REZULIN: Lawsuits against Maker of Diabetes Drug Pile up

REZULIN: Lawsuits against Maker of Diabetes Drug Pile up

Lawsuits against the maker of Rezulin, the diabetes drug withdrawn from the market after it was blamed for at least 63 deaths, are piling up as both individuals and groups seek compensation for a wide range of alleged health complications.

Some patients died or needed lifesaving liver transplants after taking Rezulin, including a Franklin man who urgently needs a donor organ. Many more, including some in Massachusetts, say they require long-term monitoring to watch for potential side effects. The suits are multiplying in the wake of the decision last month by Warner-Lambert Co. of Morris Plains, N.J., to pull Rezulin off the market, under pressure from the US Food and Drug Administration. Sales of the drug were halted in Britain two years ago.

Rezulin is one of a class of new drugs that help diabetics use their limited amount of natural insulin more efficiently.

Officials at the FDA disagreed over the drug’s risks – with some arguing that the benefits to diabetics outweighed the risks – delaying agency action until March. “This case is such a tragedy for the Americans who suffered from the drug, and a tragedy for faith in the FDA,” said Michael Hackard, a California lawyer who is representing 26 Rezulin patients.

Hackard said people who suffered severe liver damage, as well as the families of those who died, should get multimillion dollar settlements, based on previous suits in which patients needing transplants received settlements of $4 million to $6 million. However, because those suits will be so expensive to pursue – as much as $ 100,000 each – a Medford firm has filed a class-action suit to obtain compensation for people who did not have as severe a reaction to the drug. “This case is the only hope for some of the lesser-damaged people,” said Robert J. Bonsignore of Bonsignore and Brewer. The suit, said Bonsignore, aims to “force the company to set money to reimburse people who fell victim to their drug, for the cost of medical monitoring and maybe associated health costs.”

A second class-action suit was filed this month in New Jersey.

Warner-Lambert issued a brief statement in response to the lawsuits. It said the company’s conduct “was guided by strict adherence to FDA regulations.” While acknowledging that “some patients have experienced adverse events” while taking the drug, the company gave adequate warning about health risks.

In addition, some doctors continue to defend Rezulin. Dr. Martin Abrahamson, chief of adult diabetes at Joslin Diabetes Center in Boston, said he welcomed Rezulin as “a major advance” in controlling blood sugar, a major issue for diabetics. He defended the FDA’s course of action, saying that if patients were monitored properly, there was only a 1 in 100,000 chance of a “serious liver event.”

Since Rezulin’s withdrawal from the market, patients who were taking it have been switched to one of two drugs similar to Rezulin that appear to have fewer adverse effects, said Abrahamson. Hackard, the California lawyer, said his clients from across the country include six people have had or will need liver transplants, and others “who are too old or too sick to have liver transplants, and will die” as a result of damage allegedly caused by Rezulin.

The Massachusetts patient he represents, David “Chris” Ashe, 53, of Franklin, suffered such severe liver damage that he needs a transplant to survive, said Hackard. While Hackard blames the FDA in part, he says the company “apparently suppressed information” about deaths that occurred in early clinical testing so that the FDA was unaware of them.

Rezulin was touted as a great advance in diabetes treatment when it was introduced in early 1997. A growing number of deaths linked to the drug forced Warner-Lambert to strengthen warnings about possible toxicity.

Hackard said that the FDA allowed Warner-Lambert to push the drug through approval in about six months, compared with the normal three-year approval process. By not withdrawing the drug when it was pulled from the market in Britain, he said, the company “brought in an additional $1.5 billion in revenue while lots of people died.” Hackard estimates that up to 600 deaths may have occurred due to Rezulin, 10 times the reported number.

David Geiger, a Boston attorney who defends product-liability lawsuits, said Warner-Lambert would probably rely on its regulation by the FDA as a defense against its actions, and that plaintiffs would have to convince a jury that the Warner-Lambert was negligent in its warnings to doctors. (The Boston Globe, April 25, 2000)



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