Irvine Firm, FDA Assailed Over Faulty Heart Valves
A highly critical congressional report to be released today accuses federal regulators of allowing an Irvine-based heart-valve manufacturer to market faulty products that killed more than 200 patients here and abroad, even though regulators and the company were aware of quality control problems.
The study of the U.S. Food and Drug Administration’s regulation of Shiley Inc., the heart-valve maker, “raises serious questions about the FDA’s willingness and ability to . . . protect public health when faced with companies that profit from the manufacture and sale of medical devices,” the report states.
The document, prepared by the staff of the investigations subcommittee of the House Committee on Energy and Commerce, will be the focus of a subcommittee hearing today on the FDA’s ability to aggressively monitor medical-device manufacturers. The subcommittee is chaired by Rep. John D. Dingell (D-Mich.).
Officials of Shiley, which is owned by pharmaceutical giant Pfizer Inc., insist that their company has acted responsibly and that their heart valves have prolonged the lives of tens of thousands of patients who otherwise would have died.
The company, which also manufactures heart-lung machines and other products for the critically ill, employs about 1,100 at its Orange County plant.
Speaking of Shiley’s “60-degree” heart valve (called that because it opens 60 degrees), which was sold in the United States between 1979 and 1986, Shiley attorney John R. Shewmaker said: “The valve remained on the market because . . . the evidence showed that the benefits of the valve outweighed the risks associated with it.”
Shiley spokesman Robert J. Fauteux added: “No matter what the medical procedure or the medical device, there’s always going to be an element of risk involved.
“We’re very concerned that if the minimal acceptable standard for any kind of medical procedure or device or drug is absolute perfection, then the benefits of so many . . . innovations . . . are not going to be available,” he said.
Between 1979 and 1986, doctors implanted about 81,700 of the 60-degree valves in heart patients. Shiley has reported that at least 389 failed, resulting in the deaths of 178 patients. The congressional report says, however, that the problem may have been under-reported. The report charges that the FDA did not have enough information to establish clear standards defining the safety and effectiveness of the valve.
The subcommittee report concludes that Shiley:
* Failed to report to the FDA certain critical failures of the valve during the early stages of marketing the product and later delayed giving key information to the FDA to permit the agency to assess the valve’s safety.
* Continued to aggressively market the device “despite internal knowledge of serious problems in the manufacturing and quality assurance procedures.”
* Violated the spirit of an FDA order suspending export of another heart valve, the “70-degree” valve, by attempting to market valves already overseas at the time of the suspension.
The report is equally critical of the FDA. According to the subcommittee staff, the agency:
* Ignored warnings of Shiley heart-valve failures that came from its Los Angeles district office and “failed to suspend manufacturing operations until a solution to the . . . problem could be identified.”
* Applied a double standard “by approving export of the ‘70-degree’ valves without obtaining safety and efficacy data, which is required for approval for domestic marketing.”
* “Failed to aggressively monitor and demand from Shiley product performance information” and “undermined its enforcement authority by moving too slowly in issuing regulatory letters.”
In addition to prompting the congressional investigation, which began a year ago, the problems with the heart valves have brought Shiley and Pfizer a host of lawsuits. Although company officials would not disclose the number of cases they have settled, a Washington-based public interest group two years ago estimated total settlements at more than 30.
Shiley became a pioneer in the manufacture of artificial heart valves after its founding in Irvine in 1966. The devices are surgically implanted in humans to replace natural valves that are diseased or deformed. The company was acquired by Pfizer in 1979.
In 1976, about the time that federal law began to require a premarket approval process for certain medical devices, Shiley developed the “Bjork-Shiley 60-degree convexo-concave heart valve,” consisting of a flexible disc installed in a metal ring, which in turn is surrounded by another ring that is sewn into the heart.
The disc, which replaces the damaged heart valve, opens to allow blood to flow through as the heart beats, and then closes. The disc is held in place by two wire holders called struts. If either of the struts should fracture or break, the disc comes off the ring, allowing uncontrolled blood flow through the heart. The chance of dying because of a strut failure is greater than 50%, according to both the company and federal investigators.
After a five-month review process, the FDA granted Shiley permission in April, 1979, to begin selling the 60-degree valve in the United States.
Company officials said strut fractures persisted in valves manufactured through 1984, when they said the company finally corrected the problem. By then, however, it apparently was too late to save the product.
Shiley withdrew the valve from the market in 1986, largely because of flagging sales caused by increasingly unfavorable publicity about valve failures.
“Sales were declining,” Shiley attorney Shewmaker said. “Doctors were in some cases reluctant to use the valve because they had litigation exposure on their minds.”
In the early 1980s, Shiley sought permission from the FDA to market a successor product, the 70-degree valve. But researchers concluded that the strut failure rate of the 70-degree valve was seven times greater than the 60-degree valve, the subcommittee states.
The FDA never gave Shiley permission to sell the 70-degree valve in the United States. However, it granted Shiley an export license for the product in 1980. The license was suspended because of the strut failure problem in January, 1983, after Shiley had sold about 4,000 of the 70-degree valves overseas. The company voluntarily withdrew the product in May, 1983. The company has reported 94 strut fractures in the 70-degree valve, resulting in 70 deaths.
The company currently manufactures only one heart valve, the Monostrut valve, a different design that is only available overseas. Shiley is seeking FDA permission to sell the Monostrut valve in the United States. Company spokesman Fauteux said no incidents of strut failure have been reported in any of the 65,000 Monostrut valves implanted in patients.
Fauteux and Shewmaker strongly dispute any suggestion that Shiley withheld information from the FDA.
“Shiley--from the very beginning, with the first strut fracture--made the FDA aware of it,” Fauteux said. The company worked hard to resolve the problem in the early 1980s but had trouble because the statistical incidence of failure was so low, he said.
“Shiley diligently sought to eliminate the strut fracture phenomenon through a variety of actions,” said Shiley official Roger Sachs in testimony scheduled to be delivered at today’s hearing.
The FDA initiated two inquiries, but in both cases, Fauteux said, the medical evidence gathered by Shiley suggested that “the complication and mortality rate of the 60-degree valve was no worse than any of the (other valves) out there.”
Part of the reason for those findings, Fauteux said, was that the Shiley valve caused fewer problems with blood clotting than competing valves, in effect, statistically compensating for the strut failure problem.
On the issue of marketing the 70-degree valve overseas, Shewmaker said: “The 70-degree valve was sold in full compliance with all laws of the United States and the importing countries.”
Fauteux added: “They may not have had standards for testing particular medical devices, including heart valves, but if you look at the (importing) countries, these were advanced, industrialized nations (with) sophisticated governmental systems.”
Among the countries were Great Britain, Australia, West Germany, the Netherlands, France and Canada, Fauteux said.
Officials of both Shiley and the FDA are scheduled to appear at today’s subcommittee hearing to respond to the subcommittee report.
