Wyeth's PremPro 'Fertilized' Cancer, Woman's Lawyer Says

Wyeth's (WYE) PremPro hormone-replacement drug "fertilized" what eventually became breast cancer in a 66-year-old Ohio woman who has sued the company, her lawyer said Wednesday at the start of a trial.

A Wyeth lawyer disputed the claim, saying the woman had numerous other risk factors for breast cancer, such as a family history of cancer, that made it 10 times more likely she would develop the disease compared with other women in their 60s.

Jennie Nelson, of Dayton, Ohio, took Prempro to treat menopausal symptoms from October 1996 until October 2001, when she was diagnosed with breast cancer. Before that she had taken a similar regimen including the Wyeth drug Premarin since February 1995.

Nelson's lawyer, Ken Suggs, told an 8-member jury in a state courtroom in Philadelphia that more than two dozen studies have shown PremPro increases the risk for breast cancer. Suggs asserted that Nelson's use of PremPro transformed a mass in her breast known as hyperplasia into cancer.

"You'll hear how the defendant's pill took a hyperplasia and fertilized it," Suggs said in a somewhat subdued opening statement Wednesday morning. He added that the case was about "costs and consequences."

Nelson's lawsuit against Wyeth, the Madison, N.J., pharmaceutical company, is the second PremPro case to go to trial. Jury deliberations are underway in the first case to go to trial in federal court in Little Rock, Ark.

Wyeth faces about 5,000 lawsuits filed by women claiming their use of PremPro and Premarin led to breast cancer and other diseases. Most were spurred by government studies linking the drugs to increased risk for various diseases. The drugs are still on the market, but publicity surrounding the government studies has caused Wyeth sales of Premarin-related products to drop to $909 million last year from $2.1 billion in 2001, the last full year before the key government studies began emerging. Wyeth maintains that it's impossible to prove that PremPro caused individual cases of breast cancer.

Suggs said Nelson, who was in the courtroom, had invasive breast cancer and had to have both of her breasts removed and undergo chemotherapy and radiation therapy.

Wyeth attorney Michael Scott acknowledged Nelson had gone through a lot, but he said the key question was whether there's any evidence PremPro caused her cancer. He said the answer was "no."

"The evidence is not going to support the idea that Mrs. Nelson got cancer because she used PremPro," Scott told jurors.

Scott said Nelson's mother had breast cancer, her father had pancreatic cancer and a sister had eye cancer. Family history of cancer is a risk factor for cancer. Other risk factors were her age and gender.

Scott also said there is evidence that her breast tumor was present before she even started using hormone-replacement therapy. Nelson, like many other women, took hormone therapy to relieve menopausal symptoms such as hot flashes and night sweats.

Nelson had a particular type of breast cancer that can be linked to hormone therapy, Suggs claimed, which is called hormone-receptor positive breast cancer. PremPro is a combination of versions of the hormones estrogen and progesterone. Suggs suggested that the medication fed the breast cancer.

But Scott countered that 70% of all breast cancer cases are hormone-receptor positive and include many women who never took hormone drugs.

Scott also told jurors Nelson was "doing well" following her treatment and there was no further evidence of her cancer. Suggs, who gave his opening statement first, didn't address Scott's claim in court and he declined to speak to reporters.

Testimony from expert witnesses was expected to begin Wednesday afternoon.

Wednesday's proceedings marked the start of the first phase of the trial, in which jurors must determine whether PremPro caused the breast cancer, and whether damages should be awarded for any harm caused. If the jury rules against Wyeth in this phase, the trial would enter a second phase in which the jury would consider what Wyeth knew about PremPro's risks and whether it properly disclosed them, and possibly award further damages.

Judge Norman Ackerman, who is presiding over the trial, said the first phase is expected to take less than two weeks.

There are two alternate jurors in addition to the eight regular jurors. Overall, there are seven men and three women among the regular and alternate jurors.

Wyeth shares fell 14 cents to $49.78 Wednesday.