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Surgeon Says He Wasn't Told of Valve's Defects : Liability: Plaintiff would not have been given Shiley heart device implant if doctor had known of the mechanical flaws, he testifies in Santa Ana trial.

August 04, 1993|JAMES M. GOMEZ | TIMES STAFF WRITER

SANTA ANA — A surgeon who implanted a potentially defective artificial heart valve in a San Diego woman 13 years ago told an Orange County Superior Court jury Tuesday that the manufacturer did not tell him about mechanical failures in similar valves before he operated.

Marking the opening day of the first trial ever held on the controversial--and sometimes deadly--Bjork-Shiley Convexo-Concave Heart Valve, cardiac surgeon Joseph Verska told the 10-woman, four-man jury (two are alternates) that he would have given plaintiff Ruth Barillas a different artificial valve during her July, 1980, open-heart surgery.

"I was not aware of any mechanical defects," Verska said.

Barillas, 55, is suing medical device manufacturer Shiley Inc. of Irvine and its former parent company, New York-based Pfizer Corp., in Orange County Superior Court in Santa Ana.

Shiley, which made and sold the Bjork-Shiley valve from 1976 to 1986, is accused of lying to the U.S. Food and Drug Administration about potential defects when it applied for approval to sell the valve and of concealing the heart valve's fatal flaws to the medical community.

Though Barillas has lived for 13 years since the operation to treat an incurable case of congestive heart failure, she is claiming emotional and psychological stress because she does not know if the valve will malfunction.

She had little more than a week to live before she received her Shiley valve, according to testimony.

Barillas did not learn about the possibility of her Shiley heart valve malfunctioning until 1991, when she underwent open-heart surgery for an unrelated heart ailment. Her doctor at that time warned her that the Shiley valve may someday break, but was unable to replace it.

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Since then, she claims that she cannot sleep and has been forced to seek help from a psychiatrist.

Her husband, Constantine Barillas, 66, a retired machinist, is also suing the company for loss of sexual relations with his wife, who claims that she can no longer exert herself for fear the valve inside her will crack.

Shiley attorneys argued, however, that the company has long been upfront in disclosing the potential for the valves to break.

They also defended the discontinued product, saying that it continues to be the best valve in existence for preventing blood clots from forming on artificial valves, a major problem in artificial heart valve technology that in itself can lead to death.

They also painted a picture of Barillas as a woman with a long history of medical and emotional problems who would have died long ago if not for the Shiley valve implant.

"Shiley gave her the gift of life," said defense attorney Pierce O'Donnell. "She handed Shiley a lawsuit for fraud."

The trial is meant to be a bellwether in the long-running Shiley heart valve case. While there have been about 300 individual and class-action settlements, Barillas is the first of at least six valve recipients scheduled to go on trial.

The jury's decision in this case could set a precedent for all future decisions regarding the Shiley heart valve, which has generated one of the most heated controversies in the medical device industry in decades. Alarm over the case has even spurred FDA Commissioner David Kessler to scrutinize the approval process at the FDA's Center for Devices and Radiological Health.

Cross-examination of Verska by O'Donnell is scheduled to continue today. Shiley spokesman Bob J. Fauteaux said that O'Donnell is expected to challenge Verska's claim that he did not know about occasional fractures when he picked the Shiley valve over six others on the market at the time.

"It was the valve of choice for surgeons," Fauteaux said. "Its benefits outweigh the risks."

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The small, quarter-size valve--which received FDA marketing approval in 1979, malfunctions when a tiny metal strut that holds a plastic flap in place cracks where it is welded to the valve's outer frame.

To date, about 50,000 people throughout the world have a Shiley valve implant, with about 23,000 in the United States. As of January, 501 fractures had been reported to the FDA, and 164 of those people survived, attorneys said. Attorneys for Barillas estimate that Shiley valves malfunction at the rate of about 30 a year.

Barilla's attorney, Ed Kellogg of Atlanta, brought Verska to the stand Tuesday to illustrate the allegation that Shiley had not properly informed heart surgeons early-on that some valves had malfunctioned during and after clinical trials. Clinical tests are conducted on medical devices such as the Shiley valve before the FDA considers them safe and effective enough to market.

In his earlier opening statement, Kellogg told the jury that there were three confirmed breaks of the valve--one of which occurred during clinical trials--before Barillas received hers. Central to his case is the argument that Shiley committed fraud by continuing to sell the device to doctors and not informing them.

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