April 15, 1999-Rezulin Target of Lawsuit by Liver Failure Victim
A woman whose liver was destroyed just two weeks after she started taking the controversial diabetes drug Rezulin (troglitazone) today filed suit against the drug's manufacturer Warner-Lambert Company.
In a special Food and Drug Administration (FDA) hearing held in Bethesda, Md., on March 27, 1999, scientists confirmed that in the United States alone, Rezulin has been associated with at least 43 cases of acute liver failure, resulting in 28 deaths and 7 liver transplants. FDA epidemiologists have contended that most cases of liver damage from Rezulin are not being reported, and that the actual number of cases of liver failure is much closer to 400. In the lawsuit, which was filed in Kansas City's Jackson County Circuit Court, Marsha J. Bean and her husband Dr. John Bean, of Kansas City, allege that Rezulin destroyed Mrs. Bean's liver and required her to undergo a transplant. Also named in the suit were C. D. Smith Healthcare, Inc., the wholesale distributor, and Brad Kunkle, a pharmacist who dispensed the Rezulin prescription to Mrs. Bean.
According to Anita Porte Robb, attorney for the Beans, "Dr. and Mrs. Bean are outraged that a company would market and heavily promote a drug with such life-threatening risks." According to the suit papers, the manufacturer Warner-Lambert recommended testing of liver enzyme levels after a month of taking the drug. However, Mrs. Bean's liver failure was induced after only two weeks on Rezulin.
Robb added that the Beans have suffered great emotional injury, too. That's because it was Dr. Bean who prescribed the drug for his wife. He relied on Warner-Lambert's inadequate liver enzyme test schedule. "For Dr. Bean, the consequences of Warner-Lambert's irresponsibility were personal as well as professional," said Robb.
In the FDA hearings last month, FDA epidemiologist David Graham calculated that 1 in every 1,800 patients who take the drug for 6 months may experience liver failure. According to media reports, approximately 750,000 Americans now use the drug, which posted 1998 sales of $748,000,000.
Graham reported that for 9 of the 43 liver failure cases studied, the transition from normal to irreversible damage occurred within four to 34 days. He pointed out that there were few or no warning signs or an obvious risk factor for development of hepatotoxicity. Because of rapid deterioration, monthly monitoring would miss 75 percent of liver failures.
Graham warned that patients taking the drug had at least a 50 times greater chance of experiencing acute liver failure than the general population. Moreover, he reported that the longer a patient stays on the drug, the higher the risk. Scientists have recommended to the FDA that Rezulin use should be restricted, in hopes that only diabetics who need it most will risk deadly liver damage. Authorities such as Jules Hirsch of Rockefeller University have recommended that patients should try Rezulin only after finding that other, less risky therapies don't work.
Last month, the United Kingdom Medicines Control Agency refused to permit Glaxo-Wellcome to resume marketing Rezulin in the United Kingdom. Glaxo-Wellcome, a co-marketer of Rezulin, withdrew Rezulin from the United Kingdom in December 1997.
If you or a loved one has suffered an injury as a result of taking any drug or supplement, call Law Offices of Robert Dourian now at 800-790-8856 or CLICK HERE TO SUBMIT A SIMPLE CASE FORM. The initial consultation is free of charge, and if we agree to review your case, we will work on a contingent fee basis, which means we get paid for our services only if there is a monetary award or recovery of funds. Don't delay! You may have a valid claim and be entitled to compensation for your injuries, but a lawsuit must be filed before the statute of limitations expires.