Rezulin ® is the brand name for the prescription drug troglitazone, manufactured by Warner-Lambert (acquired by Pfizer), and used to treat Type 2 Diabetes or Adult-Onset Diabetes. Rezulin was a "fast track" drug that went through a shortened Food & Drug Administration (FDA) approval process. The drug was approved in January 1997 despite liver damage concerns and the objections of several FDA scientists. Despite evidence of liver damage the drug was aggressively marketed, without any recommendation for liver monitoring. Rezulin was the nation's fastest approved diabetic medication and nearly 700,000 Americans took the popular drug.
Soon after Rezulin entered the market, the FDA began receiving reports of Rezulin users suffering from liver disease (cirrhosis) and liver failure. The FDA responded to the reports by ordering Warner-Lambert to put stronger liver toxicity warnings on the drug label.
Despite reports of liver damage, the drug manufacturer continued to market the drug and successfully fought a ban of Rezulin in the U.S. for 27 months, as the drug was estimated to have made over 1.8 billion in sales. The FDA finally ordered a recall on March 21, 2000 when it had received 90 reports of liver damage in patients using Rezulin resulting in 63 in deaths and 10 liver transplants. As of 2002, the suspected number of Rezulin deaths has risen to approximately 400 and it is anticipated that over 14,000 persons may suffer liver problems related to Rezulin.
In June, 2002, the Los Angeles Times reported that internal documents indicated the manufacturer masked early indications of the drug's danger to the liver and its lethal toxicity in information provided to the FDA and to doctors.
In addition to liver damage the drug is also suspected of causing serious heart problems. Pre-marketing studies suggest that Rezulin may cause abnormal thickening in the left ventricular wall of the heart, leading to heart failure in many patients. Despite the studies, the manufacturer refused to place any warnings regarding possible heart damage and liver failure on the drug.
Since the drug's recall in March 21, 2000, Warner-Lambert Co. has been subjected to more than 35,000 lawsuits nationwide.
In a recent Los Angeles jury trial, a jury panel ruled the diabetes drug can hurt the liver but did not cause two deaths or a man's illness. Hundreds of other cases are still pending in Los Angeles.
Juries in Rezulin trials have so far reached mixed results. A Houston jury awarded a $43 million verdict in December 2001 to a 63 year old woman who claimed the drug destroyed her liver. In 2002, a jury in Edinburg, Texas, ordered the drug manufacturer to pay $25 million to an 80 year old woman who died after taking Rezulin for three months.
In response to the litigation, Pfizer announced in January 2004, that it would set aside $975 million to cover personal injury claims arising from Rezulin.
2005 REZULIN INFO & LINKS
To view the Rezulin litigation Orders and Decisions Archive 2004, click here. The manufacturer of Rezulin has reported "$1.358 billion of legal provisions recorded for Rezulin personal-injury claims and governmental investigations of marketing practices."