VA Worried About Possible Heart Valve Suits : Law: The agency could be sued by veterans because it purchased the device by Shiley, which has a lawsuit pending.

The U.S. Department of Veterans Affairs is concerned that it may be the target of future lawsuits by veterans who have received a Bjork-Shiley artificial heart valve.

“A patient could sue the VA because we purchased the heart valve,” VA spokesman Jon Wooditch, an executive assistant to the department’s inspector general, said recently.

Revelations that the VA may be drawn into the legal morass that has virtually engulfed Shiley Inc. came as lawyers prepared to wrap up the first trial the company has had to face in the 14 years since it began selling the potentially flawed device. The heart valve was taken off the market in 1986.

Ruth Barillas, 54, of La Mesa in San Diego County is suing Shiley, manufacturer of the heart valve, and its parent, Pfizer Inc., for emotional distress. Closing arguments in the stress-anxiety trial are expected Wednesday, Shiley attorney Pierce O’Donnell said.

Though no suits against the VA have materialized, Wooditch said it would mark the first time the federal government was a defendant in the long-running controversy about whether Shiley made false statements to the U.S. Food and Drug Administration and underplayed the valve’s dangers to physicians.

Such a lawsuit against the government could be expensive.

Shiley, which denies allegations of wrongdoing, has already paid out tens of millions of dollars to fund patient identification and strut fracture identification programs, according to the company. In addition, it has also set aside as much as $500 million in connection with class-action settlements, which the company is appealing.

Wooditch’s warning about potential litigation was first outlined in a 22-page report prepared for the VA’s Veterans Health Administration, which is responsible for overseeing its 171 hospitals and health clinics.

In the report, inspectors said that doctors at 24 of the VA’s hospitals implanted 564 Shiley valves in heart-diseased veterans. Of those, as many as 30% of those patients have not been located by the VA, making it difficult for inspectors to discover how many, if any, have died or have experienced fracture problems.

Medic Alert, a Northern California nonprofit medical identification organization, contracted with Shiley in 1992 to locate Shiley heart valve recipients, but it told VA inspectors that it did not have any information on how many veterans who received heart valves at VA hospitals have been notified.

Medic Alert stressed, however, that the number “was very low,” according to the report.

“Clinical managers had not taken proper actions to ensure that all patients who received . . . valves in VA medical centers were identified and informed of special risks,” the report states.

The report also said that a review of the Shiley-related legal issues revealed that the VA has no legal standing to sue the company since it has not been specifically damaged.

But, it warned, the federal agency is itself open for legal action from affected veterans.

“On the other hand, the VA’s failure to warn patients of the hazards may be a legitimate basis for an action against the VA,” the report concluded.

Wooditch said that the VA, as part of its efforts to defend itself, has initiated an investigation with the Department of Justice to see if Shiley can be sued under the federal False Claims Act. Under that act, the VA would have to prove that the company intentionally lied to the federal government by knowingly selling it a bad product and concealing the information.

“The Justice Department is looking into the whole affair,” Wooditch said. “It is still an open case.”