Chicago, ILWhen patients receive a medical device such as the Bjork Shiley Heart Valve, they probably assume the device was properly manufactured and the company that made it followed all relevant regulations in producing the device. But Bjork Shiley lawsuits from just after the Bjork Shiley valve recall was announced, suggest that the company involved in making the valves hid the dangers from patients until the FDA intervened.
Despite the Bjork Shiley valve being recalled in 1986, there are still people who may have the valve implanted and who live day to day with the fear that at any point their valve could fracture. According to the article "Bjork-Shiley Heart Valve Recall" (at biomed.brown.edu), of 500 cases of fracture reported at the time the article was written, two-thirds of those fractures resulted in death.
What may come as a shock to some recipients of the Bjork Shiley heart valve is that some paperwork was allegedly falsely filed during manufacturing of the valves. According to the Brown article, "After searching through company documents, it was found that many valves were 'rewelded' by a 'phantom' employee 2832. These were likely to have had cracks that were polished over by a worker during manufacturing, instead of being rewelded or discarded entirely."
The New York Times (3/21/92) reports that a memorandum from a supervisor at a Shiley plant complained about the policy of hiding cracked valves by falsely filing their paperwork. "I feel we are hiding our most serious defect," the supervisor reportedly wrote. According to the Times, Shiley paperwork would show that one worker found a cracked valve, another rewelded it and a third polished it. The rewelding was done by employee 2832. When lawyers for the plaintiffs asked to depose employee 2832, they discovered it was a fake employee number.
The New York Times reports that the public and the Food and Drug Administration (FDA) were kept in the dark about the risks, and notified only after lawyers for plaintiffs against Pfizer (which bought Shiley Inc) found the documents and after Pfizer allowed the FDA to see the documents. But the company got a court-enforced order to ensure secrecy and prevent patients from seeing the information.
In 1990, the FDA issued a report arguing that it was difficult to examine problems with the valve and that it has information that "supports a belief that Shiley Inc has engaged in a continuing scheme to interrupt, deflect and misdirect the F.D.A.'s regulation of the Shiley Convexo-Concave heart valve." Furthermore, the FDA said that court protective orders prevented the agency from carrying out an investigation of the valve. Meanwhile, a 1990 report by the House Subcommittee on Oversight and Investigations concluded Shiley "aggressively marketed the device despite internal knowledge of serious problems in the manufacturing and quality assurance procedures," (as quoted by The New York Times; 3/21/92).
When the Bjork Shiley heart valve was recalled, many thought the risk of undergoing surgery to remove the valve was greater than the risk of leaving it implanted. As more information about the valves came forward, the FDA ordered Shiley to send letters to patients, informing them that the risk of fracture could be higher than thought and further advising them to speak to their doctors about their options.
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