Three in North Jersey Sue Rezulin's Maker

by Christopher Mumma
The Record

Three North Jersey residents filed a class action lawsuit on Tuesday over their use of Rezulin, the diabetes drug recalled last month after being linked to 63 deaths from liver failure.

The complaint, filed in Superior Court in Hackensack, accuses Warner-Lambert Co. of misrepresenting and concealing facts about the safety of Rezulin when it applied for approval from the Food and Drug Administration in 1996.

"There has been stonewalling on the part of Warner-Lambert throughout the entire sorry history of this drug," alleged Ridgewood attorney Joseph R. Santoli, who is representing the three plaintiffs in the class action suit.

A spokeswoman for Warner Lambert, which is based in Morris Plains, did not return a phone call about the lawsuit Tuesday.

On Monday, company officials acknowledged to The Boston Globe that some patients experienced adverse reactions while taking Rezulin. But the company said it had adequately warned patients about potential side effects.

In that statement, Warner Lambert promised to "vigorously defend" any lawsuits over Rezulin.

The diabetes pill was approved by the FDA in 1997 but was recalled March 21 amid a growing chorus of criticism about potential harm to the liver and heart. Warner-Lambert has estimated that 500,000 people took Rezulin in 1999 and generated revenues of more than $1.3 billion in 1998 and 1999.

Criticism also has been directed at the FDA for putting Rezulin on a fast-track approval process that may not have adequately gauged the safety of the pill, which is taken orally. At least one member of Congress has called for hearings about the review process, and the FDA has launched its own investigation of the matter.

The FDA is not named as a defendant in the Bergen County law suit, which seeks to determine whether Warner-Lambert violated the New Jersey Consumer Fraud Act by engaging "in calculated silence" about the safety of Rezulin "because the prospect of huge future profits outweighed health and safety issues."

A number of individual lawsuits have been filed over Rezulin. In addition, another class action suit related to the drug was filed Monday in U.S. District Court in Newark. That complaint seeks to have court-ordered medical monitoring of those who took it.

The Bergen County complaint names two people who have allegedly suffered health complications because of Rezulin.

One of them, 24-year-old Lynette Curran of West New York underwent a cardiac catheterization procedure last year after taking the drug, Santoli said.

Santoli said Curran—who had no prior history of heart problems—has increased mass in her left ventricle, the thick-walled chamber of the heart that pumps blood through the aorta. Other Rezulin users have been diagnosed with a similar condition, he said.

A second plaintiff, 28-year-old Paul Scalzitti of Paterson, took Rezulin for three years, beginning in March 1997, Santoli said. Scalzitti has tested positive for liver enzymes, an indication of damage to the organ, Santoli said.

A third plaintiff, Edward Virtue of New Milford, has no documented side effects from his use of Rezulin for eight months, Santoli said.

In three years, Rezulin underwent several modifications of its product warning label, including a reclassification last year as a drug of last resort for those with adult onset diabetes. An estimated 15 million Americans have adult on set diabetes, a condition characterized by high blood-sugar levels.

When it was approved, Rezulin was hailed for its ability to stabilize blood sugar levels by helping the body use insulin to process glucose.

The complaint, however, alleges that Warner-Lambert knew of potential side effects when it first applied for FDA approval in 1996. The company did not inform the FDA of potentially life-threatening liver injuries sustained by 11 research patients in clinical trials, the complaint claims.

In addition, Warner-Lambert "took action to neutralize" the opposition of the chief medical officer overseeing the FDA review of Rezulin, the complaint says. That officer, Dr. John L. Gueriguian, was removed from the Rezulin review after the company complained about him, the lawsuit says.

The complaint also says that one doctor with the National Institute of Health involved in a clinical study of Rezulin accepted more than $78,000 in consulting fees from Warner-Lambert. The FDA is investigating whether Warner-Lambert concealed findings of liver toxicity in those trials, the complaint says.