Wyeth Loses Prempro Suit

Pharmaceutical giant Wyeth was ordered by a Pennsylvania state jury to pay $1.5 million in compensatory damages to an Arkansas woman and her husband who held the company’s hormone replacement therapy (HRT) drug Prempro responsible for the woman’s breast cancer. Citing conduct by Wyeth that was “malicious, wanton, willful, or oppressive, or showed reckless indifference,” the jury has also begun deliberating on possible punitive damages to be tacked on. However, Judge Myrna Field ruled Tuesday that the company should not be held responsible for punitive damages a decision that may be overturned in the appeals process.

Mary Daniel, 60, of Hot Springs, Arkansas, began taking Prempro, a drug that combines estrogen and progestin, to treat the symptoms of menopause. Daniel started her therapy in late 1999 and was diagnosed with breast cancer in July of 2001. Her attorneys argued that Wyeth had known for decades about Prempro’s breast-cancer risk factor in postmenopausal women, but acted negligently by failing to provide adequate warnings or conduct sufficient testing.

Last week, in a separate Prempro trial underway in Little Rock, Arkansas, Wyeth chairman and CEO Robert Essner delivered a videotaped deposition in which he said 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 and its other HRT drug, Premarin. This is the third Prempro trial to reach a verdict. 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.

“Wyeth has known for decades that postmenopausal drugs cause breast cancer but the company deliberately failed to do studies to understand or quantify that risk,” plaintiff lawyer Zoe Littlepage said in a statement. “Wyeth protected their bottom dollar instead of protecting the patients.”

In related news, Wyeth today announced a fourth-quarter profit of $855 million on $5.22 billion in sales. For the year, they are expected to generate roughly $21.6 billion in revenue, with gross margins above 70 percent.

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