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SERZONE USER SUES DRUG MAKER

The Record (Bergen County, NJ)

5/2/2002

Bristol-Myers Squibb Co., the world's fifth-largest drug maker by sales, was sued by an Ohio woman who claims the company's anti-depressant drug, Serzone, can cause fatal liver damage as well as other injuries.

Rita Ortiz of Plymouth, Ohio, contends she developed "serious and grievous personal injuries and harm" after taking the drug, which logged $409 million in 2001 sales and contains the active ingredient nefazodone hydrochloride. Her federal lawsuit, filed Monday in Cleveland, doesn't specify her injuries. Ortiz claims Bristol-Myers was negligent in the design, manufacture, and testing of the drug, and asks a court to require the company to create a medical-monitoring program for Serzone users. The drug was approved by the U.S. Food and Drug Administration in 1994. In 1999, Bristol-Myers was told by the FDA to include on the product safety label that "rare reports of liver necrosis and liver failure, in some cases leading to transplantation and/or death," were associated with Serzone, her suit says. Bristol-Myers spokesman Bob Laverty said the company "doesn't comment on matters in litigation. However, we will vigorously defend the safety and integrity of this product in any legal proceedings. "

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