Guidant soon realized
something was wrong with the product. The company made the decision not
to go public with this information. The failure to report the
malfunctions prevented the public and physicians from realizing there
was a problem with Ancure. According to court documents, the device
often malfunctioned and the company asked doctors to use it in ways not
approved by the government. Guidant sales representatives were in the
operating rooms and instructed surgeons, who were trying to help
patients who developed complications after having received an Ancure
unit, to break the defective Ancure product and remove it a piece at a
time. When that failed, the patient's chest would have to be opened in
order to correct the complications.
Even after Guidant realized there was a problem, the company was not
forthcoming about the dangers associated with Ancure. When the case went
to trial, Guidant admitted that it had hidden 2,628 complaints about the
device from the F.D.A.
Meanwhile, Guidant continued to promote and sell Ancure. Worldwide sales
of the devices were about $220 million in 2002.
Guidant's silence was not only unethical, it was also illegal. Under
federal law, a company is required to report to FDA any incident in
which its medical device may have caused or contributed to a death or
serious injury or the medical device experienced a malfunction that
would be likely to cause or contribute to a death or serious injury if
the malfunction were to recur. The reports to FDA are called Medical
Device Reports. The Department of Justice notes that "In failing to file
thousands of Medical Device Reports, the defendant concealed the true
extent of problems with the Ancure Device from patients, doctors and the
Clearly, Guidant negligence and subsequent cover-up contributed to the
damage. U.S. Attorney Kevin Ryan summed up the case. "Because of the
company's conduct, thousands of patients underwent surgery without
knowing the risks they faced; and their doctors, through no fault of
their own, were unprepared to deal with those risks."
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