A national class-action lawsuit was filed Monday, April 17, 2000 in federal court against Warner-Lambert and its subsidiary Parke-Davis over the harmful effects of Rezulin, a diabetes drug that was withdrawn from the market last month. Because of the extent of human-related injury and death, damages are expected to exceed $1 billion.

Detroit law firm Charfoos & Christensen filed the suit in U.S. District Court in Detroit on behalf of Kimberly Kent whose mother, Virginia Kent, of Detroit, Michigan, died after taking Rezulin.

An estimated 1.9 million Americans took Rezulin for the treatment of Type 2 diabetes in the past three years. Some of those users died, some have suffered liver damage requiring transplants, and some have suffered heart damage. The plaintiffs contend that everyone who has taken this drug needs extensive medical testing, even if no damaging side effects have been detected.

Rezulin was withdrawn from the market on March 21 at the request of the Food and Drug Administration (FDA) after being linked to liver failure and deaths. To date, 90 cases of liver failure and 63 deaths have been linked to Rezulin. There has been a series of damaging disclosures about the side effects of the drug since it was approved by the FDA three years ago.

The class-action lawsuit alleges that the drug remained on the market too long because Warner-Lambert and Parke-Davis withheld information from the FDA, consumers and their doctors about the adverse effects of the billion dollar drug. Some safety data reports were filed late with the FDA. There was a series of damaging disclosures before the drug was finally removed from the market.

"To have deadly side effects of a drug discovered after it is approved for use by the FDA is a tragedy, but to have it remain on the market because of misleading information and delayed safety reports is a travesty," said plaintiffs' attorney J. Douglas Peters. "Lives would have been saved and suffering prevented if this product had been pulled from the shelves when these problems were first documented."

Peters noted that the drug was withdrawn from the market in England more than a year ago.

In addition, the lawsuit alleges that there was a series of improprieties leading to the "fast track" approval of the drug by the FDA. There have been revelations about conflicts of interest and contrived data attributed to clinical-trial. As a result, the consumer watchdog group Public Citizen has called for both a criminal investigation and congressional hearings over the decision by the FDA to give Rezulin a six-month priority review in 1997.

"Fast tracking new drug approvals will only work if drug manufacturers report adverse results to the FDA honestly and in a timely manner," said plaintiffs' class attorney J. Douglas Peters of Charfoos & Christensen. "To hide this information did a disservice to the FDA, which is trying to speed up new drug approvals, and a disservice to consumers who placed their faith and trust in companies with the size and financial resources of Warner-Lambert and Parke-Davis."

For further information, or to obtain a copy of the Complaint, please contact J. Douglas Peters at 313-875-8080.