Group Urges Wider Heart Valve Recall : Organization Says Other Models of Shiley Device Are Defective and Led to 100 Deaths
The recent recall of an artificial heart valve manufactured by Shiley Inc. of Irvine is incomplete and at least 15 months overdue, according to a citizens’ activist group.
Shiley on Friday asked surgeons not to implant any of its 29- to 33-millimeter Bjork-Shiley 60-degree Convexo-Concave heart valves manufactured between March and June of 1982 because the struts that hold the valve together could fracture. So far, the company said, the mechanical defect has caused 21 valve breakdowns, resulting in 14 deaths.
But Dr. Sidney Wolfe, executive director of the Public Citizen Health Research Group, said that smaller heart valves of the same model pose a similar threat to patients and also should be taken off the market. All sizes of the heart valves together are responsible for the deaths of at least 100 people worldwide after about 150 of the valves fractured, Wolfe said.
Co-Founder of Group
The U.S. Food and Drug Administration and Shiley are “irresponsibly allowing the smaller valves to stay on the market,” said Wolfe, who co-founded the group in Washington with Ralph Nader in the 1960s.
About 2,700 of the recalled valves already have been implanted in heart patients worldwide, and those patients have been warned to be alert to any signs of imminent failure, such as dizziness or shortness of breath, which could require surgery to repair the valves.
Because of the Columbus Day holiday, FDA officials were unavailable Monday for comment.
A number of suits have been filed against Shiley alleging damage from failed heart valves, the latest by 46-year-old Bruce Peterson of Santa Monica. Peterson’s lawyer, Edgar Simon, said that Peterson, formerly a real estate loan agent, suffered brain and heart damage last January when a valve, implanted in his heart on Oct. 31, 1983, failed. Simon said Peterson was driving at the time and had only 10 to 15 minutes to reach a hospital emergency room or he would have died. Soon after he arrived at St. John’s Hospital, he lost consciousness.
Lodged in Artery
The disc portion of the broken valve traveled through Peterson’s bloodstream and lodged dangerously in an artery near his groin, Simon said.
During the emergency surgery, Simon said, Peterson’s broken mechanical heart valve was replaced with yet another of the kind that Shiley is now recalling.
Wolfe said that in July, 1984, the citizens’ group urged a recall of the Shiley valves based on information about deaths linked to them.
Later that same year a former Shiley engineer charged that artificial heart valves implanted in thousands of people are defective because of design problems, poor workmanship and lack of training at the company. But Shiley and FDA officials at the time said they considered the current valve models safe.
This is the third recall of Shiley artificial heart valves in the United States since the company opened in 1969. Frank Haskins, Shiley’s executive vice president, confirmed that another model of the artificial heart valve not distributed in the United States was recalled from European countries last year. In 1975 the company recalled the same valves after they were implicated in two deaths.
Haskins refused Monday to comment on the Public Citizen Health Research Group’s allegations, including contentions that the deaths have triggered several lawsuits and out-of-court settlements ranging between $300,000 and $600,000 each. Earlier, Haskins had confirmed that the company “has been in litigation,” but he declined to elaborate.
Haskins also said it was against the company’s policy to say which hospitals or heart surgeons have used the valves.
“We haven’t had time to evaluate the whole situation,” Haskins said Monday. He added, however, that the company would be prepared to answer more questions today.
Wolfe said Shiley “obviously is in a lot of trouble” financially over the valve problems. However, some pharmaceutical analysts doubted that the valve recalls and related litigation would deal a long-lasting blow to the finances of Shiley’s corporate parent, the giant Pfizer Inc. pharmaceutical company, which produces such widely known drug products and health and beauty aids as Ben Gay and Visine.
“Certainly it is not a favorable development image-wise, product-wise or financial-wise,” said David Saks, senior vice president in charge of drug and medical research for the investment firm of Morgan, Olmstead. “But in the total scheme of Pfizer’s $4-billion worldwide operations it is not a noticeable major setback.”
Saks said Shiley officials told him that the recalled valves represent “less than $4 million” in product sales. By contrast, he said, Shiley does about $125 million a year in sales, which is far overshadowed by Pfizer’s overall revenues. Saks said the company also has assured him that it has insurance coverage to handle litigation.
Times staff writer Roxana Kopetman contributed to this story.
