Hormone Replacement Drugs

PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) is used after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones).

PREMARIN (conjugated estrogens tablets, USP) is used after menopause and/or a hysterectomy to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones).

WHAT THESE LAWSUITS ARE ABOUT

Thousands of lawsuits have been filed against Wyeth, the manufacturer of Prempro,  Premarin and other hormone replacement therapy drugs.  The lawsuits allege Wyeth was negligent in the way it marketed and sold the drugs, which can cause serious injuries. The following information is found in some of the lawsuit documents.

Wyeth has vigorously promoted its menopausal hormone therapy drugs for 30 years, using a variety of marketing messages that emphasize long-term use of these medications.  By way of example, the 1973 key marketing statement for Premarin (estrogen therapy drug) was “start her on, keep her on.”  Even as late as 1991 Wyeth represented that “protection continued only as long as estrogen therapy continued.”

Through a massive decades-long marketing and advertising campaign, Wyeth convinced doctors and the public that menopause is a disease requiring drug treatment rather than the natural process of aging.

In 1966, Dr. Wilson published a best-selling book entitled Feminine Forever. In Feminine Forever, Dr. Wilson described estrogen as the “cure” for “the tragedy of menopause.” He argued that women who use hormone drugs “will be much more pleasant to live with and will not become dull and unattractive.” In writing about the menopause condition, which he termed the “deficiency disease,” Dr. Wilson wrote that “aside from keeping a woman sexually attractive and potent. . .estrogen preserves the strength of her bones, the glow of her skin, the gloss of her hair. . .Estrogen makes women adaptable, even-tempered, and generally easy to live with.” Dr. Wilson asserted that estrogen prevents breast and genital cancers, such as endometrial cancer (i.e., cancer of the uterine lining).  Unknown to readers, Dr. Wilson was paid by Wyeth to write, publish, promote and market Feminine Forever.

Another example of Wyeth’s false and misleading over-promotion is in a print advertisement that Wyeth published in the October 13, 1975, edition of Journal of  American Medical Association, in which Wyeth claimed that Premarin can relieve “tension, irritability, headaches, undue fatigue, depression and insomnia” caused by declining menopausal estrogen levels. At the top of the advertisement, in large print, Wyeth advised doctors, “Almost any tranquilizer might calm her down . . . but at her age, estrogen may be what she really needs.”  The 1975 advertisements also stated:  “In the treatment of middle-aged depression, there may be one thing to add . . . Premarin.”

In 1977, the Food & Drug Administration (FDA) issued a statement confirming that estrogen therapy should not be used to treat simple nervousness during menopause and that there was no scientific support for any representation that such therapy could keep a woman feeling young or keep her skin soft.

By the mid-1970s, more than 30 million prescriptions for Premarin were being written every year, later making it the fifth most frequently prescribed drug in the United States.

During the same period, a hormone therapy health epidemic arose. Two 1975 articles in the New England Journal of Medicine (NEJM) linked estrogen therapy to a significantly increased risk of endometrial cancer.  Doctors then stopped prescribing Premarin to any woman with an intact uterus.  Estrogen sales plummeted.  By 1979, the only approved use of estrogen (Premarin) was for treatment of hot flashes and vaginal dryness.

In 1979, Dr. Robert Cireenblatt published an article in the Journal of Geriatrics Society that reported that “estrogen related uterine cancer can be avoided if progesterone is added to the regimen.”  Wyeth and the other drug manufacturers immediately started promoting estrogen with an added progesterone component that together are known as combination hormone therapy.

In 1985, Wyeth put a new spin on the marketing of hormone therapy drugs by claiming that the drugs could help prevent bone loss.  After Wyeth learned that 77% of women had never heard of osteoporosis, Wyeth’s public relations campaign moved into high gear to persuade women that osteoporosis is a devastating disease they should treat with Wyeth’s drug, Premarin.

Wyeth represented to doctors, patients and the public that estrogen and combination hormone therapy drugs could prevent or reduce cardiovascular disease.  Wyeth’s sales representatives encouraged doctors to prescribe hormone therapy even if a woman was not having menopausal symptoms because of the therapy’s purported cardiac benefits.  In fact, reliable scientific evidence has never supported these alleged benefits. Nevertheless, Wyeth recommended that physicians prescribe these hormone drugs in order to provide patients with purported cardiac protection.

As a result of Wyeth’s marketing efforts, between 1990 and 1995 Premarin became the bestselling prescription drug in the United States.  At the same time, Wyeth knew about risks but did not adequately warn anyone.  For example, in 1991, Wyeth was aware that patients with a family history of breast cancer had a greater than three-fold increased risk of developing breast cancer from combination hormone therapy.  Wyeth took steps to suppress the publication of this data and never publicly informed physicians of the risks.  Wyeth never put a warning or contraindication in their hormone drugs’ labeling to advise doctors of this dramatically increased risk for their patients with a family history of breast cancer.

Wyeth began marketing its combination hormone therapy drugs in a single pill called “Prempro” in 1994.  “Premphase” is the brand name for a similar Wyeth product containing the same combination of compounds.

Wyeth has consistently downplayed studies isolating risks of hormone therapy.  For example, in 1996, European scientists and researchers found that women with vertebral fractures had a 4.6 times increased risk of developing breast cancer if they took combination hormone therapy.  These scientists felt that the risk of breast cancer associated with hormone replacement therapy had been substantially underestimated since osteoporosis is a primary indication for its use.   Wyeth never informed physicians about this dramatically increased risk for patients with bone mass density problems, fractures or osteoporosis.  Instead, Wyeth promoted hormone therapy as something that could prevent osteoporosis and encouraged doctors to prescribe the drugs to these high risk patients.

By the late 1990’s and early in 2000, Wyeth knew about studies showing a significantly increased risk of breast cancer for women using combination hormone therapy.  Indeed, studies showed a greater than four-fold increased risk of breast cancer.  Despite this knowledge, Wyeth minimized the risk in their package inserts by assuring doctors the risk was modest at most, with some studies showing no risk.  Wyeth’s representations were false and misleading and were intended to downplay the cancer risks associated with hormone therapy.

On July 9, 2002, the National Heart, Lung and Blood Institute, (NHLBI), a federal agency and part of the National Institutes of Health (NIH), halted the Women’s Health Institute (WHI) study because the investigators concluded that the risks of taking Prempro outweighed its benefits.  In July 2002, the published results of the WHI study  provided the scientific and medical communities with important information as to the varied and overwhelming risks associated with hormone therapy.  The WHI study found that Prempro caused a significant increased risk for breast cancer, strokes, heart attacks, blood clots, and cardiovascular disease.  The WHI study, and numerous studies published since, proved what the makers of hormone therapy drugs had avoided and denied for decades—hormone replacement therapy causes disease and death and these risks significantly outweigh any possible benefit.

Shortly after the WHI study results were reported, a report on a National Cancer Institute (NCI) study was released.  That study showed that estrogen drugs (e.g. Premarin) resulted in a much higher risk for ovarian cancer than women who did not take the drugs.

The results of the WHI and NCI studies and others contradict the scientific and medical assertions that Wyeth had made for decades about its products.  Wyeth told the medical community that the risks of these drugs are minimal, whereas the drugs have great benefits ranging from relief of menopausal symptoms to the prevention of life-threatening medical conditions like heart disease and osteoporosis.

The lawsuits allege warnings and labels provided by Wyeth were inadequate, misleading, and inaccurate.  Wyeth minimized the risks of hormone therapy drugs to prescribing physicians and ultimately users while simultaneously exaggerating the purported benefits.  Physicians and patients had no ability to conduct a realistic risk versus benefit assessment.

If you or a loved one has had a heart attack, stroke, or cancer and believe it may be related to any hormone replacement drug please call us for a FREE consultation.

Contact Us

If you have any questions concerning this case please feel free to contact Katie Johnson at 701-237-3166 or toll-free 877-237-3166 or by e-mail at: kjohnson@solberglaw.com