Supreme Court sides with generic drug makers
Published on June 26, 2013 at 8:06 AM
The case involved a "badly injured patient" in New Hampshire.
Reuters: Justices Block Generic Drug Liability Lawsuits
The Supreme Court ruled on Monday that generic drugmakers cannot be sued under state law for adverse reactions to their products, a decision that consumer advocates called a blow to patient safety. In a 5-4 vote, the court ruled for Mutual Pharmaceutical Co, owned by Sun Pharmaceutical Industries Ltd, overturning a multimillion-dollar jury award to a badly injured patient in New Hampshire who alleged a generic drug she had taken was unsafe based on its chemical design (Hurley and Berkrot, 6/24).
The Hill: Supreme Court Blocks Lawsuits Against Dangerous Drugs
A previous high court ruling shielded generics from most lawsuits over their warning labels, but some states also allowed lawsuits over the safety of the product itself (Baker, 6/24).
MedPage Today: Supreme Court Nixes State Suits Against Generics
The case, Mutual Pharmaceutical v. Bartlett, involves a woman who, in 2004, was prescribed Clinoril, the brand name for the nonsteroidal anti-inflammatory drug sulindac. ... The Supreme Court said the federal Food, Drug, and Cosmetic Act allows only the FDA to make labeling changes and supersedes state law -- including the one in New Hampshire where this case originated -- that tries to force drugmakers to make labeling or design changes when safety issues arise (Pittman, 6/24).
This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.