Propulsid Drug Company Endangered My Life, Man Says

By Laurie Cunningham

A Bergen County man has filed a class-action lawsuit against the drug company that markets Propulsid, a prescription heartburn medication that was recalled in March after it was linked to 80 deaths nationwide.

Robert Bernesser of Mahwah, who took the medication for two years, is suing Johnson & Johnson Corp., claiming that the company put his life in danger by delaying public notification that the drug could cause serious heart problems and even death when taken with other medications.

"There were problems with Propulsid and how it reacts with other drugs from the beginning," said Joseph Santoli, Bernesser's attorney. "But they didn't want to do anything that would affect the sales of the drug. We feel they were putting profits before people."

The lawsuit, filed this week in state Superior Court in Middlesex County claims that Johnson & Johnson downplayed the health risks of taking Propulsid and continued to promote a drug they knew was unsafe.

The suit asks that Johnson & Johnson be required to pay for a medical monitoring program for all patients who took Propulsid from 1993 to 2000 who have not experienced adverse reactions, but could in the future. The program, which would provide routine testing and monitoring for these patients, could cost the drug company billions of dollars.

"There is no reason my client or his insurance company should bear the cost when Johnson & Johnson fraudulently marketed a drug they knew caused heart injuries," Santoli said.

Propulsid is used to treat severe nighttime heartburn experienced by patients with gastroesophageal reflux disease. Since it hit the market in 1993, Propulsid has been linked to 341 cases of heart rhythm abnormalities and 80 deaths, according to the Food and Drug Administration. In most of these cases, the patients were mixing Propulsid with other drugs - including antibiotics, antidepressants or antifungal medications - or they had underlying health conditions, the report said.

In March, Johnson & Johnson, based in New Brunswick, agreed to pull Propulsid from the market, although it is still available as a last resort for patients who cannot get relief from alternatives.

"We have acted responsibly and did initiate a series of communications with physicians," said Greg Panico, spokesman for Janssen Pharmaceutical Corp, a subsidiary of Johnson & Johnson that manufactures Propulsid and is also named in the suit.

"We published information for patients as well to make sure the drug was used appropriately," he said.

As early as February 1995, the company sent letters to physicians advising them against prescribing the drug for patients who were taking certain medications, Panico said.

Bernesser, who was not mixing Propulsid with other drugs for the two years he was taking it, went to his doctor complaining of heart palpitations last year. Although he passed a health exam and hasn't had any other problems since, Bernesser filed suit as a precaution for complications that may arise in the future, Santoli said.

If the court agrees to certify Bernesser's complaint as a national class-action suit, Santoli said he expects hundreds of thousands of other plaintiffs to join in. More than 3 million patients worldwide have been prescribed the drug, he said.