Bitter Pill to Swallow
WEST NEW YORK – Lynnette Curran said she could live with the wooziness, upset stomach and scaly skin associated with Rezulin, the diabetes drug yanked from the market last month after being linked to more than 60 liver failure deaths.
But after being told that she had sustained permanent damage to her heart, she pledged to take legal action.
“Millions of people like me put their trust in them,” said Curran, 31, referring to Warner-Lambert, the Morris Plains producer of Rezulin. “They should be held accountable for what they’ve done. I’m better now, but this whole thing put me on a death alert.”
Curran and two other northern New Jersey residents filed a class action lawsuit April 11 against Warner-Lambert, and its subsidiary, Parke-Davis, accusing the company of concealing safety information about Rezulin when it applied for approval from the federal Food and Drug Ad ministration in 1996.
The complaint was filed in state Superior Court in Hackensack by Joseph Santoli, in Ridgewood and Lee Squitieri, of the New York law firm Abbey, Gardy & Squitieri. It was transferred from that court to Middlesex County on April 20, and will be heard before Judge Marina Corodemus, a specialist in mass wrongful injury cases.
No hearing date has been set yet. Santoli, a diabetic who specializes in product liability cases and is representing the plaintiffs, said the suit seeks to represent all people who took Rezulin for type 2 diabetes between March 1, 1997 and the beginning of this month.
He said he placed ads in newspapers in northern New Jersey, and took out commercials across the country last month to find former Rezulin users who were injured, and has been fielding hundreds of calls.
“It’s just scandalous,” he said. “Were they (Warner-Lambert) trading off money for lives? That’s how it would seem.
On March 21, Warner-Lambert obeyed a request by the FDA to recall the diabetes pill which was approved in 1997 after it was found to be connected to 61 deaths and seven liver transplants.
Citing higher toxic levels than other diabetes drugs, Janet Woodcock, director of the administration’s center for drug evaluation and research, said in a statement that “the continued use of Rezulin now poses an unacceptable risk to patients.”
But in a press release about its withdrawal, Warner-Lambert said it continues to believe the benefits of the Rezulin outweigh its risks. In recent news reports the company also said it strictly adhered to FDA regulations by adequately warning patients of the risks associated with the drug and would “vigorously defend” all lawsuits.
The company did not return several calls regal-ding the local lawsuit.
An estimated ~50,000 people have taken Rezulin which, when introduced, was touted for its ability to stabilize diabetes, a condition caused by high blood-sugar levels that affects about 15 million Americans. The $4 pill—recalled in Britain three months after its introduction—generated more than $1 billion in sales in 1998 and 1999.
“Basically, Warner-Lambert stonewalled the FDA the entire way,” said Santoli. “It was recalled in England because they thought it was too dangerous, and Warner-Lambert was well aware of that. But they continued with it for another two years.”
Curran, who had no history of heart problems, said she is now suffering from spotting in her lower left ventricle, the chamber of the heart responsible for pumping blood through the aorta.
She said she initially took the drug for nine days in 1998, but after experiencing shortness of breath and tingling in her extremities, was advised by her doctor to stop taking it. But in June 1999, she said she began taking Rezulin again after her doctors assured her that it was safe.
“I kept thinking that the doctor knows best,” said Curran, who took Rezulin for six months. “But they didn’t. They only know what the pharmaceutical companies tell them.”
A second plaintiff, 56-year-old Ed Virtue of New Milford, who took Rezulin for eight months, said he experienced discoloration in his bowel movements as well as shooting pains in his gut while on the drug.
“I’m angry with the pills, and l’m angry that they would let people have them for three years. And now, I wouldn’t even think about trying something new for diabetes,” he said, adding he scared of undergoing tests to determine whether he has been permanently damaged by the drug.
So far, numerous individual lawsuits have been filed over Rezulin. But Santoli—who also filed suits on the controversial diet drug fen-phen which was linked to several heart failures in Europe and japan—said he expects hundreds more to surface.
“I think this is just the tip of the iceberg,” he said. “If Warner Lambert had just acted in accordance with what other similar civilized societies were doing, they would have saved several lives,” said Santoli, referring to Britain’s withdrawal of Rezulin in December 1997.
“And part of the problem is that the drug was fast-tracked, so we really don’t know what the future holds for these people who have very grim prognoses,” said Santoli.
According to the complaint, the FDA is now investigating whether Warner-Lambert concealed findings of liver toxicity in their clinical trials.
But Richard Kahn, chief scientific and medical officer for the American Diabetes Association, in Maryland, said the organization backs the FDA request and is not concerned about health risks that may be associated with future diabetes drugs.
“We’re not wary at all. Unfortunately things come on the market and they have to be pulled. But we’re not worried,” he said.
Although for people like Curran, the damage done by Rezulin may not be known for many months.
“You rely on drugs and your doctors. You place your trust in them,” she said, adding that she believes her doctors were also poorly informed about the drug.
“And then you just feel betrayed.”