Guidant, a medial device manufacturer and a wholly-owned subsidiary of Boston Scientific, has pleaded guilty in St Paul, Minn., before US District Court Judge Donovan W Frank to criminal violations of the Federal Food, Drug and Cosmetic Act.
Guidant’s admission of criminal wrongdoing is the result of a four-year investigation into its 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 H155).
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 US. The devices, once surgically implanted, constantly monitor the electrical activity in a patient’s 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.
Under the terms of the plea agreement with the Justice Department to resolve the charges, which must still be approved by Judge Frank, Guidant pleaded guilty to withholding information from the FDA regarding catastrophic failures in some of its lifesaving devices.
As per the agreement, Guidant has been admitted to: making a materially false statement in a required submission to the FDA with regard to the Ventak Prizm 2DR device; and 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 $296m.
Frank Magill, acting US Attorney in this case for the District of Minnesota, said: “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. 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.”