Jury Awards $23.3 Million in Fen-Phen Case

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, half of the drug cocktail, is particularly significant, according to legal experts, because defendants usually win the initial cases in such product liability lawsuits.

The first cases typically are the weakest ones and are 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 one could lead to thousands of new cases.

The company’s stock dropped 11.9% 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 that 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.”

The fen-phen cases are particularly compelling, women’s advocates said, because the drug played into an obsession for thinness that prompted some women to seek out the weight-loss cocktail even after evidence began to accumulate that it was risky.

“A whole industry has grown up around making women skinny,” said Susan Berke Fogel, legal director of the California Women’s Law Center. “Maybe these drugs were not tested as much as they should be, and maybe physicians are not monitoring them as well as they should be. The fen-phen explosion was not about better health; the fen-phen explosion was about women feeling coerced in this society to be skinny.”

At the same time, fen-phen was also prescribed for people who really do struggle with their weight. A year ago, the National Institutes of Health issued a report that argued that 55% of the adult population, or 97 million people, are overweight or obese.

American Home Products, through its Wyeth-Ayerst Laboratories division, marketed Pondimin and another diet drug Redux--fenfluramine and dexfenfluramine. The drugs were widely prescribed by doctors around the country in combination with another drug, phentermine. The combination, which unlike the individual drugs was never approved by regulators, was called “fen-phen.”

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 66 more 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 do voluntarily. Interneuron, the company that developed Redux, has agreed to settle a federal class-action suit for $70 million.

Since many patients taking fen-phen were obese and at risk of heart disease generally, it is difficult to determine in individual cases whether the drugs could be blamed for the valve problems.

In fact, Lovett, who is 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.

Lovett’s lawyer, Kip Petroff of Dallas, said the prior condition was unrelated to the heart valve problems that Lovett attributed to fen-phen. But, he said, her own cardiologist disagreed with that conclusion and testified for American Home Products during the trial.

“He laughed at it,” Petroff said. “He said she doesn’t have any disease.”

The jury of eight men and four women in Van Zandt County Court in Canton, Texas, about 60 miles east of Dallas, believed Lovett, however, and returned with an award of $3.3 million in compensatory damages and $20 million in punitive damages. “We had a cardiologist who said she did have it,” Petroff said. “It was a battle of the experts, and we won.”

“I’m stunned, I’m absolutely stunned,” Lovett told Bloomberg News after the verdict. “Maybe it will send a message that they’ll have to be more careful next time.”

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.

In addition to showing that Lovett was injured, Petroff argued that American Home Products failed to properly study the effects of fenfluramine when taken over a long period of time, and then failed to warn patients quickly enough when people started getting sick.

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 patient. Arkin’s firm, Robinson, Calagnie & Robinson of Newport Beach, represents about 130 patients who claim to have been injured by fen-phen.

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 SEC 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. It included 70 class-action cases in both state and federal courts.

The company also reported two shareholder lawsuits on behalf of those who purchased American Home Products stock in the months prior to the withdrawal of the diet pills from the market in September 1997.

American Home Products has been quietly settling a number of the fen-phen lawsuits for a fraction of the amount of claims filed against it, said Steven Gerber, a senior analyst at CIBC World Markets.

But Gerber, who thinks the judgment will be overturned or modified, said that the company has put aside several hundred million dollars in reserves to pay for fen-phen judgments and settlements.

“What rattled investors is the erroneous instinct to multiply $23 million [the Texas settlement] times 3,000 cases filed, and that gives an enormous and unrealistic number,” Gerber said.

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The Rise and Fall of Fen-Phen

Here’s a look at the history of fen-phen, the diet drug combination that was blamed for heart valve damage in some patients.

* 1959: Phentermine is first approved by the Food and Drug Administration. It was originally recommended for the first few weeks of a restricted calorie weight-loss program.

* 1973: Fenfluramine (brand name Pondimin) is approved by the FDA for short-term use in dieting.

* 1979: Dr. Michael Weintraub introduces the idea of trying fenfluramine and phentermine in combination.

* July 8, 1997: Mayo Clinic study finds 24 cases of a rare heart valve disease involving women who used the fen-phen combination.

* Aug. 27, 1997: FDA says it will require drug makers to print labels, warning that use of fen-phen may damage heart valves.

* Sept. 8, 1997: State Board of Medicine in Florida approves an emergency three-month ban on the drug combination. The board cites one case of heart failure and other health problems, including 25 cases of heart valve damage.

* Sept. 12, 1997: FDA provides Wyeth-Ayerst Laboratories with new summary data on the 24 cases reported by the Mayo Clinic. Abnormal echocardiograms, a special ultrasound of the heart that can see the valves move, were identified in 92 of 291 patients studied.

* Sept. 15, 1997: Wyeth-Ayerst and Interneuron Pharmaceuticals announce they will withdraw their diet medications fenfluramine and dexfenfluramine from the market at the FDA’s recommendation.

* Oct. 7, 1997: Users of phentermine, fenfluramine and dexfenfluramine file class actions in Pennsylvania and New Jersey state courts against the manufacturers and distributors of the drugs, alleging violations of the states’ consumer protection and product liability laws.

Source: Compiled from various news and wire services. Researched by ROBIN MAYPER / Los Angeles Times