Case Info
Rezulin Drug Injury Lawsuit
Rezulin (troglitazone) was introduced in 1997 as one of the “new” types of antidiabetics to be used for Type 2 diabetes. It was a member of the thiazolidinedione group, also called “glitazones” that includes other medications such as Actos and Avandia.
Rezulin hepatotoxity, or toxic liver disease, had been known to be a potential side effect. The danger of liver damage appeared to have come from a combination of problems, including metabolic and non-metabolic issues, specific to the way the drug interacts with other proteins in the body and the way it is metabolized.
Rezulin’s application for marketing in 1996 was originally rejected due to these potentially fatal side effects. However, the FDA official who had objected to Rezulin’s approval was replaced soon thereafter, and the drug was approved for market in March 1997. Company executives agreed to stipulations that drug monitoring be conducted to monitor for liver damage.
In December of 1997, the same year Rezulin had been introduced to the U.S. market, and only 6 months after its British approval, it had already been withdrawn in the UK. By March of 1999, epidemiologists at the FDA warned that monitoring patients for liver function would not be enough to prevent liver failure and by March 2000, at least 430 cases of liver failure had already been reported.
On March 21,2000, Rezulin was withdrawn from the U.S. market, and withdrawal from the Japanese pharmaceutical market followed shortly afterward. By the time it was withdrawn, the drug had been linked to 63 liver-failure deaths but had generated over $2.1 billion in revenue for Warner-Lambert.
By 2009, Pfizer settled or resolved more than 35,000 Rezulin lawsuits in federal, state and local courts. Settling or paying damages awarded for Rezulin cases cost the companies and its subsidiaries an estimated $750 million. Most of the cases had been settled in federal multidistrict litigation (MDL) which had been consolidated in federal court in New York, but about one-third had been settled in various state courts.