DEFECTIVE DRUGS: REZULIN

Background

On March 21, 2000 head of the FDA's center for Drug evaluation and Research stated that the "Continued use of Rezulin" posed an "unacceptable risk " to diabetes patients. At least 61 Rezulin users have died of liver failure. The total number of deaths is estimated to be as many as ten times higher than the reported 61 cases.

Doctors prescribed Rezulin to diabetics who took insulin but whose blood sugar was not well controlled. It was designed to help insulin (either your own or injected) work better, by drawing the sugar from your blood into the cells to supply energy.

Warner-Lambert, Rezulin manufacturer had downplayed the Rezulin liver damage concerns when seeking federal approval by assuring the Federal Drug Administration ("FDA") that the diabetes drug risk was low. Rezulin was a "fast track" drug that went through an abbreviated version of the FDA's approval process and was approved over the objections of several FDA scientists. After Rezulin was on the market, the FDA began receiving reports of patients suffering from liver failure after taking the drug. Rezulin was banned in England in December 1997 following the death of an American who took the drug.

The FDA soon ordered Warner-Lambert to put stronger liver toxicity warnings on the drug and an advisory committee recommended the drug be available to only a select group of patients -- those whose diabetes was not well-controlled by other drugs. The drug manufacturer, Warner-Lambert, successfully fought a Rezulin ban in the U.S. for 27 months before the FDA decided to prohibit sales of the drug on March 21, 2000. Warner-Lambert had strong reason to delay the banning: Rezulin is estimated to have made over $2.1 billion in sales. At its peak, the drug was prescribed 488,000 times in January of 1999.

Although the company found the risks of Rezulin to be outweighed by the benefits, Warner-Lambert knew as early as 1993 of the potentially life threatening Rezulin liver damage.

Eventually, at least 61 patients died of liver failure while taking Rezulin and another seven required liver transplants. There is strong reason to believe that there are hundreds and possibly thousands more with similar complications.

As announced on January 22, 2004 Pfizer (the company who acquired Warner-Lambert) set aside $955 million (after tax) to be used to cover all know Rezulin personal injury claims arising from the use of the drug. The one time charge against profits was said by Pfizer to be to be used in connection with the settlements reached with approximately 35,000 individuals who had cases or claims against the company. HH participated in this global settlement on behalf of hundreds of Rezulin users (our clients) and successfully saw a portion of these proceeds from the $955 million paid to clients who rightfully had a claim.

Government officials, pharmaceutical executives, scientists, and legal scholars will all look back on Rezulin as a tragic series of errors and misjudgments.

Hackard and Holt was successful in bringing hundreds of Rezulin cases to a negotiated settlement on behalf of its clients. Our skilled team of attorneys have investigated the facts, established the claims, determined which parties and insurance companies were to be held responsible, and then organized all of the details required when composing and presenting each case for settlement demand.

For most, the best protection will come from attorneys specialized in pharmaceutical litigation. Drug-related lawsuits have become all too common lately with companies putting profits and stock price above health risks to the public-at-large. If you need legal consultation concerning a defective drug call Hackard & Holt 888-452-5805 today.