Medical Devices and Prescription Drug Policy

Supreme Court blocks lawsuits against dangerous drugs

{mosads}The case deals with a woman who was badly injured by a generic painkiller. Most of her skin burned off and turned into an open wound, causing permanent disabilities. 

She sued the drug maker, arguing that its product was too dangerous — even though the drug was approved by the Food and Drug Administration (FDA) and its label warned about the disease she developed.

Attorneys for the drug company and the Justice Department argued that her suit should be “preempted” by federal laws that require the FDA to balance risks and benefits when it decides whether to approve a new drug. Juries shouldn’t be able to second-guess those expert determinations, they argued.

The Supreme Court agreed Monday.

Justice Sonia Sotomayor, in a dissenting opinion, said the company did have another option: stop selling the dangerous drug.

The majority opinion was based on “an implicit and undefended assumption that federal law gives pharmaceutical companies a right to sell a federally approved drug free from common-law liability,” Sotomayor wrote.

The Generic Pharmaceutical Association praised the court’s ruling.

“When it comes to decisions on safety and approval of prescription medicine, the FDA is best equipped to make judgments that affect patients,” GPhA President Ralph Neas said in a statement. “The experts at FDA alone have the scientific knowledge, regulatory experience, and complete data to make these decisions.”


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