Magazine article FDA Consumer

Heart Catheter Manufacturer Pays Record High Penalty

Magazine article FDA Consumer

Heart Catheter Manufacturer Pays Record High Penalty

Article excerpt

After a government investigation found the use of unapproved heart catheters caused at least one death and 20 emergency heart operations, the New Jersey manufacturer of the devices agreed to pay the highest criminal penalty ever imposed in a medical case, $30.5 million, plus another $30.5 million in a civil settlement. This health-care fraud investigation was one of the largest in the history of FDA and the U.S. Department of Justice.

On Oct. 14, 1993, C.R. Bard Inc., of Murray Hill, N.J., one of the world's largest health-care product companies, pleaded guilty to a 391 -count criminal information that included charges of:

* illegally testing unapproved catheters in humans for safety and effectiveness and concealing the experimentation from FDA

* changing designs of catheters without seeking FDA approval and lying to the agency about catheter design

* concealing from FDA catheter malfunctions, including balloon ruptures, deflation problems, tips breaking off during use, and balloon wrapping problems.

A heart catheter is a wire with a balloon-like tip that is threaded into a clogged heart artery and inflated to flatten the clogging material against the vessel wall, thereby widening the path for blood to flow to the heart muscle.

The faulty devices--all made at the company's USCI division in Billerica and Haverhill, Mass.--not only necessitated many emergency open-heart surgeries to remove broken catheter tips, but also led to one heart attack and one death. …

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