The award, which American Home Products will appeal, is the first jury verdict against the weight loss regimen fen-phen.
A Texas manicurist who said her heart was damaged by the diet drug combination known as fen-phen was awarded $23.3-million Friday in the first jury verdict against the makers of the controversial weight loss regimen.
The award against American Home Products, which marketed fenfluramine, the potent half of the drug cocktail, is significant according to legal experts because the first such product liability cases typically are the weakest ones, allowed to proceed without a settlement because the company is convinced that it will win.
Debbie Stone Lovett was one of an estimated 6-million Americans who took the diet cocktail, the fenfluramine portion of which was pulled off the market after it was found to cause heart valve damage in some patients and lung problems in others.
Her unexpected victory _ Lovett's own doctor testified against her _ could be disastrous for American Home Products, the Madison, N.J., pharmaceutical company that marketed the drug under the brand name Pondimin. Already, 3,100 lawsuits have been filed against the company nationwide, and legal experts said that a win such as this might lead to tens of thousands of new cases.
The company's stock dropped 11.9 percent on news of the verdict, to $44.88, a decline analysts attributed to fears of more large verdicts.
"There classically is a learning curve, and plaintiffs typically lose the first couple of lawsuits," said John Coffee, a legal expert at Columbia Law School in New York. "Once they get the first couple of (successful) verdicts, it can become hyperbolic. That's what happened in asbestos."
Just this week, jury selection began on a class action case involving several thousand patients who were not injured by fen-phen but must undergo medical exams for several years to make sure that heart damage does not surface as time goes by.
Following the verdict, the company immediately announced it will appeal the Texas ruling.
"We feel the evidence presented in this case demonstrated that the company acted responsibly and lawfully in marketing and monitoring the safety of the diet drug Pondimin," said Bob Schick, the Houston-based attorney for American Home Products. "There simply is no scientific study that has established a causal link between the use of Pondimin and the heart problems claimed by Mrs. Lovett."
American Home Products, through its Wyeth-Ayerst Laboratories division, marketed Pondimin and another diet drug Redux _ fenfluramine and dexfenfluramine. The drugs were prescribed widely by doctors around the country in combination with another drug, phentermine. The combination, which unlike the individual drugs never was approved by regulators, was called "fen-phen."
But in the summer of 1997 researchers at the Mayo Clinic reported 24 cases of a rare heart valve disease in women who took the fen-phen combination.
A few months later, after another 66 cases of heart valve disease were reported, the Food and Drug Administration asked the company to pull both Pondimin and Redux from the market, which Wyeth-Ayerst agreed to voluntarily. But because most patients taking fen-phen were obese and were at risk of heart disease generally, it is difficult to determine in individual cases whether or not the drugs could be blamed for the valve problems.
Lovett, 36, had had a heart valve problem when she was 17, years before she took fen-phen, according to both American Home Products and her own attorney, Kip Petroff of Dallas.
Because Texas has a cap on liability awards, Petroff expects the final payout in the case to be much lower than $23.3-million. Most likely, he said, it will be reduced to about $12-million.
The jury's willingness to award millions of dollars to a woman whose own doctor testified against her shows the public's growing distaste for actions by corporations that appear to be deceitful, said Sharon Arkin, a health care liability attorney who in March won a $120.5-million verdict against Aetna U.S. Healthcare for delaying potentially life-saving treatment to a San Bernardino County, Calif., patient.
American Home Products is no stranger to lawsuits: Last year it settled a class action suit filed by users of its Norplant contraceptive implants; and it took over a company that manufactured the Dalkon shield, another birth control device that was linked to a number of deaths and resulted in a number of liability suits.
The company's annual Securities and Exchange Commission disclosure, filed in March, described more than 2,600 lawsuits that have been filed against it by the end of 1998 as the manufacturer of Pondimin and the distributor of Redux _ including 70 class action cases in both state and federal courts.