US Supreme Court Upholds Patient’s Right to Sue Drug Maker for Dangerous Drug Even if it Has FDA Approval

March 5, 2009, by Michael A. DeMayo

The Supreme Court dealt a huge blow to the pharmaceutical industry by upholding the right of patients to sue a drug maker for damages over a dangerous drug, even if the medication has Food and Drug Administration approval. While the Bush Administration told the court last year that a drug maker should be exempt from such lawsuits alleging personal injury or death, the judges, in a 6-3 decision on Wednesday, ruled otherwise.

They upheld a $6.7 million verdict that ruled in favor of Diana Levine, a musician who had her right arm amputated when she developed gangrene after being injected with Phenergan, an anti-nausea drug made by Wyeth. Levine has already settled her medical malpractice lawsuit against the clinic that administered the drug to her via IV-push, causing her artery to accidentally be injected with the powerful drug. Her dangerous drug lawsuit against Wyeth accused the drug manufacturer of failing to properly warn consumers of the risks that could arise from taking the anti-nausea medication even though its warning to use a great deal of caution when injecting the drug met FDA standards.

Levine won her civil lawsuit in Vermont civil court and Wyeth appealed the decision, arguing that federal law protected it from such lawsuits. The Court, however, found that Wyeth failed to prove that failure-to-claim warnings conflicted with federal laws regarding drug labeling. Wyeth doesn’t manufacture Phenergan any more.

This Supreme Court decision paves the way for lower court judges to allow state liability cases against drug makers to proceed even if the federal government is charged with regulating the area.

Dangerous Drugs
Unfortunately, despite regulation by the federal government, there are dangerous drugs that manage to enter the marketplace and cause injury or death to patients. Drug manufacturers must be held accountable for their dangerous or defective drugs.

Supreme Court ruling supports drug lawsuits, USA Today, March 4, 2009

Supreme Court backs patients’ right to sue drug makers, Baltimore Sun, March 4, 2009

Musician gets high court OK to sue Wyeth, March 4, 2009

Related Web Resource:

Wyeth V Levine, US Supreme Court Opinion (PDF)


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