New Jersey Judge Rules Federal Law Does Not Bar Lawsuits Alleging Wyeth Did Not Warn About HRT Prempro's Risks

Main Category: Menopause
Also Included In: Pharma Industry / Biotech Industry;  Litigation / Medical Malpractice
Article Date: 03 Jul 2007 - 9:00 PDT

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New Jersey Superior Court Judge Bryan Garruto on Wednesday ruled a federal law giving FDA the exclusive right to determine whether a drug's label or package insert has adequate health risk information does not bar state lawsuits alleging that drug companies did not adequately warn about the medication's risk, the AP/Houston Chronicle reports. The ruling comes in response to a suit filed by Ellen Deutsch of Livingston, N.J., who took Wyeth's hormone replacement therapy Prempro from 1996 to 2002, as well as the company's earlier menopause treatment Premarin. Deutsch is alleging that the drugs caused her to develop breast cancer (Johnson, AP/Houston Chronicle, 6/27).

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. A jury in a U.S. District Court in Little Rock, Ark., in September 2006 dismissed negligence charges in the first of the suits to go to trial (Kaiser Daily Women's Health Policy Report, 10/12/06). According to the AP/Chronicle, about 10,000 lawsuits have been filed over use of the drug, and about 250 lawsuits are pending in New Jersey.

Pharmaceutical companies since at least early 2006 have said that product liability suits are barred because of the federal Food, Drug and Cosmetic Act, but Garruto's ruling is at least the third by state and federal judges that says the law does not pre-empt such suits, the AP/Chronicle reports.

According to the AP/Chronicle, Garruto's ruling will allow Deutsch's case to proceed and also likely will help other plaintiffs who have filed suits against drug makers. Wyeth spokesperson Christopher Garland declined to comment on Garruto's ruling. Deutsch's attorney, Esther Berezofsky, said, "The point is, a drug being approved by the FDA does not protect drug companies from being sued," adding, "The FDA regulations (on label warning) are a floor, not a ceiling."

Garruto, who is handling hundreds of Prempro lawsuits, on Wednesday also issued other pretrial rulings in the Deutsch case, which is scheduled to go to trial July 9 (AP/Houston Chronicle, 6/27).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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