Patients who are injured by a drug can sue the drug’s manufacturer for damages, even if the drug has been approved by the Food and Drug Administration, the US Supreme Court ruled Wednesday.

 

“The message here is that consumers will get their day in court,” said lawyer David Frederick, who represented Diana Levine, a former guitarist who lost her arm after she had gone to a health clinic in April 2000 for treatment of a migraine. She was injected Wyeth’s Phenergan drug directly into a vein, allowing the drug to reach an artery. It caused immediate gangrene.

 

“I was hanging on and crying for dear life. If I had lost, the rights of people to tell their story in court if they were hurt by a drug unnecessarily would have been taken away,” said Levine, 63, who runs a small record company.

 

Levine sued Wyeth alleging that it failed to sufficiently warn of serious risks associated with intravenous injection of the medication. On the other hand, Wyeth argued the drug’s label, which had been approved by the FDA, advised extreme caution when the drug was injected.

 

“We believed that federal law prohibited the company from revising its product label as the Vermont court required, and we regret that the Supreme Court disagreed. The medical and scientific experts at FDA are in the best position to weigh the risks and benefits of a medicine and to assess how those risks and benefits should be described in the product’s label,” Wyeth’s lawyer told the Wall Street Journal.