On March 21, 2000 the head of the FDA's Center for Drug Evaluation and Research (CDER) stated that "continued use of Rezulin posed an unacceptable risk to diabetes patients." This was not first time the drug's dangers were called into question. In 1996, during the FDA approval stage, the lead medical officer cited Rezulin as potentially harming to the liver and the heart. The drug, however, was approved in January 1997. By fall of 1997, dozens of patients on Rezulin were hospitalized and cases of hepatocellular cancer, cirrhosis of the liver, and deaths from sudden liver failure were being reported.
Rezulin was banned in England in December 1997 following these reports. In the United States, FDA officials considered banning the drug, but Warner-Lambert, the manufacturer, successfully fought a ban in the U.S. for 27 months before the FDA decided to prohibit sales of the drug on March 21, 2000. Before the ban, sales of Rezulin generated Warner-Lambert $1.8 billion in revenues. At its peak, the drug was prescribed 488,000 times. As of January 2001, 391 Rezulin users have reportedly died from liver failure. It is now clear that Warner-Lambert Co. knew about Rezulin's potential to cause liver damage as it sought federal approval for its diabetes drug. Over 1,000 lawsuits have been filed against the company claiming Rezulin-related injuries and deaths. In June, the United States Judicial Panel on Multi-District Litigation ordered the transfer and consolidation of all pending federal Rezulin cases to the U.S. District Court for the Southern District of New York for coordinated pre-trial discovery and litigation purposes. This decision has no direct impact on the hundreds of Rezulin cases filed in state court against the company.