On April 5, Guidant LLC pleaded guilty to criminal violations of the Federal Food, Drug and Cosmetic Act, the Justice Department announced. The medical device manufacturer's admission of criminal wrongdoing is the result of a four-year investigation into Guidant's handling of short-circuiting failures of three models of its implantable cardioverter defibrillators: the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H1.)
Guidant pleaded guilty today to withholding information from the U.S. Food and Drug Administration (FDA) regarding catastrophic failures in some of its lifesaving devices. Specifically, Guidant admitted to: (1) making a materially false statement in a required submission to the FDA with regard to the Ventak Prizm 2DR device; and (2) failing to notify the FDA of a "correction" to the Contak Renewal devices, which the company made to reduce a risk to health caused by the devices. As a result of these offenses, the agreement calls for Guidant to pay a combined criminal penalty in excess of $296 million.
Implantable cardioverter defibrillators are lifesaving devices used to detect and treat
abnormal heart rhythms that can result in sudden cardiac death, one of the leading causes of mortality in the United States. The devices, once surgically implanted, constantly monitor the electrical activity in a patients heart for deadly electrical rhythms and deliver an electrical shock to the heart in an effort to return the heartbeat to normal. If they fail to operate properly when needed, a person can die within minutes.
"The guilty plea today should serve as a reminder and deterrent to those who would
break the laws requiring honesty and cooperation with government regulators whose mission is to protect the health and safety of the public," said Frank J. Magill, Acting U.S. Attorney in this case for the District of Minnesota . "The health care laws are as important as ever. When medical device and pharmaceutical companies fail to live up to their legal obligations, serious criminal consequences will follow."