After one of the largest health care fraud investigations in history, the Justice Department and the Food and Drug Administration said Friday that a manufacturer of health care products has agreed to plead guilty to selling faulty heart catheters that resulted in numerous emergency surgeries and at least one death.
Additionally, the U.S. attorney in Boston announced Friday that a federal grand jury there has returned an indictment against six former and current officials of the company, charging them with violations related to the sale and distribution of the devices.
C. R. Bard Inc. of Murray Hill, N.J., with manufacturing sites in the Boston area, has agreed to pay a $61-million fine, half as a criminal fine and half as a civil liability settlement, stemming from activities by its USCI division in Boston.
The FDA said that the fine was several times larger than those from any prior enforcement action by the agency.
U.S. Atty. A. John Pappalardo said that the indictment against the individuals alleges "that for over three years, Bard and several of its top officers, in their effort to maximize profits, ignored the laws that protect the health and safety of all patients in the United States."
A heart catheter is a wire with a balloon-like tip that can be threaded into a clogged coronary artery by a physician and then inflated to flatten the clogging material, thus enlarging the blood's route to the heart.
The charges said that tips broke in numerous patients, resulting in many emergency coronary bypass graft surgeries to remove them--and in one heart attack. Also, according to the documents, one of the catheters failed to deflate, causing a death. Other malfunctions included balloon ruptures and balloon wrapping problems.
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.
In another instance, the company lied to the FDA about the existence of animal studies that showed troubles with a third type of catheter that had been released onto the market, the indictment alleged.
"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," FDA Commissioner David A. Kessler said in a statement. "The facts of the case speak for themselves."
All of the products in question were recalled in 1989 and 1990, the FDA said. All of the company's other products have been reviewed and no other safety problems were found, the FDA said.
William G. Reilly Jr., a spokesman for Bard, said that the company "sincerely regrets the activities that led to this plea agreement. We are a company whose primary concern is the quality and integrity of our products and the welfare of patients."
He said that all of the company's products currently on the market "can be used with confidence."
The core of the criminal charges against individuals involved the unlawful use in heart patients of catheters not approved by the FDA for human use, the Justice Department said. The violations occurred between 1987 and 1990, the department said.
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.
Maloney has taken a leave of absence as Bard's chief executive officer and chairman to work with his attorneys on his defense, Reilly said. His duties have been assumed by William Longfield, Bard's president and chief operating officer.
In addition to the fine, the company has agreed to institute a range of remedial measures during the next four years. During this time, the company's operations will be under the scrutiny of an outside consultant who will report to the FDA and will have unimpeded access to all company employees, the Justice Department said.
Also, the company's senior corporate management will have to approve personally all regulatory submissions to the FDA, putting them on notice that they will be responsible for any future regulatory actions, the department said.
"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," Pappalardo said.