A lawsuit was filed Monday in the Supreme Court of the State of New York on behalf on plaintiff Harry E. French, Jr., who alleges he developed Serzone-induced hepatitis on or about December 2000 and March 2001. (A copy of the complaint is attached.)
According to the complaint, on or about January 23, 2001, the FDA again required Bristol-Myers to change the product safety label of Serzone to exclude the word “rare” from the statement in the product safety label to explain there had been “reports of liver necrosis and liver failure, in some cases leading to liver transplantation and/or death.”
As of June 2001, 109 cases of serious adverse hepatic events with a temporal relationship to Serzone therapy were reported to either Bristol-Myers or the FDA. Of these 109 cases, there were 23 cases of liver failure – 16 of which led to transplantation and/or death.
Attorney Roger Smith of Beasley, Allen, Crow, Methvin, Portis & Miles in Montgomery, Alabama, who represents Mr. French, said the firm has as many as 30 to 35 cases involving Serzone. In fact, May 17, 2004, the firm filed a lawsuit against Bristol-Myers on behalf of a teenager who was prescribed Serzone when she was only 15, and subsequently suffered liver failure, underwent a liver transplant, and died at age 19.
“Needless deaths and injuries still are occurring because of Serzone having been sold in the United States market,” Smith says.
This past May, the firm’s founder, Jere Beasley, requested that Bristol-Myers recall Serzone before anyone else is harmed.
The lawsuit was filed by New York attorney Roberta Ashkin, who served as local counsel for Beasley Allen.