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Supreme Court Rules Regarding Drug Manufacturer Case

According to the U.S. Supreme Court ruling, pharmaceutical companies can be sued over serious side effects of drugs even when the warning labels have been approved by the U.S. Food and Drug Administration (FDA). 

The Supreme Court issued a 6-3 judgment against the drug manufacturer Wyeth, which could open the door to litigation in thousands of similar drug cases.

The ruling was in favor of Diana Levine, a musician who had lost her arm to gangrene after receiving the Phenergan injection.  Levine had been awarded $6.7 million in damages by a Vermont court in her lawsuit against Wyeth, the company that manufactures Phenergan.

Levine had gone to a local health clinic in April 2000 for treatment for a migraine headache.  She was given the Phenergan injection.  A physician’s assistant injected the drug intravenously, which caused the Phenergan to enter Levine’s artery.  As a result, she developed gangrene and doctors had to amputate her right forearm.  According to evidence presented by Levine, there have been at least 20 other cases in which the use of Phenergan resulted in gangrene and amputation.

The trial court had concluded that Levine’s injuries wouldn’t have occurred if Phenergan’s label had included an adequate warning about the risks of delivering it by means of intravenous injection.

Wyeth had argued to the Supreme Court that the FDA had approved warning labels for Phenergan and that this approval took precedence over the state law where the lawsuit was filed.

Some believe that the judgment opens the way for individuals to bring lawsuits against manufacturers for negligence even when the FDA has approved a drug and its warning label.

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