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SALT LAKE CITY - (Mealey's) A Utah federal jury on Sept. 7 awarded a hormone replacement therapy plaintiff $5.1 million in compensatory damages after finding that her breast cancer was caused by Premarin, Provera and Prempro and that manufacturer defendants Wyeth and Pharmacia & Upjohn Co. LLC negligently failed to warn about the risk (Toshilo Okuda v. Wyeth LLC, et al., No. 1:04-80, D. Utah, N. Div.).
(Verdict available. Document #28-120920-006V.)
The jury in the U.S. District Court for the District of Utah found that plaintiff Toshiko Okuda proved by a preponderance of evidence that Premarin, Provera and Prempro caused her breast cancer. It then found that she proved her claim of negligent failure to warn against Wyeth and/or Upjohn by a preponderance of evidence.
The jury found that $5.1 million would fairly and adequately compensate Okuda for harm caused by the defendants.
However, the jury also found that Okuda did not prove her claims for strict liability failure to warn and negligent design defect.
17 Years Of Drug Use
In 1985, Okuda, then 47, underwent a total hysterectomy to treat heavy bleeding and an enlarged uterus. She took the defendants' drugs between 1985 and 2002 to relieve menopausal symptoms.
Okuda argued that the defendants failed to adequately test their drugs for safety and schemed to promote unproven benefits and downplay the drugs' risks.
The defendants argued that their drugs did not initiate or promote Okuda's breast cancer. They said the fact that Okuda's tumor was positive for estrogen and progesterone receptors was not a marker or proxy for the cause of her breast cancer since normal breast cells have the same receptors.
Other Risk Factors Alleged
The defendants said Okuda had a number of risk factors for breast cancer besides taking hormone replacement therapy drugs: her age, her gender, her breast density, a family history of colon cancer, her long exposure to secondhand smoke, post-menopausal weight gain, long-term used of oral contraceptives and possible exposure to environmental toxins.
They also argued that their drugs were properly designed and tested and that warning labels were adequate.
Okuda's experts included Donald F. Austin, M.D., M.P.H., an epidemiologist; Graham D. Colditz, M.D., an epidemiologist; Vijayakrishna K. Gadi, M.D., an oncologist; Paul Michaels, M.D., a pathologist; Elizabeth Naftalis, M.D., a breast surgeon; Suzanne Parisian, M.D., a regulatory expert; and Wayne Tilley, Ph.D., a breast cancer researcher.
The defendants' experts included Geza Acs, M.D., a pathologist specializing in breast and gynecological cancers; Lisa Bailey, M.D., a breast surgeon; Teresa Reading, M.D., a breast surgeon; Elizabeth Morris, M.D., a radiologist specializing in breast imaging; Thomas Stovall, M.D., an obstetrician/gynecologist; Raquel Arias, M.D., an obstetrician/gynecologist; and Lewis Chodosh, M.D., a breast cancer biologist.
The trial began Aug. 14, and the jury began deliberating Sept. 5.
Judge David Nuffer presided.
Okuda is represented by Matthew P. Teague, Russell T. Abney, Ted G. Meadows, James W. Lampkin II and Frank Woodson of Beasley, Allen, Crow, Methvin, Portis & Miles in Montgomery, Ala., and James Esparaza of Salt Lake City.
The defendants are represented by Tracey H. Fowler and Elisabeth M. McOmber of Snell & Wilmer in Salt Lake City; Kelly Evans of Snell & Wilmer in Las Vegas; Heidi K. Hubbard and Ryan T. Scarborough of Williams & Connolly in Washington, D.C.; and Charles Padgett Goodell Jr. of Goodell, DeVries, Leech & Dann in Baltimore.
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