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Catheter Manufacturer Pleads Guilty in Huge Medical Fraud Case

December 16, 1993

BOSTON (AP) _ A pioneering heart catheter manufacturer agreed Wednesday to pay $61 million in fines for making faulty devices and then covering up the defects. Two people died as a result of the flaws, a prosecutor said.

C.R. Bard Inc. of Murray Hill, N.J., pleaded guilty to 391 criminal counts before U.S. District Judge Mark Wolf. It agreed to pay fines equal to ″every penny paid to Bard for the sale of such catheters,″ said Assistant U.S. Attorney Michael Loucks.

Sentencing was set for Feb. 24.

Catheters are thin tubes with tiny balloons on the end used to reopen partially blocked blood vessels. Bard was the first in the nation to market catheters for repairing damaged blood vessels, and was the only company with permission to market them from 1980 to 1985.

In some cases, the balloon tips failed to deflate in people’s arteries. Other balloon tips broke off inside people’s hearts, forcing emergency bypass surgery.

Loucks said the flaws caused two deaths, but didn’t elaborate. In October, then-U.S. Attorney A. John Pappalardo said one death was in Missouri in 1988.

The company used people as ″guinea pigs″ to test unapproved catheters and lied to the Food and Drug Administration about their designs in hopes of reaping ″huge profits,″ Loucks said.

Bard admitted making faulty catheters, covering up their malfunctions and lying to the FDA about it.

″Bard sincerely regrets the activities that led to the plea entered today. Bard’s principal concern is the quality and integrity of its products and the welfare of its patients,″ said William G. Reilly Jr., the company’s assistant general counsel.

″All the products affected by this matter were withdrawn from the market in late 1989 and 1990. All Bard products now on the market have FDA approval, are safe and effective and can be used with confidence,″ Reilly said in a telephone interview.

Six current or former Bard officials, including former President George Maloney, have pleaded innocent to federal charges of racketeering, conspiracy and mail fraud. They are awaiting trial.

The case involved up to 20,000 catheters made by Bard’s USCI Division in Haverhill and Billerica. They were sold from 1987 to 1990.

Bard, an international health care products company, sells products for use in urology, surgery and cardiology. It employs about 8,500 people worldwide.

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