A primer on fen-phen litigation: allegations and defenses

The diet drug known as Fen-Phen was recently implicated as a cause of valvular heart disease in women. Fen-Phen is a combination of Fenfluramine and Phentermine, 2 commonly prescribed appetite suppressants. Both drugs were approved by the FDA for the short-term management of obesity. However, the FDA has never approved the combined use of Fenfluramine and Phentermine. Consequently, physicians who prescribe Fen-Phen are using the drugs in an off-label manner not approved by the FDA. The recent media coverage has attracted the attention of the plaintiffs' personal injury and product liability bars. The pharmacology, pathophysiology, and legal ramifications pertaining to Fen-Phen are reviewed.