On Oct. 17, 2006, victims of drug companies’ failure to warn were victorious in a Philadelphia U.S. District Court ruling. Judge Stewart Dalzell ruled against the claims by drug maker Novartis that FDA regulations and the Federal Food, Drug and Cosmetic Act “preempt state failure ot warn tort claims.”
An Association of Trial Lawyers Association memo details the issues at hand:
The issue of FDA preemption has been a hot one since the FDA issued a new drug labeling regulation in January 2006. At that time, the agency claimed in the preamble to the rule that federal drug labeling regulations preempt most state failure-to-warn claims against pharmaceutical manufacturers. This new language on preemption was added to the notice of final rulemaking, even though it as never included in, and directly contradicted, the notice of proposed rulemaking.
By rejecting the FDA position and agreeing with a majority of the plaintiff’s argument, this landmark ruling is a great victory for victims of pharmaceutical company misconduct.
If you or someone you know has been a possible victim of a defective drug, you may want to speak with one of our personal injury attorneys who specialize in this area. Just complete the form at the right for a free case evaluation.