Makers of Unsafe Drugs Can No Longer Hide Behind FDA Approval

Drug manufacturers have often tried to fend off litigation by claiming that their FDA approval should immunize them against lawsuits. No more. The United States Supreme Court just ruled that state juries may award damages for harm from unsafe drugs even though the drug maker has satisfied FDA requirements.

The decision before the Supreme Court was the case of a musician whose arm had to be amputated after she was injected with an anti-nausea drug. The drug maker claimed that it had fully complied with federal law by labeling the product appropriately. It argued that it had printed clear warnings about potential side effects, as required by the FDA, and therefore should be exempt from lawsuits.

"The court recognized that FDA approval does not guarantee the safety of a drug, nor that the drug is free of the potentially serious side effects explained on its label," said Personal Injury attorney Howard Krepack. "Unfortunately, the FDA sometimes approves a product that later causes serious, life-changing injury or death. This decision will allow victims of unsafe drugs to continue to prove their claim in state courts."

The law firm of Gordon, Edelstein, Krepack, Grant, Felton & Goldstein, LLP has a proven record of success representing clients harmed by toxic substances such as unsafe drugs.