Prempro class action begins in the US

More than 5,000 lawsuits have been filed in the US against Wyeth, the manufacturer of Prempro, a combination hormone replacement therapy which has been linked to an increase in risk of invasive breast cancer. The first case began on Wednesday in the U.S. District Court in Little Rock, Ark.

As many as six million women had taken Prempro, which contains estrogen and progestin, to treat menopause symptoms before results from the Women's Health Initiative released in 2002 linked the medication to a 24% increase in risk for invasive breast cancer and other health risks.

According to the NIH Web site, the increased risk translates to eight additional cases of breast cancer per 10,000 women annually. In the first Prempro lawsuit to reach trial, plaintiff Linda Reeves alleges that the medication, which she took for eight years, caused her to develop breast cancer.

According to the lawsuit, Wyeth was aware of the link between Prempro and increased risk for breast cancer prior to the release of the WHI results but did not inform the public. Some Wyeth sales representatives are expected to testify that they were instructed to play down the drug's risks.

Wyeth has denied the allegations and has said that there is a warning about increased risk for breast cancer on the Prempro label. U.S. District Judge William Wilson on Tuesday told the nine female and three male jurors that the case might last three to four weeks (Kaiser Daily Women's Health Policy Report, 8/23).

Reeves' attorneys have said she is seeking a judgment that could award her more than $1 million, Reuters reports (Reuters, 8/23).

Opening Statements

Wyeth attorney Lyn Pruitt said that most women who develop breast cancer never have taken HRT, adding that most women who have taken HRT never develop breast cancer, the AP/Philadelphia Inquirer reports (Demillo, AP/Philadelphia Inquirer, 8/24).

Zoe Littlepage, one of Reeves' attorneys, said Wyeth never told physicians about the risks of Prempro because it ignored "signal after signal" that Prempro increased a woman's risk of developing breast cancer. Littlepage also said that the jury should consider whether Wyeth had a responsibility to conduct long-term studies on Prempro to see if the drug was safe and effective (Arkansas Democrat-Gazette, 8/24).

Littlepage added that Wyeth as early as 1983 could have conducted a study on Prempro's effect on breast cancer risk, adding that the company is liable for not delaying the release of relevant information to physicians (AP/Philadelphia Inquirer, 8/24).

Rainey Booth, another of Reeves' attorneys, said, "If Wyeth had done the testing when it should have been done, ... Reeves probably wouldn't have taken the drugs at all, but if she did, she would have taken them for a shorter period of time at a lower dose."

Pruitt said that Prempro still is prescribed to women "in the same doses as taken" by Reeves. However, Littlepage said that after the WHI study, "Wyeth brought to the market a new drug called low-dose Prempro," which FDA would not permit to be renamed. "That is what is sold now. ... It is a different drug with a different dose," she said, adding, "It is recommended for short-term and limited use" (Arkansas Democrat-Gazette, 8/24).

Wyeth attorneys said Reeves in a deposition said she did not read the patient-information slip provided with Prempro prescriptions that noted the elevated risk of breast cancer.

Stephen Urbanczyk, a Wyeth attorney, said, "Wyeth met its responsibility in this case" (AP/Philadelphia Inquirer, 8/24).

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