Courts • Jury finds hormone therapy led to breast cancer; drug companies vow to appeal.
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A federal jury awarded $5.1 million in compensatory damages to a Utah woman Friday after finding hormone therapy drugs caused her breast cancer and drugmakers were negligent because they failed to adequately warn of that risk on labels provided to doctors and patients.
The U.S. District Court jury, comprised of seven women and five men, sat through four weeks of expert testimony and scientific presentations before being handed the case early Wednesday afternoon. They came back with a decision two days later.
Toshiko Okuda, who filed her case in 2004, wept at the news after the jury left the courtroom.
In a statement released later through James Esparza, her Utah attorney, Okuda said she was "pleased that the jury, after four weeks of hearing the facts of this case, elected to stand up and tell Wyeth and Upjohn that their conduct in marketing and promoting Premarin, Provera and Prempro was unreasonable and irresponsible for an American corporation."
"I plan to move forward and will support other women when they have their day in court," Okuda added. "I want to thank all the attorneys and others involved in my case whether in the courthouse or outside the courthouse who worked countless hours to give the opportunity for success in this case. I want to thank the jury and their families for giving up four weeks of their lives to serve on this jury and serve this important civic responsibility."
The drug companies also released a statement Friday afternoon, saying they plan to seek to have the decision reversed through post-trial motions and an appeal. A spokesman pointed out that nine of the last 12 hormone therapy cases heard by juries that reached a final verdict were decided in their favor.
"We are disappointed with the jury's verdict and believe there is no basis in fact or law for this decision," said Christopher Loder, a spokesman for Pfizer, Wyeth's parent company. "Hormone therapy medicines are an important treatment option for many women with debilitating symptoms of menopause."
Okuda was among dozens of Utah women, and thousands nationally, who sued Wyeth and other drug manufacturers after the Women's Health Initiative study, sponsored by the National Institutes of Health, found an increased risk of invasive ductal breast cancer among women taking Prempro, a combination hormone replacement drug. About 10,000 cases were filed against the companies. Pfizer has spent nearly $900 million to resolve more than half those cases.
Okuda underwent a hysterectomy in 1985 at age 47 and, because of severe menopausal symptoms, took various doses and combinations of hormone therapy drugs Premarin, Provera and Prempro over the next 17 years. In 2002, she was diagnosed and successfully treated for infiltrating ductal breast cancer.
Jurors were asked to answer two questions: Did Wyeth's drug Prempro cause and promote Okuda's cancer? And did Wyeth and Pharmacia & Upjohn, which makes the progestin drug Provera, fail to use reasonable care in product warnings about the elevated risk of breast cancer associated with the products? Under Utah law, jurors were allowed to consider compensatory damages, but not punitive damages, if they found in favor of Okuda.
Frank Woodson, an attorney for Okuda, said during his closing arguments on Wednesday that "the evidence in this case is obviously these people knew" about the increased cancer risk. Okuda's attorneys said researchers first raised concern about a breast cancer risk in the 1960s and, while it remained an unsettled question for decades, an internal Wyeth memo showed the company had "valid concerns" about a connection.
Woodson said neither company did its own long-term studies on the safety of its products, but researchers consistently showed an increased risk of breast cancer among women taking estrogen plus progesterone medications. The labels for Prempro and Provera provided to physicians and patients failed to adequately acknowledge that risk, Woodson said.
That led Okuda's doctors to believe science had not found a definitive link between hormone replacement therapy and breast cancer, he said.
The drug companies "didn't use reasonable care," Woodson told the jury during his closing argument, in warning that "this stuff is like gasoline on a fire that promotes abnormal cells into a breast cancer."
One expert testified that his research showed as many as 15,000 cases of breast cancer per year occurred in women taking the combination hormone drug. Yet the "defense witnesses told you the same thing, the same story line, that Wyeth wanted them to tell you over and over that no one knows what causes breast cancer," said Russell T. Abney, another attorney representing Okuda. "We are not arguing that Ms. Okuda didn't have an abnormal cell in her body. What we are arguing is that [estrogen plus progesterone] promoted that abnormal cell to grow."
Abney later put it more emphatically: "This drug created a tumor in Ms. Okuda."
Woodson told the jury that Okuda's medical bills tallied $31,000 but asked, "What's it worth" when someone gets breast cancer, undergoes radiation, chemotherapy and "has to tell her family she's got it?"
Attorneys for the drug companies argued that there was no way to prove Okuda would not have gotten breast cancer if she had not used the hormone products.
"There is no way on the face of the earth, given what we know and what we don't know about breast cancer, to sit here and honestly say, as all the doctors we have brought to you have said ... we don't know and we can't tell you," said Charles P. Goodell.
Defense experts testified that Okuda's breast cancer was the most common type, occurring in women regardless of their hormone therapy drug use. She also had other risk factors for breast cancer, including dense breast tissue.
"We don't know what caused her first breast cancer mutation," Goodell said in his closing argument. "But we know that without that mutation she would never have developed breast cancer."
He reminded the jury that the Women's Health Initiative found that 99.6 percent of women who took hormone replacement therapy remained cancer-free, compared to 99.7 percent of women who never took the drugs.
That means the risk of breast cancer is one in 7.8 women who take combined hormone therapy drugs, versus a one in eight risk for women who do not, he said.
"We accept that," Goodell said. "There is a small increased risk. ... If it has any effect, it is on an already existing cancer. It is taking the same thing and making it bigger."
Okuda's attorneys said the risk was triple.
"We have a debate about the right number that reflects the risk," Goodell told jurors.
Attorneys for the drug companies argued that the risk was properly characterized on the Premarin, an estrogen-only drug, and Prempro labels.
Heidi K. Hubbard, who also represented the drug manufacturers in the trial, said the Prempro physician's label in use at that time Okuda took the drug which was approved by the Food and Drug Administration made multiple references to the fact that some studies had shown a moderately increased risk of breast cancer was associated with longer-term use and that progestins may "enhance" that risk. The label also specifically said the medication was not intended for use by women like Okuda who have had a hysterectomy.
While Wyeth did not conduct its own long-term studies on hormone use, it donated pills and data to the studies, including the Women's Health Initiative study, Hubbard said.
"The decisions that were made were not relying on the label," Hubbard told jurors. "A different warning would not have made a difference."