In a scathing internal report, the Food and Drug Administration has concluded that Shiley Inc. of Irvine repeatedly confused and misled the FDA about defects in Shiley heart valves and knowingly shipped valves that were manufactured under substandard conditions.
"The Shiley Convexo-Concave heart valve was defective from the time of its approval," the FDA report says. "Shiley secured approval by failing to reveal material information it had regarding the defect. . . ."
The report also found that at least 24 people were implanted with the potentially faulty heart valves after the valves were removed from the market, raising questions about Shiley's diligence in trying to retrieve them.
In addition, the report reveals that former Shiley employees have alleged "extremely serious (manufacturing) violations, such as lack of training and experienced personnel, drug use by employees and supervisors, falsification of records to conceal questionable practices, etc."
More than 80,000 people were implanted with Shiley heart valves before the valves were pulled off the market in 1985 and 1986. At least 442 of the valves have fractured, leading to about 250 deaths and hundreds of lawsuits by patients who claim emotional distress from living with valves that could suddenly fail.
Shiley has denied any wrongdoing and has consistently argued that the benefits of its heart valve far outweighed the small risk of valve failure.
The internal FDA report was written in December, 1990, but was released by a congressional subcommittee late Thursday. Sections of the 27-page report, including the last three pages, were deleted by the FDA legal counsel before the document was made public. The agency declined to comment on the report Friday, saying the case was still under investigation.
Shiley's parent, Pfizer Inc., said in a statement Friday that it "vigorously disputes the conclusions reached by the report." Shiley spokesman Robert J. Fauteux said the company would have no comment on details of the allegations until Monday.
However, Fauteux said the report contained nothing new of substance and that its findings were "no more than a rehashing" of issues raised during hearings held in February, 1990, before the congressional subcommittee on oversight and investigations chaired by Rep. John D. Dingell (D-Mich.).
The subcommittee was sharply critical of both Shiley and the FDA. It titled its report on the Shiley heart valve problem "Earn As You Learn." The FDA has been more muted, however. During testimony before the subcommittee, James S. Benson, then FDA's acting commissioner, declined to comment when asked if he believed there had been misconduct by Shiley.
After reviewing thousands of documents, the three FDA investigators struck a sharply different tone.
"Our study has identified information that supports a belief that Shiley Inc. has engaged in a continuing scheme to interrupt, deflect and misdirect FDA's regulation of the Shiley Covexo-Concave heart valve," they wrote.
The FDA approved the heart valve in 1979--although one valve had already fractured during testing--and allowed the valve to stay on the market even after reports of valve defects mounted. That was because Shiley persuaded the agency that the valve substantially reduced the risk of blood clots and related complications that prove fatal to many heart valve patients.
From 1% to 4% of patients experience thromboembolic, or blood clotting, complications each year, while fractures of the Shiley heart valves occurred in less than 0.13% of patients each year, the FDA found. The agency concluded that the benefits of the valve outweighed the risk.
But the more recent FDA report concludes that Shiley based the claim of reducing blood clots on insufficient and incomplete data--and so confused the issues that regulators accepted Shiley's claims until at least 1984.
"FDA was ultimately to find that the purported thromboembolic benefits could not be substantiated," the report said.
It cited internal Shiley documents that showed that company executives knew "from the beginning" that their claim of fewer blood-clot complications would be extremely difficult to prove. Despite this lack of substantiation, the company continued to assert to the FDA, to physicians, and in its advertising that the reduced complications outweighed the risk of sudden valve failure, the report found.
The FDA report will bolster the cases of the more than 430 people implanted with Shiley valves who are suing the company for emotional distress, one of their lawyers said Friday.
"We think the evidence supports the statements that are made in this report," said attorney Bruce A. Finzen of Robins, Kaplan, Miller & Ciresi in Minneapolis and Newport Beach, which represents about 350 of the plaintiffs. Finzen said the FDA report should be admissible in court.
"When you look at the evidence as they have, there are only these rather strong conclusions that you can come to: that there was a pattern of fraudulent conduct engaged in that stretched from before (FDA approval of the heart valve) literally to the present," Finzen said.
Shiley has settled lawsuits related to patients who died when their heart valves fractured, but insists that those whose lifesaving valves continue to function have no right to sue.
Moreover, the company claims a reported valve fracture rate of well under 1% does not justify emotional distress claims when heart patients remain far more likely to die of other causes.
The courts have ruled that plaintiffs may press claims for emotional distress if they can prove that Shiley acted in a fraudulent manner or concealed the defects.