by Ben Vernia | February 25th, 2010
DOJ announced February 25 that Guidant LLC (a subsidiary of Boston Scientific Corp.) had been charged in a criminal information with violating the Food, Drug, and Cosmetic Act for its failure to report failures in two of its defibrillator models:
According to the information filed today in federal district court in St. Paul, Minn., Guidant concealed information from the U.S. Food and Drug Administration (FDA) regarding catastrophic failures in some of its lifesaving devices. The charges were filed following a four-year investigation into Guidant’s handling of short-circuiting failures of three models of implantable cardioverter defibrillators (ICDs): the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155). Guidant issued safety advisories regarding the failures in June 2005.
ICDs 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 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.
The information alleges that beginning in 2002, Guidant became aware that one of its ICDs, the Ventak Prizm 2 DR, was prone to electrical arcing, rendering the device inoperative and unable to deliver life-saving therapy to the patient in whom it was implanted. Guidant changed the design of the Prizm 2 in November 2002 to correct the problem. The information charges that in August 2003, Guidant falsely told the FDA that the design changes did not affect the device’s safety or effectiveness. In fact, the 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. 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 information alleges that this communication was actually a correction to the device which attempted to mitigate the safety risk posed by the short-circuiting. Guidant was required by law to alert FDA of this action within ten days. 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.
DOJ did not announce the signing of a Corporate Integrity Agreement with HHS. The company’s delay in entering its plea may reflect that the terms of such an agreement are still being negotiated. (Boston Scientific Corp. entered into a five-year CIA in December of last year, concurrent with its settlement of allegations that it used post-market studies to pay kickbacks to physicians.)
Disclosure: I represented a member of Guidant’s Independent Panel as a third-party witness in product liability litigation.
