More than eight years after alleging hormone therapy drugs caused and promoted her breast cancer, Toshiko Okuda is finally getting her day in court.
Okuda was among dozens of Utah women and thousands nationwide who filed federal civil lawsuits against Wyeth and other drug manufacturers after researchers halted a National Institutes of Health sponsored study in 2002 upon finding an increased risk of invasive breast cancer among those using hormone replacement drugs. Her lawsuit, along with 68 others filed in Utah, was initially transferred to the Eastern District of Arkansas; three were remanded back to Utah's district court in April 2010.
Okuda's lawsuit is the only one of the three to proceed to trial; the other two cases were dismissed last year. U.S. District Court Judge David Nuffer is presiding over the jury trial, which is scheduled to end Sept. 7.
The jury, comprised of seven women and five men, is expected to hear from at least 30 witnesses some in person, others in taped video presentations or depositions read in court Â before the trial concludes. A majority of the witnesses are either current and former drug company employees or expert witnesses familiar with the latest research on breast cancer, hormone therapy and breast cancer risk. Okuda, her husband and daughter are also expected to testify.
Okuda's lawsuit, like others in Utah and across the nation, was filed after the Women's Health Initiative study reported in 2002 it had found increased risks of various diseases among women who took Prempro for an average of 5.2 years. It specifically found increases in breast cancer, strokes, heart attacks, blood clots and cardiovascular disease.
A supplemental report issued in 2003 reiterated the breast cancer risk finding, which an editorial in the Journal of the American Medical Association said offered "further compelling evidence against the use of combination estrogen plus progestin hormone therapy." A similar study in the United Kingdom released that year echoed the concern, reporting that post-menopausal women using combination hormone therapy were twice as likely to develop breast cancer as non-users.
In all about 10,000 cases have been filed against drug companies by women who allege the products caused or contributed to their breast cancers. In June, Bloomberg News reported that Pfizer, Wyeth's parent company, had paid $896 million to resolve 6,000 lawsuits. It said Pfizer has set aside another $330 million to resolve 4,000 cases still pending.
Of the cases that have gone to trial, outcomes have been mixed. Bloomberg reported in May that the drug manufacturers have won 10 of 21 cases decided by juries since 2006, when the first legal proceedings began. In cases that went against the companies, monetary awards have been sizable, ranging from $1.5 million to more than $70 million.
Okuda sued the drug companies in May 2004, claiming their products caused and contributed to her disease. The companies "promoted hormone therapy as drugs of prevention as well as being safe and effective," her complaint states. "The reality is the exact opposite."
Okuda underwent a hysterectomy in 1985 when she was 47. Over the next 17 years, she took various doses and combinations of hormone therapy drugs including Prempro, Premarin and Provera to treat menopausal symptoms. In 2002, Okuda was diagnosed and successfully treated for infiltrating ductal breast cancer.
In her complaint, Okuda alleges the drug companies failed to adequately test and study their products and worked to "distract" consumers and physicians from the breast cancer risks associated with hormone therapy drugs, efforts that included a ghost-writing campaign orchestrated by Wyeth to attack studies questioning the safety of the hormone treatments. She alleges the companies knew about but failed to "disclose, misstated, downplayed and understated" the health hazards and risks associated with Prempro, a prescription drug that contains a combination of estrogen and progestin, and other hormone therapy products.
One expert witness testified last week that the hormone therapy drugs acted like "fuel on the fire" of Okuda's breast cancer.Another expert called by Okuda said there was a dramatic drop in breast cancer diagnoses among women ages 50 to 69 that corresponded with reduced numbers of women taking hormone therapy drugs following release of the Women's Health Initiative study findings and was "completely consistent" with the estimated number of breast cancers related to hormone therapy drug use.
Wyeth and Pharmacia & Upjohn Co., which makes the progestin drug Provera, counter that the hormone therapy drugs were properly designed and tested, and used FDA-approved warnings during the period Okuda used them, including a warning about the potential for increased breast cancer risk and "cautioned" Prempro was not intended for use by women who had undergone a hysterectomy. Defense witnesses have told the Utah jury that it was long-standing knowledge that estrogen therapy drugs may promote growth of pre-existing breast cancer cells in some women, but no evidence they cause the cancer.
"There is no reliable evidence that [Okuda] would not have developed breast cancer but for her use of [hormone therapy]," the companies state in a court filing. "To the contrary, Mrs. Okuda was diagnosed with the most common type of breast cancer in postmenopausal women that she could have gotten" and "all available evidence points away from [hormone therapy] as having any impact on the growth of her cancer."
The companies argue that thousands of women who have never taken hormone therapy drugs have developed the same type of breast cancer after entering menopause and that other risk factors may have been factors in Okuda's disease.