22 federal suits filed over hormone replacement drugs

By Kelly Holleran | Nov 28, 2008

HUNTINGTON -- At least 22 federal lawsuits were filed over a period of two days against drug company Wyeth in which plaintiffs alleged the company's hormone replacement therapy drugs for menopausal women can cause severe side effects such as cancer and cardiovascular disease.

In the complaints, the plaintiffs say they face an increased risk of heart attacks, blood clots, cardiovascular disease and breast cancer after taking Wyeth's Prempro. They based their claims on the findings of a 2002 Women's Health Initiative study.

The studies and findings came years after Premarin, the first Wyeth hormone replacement therapy drug, was placed on the market in 1942, the suit states. It received FDA approval the same year.

Throughout the years, Wyeth touted the drug's ability to provide cardiovascular benefits to women and to "make women look and feel 'feminine forever,'" the suit states.

A New York gynecologist wrote an article in 1962 claiming estrogen reduced breast and genital cancers. He wrote a book called "Feminine Forever" where he recommended estrogen for menopause, saying that women who used the drugs "will be much more pleasant to live with and will not become dull and unattractive."

Although the FDA refused to accept the gynecologist's data, Wyeth began to distribute the book to physicians across the country, the suit states.

Following the publications, Premarin sales quadrupled, and by the mid-70s more than 30 million prescriptions for Premarin were written every year.

Numerous other articles and advertisement were published throughout the 1970s, highlighting the drug's benefits.

Wyeth told physicians and patients there would be no harm in taking the drug for an extended period of time, and even encouraged the practice.

The first sign of danger appeared in the mid-70s when the first study was published that showed a link between the drugs and endometrial cancer, according to the complaint.

Sales dramatically decreased and Premarin was only prescribed to women for treatment of hot flashes and vaginal dryness.

Feeling it had to do something to increase sales, Wyeth added progestin to estrogen, which had been reported to lead to a decline in endometrial cancer. Prempro was born out of the combination in 1995, the suit states.

Wyeth continued to print numerous advertisements, some with models, and distribute videotapes promoting the drug.

In 2002, multiple studies claimed the drugs' risks outweighed its benefits and warned of a 60 percent increased risk of ovarian cancer for those women who took the drug.

"The WHI and NCI studies released in July 2002 changed the way doctors and scientists viewed estrogen – not only does estrogen hormone therapy fail to prevent disease, it substantially increases the risk of causing disease," the suit states.

In fact, while the risk of cardiovascular disease drops within three years after women stop using the drug, the cancer risk increases, the complaint states.

"Women who stopped using the product and who thought they were safe from increased risk of serious or fatal disease are now condemned to years of uncertainty, anxiety and emotional distress from wondering whether or when they will be diagnosed with cancer caused by use of Defendants' hormone therapy drugs," the suit states.

Again sales of Prempro and Premarin plummeted following the studies' releases, the plaintiffs claim.

At the time of the studies, approximately 38 percent of the estimated 50 million postmenopausal women in the United States were taking hormone replacement therapy. Of those women, six million were taking Prempro, according to the complaint.

Until August 2002, the labels on Premarin and Prempro did not mention the associated risk of ovarian cancer and were "inadequate, misleading, and inaccurate," the suit states.

It was not until Jan. 6, 2003, that Wyeth abandoned its "long-standing marketing strategy of promoting the long-term use of Premarin and Prempro" in a "Dear Doctor" letter, according to the suit.

The plaintiffs claims they suffered bodily injury, pain and suffering, disability, disfigurement, mental anguish and the loss of their capacity to enjoy life.

Because they took the hormone replacement therapy, the plaintiffs face a shortened life expectancy, medical expenses, a loss of earning and have suffered permanent and ongoing psychological damage, according to the complaint.

Their families have incurred medical, funeral and estate administration expenses, plus disintegration and deterioration of the family unit and its relationships resulting in anguish and depression, the suit states.

Plaintiffs claim Wyeth is liable because it failed to use due care when it prepared and designed its hormone therapy drugs, failed to perform adequate pre-clinical testing and failed to conduct post-marketing surveillance to determine the drug's safety.

In addition, the company failed to accompany its products with appropriate warnings, failed to use due care in the development, manufacture, inspection, marketing, labeling, promotion and selling of their drugs and failed to provide adequate training, according to the complaint.

It also failed to warn users of the need for regular medical monitoring to check for problems such as potentially fatal strokes, heart attacks, blood clots, cardiovascular disease, breast cancer and ovarian cancer, the suit states.

Wyeth failed to warn physicians and consumers about the possibility of becoming disabled and of the drug's adverse side effects, the plaintiffs claim.

Even though the company knew the drugs caused serious injury and illness, it continued to market them, which constitutes fraud and misrepresentation, the plaintiffs claim.

"Plaintiffs allege that Defendants colluded to publish and disseminate false information about the safety and efficacy of hormone therapy products to increase sales and profits," the suit states.

Wyeth breached its express warranty when it assured the drugs were safe for use through written and verbal assurances, press releases, verbal assurances, false and misleading written information, promotional pamphlets and advertisements, according to the complaint.

In the 13-count suit, the plaintiffs are seeking unspecified compensatory and punitive damages, plus attorneys' fees, prejudgment and post-judgment interest, punitive damages and other relief.

W. Stuart Calwell and Thomas G. Wilson of the Calwell Practice in Charleston will be representing them.

U.S. District Court case number: 3:08-1235

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