Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety.
In 2008 and 2009, the Supreme Court reviewed the question of whether patients injured by dangerous prescription drugs or medical devices can bring tort lawsuits against pharmaceutical and device manufacturers. The Court ruled that claims against device manufacturers were preempted while claims against pharmaceutical manufacturers were not. The threat of product liability lawsuits promotes patient safety by encouraging manufacturers to take greater responsibility in providing clear warnings about known adverse effects of their products.
Kesselheim
A S
AS
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA. akesselheim@partners.org
D018795:Device Approval; D017277:Drug Approval; D004345:Drug Industry / Q000331:legislation & jurisprudence* / Q000379:methods; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D064420:Drug-Related Side Effects and Adverse Reactions; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence* / Q000379:methods; D016365:Liability, Legal; D011356:Product Labeling / Q000331:legislation & jurisprudence; D035521:Supreme Court Decisions; D014481:United States; D014486:United States Food and Drug Administration