September 10, 2001-Deaths, lawsuits on rise as Fen-Phen/Redux withdrawal approaches 4-year anniversary; cases against diet drug manufacturer could double
Two wrongful death complaints filed today in California could signal a renewed wave of lawsuits against American Home Products just as the pharmaceutical company coaxes investors back with predictions that its legal troubles over Fen-Phen/Redux are coming to an end. The lawsuits were filed just days before the anniversary of Fen-Phen's removal from the U.S. market on Sept. 15, 1997. Since then, more than $11 billion has been distributed to victims of the drug or their families. That figure could easily double as more former users of Fen-Phen/Redux are diagnosed with either heart valve damage or primary pulmonary hypertension, commonly called PPH, said attorney Michael Hackard.
"As much as American Home wants to sweep Fen-Phen/Redux under the carpet, the devastation caused by this drug is about to reach epidemic levels as the effects of heart and lung damage caused by Fen-Phen become apparent to hundreds of thousands of former patients," Hackard said. "This company must be held responsible for marketing a drug they knew could hurt and even kill people."
Hackard represents the surviving families of Donald Holmes of San Juan Bautista, who died last November at age 63, and Yolanda Gallegos of Downey, who died three weeks ago at age 55. Both died of PPH resulting from their ingestion of Fen-Phen/Redux to lose weight. The Holmes lawsuit was filed in San Benito County Superior Court, and the Gallegos case was filed in Los Angeles County Superior Court.
In the United States, between 6 million and 7 million people took Fen-Phen/Redux. As the diet pills' popularity soared, doctors started connecting the use of the drug with heart valve damage and PPH, which shrinks and hardens blood vessels in the lungs. Those findings resulted in the U.S. Food and Drug Administration pressuring American Home to withdraw Fen- Phen/Redux from the market.
A Boston University School of Medicine study charted the heart valve defect rate caused by Fen-Phen/Redux at 28 percent. That means almost 2 million former users have heart valve damage. So far, fewer than 500,000 users have received compensation from lawsuits.
A recent surge in diagnosed cases of primary pulmonary hypertension would echo earlier findings by French doctors on a nearly identical diet drug called Aminorex used in Europe during the 1960s. That study outlined a roughly 4-to-6-year interval between Aminorex use and the onset of an epidemic in cases of PPH, which continued into the 1970s, years after the European authorities pulled Aminorex from the market.
"Even though it's been four years since Fen-Phen/Redux was pulled from the market, many users are just now being diagnosed with valve problems or PPH," Hackard said. "We hope this information will help save lives as former users seek exams from their doctors."
Before the advent of Fen-Phen/Redux and other appetite suppressants, PPH was rare, with one or two cases reported among 1 million people in a year. That same number is now 23 to 46 new cases among 1 million people a year, according to medical journals.
"Although this incidence is still relatively low, it represents a significant increase over the background incidence of a potentially lethal disease," stated an article in the medical journal Chest, published by the American College of Chest Physicians.
American Home Products settled 375,000 cases through a $3.75 billion class-action suit. But claims continued to mount, and the company agreed to settle 75,000 more cases.
Hackard added that American Home is throwing complicated legal delays into new cases as a deliberate attempt to wait until patients die, because wrongful death suits are less expensive for the drug company to settle than cases pursued by living plaintiffs.
American Home Products' market capitalization is more than $75 billion. They've already set aside close to 16 percent of that market capitalization to pay for their wrongdoing. By the time this is over, they may have to add another 16 percent. Lawyers believe "In the meantime, they're literally running the clock on people's lives. It takes corporate cynicism to new depths."
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