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In a 6 – 3 decision, the U.S. Supreme Court ruled that patients do have the right to sue drug companies when they have been harmed by medications with inadequately disclosed risks.

Here’s what happened

Diana Levine, a musician from Vermont lost her arm in 2000 after being given an injection of an anti-nausea drug at a health clinic. Gangrene quickly set in as a result of that injection and lead to the loss of the limb. Levine sued Wyeth, the drugmaker, alleging that the company failed to sufficiently warn of the serious risks associated with intravenous injection of the medication.

A Vermont jury awarded Levine $6.7 million and the Vermont Supreme Court reaffirmed the original jury verdict in 2006.

During the trial, Wyeth’s attorneys argued that the drug’s label, which had been approved by the FDA, advised extreme caution when the drug was injected. The pharmaceutical industry itself maintains that federal regulation by the FDA should pre-empt product liability actions brought in state courts, but the Supreme Court wholly rejected that argument.

Writing for five justices in the majority, Justice John Paul Stevens noted; “congress has repeatedly declined to pre-empt state law and the FDA’s recently adopted position that state tort suits interfere with its statutory mandate is entitled to no weight. Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.”

Chief Justice John Roberts, Justices Antonin Scalia and Samuel Alito all disagreed with the majority decision and in their dissenting opinion called the ruling “a frontal assault on the FDA’s regulatory regime for drug labelling.”

Wyeth’s lawyer stated; “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.

See additional media coverage articles:

Chicago Tribune - http://newsblogs.chicagotribune.com/triage/2009/03/patients-can-sue-drug-companies-supreme-court-rules.html

Inquirer.Net -  http://newsinfo.inquirer.net/breakingnews/world/view/20090305-192407/US-Supreme-Court-rules-amputee-can-sue-Wyeth
Editor’s Note:

We believe that the Supreme Court got it right in this case and that it should be honoured for a truly remarkable decision. One that attempts to provide our citizens with some recourse from the FDA’s frequent collusion and growing failure to protect the American people from an industry fraught with incompetence and often criminal negligence. 

It would appear that the extended “honeymoon” enjoyed by the pharmaceutical industry and the FDA may well be coming to a close. Certainly, one would hope the FDA’s inability to protect the drug company in this case will at least start the rift.