Video testimony shown in diet drug trial
Published 12:00 am Monday, December 6, 1999
FAYETTE — In videotaped testimony Monday, American Home Products employees were questioned about safety concerns the company had on record concerning its diet drugs.
Five Mississippi plaintiffs, including a Natchez man and a Fayette woman, are suing the No. 5 drug maker because they claim AHP’s diet drugs Pondimin and Redux have caused damage to their hearts and lungs.
In testimony shown on two screens in a Jefferson County courtroom Monday, AHP employees were questioned about labeling practices for both drugs and about efforts to get Redux approved by the Food and Drug Administration.
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In the videotaped depositions, AHP employees admitted the company’s database included more reported cases of pulmonary hypertension associated with the diet drugs than were listed on the company’s package inserts and warning labels. But, said AHP employee Roberta Michaelis on tape, &uot;the basic safety information was there.&uot;
During the 1990s Pondimin and later Redux were often prescribed for weight loss in combination with diet drugs called phentermines, which American Home does not make or market. Because Pondimin is a fenfluramine, the name fen-phen applies to the drug cocktail.
Plaintiffs attorneys have argued the company hid from the FDA its knowledge of cases of pulmonary hypertension and valvular heart disease being associated with Pondimin and Redux — similar drugs. In Monday’s taped testimony, plaintiffs lawyers asked AHP employee Dr. Jo Alene Dolan, whose main responsibility was Redux, about a so-called company &uot;SWAT team&uot; whose main goal was to get the drug approved by the FDA. Plaintiffs attorneys said the group’s goal was to keep the FDA from putting a &uot;black box&uot; warning to doctors on the label for the drug – a likely sign, attorneys say, most doctors would not prescribe it.
Dolan said doctors and patients did receive warnings about the drugs and said patients had some responsibility for the drugs they took.
&uot;If that warning is there and it’s been communicated, whether or not there’s a black box … the patient has assumed some risk,&uot; she said.
Defense attorneys have said the plaintiffs were warned about the possible side effects and also argue that they are not ill. Plaintiffs are Claude Pickett of Natchez, Kenya Tenner of Fayette, Ruth Bishop of Greenville, Vinestra Williams of Itta Bena and Brenda Hamm of Bay Springs. They are reportedly seeking $2 billion in damages.
Drug company Smith Klein Beacham, maker of a phentermine called Fastin, is also named in the lawsuit. And Bankston Drugs, located just down the street from the Jefferson County Courthouse, is also named because plaintiff Kenya Tenner said the drugstore filled her prescription for the diet drugs. State law requires the seller of an allegedly defective product to be included in a lawsuit concerning the product.
American Home also makes such over-the-counter medications as Advil and Robitussin.