DoJ files suit against Guidant for ICD problem cover-up
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The charges were filed in the federal district court in St. Paul. Minn., following a four-year investigation into Guidant’s handling of its three ICD models that were found to short circuit while implanted in patients.
According to a statement released in November by Boston Scientific, the company had said that it would plead guilty to two charges related to this falsely reported information and that it would pay $296 million on behalf of Guidant to clear up the charges.
The DoJ said in its statement that Boston Scientific is expected to file a formal guilty plea agreement at a later date to resolve the charges.
“A manufacturer of a medical device must promptly report [to the FDA any correction of a medical device if the correction was undertaken to reduce a risk to health posed by the device,” according to the court documents.
Charges ensued after the DoJ accused Guidant of becoming aware that its Prizm 2 DR ICD device was prone to electrical arcing and had the potential to malfunction in patients implanted with the device, but never reporting it.
According to DoJ, in August of 2003, Guidant falsely reported to the FDA that “design changes did not affect the device’s safety and effectiveness,” and stated that its “[d]evice performance [was] unaffected by this change and the devices continue[d] to meet physical and functional requirements," according to the court documents.
In 2004, a patient in Spain died after his Renewal 1 ICD device faulted and short circuited without giving warning, and later caused cardiac arrest and death. Guidant reportedly sent a Product Update pertaining to the ICD’s risk of short circuiting after this incident, however, according to the court documents, while Guidant was “aware of 12 Renewal short-circuiting failures … the Product Update mentioned none of them.”
Guidant had 10 days to report these risks to the FDA, but failed to do so, according to the DoJ. “Guidant failed and refused to furnish this required report to FDA,” the court documents state.
“The government charges that Guidant committed serious crimes by undermining the FDA’s role to guard the American public against potentially dangerous medical devices,” said Tony West, assistant attorney general, and head of the DoJ’s Civil Division. “Our message is clear: We will vigorously prosecute individuals and organizations who put profit over public health and safety by violating the law."
A company representative of Guidant is expected to appear in court March 16.