Wyeth CEO: Company Knew Prempro Risks in 1991

The third trial against Wyeth Pharmaceuticals and its menopause drug Prempro is underway in Little Rock, Arkansas, as the company tries to defend itself against charges of negligence and intentionally misleading consumers about the drug’s connection to breast cancer. On Tuesday, Wyeth chairman and CEO Robert Essner delivered a videotaped deposition in which he says the company was “concerned” about the breast-cancer risks associated with Prempro as far back as 1991.

Wyeth is facing more than 5,000 lawsuits with regard to Prempro, a hormone-replacement drug that uses doses of estrogen and progestin to treat menopausal symptoms, including hot flashes and mood swings. So far, the drug maker has fared well in the previous two cases that have gone to trial. In one trial, an Arkansas woman’s case was dismissed by the jury; in the second, a Pennsylvania couple was initially awarded a $1.5 million jury judgment before a mistrial was declared in October. (A new trial is in progress in Philadelphia.)

Although the company may have known about the risks of Prempro as early as 1991, it wasn’t until 2002 that the drug’s safety issues became widely known. A 2002 Women’s Health Initiative study sponsored by the National Institutes of Health (NIH) found that the use of an estrogen-progestin combination led to a 41 percent increase in strokes, a 29 percent increase in heart attacks, a doubling of rates of blood clots, a 22 percent increase in total cardiovascular disease, and a 26 percent increase in breast cancer. The study examined 16,608 healthy menopausal women, ages 50 to 79 years. Due to the increased risk of breast cancer, the NIH’s National Heart, Lung, and Blood Institute (NHLBI) halted clinical trials after delivering these findings in the Journal of the American Medical Association in July of 2002.

In the current Arkansas case before U.S. District Judge Bill Wilson (who also heard the previous Arkansas case), Little Rock resident Helene Rush is claiming that Prempro gave her breast cancer and that the company waited until after the 2002 NIH trial to add a “black box” warning to the product label, even though Wyeth was aware of the potential risks before that. Rush began using Prempro in 1996 and stopped after being diagnosed with cancer in 1999. Before the 2002 revelations, it is believed that roughly 6 million women took Prempro.

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