Bristol-Myers Squibb Co. announced (May 2004) that it would halt the manufacture and sale in the United States of Serzone, an anti-depression drug which has been linked to liver failure. Kline & Specter, one of the nation's leading law firms in actions against pharmaceutical manufacturers, handled a number of lawsuits against Bristol-Myers Squibb on behalf of consumers who suffered severe illnesses after using Serzone. One of them, a 40-year-old woman from Washington, D.C., died after using the drug.
The litigation was spearheaded by Lee Balefsky, a partner and head of the firm's Mast Tort Department. Balefsky has 25 years of experience in litigation involving a range of products, including prescription drugs.
Serzone had previously been withdrawn in other major markets such as Europe and Canada before it was removed from the market worldwide.
Bristol-Myers Squibb said the reason it was taking Serzone off the market was because of lagging sales. But Balefsky, in a news release issued on May 20, said the company's statement merely sought to obfuscate the real reason.
"They said they're taking it off the market because it wasn't selling. Well, the reason it wasn't selling was because it was more dangerous and life-threatening than the company would like to admit," he said, noting the drug has been linked to 55 cases of liver failure and at least 20 deaths.
Although the FDA estimated the reported rate of liver failure in the United States at one in every 250,000 to 300,000 users, those affected face death or the need for a liver transplant. Serzone sales have been estimated at about $400 million annually.
Bristol-Myers Squibb was informed by the U.S. Food and Drug Administration in December 2001 that it had to include a "black box" warning on all labels because Serzone could lead to liver failure in some patients. (Such warning labels bear a black outline as well as patient insert warnings.) Letters to prescribing doctors were also mandated.
The following month the company issued a manufacturer's warning to health care providers advising them that "cases of life-threatening liver failure have been reported by patients treated with Serzone." It said the rate of liver failure associated with Serzone use was "about 3-4 times the estimated background rate of liver failure."
The "black box" read in part:
WARNING
Cases of life-threatening hepatic failure have been reported in patients treated with SERZONE. The reported rate in the United States is about one case of liver failure resulting in death or transplant per 250,000 - 300,000 patient-years of SERZONE treatment...
Ordinarily, treatment with SERZONE should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases. There is no evidence that pre-existing liver disease increases the likelihood of developing liver failure, however, baseline abnormalities can complicate patient monitoring.
Patients should be advised to be alert for signs and symptoms of liver dysfunction (jaundice, anorexia, gastrointestinal complaints, malaise, etc.) and to report them to their doctor immediately if they occur. SERZONE should be discontinued if clinical signs or symptoms suggest liver failure...
Kline & Specter, PC, with some 30 experienced attorneys, several of whom are also highly regarded doctors, is one of the nation's leading law firms with the ability to litigate pharmaceutical drug lawsuits.
If you or someone you know has suffered liver dysfunction suspected as a result of Serzone use, you may have a legal claim. Click here to contact a Serzone lawyer for a free evaluation of your case.