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For Immediate Release

Media Contact:
Raquel Guillory, 410-576-6357
rguillory@oag.state.md.us

Attorney General Gansler Announces Settlement with Manufacturer of Medical Devices

BALTIMORE, MD (August 30, 2007) - Attorney General Douglas F. Gansler announced today that his Consumer Protection Division, together with 35 other Attorney General offices, have reached a settlement with Guidant Corporation, Cardiac Pacemakers, Inc., and Guidant Sales Corporation (the “Guidant companies”), subsidiaries of Boston Scientific Corporation. The Guidant companies are among the world’s largest manufacturers and sellers of Implantable Cardioverter Defibrillators (ICDs). The settlement resolves allegations that the Guidant companies continued to sell an ICD model after they had discovered a wiring problem with the model and they failed to adequately disclose the problem. Under the settlement, the Guidant companies must implement safety programs and publicly report important safety information about the devices they manufacture and sell.

ICDs are medical devices that doctors surgically implant in a patient’s chest to monitor heart rhythms. If the ICD detects an abnormal heartbeat, it can deliver calibrated electrical shocks to restore a normal heart rhythm. For certain patients, ICDs can help prevent life-threatening irregular heart rhythms and can reduce the risk of cardiac arrest.

The complaint filed by the Consumer Protection Division alleges that the Guidant companies made changes in 2002 to correct a wiring problem with the Ventak Prizm 2 DR Model 1861 (“Prizm”) that could cause the unit to short circuit. If the Prizm short-circuited, it could fail to deliver a life-saving jump-start to a patient’s heart when needed. The Guidant companies continued to sell unmodified Prizms even after making two separate changes to correct the Prizm wiring problem. The Guidant companies did not inform physicians or the public until May 2005 that they had continued to sell unmodified Prizms in 2002 and 2003.

“It is essential that makers of medical devices that are critical to patients’ health and safety immediately inform doctors and consumers of problems that are discovered in their products,” said Attorney General Gansler.

Although the Guidant companies deny any wrongdoing, as a result of the settlement, they have agreed to:

  • 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 safety-related information;
  • disclose any modification of their ICDs to correct a failure pattern;
  • solicit the return of out-of-service ICDs;
  • maintain a data system to track the serial numbers, implant and explants dates of all ICDs the Guidant companies distribute in the United States; and
  • make a monetary payment to Maryland in the amount of $390,000.

Currently, the Guidant companies are 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. The Guidant companies have also agreed to extend this warranty program for an additional six months. A million dollar fund will be created to reimburse warranty program participants for expenses they incurred beyond $2,500. For information about the replacement of the device and the warranty program, consumers should contact Boston Scientific Corporation at 1-800-227-3422.

   

Attorney General of Maryland 1 (888) 743-0023 toll-free / TDD: (410) 576-6372
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