Diabetes Patients v Pfizer, Inc. (maker of Rezulin)

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Diabetes Drug Damages Some Patients' Livers

The Dugan Law Firm is investigating possible legal actions against drug manufacturer Pfizer to recover for liver damage and other severe side effects suffered by users of the now-withdrawn diabetes medication Rezulin (troglitazone). Rezulin was prescribed for type 2, or non-insulin dependent, diabetes patients who had not responded to other therapies. This type of diabetes typically is found in adults. Although the federal Food and Drug Administration (FDA) has publicly acknowledged 63 deaths from liver damage resulting from Rezulin use, a review by the Los Angeles Times identified 391 deaths in which Rezulin use was suspected to be the primary factor. Thousands more suffered non-fatal liver damage.

Rezulin was approved for use in the U.S. in January, 1997 after 'fast-track' approval by the FDA. The first medical examiner for the FDA who investigated the drug concluded that it was too dangerous to approve. He was stripped of the assignment, and his report was purged from agency files and withheld from an FDA advisory committee.

By fall 1997, dozens of patients on Rezulin had been hospitalized and a handful of cases of sudden liver failure had been reported to the FDA. These first cases prompted the removal of Rezulin from the market in Great Britain in December, 1997. But still it remained on the U.S. market. In March 1999, a senior FDA epidemiologist warned that Rezulin was among the most dangerous drugs available. He said that patient monitoring would not protect them from liver failure. Indeed, three patients who were monitored monthly in controlled studies suffered liver failure and died.

Other side effects that may be linked to Rezuline use include accidental injury, athenia, back pain, diarrhea, dizziness, headache, infection, nausea, pain, peripheral edema, pharyngitis, rhinitis. and urinary tract infection.

Another concern related to Rezulin use is damage to patients' hearts. As a condition of approval, the FDA requested the manufacturer to perform a study of the drug's effect in heart-failure patients, but the study was never completed. Meanwhile, scores of patients who took Rezulin have died of heart failure. But doctors say that because so many of these patients had pre-existing heart problems or were simultaneously treated with other drugs, it would be difficult to prove that Rezulin was the culprit.

Finally, on March 21, 2000, Rezulin was withdrawn from the U.S. market. The FDA has estimated that two million people used Rezulin.

When Rezulin was approved, the manufacturer's chief executive told investors he saw it as a 'billion-dollar blockbuster.' In fact, in three years on the market, Rezulin generated more than $2 billion in sales.

The Rezulin victims have names. Audrey LaRue Jones was a 55-year-old high school English teacher in East Saint Louis. She volunteered for a Rezulin study by the National Institutes of Health. She wasn't even a diabetic; the study was intended to determine whether taking Rezulin could prevent the onset of diabetes. She died at 2 a.m. on May 17, 1998 after taking Rezulin for several months. The Institutes banished Rezulin from the Diabetes Prevention Program.

Edith Ann West was a healthy 65-year-old widow before she began taking Rezulin. Although her diabetes had been diagnosed 14 years before, she managed the illness with twice-daily shots of insulin and a restricted diet. Several months after her doctor switched her to Rezulin, she became ill and eventually died of 'multiple organ failure caused by liver failure.'

JoAnn Ottmers survived her Rezulin use by receiving a liver transplant in time. But she needs 39 pills to get through the day since getting her new liver.

The actions in federal court have been consolidated in a New York federal court. Many other actions are pending in state courts around the country.

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