July 31, 2001-Four file suit over Rezulin dugs claims
Four Florida diabetics, including a Broward County woman, have filed a lawsuit in state court against the manufacturer of the drug Rezulin, which was pulled from the market for causing fatal liver damage.
In contrast to more than 1,000 other Rezulin lawsuits across the country, the diabetics in this case were not harmed by the pills. They accuse drug maker Warner-Lambert of deceiving them with false safety claims. "People were told this was safe," their Miami attorney, David Heffernan, said on Monday. "These were lies from Warner-Lambert. The company knew there were problems in the initial trials but didn't disclose it."
The lawsuit, filed earlier this month in Miami-Dade Circuit Court, asks a judge to order the company to repay out-of-pocket costs plus damages and to certify a class action for all of the hundreds of thousands of Rezulin users in Florida. Their health insurers might be added later. The Broward patient, Geraldine Holland, could not be reached for comment.
The lawsuit also names as defendants pharmacies that sold Rezulin, including Eckerd, Walgreens, Albertson's and Kmart. The claim against Warner-Lambert focuses on news reports and other evidence that the company downplayed information about patients who developed serious liver damage during testing, before Rezulin was approved by the U.S. Food and Drug Administration in 1997. Warning labels and ads for the drug described its side effects as "comparable to a placebo." The company took in about $2 billion in revenues on Rezulin. A spokesman denied the company knew about the drug's potential for severe side effects.
Liver damage was seen during testing, but it was relatively minor and was disclosed to the FDA and on the label, said Bob Fauteux, a spokesman for Pfizer Inc., which acquired Warner-Lambert last year.
Over the next three years, the FDA linked Rezulin to 61 deaths from liver failure and hundreds of cases of serious liver disease, including seven that required transplants. At the FDA's urging, Warner-Lambert pulled the drug from the market in March 2000.
"While it was available, it offered an innovative treatment to more than 2 million people. Virtually all were helped by it," Fauteux said. The drug was the first to help type II diabetics, who develop the disease later in life, to compensate for their body's inability to use insulin. Other drugs now do the same thing, with fewer side effects. More than 1,250 Rezulin patients who suffered liver disease have individually sued the company for damages, and more than 60 lawsuits seek class-action status for injured users of the drug.
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