Mary Buchanan lived a tragedy. In 1996, soon after the Food and Drug Administration approved a new Wyeth prescription weight loss drug called Redux, she began taking it. Redux stayed on the market for less than two years; Wyeth pulled the drug in 1997, after it became clear that Redux users had a significantly elevated risk of developing primary pulmonary hypertension, a potentially fatal disorder. That was too late for Mary Buchanan. She was diagnosed with primary pulmonary hypertension in 2001 and died of it in 2003.
Her estate continued to pursue the product liability and negligence suit she had filed against Wyeth (now part of Pfizer). The case was a complete failure at the federal district court level. In 2008 Cleveland federal district court Chief Judge Solomon Oliver Jr. granted summary judgment to Wyeth, finding Buchanan’s claim that Wyeth was negligent before the FDA approved Redux was pre-empted by the FDA’s approval of the drug. Her post-approval claims of strict liability, he found, failed on their merits.
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