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The trial of a lawsuit filed by Linda Reeves of Benton is drawing the attention of women across the United States, the pharmaceutical industry and lawyers. Reeves alleges that the hormone replacement therapy drug Prempro, made by Wyeth Pharmaceuticals, caused her breast cancer.
The trial, set to start Monday, Aug. 21, in federal court in Little Rock, is the first of about 4,500 lawsuits over Prempro, a drug prescribed to ease the symptoms of menopause such as hot flashes and osteoporosis. Many of the suits are set for trial in U.S. District Judge Bill Wilson’s court.
The results here may signal the fate of other such lawsuits. “It will sort of indicate which way the wind is blowing,” said Margaret Berger, a professor at the Brooklyn Law School and an expert in scientific evidence. The suits number in the thousands; millions of women have taken Prempro.
Reeves, 67, began taking Prempro and Premarin, another hormone replacement therapy (HRT) in 1983 but stopped in 2000 when she was diagnosed with breast cancer, her lawsuit says. She later underwent a mastectomy. Tom McGowan of Little Rock is one of the lawyers representing Reeves.
“They [Wyeth] wanted doctors to look at the benefits and not the risks. They corrupted the science,” Jim Morris, another of Reeves’ lawyers, has said. Wilson has since asked the parties in the lawsuit not to comment.
Reeves alleges that Wyeth failed to adequately study the HRT drugs and to disclose their risks, and also misrepresented the health benefits of taking the drugs.
Controversy over the use of Prempro and other hormone replacement therapy (HRT) drugs erupted in 2002 after a clinical study of the drugs found that Prempro users faced an increased risk of breast cancer, stroke and heart disease. The Women’s Health Initiative, conducted by the National Institutes of Health, stopped the study after initial findings indicated that the group taking a combination of estrogen and progesterone had a 26 percent higher risk of breast cancer, a 41 percent greater chance of stroke, a 29 percent increased risk of heart attack and a 22 percent greater risk of heart disease.
Sales of Prempro and the related HRT drug Premarin, which totaled $2 billion in 2001, had fallen to $909 million in 2005. Wyeth has noted that the drugs are still on the market and that the labels warn of the risk of breast cancer. “This is an incredibly valuable treatment. There are really benefits to this medication,” Heidi Hubbard, a lawyer for Wyeth, told the Associated Press.
The Prempro case follows other Wyeth troubles over fen-phen, a combination diet drug that was pulled from shelves after reports surfaced that it damaged heart valves. Wyeth, then called American Home Products, faced a storm of bad publicity and lawsuits. It has now reached settlements over most of the suits, litigation that has cost the company $21 billion so far.
Berger, a member of the National Academy of Science’s Panel on Science, Technology and Law, told the Arkansas Times that Reeves’s lawyers had a “two-fold burden. First they have to prove that Prempro is capable of causing cancer. Then they have to show that that is what happened in this particular case.” Wyeth’s lawyers, Berger said, will likely say that the fact that the drug has not been taken off the market indicates that it is safe.
Berger said the Prempro cases more closely resembled the lawsuits over the Merck-manufactured pain medication Vioxx, which the company took off the market in 2004 after reports that it increased the risk of heart attacks. More than 16,000 lawsuits involving Vioxx have been filed. Merck has won five of the cases so far, but has lost three, including one in which a Texas jury awarded $253 million to the widow of a man who had taken the drug. Because Texas sets a ceiling on punitive damages, however, that verdict will be reduced to $26 million, and Merck plans to appeal.
Like Vioxx, Prempro is a prescription drug approved by the Food and Drug Administration, Berger said.
She also said that the nature of such product liability cases had changed. In the past, plaintiffs’ lawyers often had far fewer economic resources than the defendants, usually huge corporations. The playing field has leveled in recent years, with plaintiffs now better prepared to take on corporate Goliaths, having learned from previous cases the kind of scientific and medical evidence required to make their arguments.
But, Berger said, “One of the problems [for plaintiffs] of these cases is it often turns out there’s very little evidence if the drug companies have done little research on their products.” This is a disturbing consequence of the proliferation of product liability cases against drug makers: The drug companies have become less transparent about their research, even less likely to perform scientifically strict studies.
“If you have a study and it doesn’t come out right, you’re in more trouble than if you haven’t done the research,” she said, because the problematic results might provide fodder for plaintiffs’ lawyers.
“It sounds kind of cynical, but it’s true,” Berger said. To compensate for this lack of research, “medical journals are spearheading a system to register every single [drug] trial.”
The trial is expected to last several weeks.
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