Academic journal article
By Fox, Karina
Brigham Young University Law Review , Vol. 2001, No. 3
In 1996, pharmacists dispensed over 18 million prescriptions for fenfluramine in the United States.' As the more dangerous half of the diet drug combination popularly known as "Fen-Phen," fenfluramine promised overweight Americans something that seemed too good to be true: the body of their dreams as excess flab melted away without hunger.2
The honeymoon, however, was short-lived. Americans' love affair with Fen-Phen came to a bitter end when, in July of 1997, the U.S. Food and Drug Administration ("FDA") published a report linking valvular heart disease to the use of Fen-Phen.3 On September 15,
1997, the FDA announced the withdrawal of fenfluramine from the market.4 Sales ground to a halts stock plummeted,6 and thousands of Fen-Phen consumers lined up at their doctor's offices for echocardiograms.
No one was surprised8 when these same consumers found their way en masse into lawyers' offices around the country as a wave of litigation ensued. As of May 2000, "approximately 18,000 individuals" had filed lawsuits against American Home Products, the maker of fenfluramine.9 Although a federal judge recently approved a $3.75 billion class action settlement against American Home Products,' 44,423 plaintiffs exercised their right to opt out," thousands more are challenging the settlement as unfair,12 and many more cases remain pending in state court.13
As the unwitting middlemen caught in a litigation feeding frenzy, pharmacists and the future of their profession are on shaky ground. 14 While courts traditionally have held pharmacists to a duty
of clerical accuracy only, some courts recently have shown a willingness to extend this duty to include the duty to warn of the dangers of prescription drugs.ls
Kohl v. American Home Products Corporation, the principal case in this Note, purported to apply the traditional rule but nevertheless suggested that a pharmacist could be held liable for failing to second-guess labeling information supplied by the manufacturer of fenfluramine.16 While the holding itself is unimportant (the court eventually dismissed the plaintiffs claims on procedural grounds), the court's rationale is significant because it further muddied the waters of pharmacists' liability. More importantly, as the Kohl court was the only judicial body in the country to address squarely the issue of a pharmacist's duty to warn of the dangers of Fen-Phen, other courts will likely look to the Kohl rationale as the Fen-Phen litigation filters down into the state courts.
Part IT of this Note gives a brief synopsis of the Fen-Phen controversy and traces the recent judicial history of pharmacists' liability. Part III gives the facts of Kohl and explains the court's reasoning in suggesting that a pharmacist could be held liable for failure to warn of the dangers of fenfluramine. Part IV analyzes the court's opinion, compares that opinion with other recent decisions involving a pharmacist's duty to warn, and argues that the court improperly expanded and confused the scope of pharmacists' liability. Furthermore, this Note concludes that the modern trend toward expanding pharmacists' liability could displace the physician's role and thereby compromise patient care.
Fenfluramine leapt from relative obscurity in 1992 to become one of the hottest selling diet drugs of the century." Sales were brisk
until reports surfaced in 1997 linking fenfluramine to heart disease.18 Although the Mayo Clinic suspected an association between the use of fenfluramine and valvular heart disease in March 1997, the FDA did not make those findings public until July 8, 1997.19 When the FDA did issue a public warning about the use of fenfluramine, it pointed out that the evidence linking fenfluramine to heart disease was not yet conclusive.20 The FDA did not officially withdraw fenfluramine from the market until September 15, 1997, over two months after the initial reports were made public. …