Rezulin (Troglitazone)

Development and Release

In the mid-1990s, pharmaceutical company Warner-Lambert developed Rezulin as a drug to treat the effects of Type 2 Diabetes. Soon after its FDA approval and release in January of 1997, the drug became very popular among diabetics as a method of controlling glucose levels. Eventually, almost two million people were regularly taking Rezulin, leading to an estimated revenue total of $1.8 billion earned by Warner-Lambert… before the drug was pulled from the market in March of 2000.

Health Problems Associated With Rezulin

Even at the initial time of release, there were some concerns with Rezulin’s effect on the liver. Because of these concerns, patients who were prescribed Rezulin were regularly tested for the development of liver problems. Unfortunately, even with regular testing, some patients had such problems develop so quickly that by the time they went in for scheduled testing, toxicity in the liver had already arisen. Such liver problems persisted from the use of Rezulin, and it is estimated that at least 63 people died from liver failure due to their use of the drug (in addition to the many who suffered lesser harm).

Warner-Lambert’s Response

Despite initial concerns that the use of Rezulin was causing liver problems in patients, Warner-Lambert maintained that the drug was safe to use. Rezulin was pulled from shelves in England less than a year after its release. The FDA considered a similar measure at the time, but Warner-Lambert fought off its imposition until March of 2000, when the FDA finally banned the drug.

In the wake of the FDA ban, Warner-Lambert was sold to Pfizer—the world’s largest pharmaceutical company—for approximately $116 billion. Pfizer continued defense of the drug, both in the courts and in the media, until the final settlement was reached in 2009.

Legal Action

Rezulin lawsuits began in 2001 with plaintiffs claiming fraud, as Warner-Lambert publicly maintained the drug was safe despite mounting evidence that it caused severe liver problems. One jury determined that there was clear and convincing evidence showing that Warner-Lambert had withheld from physicians who were prescribing the drug material information that illustrated the dangerous nature of Rezulin.

While the estimated death toll resulting from the use of Rezulin tops out at less than 100, there were approximately 35,000 claims of personal injury from Rezulin users. Roughly 20,000 of those were resolved through dismissal, settlement, or verdict in state courts for a total of about $250 million. The remaining 15,000 cases handled by federal court in New York were settled for a reported total of $500 million paid out by Pfizer in 2009.

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