Firm Denies Hiding Diet Drug Risks
American Home Products Corp. Tuesday denied allegations that it deliberately suppressed information about potentially fatal side-effects of the widely prescribed "fen-phen" combination of diet drugs.
In opening statements in a civil trial, lawyers for the family of a Texas woman who they say died in 1997 because of using one of the two drugs accused the company of covering up the hazards of the diet-drug tandem. Mary Marisa Smith's relatives are seeking unspecified damages from the company.
"They knew people were going to die," Tommy Fibich, a lawyer for Smith's family, told a Texas district court jury in Houston. "It's the pharmaceutical equivalent of a drive-by shooting. They just didn't know who they were going to kill."
But David Kiernan, a lawyer for American Home Products, rejected the charge that the company kept doctors in the dark about the risks of the drug's potentially serious side effects and misled and manipulated the U.S. Food and Drug Administration.
Madison, N.J.-based AHP is one of the world's largest pharmaceutical and health care products companies.
"The FDA had complete information about the potential risks," Kiernan told jurors in his opening statement. "No one manipulates the FDA. No one."
Smith, who lived in Harris County, began taking the appetite suppressants fenfluramine and phentermine under medical supervision after an unsuccessful 10-year fight against obesity.
Smith succeeded in reducing her weight from 266 pounds to 196 pounds, but in 1997 she began to suffer from breathlessness and was subsequently diagnosed as having a rare lung disorder called primary pulmonary hypertension.
She underwent surgery to stabilize her condition but developed an infection and died in November of that year at the age of 34, leaving a husband and two young children.
Two months before Smith's death American Home Products halted sales of fenfluramine, marketed under the trade name of Pondimin, and a similar product, dexfenfluramine, marketed as Redux, at the request of the Food and Drug Administration.
Phentermine, the other half of the fen-phen cocktail, remains on the market.
Plaintiffs lawyer Fibich told the jury that there had been growing evidence since the early 1990s of the potential dangers of fenfluramine, but American Home Products withheld the information from doctors to protect its profits.
But AHP lawyer Kiernan said it was not until August 1996 that an international survey indicated a statistically significant link between fenfluramine and primary pulmonary hypertension.
Even then, the FDA had concluded that the benefits of the drug for obesity patients outweighed the risks, he said.
American Home Products eventually withdrew fenfluramine from the market after evidence emerged in 1997 that it also could adversely affect a patient's heart valves.
The company is facing thousands of lawsuits around the country linked to fenfluramine and dexfenfluramine, which have been used by an estimated six million people.
In April, American Home Products confirmed it had settled one suit in which a Texas woman claimed fenfluramine had damaged her heart. The company has refused to comment, however, on reports of discussions about a broad settlement of the other cases.