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Manufacturer Agrees to $61 Million Fine for Faulty Catheters

October 15, 1993

BOSTON (AP) _ A company that makes heart catheters engaged in a conspiracy to use patients as ″guinea pigs″ to test new products, resulting in the death of at least one person, prosecutors said Friday.

C.R. Bard Inc., a pioneer in catheters used for reopening damaged blood vessels, agreed in a plea bargain to pay $61 million in fines to settle a case involvikng 391 criminal counts, said U.S. Attorney A. John Pappalardo.

The company made faulty catheters, covered up their malfunctions and lied to the Food and Drug Administration, Pappalardo said. In some cases, the catheters failed to deflate in people’s arteries. In others, tips broke off inside people’s hearts, forcing emergency bypass surgery, he said.

The fine was one of the stiffest in an FDA case, Pappalardo said.

Six current or former company officials pleaded innocent to federal charges of racketeering, conspiracy and mail fraud.

Company President George Maloney, who stepped down Friday, was among five defendants who walked handcuffed into the courtroom for arraignment before U.S. Magistrate Zachary Karol.

Karol released Maloney, David Prigmore, John Cvinar, Ken Thurston and Janice Piasecki on personal recognizance. Lee Leichter was to be arraigned late Friday.

The case involved up to 20,000 catheters made by Bard’s USCI Division in Haverhill and Billerica. Company spokesman G. Reilly Jr., a Bard spokesman, said no catheters now on the market were among those referred to in the indictment.

The alleged lies and cover-ups were aimed at enriching the company, which made tens of millions of dollars off the sale of adulterated catheters, Pappalardo said.

Reilly said company management ″sincerely regrets the activity.″

The person who died was not identified. The death occurred in Missouri in 1988, said Assistant U.S. Attorney Michael Loucks.

A heart catheter is a wire with a balloon-like tip that is inserted into a person’s arteries, then inflated to open a clogged artery, improving blood flow.

″For a company to engage in a pattern of using unsuspecting patients as guinea pigs and operating rooms as laboratories for unapproved products shows a blatant disregard for the health and safety of the patients who literally entrusted their lives to the company’s products,″ said FDA Commissioner David Kessler.

Bard, a multinational health care products company based in Murray Hill, N.J., sells products for use in urology, surgery and cardiology. It employs about 8,500 people worldwide.

The company was the first in the nation to market catheters for angioplasties and was the only one with permission to market them from 1980 to 1985.

But by 1988, its market share had plunged to 50 percent, Pappalardo said. It filed phony documents with the FDA and sold catheters that had never been approved by the government, Pappalardo said.

In addition to paying the fine, the company agreed to open its books to an FDA consultant. Senior company officers will have to approve all submissions to regulatory agencies.

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