The Zyprexa's label currently bears a black box warning, the FDA's strongest warning, cautioning of the increased risk of death when Zyprexa is used to treat elderly patients with dementia. According to Deming, "prescribing atypical antipsychotics like Zyprexa off-label to treat behavioral disorders in elderly patients with dementia has been shown in clinical studies to be associated with nearly a two-fold increase in mortality, primarily due either to heart-related events, such as heart failure and sudden death, or to infections such as pneumonia."
The federal investigation into Lilly's Zyprexa marketing practices was conducted by the U.S. Attorney's Office for the Eastern District of Pennsylvania under the direction of acting U.S. Attorney Laurie Magid, Assistant U.S. Attorney Virginia Gibson, Chief of the Civil Division and Assistant U.S. Attorney Joe Trautwein.
Massachusetts Assistant Attorney General Bill Patten and Delaware Deputy Attorney General Dan Miller led the investigation on behalf of the states and the National Association of Medicaid Fraud Control Units ("NAMFCU").
UNITED STATES ex rel. STEVEN WOODWARD et al. v. ELI LILLY AND COMPANY, et al., Eastern District of Pennsylvania, CA No. 06-5526.
UNITED STATES ex rel. JAYDEEN VICENTE et al. v. ELI LILLY AND COMPANY, Eastern District of Pennsylvania, CA No. 07-1791.
Call Tavy Deming or Brian P. Kenney at 610-940-9099 to arrange availability for the complete news release; or other public material related to the case.
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