Guidant pays massive settlement for failing to disclose safety information regarding defibrillators
Guidant Corporation, now a division of Boston Scientific Corp., agreed to pay a fine of $296 million dollars to settle federal prosecutors' claims that it violated the law by failing to disclose implantable defribillator short-circuit defect information and by making false and misleading statements to the FDA. The defects--which Guidant attempted to address through a "stealth recall"--are linked to "at least 13" reported deaths. Prosecutors suggested the defects were likely responsible for additional unreported deaths.
Guidant pleaded guilty to the charges in April of 2010, but the Federal judge hearing the case would not approve the plea deal until Guidant/Boston Scientific agreed to a three-year probation period. The problem with Guidant defibrillator implants only surfaced when two Minnesota doctors investigating the short-circuit death of a 21-year old patient went to the media after learning that Guidant was concealing the causative product defect. Apparently, Guidant knew about the short-circuiting problem as early as 2002 or 2004, but failed to alert doctors or patients so that it could be addressed.
Since the FDA originally approved the devices, it is problematic whether Michigan patient-victims could sue Guidant. Michigan is the only state that gives immunity to manufacturers of drugs and medical devices if they have been approved by the FDA. That approval process has been questioned in recent years, as it relies heavily upon manufacturer's representatives, has on several occasions been duped by false research, and has resulted in questionable approval of several drugs and products where approval was subsequently revoked or the items were recalled for safety reasons.