Office of the Attorney General
Attorney General Greg Stumbo Announces Settlement With Maker Of Implantable Defibrillators
Attorney General Greg Stumbo and 34 other state attorneys general today announced that they have reached a settlement with Guidant Corporation, a wholly owned subsidiary of Boston Scientific and one of the world’s three largest manufacturers of Implantable Cardioverter Defibrillators (ICDs).
Stumbo began investigating Guidant when they learned that the corporation made changes in 2002 to correct a wiring problem that could cause the unit to short circuit. The Prizm could fail to deliver a life-saving shock to a patient’s heart when needed if it short-circuited.
Guidant continued to sell unmodified Prizms even after making two separate changes to correct the Prizm wiring problem. Guidant did not inform physicians or the public until May, 2005, that it had continued to sell unmodified Prizms in 2002 and 2003 In June, 2005, Guidant sent notices to doctors, along with a list of affected patients, concerning the possible problem and implemented a replacement procedure.
“Selling these dangerous devices was unconscionable and put vulnerable Kentucky citizens at serious risk,” Stumbo noted. “The faulty units should never have been sold once the potentially fatal problem was known.”
The settlement, which has be approved by the Franklin Circuit Court, concerns the sale of the Ventak Prizm 2 DR Model 1861 (“Prizm”).
Under the terms of the binding resolution, Guidant has agreed to implement certain ICD safety programs, publicly report important safety information about the heart devices it manufactures and pay $16.75 million to the states, up to $1 million of which will supplement Guidant’s warranty program in order to compensate consumers for medical expenses related to Prizm units.
ICDs are medical devices that doctors surgically implant in a patient’s chest to monitor for abnormal heart rhythms. If the heart stops, the ICD delivers a small jolt of electricity to start the heart functioning again.
Pursuant to the settlement, Guidant agreed, among other matters, to do 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 distributed in the United States.
Currently, Guidant is 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. Pursuant to today’s settlement, Guidant has agreed to extend this warranty program for an additional six months. Also, the States will use up to $1,000,000 of the $16,750,000 payment to reimburse warranty program participants for expenses they incurred beyond $2,500.
Consumers with Prizm ICDs who have incurred un-reimbursed medical expenses relating to their unit, or who were previously denied warranty coverage by Guidant, should contact the Attorney General’s Office of Consumer Protection at (502) 696-5389.
In addition to participation in the $1,000,000 restitution program, Kentucky’s share of the settlement is $390,000. Guidant does not admit to any wrongdoing.