billion Patent Infringement Verdict For Pharmaceutical Company

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. On Feb. 24, 2017, a jury had awarded Idenix...

Brand-Name Pharmaceutical Companies Can Be Liable to Generic Drug Users for Recklessly Providing Inadequate Warnings on Brand-Name Drugs

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 County Superior Court. Brian Rafferty had been...