Published July 31, 2009
What to do when drugs cause unexpected health problems
In a rare court ruling that pleases me, the U.S. Supreme court upheld damages for a woman injured by one of Big Pharma’s drugs. And this decision is extremely important to you.
A Vermont woman received an intravenous injection of the drug Phenergan, which the FDA approved years ago. The drug found its way into her artery and caused gangrene. She lost her right arm. She brought suit claiming that the drug maker, Wyeth, should have had more stern warnings about injection of the drug on the label. The FDA approves of such warnings.
Here was the problem. The FDA might not go far enough in stressing a warning. An injury could occur that might not have otherwise happened if the label carried full disclosure of the known risks. Wyeth argued that since the FDA approved the label, the company should be immune from attack. The court held that such defense would apply only if the issue was presented to the FDA and the agency rejected the proposed warning.
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