Lawyers gearing up for Prempro liability trials
Last Updated: 2006-05-04 10:31:05 -0400 (Reuters Health)
By Anna Driver
NEW YORK (Reuters) - A new wave of prescription drug trials kicks off this summer, as Wyeth and other companies answer charges that they failed to adequately warn about breast cancer risks for women taking a combination of hormones to treat menopause.
As Merck & Co. Inc. battles more than 10,000 Vioxx product liability lawsuits, Wyeth faces some 4,000 cases alleging that combination hormone replacement drugs such as its Prempro cause breast cancer or, in fewer instances, some other form of cancer or heart attack.
"We know that combined hormone replacement therapy played a positive role in causing breast cancer," said Les Weisbrod, an attorney who has 800 hormone replacement cancer lawsuits.
The first "bellwether" trial in the hormone replacement litigation is set to begin in U.S. District Court in Little Rock, Arkansas, on July 31.
Wyeth, which has spent over $21 billion to settle suits over its recalled diet pills once used in the fen-phen slimming cocktail, has historically dominated the market for women's health products and is named as a defendant in most lawsuits, plaintiffs' lawyers said.
CHANGES AFTER STUDIES
Prempro has been on the market since 1995 and combines estrogen with a synthetic chemical called progestin, used to lower the increased risk of uterine cancer that comes with taking estrogen. Women who have had hysterectomies can take estrogen to control post-menopausal symptoms without need to also take progestin.
In July 2002, a study spearheaded by The Women's Health Initiative suggested Prempro carried a slightly increased risk of breast cancer, stroke and heart disease after five years of use.
After that study, Wyeth changed its prescribing recommendations, advising that women remain on its Premarin, Prempro and Premphase hormone replacement therapies for the shortest time possible. Premarin is an estrogen replacement drug that has been on the market for 65 years.
Premarin and other hormone therapy drugs are forecast to bring in $1 billion in sales in 2006, a Wyeth spokesman said. Even so, sales of the drugs dropped by as much as half after the 2002 study.
Hormone replacement therapy was once routinely prescribed to women as they reached menopause in the belief that it would relieve unpleasant symptoms like hot flashes while protecting against heart disease and osteoporosis.
Lawyers for the women assert that prior to the Women's Health study, Wyeth never performed any long-term trials on its hormone replacement drugs like Prempro and Premarin. They say the company also encouraged doctors to put their patients on the drugs "for life."
"I don't think there has ever been a scenario where a specific group of people, and in this case, post-menopausal women, were preyed upon to test a drug," said Tobias Millrood, a Pennsylvania attorney who is handling 1,000 hormone replacement therapy cases.
Wyeth spokesman Doug Petkus said the drugs are still used to treat millions of women.
"The products have always included information with regard to the potential for increased risk of breast cancer," he said. The Madison, New Jersey, company has "always promoted the product based on the current science at the time," he added.
MORE TRIALS COMING UP
Another trial is scheduled to start in Pennsylvania state court in Philadelphia on Sept. 11. Millrood will represent a 67-year-old woman who was on Prempro for 6 years.
He plans to attack Wyeth marketing materials that he said tout Prempro as a "wonder drug" for ailments including osteoporosis and macular degeneration, a major cause of blindness. He also said that Prempro causes a certain type of breast cancer, making it easier to prove the link.
"The Prempro drug has left its fingerprint on the breast cancer," Millrood said. He noted that the breast cancer tumors in some of his clients test positive for estrogen and progestin receptors, a fact he says proves that the hormone therapy is linked to the cancer.
Pfizer Inc., which makes the hormone drug Provera, is also being sued by women who took that drug in combination with estrogen therapy.
In a statement sent by email, Pfizer said the U.S. Food and Drug Administration still considers hormone replacement therapy "to be safe and effective for its indicated uses," and doctors and patients should balance the drug's benefits and risks when choosing a treatment.
