HACKARD & HOLT IN THE NEWS
Leading Rezulin Attorney Urges FDA to Revamp Drug Reporting Process
Hackard Denounces Warner-Lambert's Tactics to Keep Diabetes Drug on Market
Bethesda, MD., May 19 /PRNewswire/ -- Speaking before a U.S. Food and Drug Administration committee today, an attorney spearheading nationwide legal action against pharmaceutical giant Warner-Lambert Co. pleaded with committee members to fix the FDA's system for reporting dangerous drug side effects and avoid repeating a 1999 decision that kept the diabetes treatment Rezulin on the market another year.
Meeting in Bethesda, Md., to discuss Rezulin, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee heard testimony from Michael Hackard of Sacramento, who has filed eight cases in federal court on behalf of former Rezulin patients who suffered severe liver damage as a result of taking the drug.
Hackard described how Warner-Lambert successfully manipulated a reporting system that relies on pharmaceutical companies tracking the adverse side effects of their own drugs.
As a result of this system, Warner-Lambert's figures prevailed over estimates from one of the FDA's own experts that only 10 percent of all liver failure cases linked to Rezulin were being reported. The FDA expert also told committee members during a 1999 hearing that one patient out of 1,800 could suffer liver failure within six months of starting a Rezulin prescription, countering company claims that only one patient out of 57,000 suffered side effects.
Warner-Lambert pulled Rezulin from the market March 21 after FDA officials expressed renewed concerns. By then, it had been linked to 90 cases of liver failure, including 63 deaths, and posed a much higher risk than previously believed to 500,000 people still taking the drug.
Given that higher risk, thousands of these people have probably suffered liver damage, which is difficult to diagnose before it enters its final stages, Hackard said.
"To me, the failure to withdraw Rezulin is so entwined with tragedy that I must admit that I cannot think about it without an overwhelming sense of regret," Hackard told the committee. "I see the ruined lives of people who asked me to speak here today -- people who I have come to know -- fathers who want to see their children graduate from high school, mothers who want to stay alive long enough to see their children grow to early adulthood, and adults and their families who are perplexed by this committee's, this government's and this manufacturer's failure to act sooner."
Hackard represents more than 40 people in addition to the eight plaintiffs with cases pending in federal court. They include at least eight liver transplant patients, 30 people diagnosed with non-alcoholic cirrhosis and 10 families who lost loved ones whose deaths are believed linked to Rezulin use. He is representing each client on a contingency basis.
Working out of Sacramento, Hackard focuses his practice on pharmaceutical liability, a field he entered during the early 1990s after his own encounter with a defective medication following surgery to remove a brain tumor.
In each of the suits filed against Warner-Lambert, Hackard alleges a reckless drive for profits motivated the company's decision-making on Rezulin. Prior to its 1997 release, the drug was placed on a "fast-track" approval schedule after the company pressured FDA officials and even lobbied to have a scientist critical of Rezulin removed from the process. Millions of diabetes patients received Rezulin prescriptions after its FDA approval, earning Warner-Lambert an estimated $1 billion in revenue.
Calling on Warner-Lambert to inform former Rezulin users of the danger they face with the same zeal with which it marketed the drug, Hackard went on to urge the FDA committee to fix a system he described as "a narcotic for post-approval nonintervention."
"This system has also been used by companies like Warner-Lambert to minimize the risks that their drugs present. As recently as May 12, 2000, the chief executive officer of Warner-Lambert trumpeted that 'the number of Rezulin cases and the magnitude are insignificant.' Hundreds of deaths, thousands of injuries are 'insignificant'? Those who believe in basic human rights don't think so," Hackard told committee members.