Celgene Accused of Urging Unapproved Uses for Thalomid
Celgene Corp. (CELG) was accused of promoting its cancer drug Thalomid and related compound Revlimid for uses not approved by U.S. regulators in a newly unsealed lawsuit filed by a former saleswoman.
Thalomid, which the U.S. Food and Drug Administration has approved to treat multiple myeloma, is a new generation of thalidomide, a morning-sickness drug linked to birth defects in the 1960s and revived decades later to fight cancer, according to a complaint. Celgene marketed the “highly toxic” Thalomid for a wide range of cancers while downplaying its risks for blood clots, according to the complaint.
“Celgene’s initial marketing efforts for Thalomid were tantamount to ongoing human experimentation,” ex-saleswoman Beverly Brown said in the complaint unsealed yesterday in federal court in Los Angeles. “Because Celgene marketed the drug off-label, patients and their medical advisors were denied the appropriate warnings provided in a package insert when a product is used on-label.”
Brown said she worked as a Los Angeles-based pharmaceutical saleswoman from 2001 to 2011. She previously filed her lawsuit under seal citing the False Claims Act, which allows private citizens to sue on behalf of the government and share in the recovery.
The U.S. Justice Department chose not to intervene in the case, Reuben Guttman, Brown’s attorney, said in a phone interview.
Brian Gill, a spokesman for Summit, New Jersey-based Celgene, didn’t immediately return a call seeking comment on the lawsuit.
The case is U.S. ex rel. Beverly Brown v. Celgene Corp., 10-cv-03165, U.S. District Court Central District of California (Los Angeles).
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