Shiley Valve-Linked Death Sparks Mission : Medicine: Victim’s fiance turns to Arizona Sen. DeConcini, Veterans Administration for ‘justice.’

SANTA ANA — Five years ago Wednesday, the artificial heart valve that Suzi Hollowell had lived with for seven years suddenly snapped, sending her into cardiac arrest.

An autopsy found that the 33-year-old Hollowell, a dietitian at the Veterans Administration Medical Center in Prescott, Ariz., had been implanted with a Bjork-Shiley Convexo-Concave Heart Valve, says Eric Adam, who was her fiance.

Since then, Adam, now 35, has been on a mission.

“Right from that point on, I felt there had to be other people who had this valve,” Adam said in a phone interview from Arizona on Wednesday. “I’m not out for revenge, I just want justice. She died five years ago today.”

A former photojournalist who now works in the VA hospital in Prescott, Adam said he collected more than 900 pages of documents and talked to hundreds of heart-valve recipients. He learned that the Shiley valves are suspected of having contributed to the deaths of 900 people worldwide. And he asked Sen. Dennis DeConcini (D-Ariz.) to start an investigation.

A month ago, VA Inspector General Stephen Trodden in Washington sent a letter to DeConcini stating that Adam had contacted his office and urged that criminal charges be brought against the maker of the Bjork-Shiley valve, Shiley Inc. of Irvine.

Though Trodden stated in a two-page letter that “VA does not have standing to pursue an action against the manufacturer of the valve,” the VA is working with the Justice Department to “determine any monetary loss to the government in relation to use of the . . . heart valve,” Trodden wrote.

“When such loss is determined, efforts will be made to recoup the loss.”

The letter marked the first progress for Adam in his quest to see Shiley and its parent company, Pfizer Inc., penalized for what he says is negligence.

“When I saw that letter, it gave me goose bumps,” Adam said. “I’m very optimistic because they’ve made statements in that letter they won’t be able to turn back on. There will be pressure from the public.”

Shiley has maintained from the start that the controversial valve is not defective.

While Adam was observing the grim anniversary, the company was defending itself in Orange County Superior Court. Fifteen years after the first Bjork-Shiley valve broke, one of many lawsuits against the company is finally being tried.

Ruth Barillas, 54, of San Diego, who received a Bjork-Shiley valve in 1980, is suing the Shiley for emotional distress and psychological damage. Attorneys for Barillas accuse the company of lying to doctors and the U.S. Food and Drug Administration about the potential for strut fractures.

Company attorneys deny that allegation and say that the vast majority of the 86,000 valves implanted in cardiac patients have worked properly--including Barillas’.

They also say that Shiley has acted in good faith, struggling to identify the cause of fractures, paying millions to the families of victims and for a system to identify valve recipients, and working to design safer valves.

The issue continues to cause a stir, however, from Orange County to Washington.

Last year, Assistant Atty. Gen. Stuart M. Gerson wrote to Sen. John McCain (R-Ariz.) that the statute of limitations prevented the Justice Department from filing criminal charges against Shiley. The government, however, is looking into whether the company violated the federal False Claims Act by marketing the heart valves to the VA, Gerson wrote.

Myron Marlin, a spokesman for the Department of Justice, said Wednesday that, because Shiley and the government are negotiating, the agency cannot comment.

The Justice Department decision not to seek criminal charges has raised the ire of Dr. Sidney M. Wolfe, a co-director of Public Citizen, a consumer group founded in Washington by consumer advocate Ralph Nader. In a scathing letter to Gerson late last year, Wolfe criticized the department for not acting against Shiley. “It is clear that an injustice has occurred,” he wrote.

In a phone interview Wednesday, Wolfe said, “We never received a reply. We are hopeful that the issue has been reopened, but we have no evidence of that.”