Shiley Lawyer Counters Claim by Valve Recipient : Courts: Attorney’s documents suggest Ruth Barillas suffered from depression years before she knew about the potentially faulty device.
SANTA ANA — An attorney for Shiley Inc. produced documents Friday suggesting that plaintiff Ruth Barillas suffered severe mental depression three years before learning that she had a potentially faulty artificial heart valve.
Barillas, 54, alleges that she suffers from depression, anxiety and insomnia because of fears that the Bjork-Shiley Convexo-Concave Heart Valve she received 13 years ago may fail. She had surgery to implant the Shiley valve in 1980 but did not learn until 1991, when she had unrelated surgery, that the device was among a batch that had been recalled.
During her second day on the stand in Orange County Superior Court, Barillas admitted that she filled out a “psycho-social” form at her medical clinic in 1988 indicating that she felt overwhelmed by health, marital and financial problems.
Her multimillion-dollar lawsuit against Shiley is linked to her attorneys’ ability to persuade the jury that the stress she is undergoing is related solely to the implanted valve.
The Shiley valve gained worldwide notoriety when it was learned that hundreds of them failed when tiny struts that hold the valves together snapped at weld points.
Some critics have charged that the company was guilty of sloppy manufacturing procedures, which caused welded struts in more than 500 valves to break.
In fact, documents filed in Superior Court--which will not be used in the first phase of the trial--suggest that some Shiley assemblers may have drank beer and smoked marijuana during work breaks.
In a deposition that was disqualified for use in the trial, former Shiley employee Judy Schuetz also alleged that workers who polished the valves were taught how to cover up faulty welds.
Other Shiley critics--spurred by concerns over blood clotting in the heart--have claimed that the design was inadequate and that the company dragged its feet to improve the device.
Shiley has maintained that the valve was actually safer than other models on the market at the time and only has a 0.1% rate of failure.
Of the 83,000 Shiley valves implanted worldwide, some 500 have failed, resulting in about 255 deaths, according to Food and Drug Administration records. Others, however, estimate that the death toll could be as high as 900.
During cross-examination on Friday, Shiley attorney Pierce O’Donnell attempted to cast doubt on Barillas’ testimony on Thursday. In earlier statements, she and her husband, Constantino, described their home life as “beautiful” and peaceful.
Her first day on the stand clearly had an effect on the 13-member jury, which listened attentively as her attorney walked her through a diary she kept from late 1990 to mid-1992. The diary is a key piece of evidence because it contains a number of emotionally charged passages and suggests how fears about the device’s failure kept increasing as time went by.
On Friday, O’Donnell showed the jury the form, on which Barillas wrote that she had “serious problems” with “financial matters and sexual functioning.”
Contrary to testimony Thursday by her husband that Barillas was so worried about her heart valve that she lost her desire for sex, she wrote on the 1988 questionnaire that she had a “lack of interest, going on for years now.”
O’Donnell also presented criminal records dating from 1990 to 1992 showing that the couple’s 28-year-old son, Steven, had been convicted on two misdemeanor charges and one felony charge involving drugs and illegal firearms. The records also showed a felony drug arrest for their 27-year-old son, Oscar.
The attorney attempted to show the court that Barillas was more upset with her sons’ conduct than with the potential for her heart valve to fail. To that end, O’Donnell also presented February, 1991, records from a psychiatric visit that suggest that Barillas was upset that “my sons don’t settle down.”
O’Donnell then reminded jurors about earlier testimony by her psychiatrist, Dr. Edwardo Baretto. The psychiatrist had told the court that, in sessions following her 1991 surgery, Barillas did not mention worries over the heart valve.
Barillas’ turn on the stand marked the end of the plaintiff’s presentation. After that, the defense called its first witness, a cardiologist and professor at Rhode Island’s Brown University, who spent an hour educating jurors on the functions of the heart and how heart-valve replacement is performed.
Dr. Anthony Moulton also testified that during a 1982 cardiology symposium, sponsored by Shiley, 50 cardiologists met and discussed “at length” the strut fracture problem. Such disclosures are key to the defense, which must show that it did not underplay the problem, as alleged by the plaintiff.
“We (cardiologists) were all keenly aware of it,” Moulton said.