FEN-PHEN: $23M Awarded Against Makers of Diet Drug
A Texas jury Friday ordered Madison, NJ-based American Home Products, the nation's seventh largest pharmaceutical maker, to pay $23 million to a woman who claims its contribution to the diet drug combination known as fen-phen damaged her heart valves. Attorney Bob Schick said the company will appeal the decision. "This is just one jury's opinion," he said, adding, "Through sympathy, they wanted to award money" (AP/Newsday, 8/8). However, the Wall Street Journal reports that the "large punitive-damage award is a particularly troubling sign for American Home because the plaintiff, Debbie Lovett, had few medical expenses and her symptoms ... weren't severe." The company currently faces 3,000 outstanding personal-injury lawsuits filed by people claiming the drug Pondimim caused them similar harm. The company also faces a federal lawsuit and several state level class-action suits by "former users ... who aren't sick now but allege they may suffer heart-valve damage in the future." A Texas district judge must approve the award; his ruling is expected within 30 days (Langreth, 8/9).
Lawyers for the plaintiff, Debbie Stone Lovett, 36, a manicurist from Grand Saline, TX, said the drug combination caused her to develop "leaky heart valves." But her own doctor testified that her heart problems existed before she started taking the drug. Her attorneys countered that even if she had already been sick, "the company's failure to alert physicians and consumers to the risks placed her in further danger." "If that case can be won, that tells me almost any case can be won," said Houston attorney Tommy Fibich. Kip Petroff, a lawyer for Lovett, said, "This is a case that American Home Products chose. They were very arrogant and confident they were going to win this one" (Yardley, New York Times, 8/7).
Long Road Ahead
News of the verdict caused shares of American Home Products to tumble 11.9%, making AHP the "most cheaply priced stock among the largest U.S. drugmakers" (Pierson, Reuters/Nando Times, 8/6). Wall Street analysts say the news could "depress shares for months to come amid uncertainty over just how great the company's ultimate fen-phen liability will be" (Reuters/Boston Globe, 8/7). The fen-phen controversy "hints at a larger drug problem," a USA Today editorial argues. Every year, 25%-50% of prescribed drugs are used for "off-label" treatments, often with "deadly results." Yet the FDA "doesn't do its own research into off-label uses ... [it needs to] build a comprehensive approach to identifying dangerous off-label drugs" (8/9). Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, argues that allowing the promotion of off-label uses of drugs is too risky, since it has the potential to "halt much clinical testing of unapproved uses needed to ensure safety and effectiveness" (Wolfe, USA Today, 8/9).