Prempro Trial Ends in $4M Compensatory Damage Award, Plus Punatives

A Connecticut jury has ordered Pfizer to pay $4 million in compensatory damages to a woman who was diagnosed with breast cancer after taking the hormone replacement therapy (HRT) medication Prempro, and the drug maker will also be hit with additional punitive damages by the judge as a result of the actions of their Wyeth subsidiary. 

The Prempro lawsuit was brought by Margaret Fraser against Wyeth, which developed Prempro as an independent company before being absorbed by Pfizer. Fraser accused the company of marketing an unreasonably dangerous drug and failing to warn women and doctors about the risk of breast cancer from Prempro side effects.

Following trial, the jury not only ordered Pfizer to pay $4 million in damages to compensate Fraser, but also found the company’s actions to be reprehensible enough to qualify for additional punitive damages, which are meant to punish and deter other pharmaceutical companies from similar conduct. Those damages will be decided later by a federal judge, but could be several times larger than the compensatory award the jury gave Fraser last week.

About 10,000 Prempro suits have been filed against Pfizer’s subsidiaries, all involving similar allegations that the drug makers failed to adequately research the side effects of Prempro or warn that the medication may increase the risk of breast cancer.

Prempro contains a combination of the drugs Provera and Premarin, which artificially boost hormone levels in women undergoing menopause due to surgery or in postmenopausal women. Known as hormone replacement therapy, or HRT, the drugs are designed to provide relief from symptoms such as hot flashes, irregular menstruation or weight gain.

Most of the complaints were filed after a 2002 study by the National Institutes of Health found that women receiving HRT were at a higher risk of breast cancer, strokes and heart attacks. By that time, Prempro and other HRT drugs had been used by more than 6 million women.

Pfizer has now lost 11 of the 20 Prempro cases that have gone before a jury, with several trials resulting in multi-million dollar compensatory awards and even larger punitive damage awards after juries determined that Wyeth intentionally hid the risk of breast cancer from Prempro.

In December, Pfizer announced that it had set aside a total of $840 million to settle nearly half of the 10,000 claims against it. The company hopes to settle the remaining lawsuits with a set-aside of another $260 million in the first nine months of this year.