Media Center

Guidant To Pay $16 Million To States in Settlement with Attorneys General Over Sale of Defibrillators Knowb To Be Defective

 

MADISON - Attorney General J.B. Van Hollen and 36 other state attorneys general have reached a settlement with Guidant Corporation for selling heart defibrillators they knew were defective. Guidant will pay the states $16,750,000, of which Wisconsin will receive $390,000. Approximately 49 Wisconsin consumers were recipients of the faulty product.

 

Guidant is a wholly owned subsidiary of Boston Scientific and one of the world's three largest manufacturers of Implantable Cardioverter Defibrillators (ICDs). 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. The settlement concerns the sale of one type of ICD, the Ventak Prizm 2 DR Model 1861 (Prizm).

 

Attorney General Van Hollen and the other attorneys general began investigating Guidant when they learned that Guidant made changes to correct a Prizm wiring problem that could cause the unit to short circuit, but continued to sell unmodified Prizms in 2002 and 2003 even after making changes to correct the Prizm wiring problem. If the Prizm short-circuited, then it could fail to deliver a life-saving jump-start to a patient's heart when needed. Guidant did not inform physicians or the public that it had continued to sell unmodified Prizms until May 2005.

 

"Doctors and patients must be assured that they are getting complete disclosures about the safety of medical products." said Van Hollen. "Wisconsin's consumer laws require companies to make accurate disclosures, and when they fail to do so, the state is empowered to enforce those laws."

 

Pursuant to the settlement, Guidant has agreed to implement certain ICD Safety programs, publicly report important safety information about the potentially life-saving heart devices it manufactures and pay $16,750,000 to the states, up to $1,000,000 of which will supplement Guidant's warranty program in order to recompense consumers.

 

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 distributes 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.

 

Wisconsin consumers must first apply through Guidant for any restitution of their out-of-pocket expenses and follow Guidant's extended warranty process prior to contacting the Attorney General's Office. Under the settlement, Guidant will provide a free replacement device and reimburse patients up to $2,500 for out-of-pocket medical expenses. Doctors and patients will be able to find information about the warranty program by calling 1-800-CARDIAC and asking for the "URM Group."

 

The Wisconsin Department of Justice Consumer Unit can be reached for more information at 608-266-1852.

 

Assistant Attorney General Cynthia Hirsch represented Wisconsin.