February 7, 1994 — New York Times

A unit of Pfizer, Inc. has agreed to pay $10.75 million to settle Justice Department claims that the company lied to get Federal approval for a mechanical heart valve that has fractured, killing hundreds of patients worldwide.

Under the settlement, which was announced Thursday, both Pfizer and Shiley, Inc. also agreed to pay $9.25 million in coming years to monitor patients who received the device at Veterans Administration hospitals or pay for its removal. Both companies denied any liability or wrongdoing. Government officials applauded the agreement, which they said was one of the largest ever involving a medical device.

“This agreement represents a landmark health care settlement,” an assistant United States Attorney General, Frank Hunger, said in a statement. “It is significant that a company accused of making false representations to the Government has been held accountable.”

But the deal was criticized by consumer activists who had long urged Government officials to bring criminal charges against Shiley officials, contending that they had covered up hazards of the device even as it was fracturing and killing patients.

“For this multi billion-dollar company to get off with a 10-plus million-dollar civil penalty, and for the responsible officials to escape jail sentences for the tragic loss of so many lives, is inexcusable,” Dr. Sidney Wolfe, director of the Public Citizen Health Research Group, said in a statement.

In a June 1992 letter to Senator John McCain, a Republican of Arizona, Stuart M. Gerson, an Assistant Attorney General, said Government officials could not criminally prosecute the matter because the statute of limitations had expired.

The settlement marks the latest twist in the long-running saga of the Bjork-Shiley Convexo-Concave mechanical heart, which was marketed in the United States from 1979 to 1986. Life-threatening fractures of a tiny valve strut occurred in 196 of the estimated 31,370 patients in this country who received the device, according to the Federal Drug Administration. Such fractures proved fatal in two out of every three cases.

240 Reported Fractures

Dr. Wolfe said Federal officials had received more than 240 reports of Shiley valve fractures from officials in other countries, though he said his group thought the number was actually higher because many had gone unreported.

Justice Department officials had charged that in order to win approval to market the device, Shiley withheld evidence indicating the valve’s potential to fail. They also said Shiley made questionable representations about the device’s medical value to keep it on the market and that some of the company’s manufacturing processes were also flawed.

In January 1992, Shiley proposed a settlement estimated at $155 million to $205 million that would cover about 55,000 heart-valve patients. Under the proposal, the company agreed to pay for monitoring of the valves by physicians and research to identify the patients at greatest risk for fractures.