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Wood v. Wyeth-Ayerst Laboratories8/22/2002
TO BE PUBLISHED
Affirming
I.
In 1973, the United States Federal Food and Drug Administration approved the use and sale of fenfluramine, an appetite suppressing diet medication. The drug was tested, manufactured, and packaged by A.H. Robins and sold by Wyeth-Ayerst Laboratories, under the trade name Pondimin. Appellees, American Home Products Corporation (hereinafter referred to collectively as "AHPC"), of which Wyeth-Ayerst is a division, also marketed another FDA-approved medication for obesity containing fenfluramine, called Redux. Demand for fenfluramine soared during the mid-1990's, when people began using it along with phentermine in a diet drug combination known as "Fen-Phen." The FDA never approved this drug combination.
In response to reports linking fenfluramine consumption to an increased risk of heart valve regurgitation, and apparently under pressure from the FDA, AHPC withdrew both Pondimin and Redux from the market in September 1997. Since then, many medical studies have confirmed the relationship between fenfluramine use and heart valve abnormalities.
In November 1999, AHPC entered into a "Nationwide Class Action Settlement Agreement" to redress physical injuries of fenfluramine users and provide medical screening to detect health problems arising in others in the future. Appellant, Erma Rae Wood, and many others "opted out" of this settlement because it specifically excluded claims for primary pulmonary hypertension, an often fatal disease stemming from decreased blood flow between the heart and lungs. Appellant seeks relief instead in the immediate suit. She has filed a motion for class certification under CR 23, requesting designation of the suit as a class action with her as the class representative.
Appellant claims to have used the drug fenfluramine from June to December of 1996, and she alleges her exposure to the hazardous substance was the result of AHPC's negligence. In her complaint, Appellant, on behalf of,a proposed class, seeks the following relief: (I) court-supervised notice and medical monitoring to enable people who have ingested Fen-Phen to be monitored for the existence of potentially dangerous side effects caused by the drugs, including, but not limited to, valvular heart disease, primary pulmonary hypertension, and for altered serotonin levels and associated cognitive and/or neurophysiological manifestations of impairment or injury ; (2) a fund to pay for such monitoring and also medical research concerning the effects of the drugs; (3) reimbursement of the costs of the drugs and/or previously incurred examination costs; and (4) punitive damages. Appellant has advanced various theories of liability as bases for recovery, including negligence, strict liability, concert of action, and enterprise liability.
The trial court dismissed Appellant's complaint for failure to state a claim upon which relief can be granted, pursuant to CR 12.02. A motion for dismissal for failure to state a claim should only be granted if it appears the pleading party could not prove any set of facts in support of his claim that would entitle him to relief. Pari-Mutuel Clerks' Union of Kentucky. Local 541, SEIU. AFL-CIO v. Kentucky Jockey Club, Ky., 551 S.W.2d 801, 803 (1977). The trial court concluded that Kentucky law requires a plaintiff to prove some present physical injury to support a tort claim, and Appellant had proven no such injury. The Court of Appeals upheld the trial court's decision dismissing the case, also finding that Appellant did not allege in her complaint any "present physical harm as a result of her ingestion of Fen-Phen." Appellant then petitioned this Court for review. There being recent deve
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