District Court slams Guidant with fees, probation in ICD dispute
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The suit, brought forth by the Department of Justice (DoJ) last November, claimed that Guidant improperly handled short-circuiting failures of its Ventak Prizm DR (Model 1861) and Contak Renewal (Models H135 and H155) ICDs, and failed to report these incidents to the FDA.
Guidant, who pleaded guilty to the charges last April, was charged with withholding pertinent information from the FDA regarding the “catastrophic failures” in its ICDs, according to the DoJ.
U.S. District Court Judge Donovan W. Frank said that “Guidant made decisions at various junctures to conceal information from the FDA and medical professionals regarding the device failures.”
The company reported the safety concerns to the public 10 months after knowing about the problem. At that time, three deaths had occurred. DoJ said that Guidant continued to implant hundreds of the defective ICD models even after the company stopped shipping the products due to the health concern.
Last April, Judge Frank denied a $296 million plea agreement between the company and the DoJ.
The DoJ reported that under the sentence Guidant will be required to pay more than $42 million to the U.S., and more than $254 million in criminal fines. Under the three years of probation, Guidant will be required to make quarterly reports to the U.S. Probation Office, in addition to submitting unannounced inspections of its records to the office.
“The safety and integrity of critical medical devices is assured only by close FDA oversight,” said First Assistant U.S. Attorney John Marti of the District of Minnesota. “This agency can only perform its mandated duty when medical device manufacturers provide the agency with timely and accurate information. When Guidant withheld important information, patient safety was jeopardized. The court’s sentence recognizes the harm of Guidant’s conduct.”