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Guidant Faces Ind. Class Suit Over Ventak Defibrillators

Guidant Corp. has been hit with a prospective nationwide class-action suit on behalf of more than 13,000 people implanted with defibrillators that may short-circuit for a day and then return to normal operation.

Filed in the U.S. District Court of the Southern District of Indiana, near Guidant's Indianapolis corporate headquarters, the products liability and breach-of-warranty suit seeks a declaratory judgment holding Guidant liable to all patients with Ventak Prizm model implantable cardiac defibrillators, or ICDs.

John Brennan, a 74-year-old Pennsylvania man serving as lead plaintiff, says he fears fatal injury in the event that the Ventak Prizm 2 DR Model 1861 he received in 2001 should short-circuit and shut down.

In a statement on its Web site, Guidant recommends that physicians continue "normal monitoring" for all patients with the Ventak Prizm 2 DR and says the defibrillators need not be replaced for any reason outside "normal elective replacement indicators." Guidant says the device "continues to demonstrate exemplary overall reliability performance," exceeds design specifications and "ranks overall as one of the most reliable ICD products available."

The suit alleges causes of action for fraud, negligence, and intentional and negligent infliction of emotional distress. It asks that Guidant be ordered to pay the cost of medical monitoring and surveillance of those who own the defibrillators, refund the purchase price of the devices, disgorge related profits, and seeks a court order lifting any statutes of limitations that may apply to patients with the devices. The suit also seeks recovery of the costs of explanation, or removing the implants, where applicable.

The class suit encompasses patents with a dozen different Guidant Ventak ICDs sold since 1994. They are the Ventak Prizm 2 VR/DR, models 1860 and 1861; the Ventak Prizm VR/DR, models 1850, 1851, 1855 and 1856; the Ventak Prizm VR/DR HE, models 1852 and 1853; the Ventak Mini IV, models 1790, 1793 and 1796; and the Ventak Mini III HE, model 1789.

The suit questions whether Guidant and subsidiary Guidant Sales Corp. failed to follow U.S. Food and Drug Administration good manufacturing practices and properly investigate reports, dating as far back as 1994, that a defect in Ventak models made them prone to short-circuit and turn off for 24 hours. The suit alleges that after 24 hours passed, the device restarts, erasing its internal memory, making it unlikely for medical personnel to determine that the shutdown occurred.

Guidant, the suit asserts, may have "intentionally, knowingly, carelessly, recklessly, or negligently concealed information regarding the existence of a defect in the implantable defibrillator devices from the FDA, physicians and the class."

The suit says a class action could be an efficient way to find answers to many related common questions of fact regarding the defibrillators: whether the defendants' conduct in the design, manufacturing and marketing of the devices fell below the duty of care owed class members; whether they concealed information on the defect from the FDA, doctors and patients; and whether the Guidant Ventak Prizm defibrillators included in the class definition "share a common and inherent design defect that causes them to short-circuit, creating a risk of injury or death to patients in whom they were implanted."