Business Wire
April 17, 2002
On April 16, 2002, Kenneth B. Moll & Associates, Ltd., filed a nationwide class action lawsuit, in the United States District Court for the Northern District of Illinois, against Bristol-Myers Squibb Company, Inc., the manufacturer of Serzone (nefazodone hydrochloride).
Over 109 cases of serious liver injuries allegedly associated with Serzone have been reported. In at least 23 cases, Serzone users experienced liver failure and 16 underwent a liver transplant and/or died. Bristol-Myers admits that liver failure rates are 3-4 times greater for Serzone users than non-users.
The FDA estimates that the reported rate of liver failure in Serzone patients who used the drug for at least one year is about one case in every 250,000 to 300,000.
Serzone is an anti-depressant that is structurally different than other antidepressants. Serzone inhibits serotonin reuptake and blocks one type of serotonin receptor. It is prescribed for depression that causes anxiousness.
On January 9, 2002, Bristol-Myers warned health care providers that _cases of life threatening [liver] failure have been reported in patients treated with Serzone_ and that liver failure rates are underestimated because of under reporting. The true risk could be greater. According to Bristol-Myers, extreme cases of liver failure can occur within 2 weeks to 6 months after beginning Serzone treatment. Health Canada issued a warning in June 2001 regarding Serzone's serious side effects. Subsequently, the FDA announced on December 7, 2001 that it would require a Black Box warning on the drug, designed to inform patients about life threatening liver damage that can occur with the use of Serzone.
Kenneth Moll said, 'the primary goals of this class action are to (1) obtain a Court Order forcing Bristol-Myers to stop the manufacture and sale of Serzone and issue a recall, (2) inform the public that Serzone users are at an increased risk of liver complications, (3) provide compensation to all victims for death and personal injuries, (4) provide a medical monitoring fund for Serzone users and (5) reimburse monies paid for Serzone.'