Among other things, the indictment charges that company officials failed to notify the FDA when serious problems arose with one catheter model and that they allowed studies to be conducted in humans without FDA approval using a second type of catheter that they had developed.

Those charged were George T. Maloney, chief executive officer and chairman of Bard; David Prigmore, former group executive vice president; John Cvinar, former president of the USCI division of Bard; Lee Leichter, USCI's director of regulatory affairs and quality assurance; Kenneth Thurston, director for regulatory affairs of USCI, and Janice Piasecki, a supervisor in the regulatory affairs department.

"This extraordinary settlement with Bard is a reflection both of the severity of the criminal conduct by the company's USCI division between 1987 and 1990, and Bard's desire to assure that this unfortunate episode in its past is never repeated," [A. John Pappalardo] said.