X-Ray Data May Bring Shiley Case Back Into Court : Medicine: An attorney for heart valve recipients says new technique could show greater incidence of failure.
An Irvine lawyer said Monday that he may ask a Cincinnati court to take another look at a settlement involving hundreds of recipients of potentially defective heart valves now that researchers have succeeded in using an X-ray technique to identify cracks in the devices.
Attorney James Capretz, who represents more than 300 heart-valve recipients, also said the researchers’ data may suggest that the rate of fracture is much greater than previously thought, given that researchers spotted three flaws in the 70 valves examined so far.
In New York, Pfizer Inc., parent company of the valves’ manufacturer, said Monday that Capretz’s comments are “misguided.”
Meanwhile, reports of the success of the technique made Wall Street investors skittish, fearing that the procedure could end up costing Pfizer hundreds of millions of dollars in claims. In trading on the New York Stock Exchange, the company’s stock slipped $1 a share Monday to close at $73. Pfizer contended that the new data “may be misleading” and pointed to the $300-million charge it took against its 1991 earnings to pay for claims.
“We do not see anything now that would lead us to believe that amount is not adequate,” Pfizer spokesman Rick Honey said. He also cautioned against false optimism, noting that the X-ray technique is experimental, has yet to be fully tested and must still be approved by the U.S. Food and Drug Administration.
The valves, made by Shiley Inc. in Irvine, were implanted in about 51,000 people worldwide before the company stopped making them in 1986. Of those patients, 300 have died when the struts holding the valves together came apart.
As part of a class-action settlement approved in August by U.S. District Judge S. Arthur Spiegel in Cincinnati, Shiley agreed to set aside $75 million for heart-valve research, including the X-ray technique being studied at William Beaumont Hospital in Royal Oak, Mich. The X-ray technique is one of several being developed to determine the likelihood that a valve will fracture. The settlement also includes about $4,000 per patient for physician consultations.
Capretz, who is the special counsel selected to implement the settlement program, questioned whether it provides enough funding for replacement surgery, given that the Michigan tests have found valve fractures at a higher rate than previously thought.
“Our focus is on how much is this going to cost and is Shiley going to pay for it,” Capretz said. “We are going to try to get these questions answered.”
Pfizer officials said the 300 patients who are participating in the study have artificial mitral valves that were implanted in 1982. The company says it has determined that such valves have a greater risk of fracture than others.
“These are all high-risk patients,” Honey said. “They are not indicative of all of (the valve recipients).”
Capretz also questioned whether the company would pay for regional diagnostic testing centers where the X-ray technique could be used. Pfizer replied that the idea is “premature” and was suggested in news reports by Dr. William O’Neill, who is leading the study.
If the X-ray technique is used, patients would first be screened to determine if they are at high risk for valve fracture. Then they would undergo the procedure to see if their valves do, indeed, have cracks.
Capretz also said information on the X-ray technique was not made available when the terms of the settlement were being negotiated.
“Certain recipients who opted out of the suit may have instead decided to be part of the class-action settlement had they known about the device and Pfizer’s apparent commitment to its funding,” he said.
But Pfizer officials said that word of the technique was given to Capretz’s firm, Capretz & Kasdan, in May, 1992, and made public in a court hearing the next month.
