HARRISBURG – Pennsylvania, 34 other states, and the District of Columbia have reached a $16,750,000 settlement with the Guidant Corporation resolving allegations that the company failed to warn physicians and consumers about a design flaw in one of their implantable defibrillators, a device used by patients with life-threatening heart conditions.
Attorney General Tom Corbett said the Guidant Corporation is a subsidiary of Boston Scientific and one of the world’s largest manufacturers of Implantable Cardioverter Defibrillators.
Corbett explained that an ICD is a medical device that is surgically implanted into a patient’s chest to monitor for abnormal heart rhythms, and if necessary, deliver an electric shock to restore a normal rhythm. He said if the ICD is not working properly and the electric shock is not delivered when needed, there is a serious risk that death can occur.
Corbett said that in August 2000, the Food and Drug Administration approved Guidant’s application for the Ventak Prizm 2 DR Model 1861 (Prizm). In February 2002, Guidant allegedly learned that a wiring problem in the device caused a short circuit to occur when it was called upon to deliver a life saving shock.
Corbett said Guidant modified the device in 2002 to address the design flaw and prevent the electrical short, but allegedly failed to disclose to consumers and physicians that a defect had been discovered and a corrected device was available.
According to the multi-state consumer protection investigation, after the modifications were made, Guidant allegedly continued to sell the defective device to approximately 4,000 unaware consumers.
“In order to make appropriate decisions regarding an individual’s health and well-being, the doctor and patient must have full knowledge of the risks associated with any medical device, drug, or procedure,” Corbett said. “It is incumbent upon any medical manufacturer to pass on any and all information that may have an impact – positive or negative – on these decisions.”
According to the settlement, Guidant agreed to pay $16,750,000 to the states. Pennsylvania will receive $390,000, which will be used to fund consumer education and enforcement of consumer protection laws.
In addition, Guidant agreed to the following:
· Establish a patient safety advisory board consisting of independent experts to evaluate data concerning ICD performance;
· Establish a patient safety officer position, staffed by a physician whose primary responsibility is to advance ICD patient safety;
· Clearly disclose and disseminate to the public specific information on a quarterly basis, including worldwide failure data, survival probability estimates, and current information in the event of an FDA recall of any ICD;
· Post a notice on its website within 30 days of any modification to any of its ICDs to correct a failure pattern;
· Solicit the return of out-of-service ICDs; and,
· Maintain a data system to track the serial numbers, implant dates and explant dates of all ICDs Guidant distributes in the United States.
Corbett said Guidant is currently conducting a warranty program to provide consumers who wish to replace their Prizms with a new device at no cost and to reimburse consumers up to $2,500 for out-of-pocket expenses they incur with this replacement. $1 million in settlement money will be set aside to reimburse warranty program participants for out-of-pocket expenses in excess of $2,500.
Corbett said Guidant would extend this warranty program for an additional six months.
The settlement was filed in Commonwealth Court by Deputy Attorney General Timothy E. Gates of the Attorney General’s Health Care Section.