Justice Department Charges Guidant in Implantable Defibrillator Failures

The U.S. Department of Justice has charged Guidant LLC, a subsidiary of Boston Scientific Corp., with criminal violations related to safety problems with some of its implantable defibrillators.

According to information filed in federal district court in St. Paul, Minn., Guidant concealed information from the U.S. Food and Drug Administration (FDA) regarding failures in some of its devices. The charges were filed following a four-year probe into Guidant’s handling of short-circuiting failures of three models of implantable cardioverter defibrillators (ICDs): the Ventak Prizm 2 DR and the Contak Renewal. Guidant issued safety advisories regarding the failures in June 2005.

The information alleges that beginning in 2002, Guidant became aware that the Ventak Prizm 2 DR was prone to electrical arcing, rendering the device inoperative.

Guidant changed the design of the Prizm 2 in November 2002 to correct the problem, the Justice Department said. The information charges that in August 2003, Guidant falsely told the FDA that design changes did not affect the device’s safety or effectiveness. However, device changes were made to correct this flaw, according to the information.

In early 2004, Guidant allegedly discovered a similar short-circuiting problem with its Renewal 1 and Renewal 2 devices, according to the Department of Justice.

Following the July 2004 death of a patient associated with a shorted Renewal in Spain, the information charges that Guidant knew that the physician operating instructions for responding to a short-circuit within the device were false and misleading. In an effort to remedy this, Guidant sent a communication by overnight delivery to physicians which the company dubbed a “Product Update,” the Justice Department said. The information alleged that this communication was a correction to the device that attempted to mitigate the safety risk posed by the short-circuiting. Guidant was required by law to alert FDA of this action within 10 days, and the information charges that Guidant failed to make that notification.

Guidant issued safety advisories on the Prizm 2 and Renewal devices in June 2005. FDA classified those advisories as Class I recalls, the most serious classification of recall, concluding that there was a reasonable probability that the affected devices could cause serious adverse health consequences or death, the Justice Department said.

“The community has the right to expect that companies that violate federal law by submitting false or misleading information to the FDA will be held accountable, particularly when that information relates to lifesaving devices, such as defibrillators,” said Frank Magill, acting U.S. attorney for the District of Minnesota on this case.

The case was investigated by the FDA’s Office of Criminal Investigations.

Boston Scientific wasn’t immediately available for comment.