Lawsuits alleging harm from the recalled diet drugs Redux and Pondimin are multiplying, fueling expectations of a lengthy legal battle over the widely used treatments.
The two drugs, which alter levels of the brain chemical serotonin to make people feel full, were withdrawn from the market Monday at the request of the U.S. Food and Drug Administration. The agency cited recent reports of heart-valve abnormalities in 32% of diet-drug users given diagnostic echocardiograms by physicians who reported the results to the FDA.
One development that could affect the suits: American Home Products Corp., which sells both drugs, confirmed this week it was informed by doctors of heart-valve problems among users as early as March, four months before a public warning was issued by the FDA.
"We were being very cautious and working with the FDA to determine if these were isolated incidents or whether this required a higher level of warning," says Marc Deitch, vice president and global medical director of Wyeth-Ayerst, the American Home unit in charge of marketing Redux.
About 100 suits have been filed already around the country -- alleging not just heart-valve problems, but also brain damage and primary pulmonary hypertension, a rare and often fatal lung disease. Ads seeking clients are cropping up in major newspapers. One group of lawyers is selling memberships in a new diet-drug litigation network for $250, complete with a regular newsletter on new developments.
"Lawyers are coming out of the woodwork," says Louis Rubin, a specialist in pulmonary hypertension at the University of Maryland School of Medicine in Baltimore. "They want information. They want expert testimony. Most of all, they want to know who knew what -- and when."
Paul Rheingold, a New York lawyer who has filed four cases in New York state related to the diet drugs and promises "dozens" more on the way, calls the situation "a model for relatively easy litigation for lawyers." He predicts "thousands of lawsuits scattered all around the country."
How such litigation will ultimately play out is difficult to gauge, but rarely do drug companies confront liability issues concerning so large a group. American Home estimates that about two million people have taken Redux since it was approved for marketing in the U.S. in April 1996, and about four million have taken Pondimin since it hit the market in 1973.
The targets of the suits so far have been physicians who prescribed the drugs, American Home and Interneuron Pharmaceuticals Inc., which developed Redux. Interneuron had no immediate comment on potential liability. American Home said Monday it had been served with several suits and expected further claims. In a prepared statement Tuesday the company said it "acted responsibly in the marketing of these products according to FDA guidelines" and planned to defend itself against the suits.
If the heart-valve problems turn out to be as common in the total population of diet drug users as the early statistics show -- and this is a large unknown -- some analysts estimate the fat-pill liability could exceed the $4 billion expected to be paid out in cases involving breast implants.
The diet-drug liability "has the potential for being one of the biggest ever," says Hemant Shah, an analyst at HKS & Co. In the breast-implant cases, large settlements were reached despite a lack of firm data on the harmfulness of the devices.
In this case, Mr. Shah says, "there is no question the drugs are associated with these side effects. The question will be what percentage of users are affected."
Compared with other recent mass-injury cases, some lawyers say the diet debacle is off to a strong start for plaintiffs. In cases such as those involving breast-implants, manufacturers of the devices have continued to deny they cause systemic disease, notwithstanding years of litigation and settlements. While the diet-pill companies may ultimately argue their products are safe, the withdrawal this week, along with a July report from the Mayo Clinic about heart side-effects, is strong evidence to the contrary, the lawyers contend.
Ultimately, the cases will rest on what evidence the lawyers can turn up about what the companies did or didn't do to warn customers about dangerous side-effects, a process of legal fact-finding that is just beginning.
Legal experts say FDA involvement in approving the drugs would not necessarily be a bar to suits. Indeed, some lawyers are contemplating a suit against the agency itself, under the Federal Tort Claims Act, although the statute customarily immunizes government officials for "discretionary" acts, such as the handling of drug applications.
The pulmonary side effects were well known for years — and were in fact included on package inserts. The label also warned that the drugs caused brain damage in animal tests. There were no warnings, until recently, on heart-valve complications because that information came to light in July, after the Mayo Clinic announced it had observed 24 cases of unusual heart-valve damage in people using fen-phen, a combination of Pondimin (fenfluramine) and phentermine, a stimulant.
There are now 100 known cases of people who developed heart-valve problems after taking Redux or Pondimin; 25 have had surgery and three have died, says Mayo Clinic cardiologist Heidi M. Connolly, the lead author in an article published last month in the New England Journal of Medicine. The findings of that article, released in early July before publication because of their urgency, prompted the FDA to issue the public warning.
American Home got a detailed report in March from the Mayo doctors in a four-hour meeting at the prestigious Rochester, Minn., medical center. At the time there were five known cases of heart-valve problems. Dr. Connolly told the two American Home officials who visited that she'd never seen that type of valve damage except in patients with rare cancers or in those who had taken ergotamine, a migraine drug that -- like the diet drugs — affects the brain transmitter serotonin.
American Home heard about more cases later that month in a meeting with doctors at MeritCare Medical Center in Fargo, N.D. That group had seen more than a dozen patients who developed heart-valve problems after taking diet drugs. Two American Home officials were there, says Dr. Jack L. Crary, interventional cardiologist at MeritCare. "Their reaction was, 'This is worrisome, but we need more information,' " says Dr. Crary. "I was very concerned about this. I thought we needed more information, too, but I thought until we had it we should put a moratorium" on the drugs.
American Home was cautious about condemning the drugs too early, in part because they had been widely sold for decades world-wide with no reports of heart-valve problems. The company thought it was "in the best interest of patients and doctors to investigate before we took any kind of drastic action," the company's Dr. Deitch says.
It isn't yet proved that diet drugs cause heart-valve problems -- and American Home is funding a full-scale research effort to find out. It also isn't known if the problems go away when diet drugs are stopped, a question that could prove key in determining legal liability.
One big potential defense for American Home: It never endorsed the popular fen-phen combination. Boston plaintiffs attorney Sam Pollack says that doesn't matter because "the company knew the drugs were being prescribed together."
The law firms involved in cases so far represent a Who's Who of the plaintiffs' bar. Peter Angelos, the owner of the Baltimore Orioles baseball team who made a fortune suing asbestos companies, has filed suit over the diet pills in Maryland state court. In San Francisco, a federal court suit seeking class-action status has been launched by Lieff, Cabraser Heimann & Bernstein, a firm that has been heavily involved in suits over alleged defects with silicone breast implants.
Lawsuits began even before the drugs were withdrawn from the market. Rose Jonez, a 45-year-old computer consultant from Santa Cruz, Calif., who got primary pulmonary hypertension after several years of taking fen-phen, received a settlement in May from A.H. Robins Co., a part of American Home, in Richmond, Va. Her attorney, Nancy Hersch of San Francisco, says the terms of the settlement are confidential but called them "extremely satisfactory."
Ms. Jonez, who had to quit her job and now is being kept alive with a medication fed intravenously through a pump she wears constantly, says the money from the settlement won't replace her health. "I bought a Mercedes and when I went to sit in it I started to cry," she says. "I'm only 45 and I don't know how long I'm going to be around." The disease is fatal in about 50% of people who get it, according to Dr. Rubin of the University of Maryland.
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