Justice Department Urged to Reconsider Shiley Suit

A consumer group this week called on the U.S. Justice Department to reconsider a decision not to file criminal charges against the maker of a potentially defective heart valve.

In a letter dated Thursday to Assistant Atty. Gen. Stuart M. Gerson, Director Sidney Wolfe of Public Citizens Health Research Group called the decision not to prosecute Shiley Inc. in Irvine and its parent company, Pfizer Inc. in New York, a “travesty of justice.”

About 51,000 people nationwide have been implanted with the artificial valves, made from 1979 to 1986. About 300 people have died when the struts holding the devices together cracked and came apart.

The group, founded by Wolfe and consumer advocate Ralph Nader, has been pressing the Justice Department to prosecute Shiley and Pfizer on charges of lying to the Food and Drug Administration and withholding other information in an effort to gain approval for sale of the device. The Justice Department announced last year that it would not prosecute in response to an FDA request to review the case.

“The government’s conduct here sends a strong but inexcusable signal that future corporate criminals have little to fear,” Wolfe wrote.

Wolfe’s letter came in response to a memo that Gerson wrote to Sen. John McCain (R-Ariz.) last summer. In the memo, Gerson wrote that criminal prosecution was not pursued “largely because it appeared that the statute of limitations had expired for most, if not all, prosecutable violations.”

But Wolfe urged the Justice Department to pursue the case through other means. He wrote, “It is likely that the statute of limitations has not run out on possible criminal conspiracy or racketeering charges.”

A lawyer with the Irvine law firm of Capretz & Kasdan, which represents about 300 valve recipients, urged the Justice Department to “do the right thing.”

“If we let corporations get away with this kind of conduct for whatever reason, what kind of society do we live in?” Vance Simonds asked. “What sort of message do we send to other companies which make potentially lethal products?”

Gerson said in his letter that the Justice Department was considering filing a civil lawsuit against Pfizer because the heart valves were implanted in patients whose bills were paid by Medicare or the Veterans Administration.

Justice Department officials could not be reached for comment.

A Pfizer spokesman rejected Wolfe’s allegations.

“There is not, nor has there ever been, any basis for criminal charges regarding the Shiley Convexo-Concave heart valve,” Pfizer spokesman Rick Honey said. “In addition, we do not believe civil claims are warranted.”