Ancure

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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 public."

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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