Attorney General's News Release

August 30, 2007

Maker of faulty heart defibrillators to expand warranty program; pay $16,750,000 to Missouri, 35 other states

Jefferson City, Mo. — Guidant Corporation will expand outreach efforts to cardiac patients to inform them about and reimburse them for wiring problems associated with its Prizm implantable heart defibrillator, Attorney General Jay Nixon announced today. Under the nationwide settlement with Missouri and 35 other states, Guidant also will pay $16,750,000 to resolve concerns that it continued to sell Prizm units it knew could short circuit, even as it corrected the wiring problems in other units it sold. Missouri will receive $390,000 under the settlement, Nixon said.

The settlement with Guidant, a wholly owned subsidiary of Boston Scientific, concerns the sale of the Ventak Prizm 2 DR Model 1861. Guidant is one of the world’s three largest manufacturers of implantable cardioverter defibrillators (ICDs), medical devices surgeons 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.

Nixon and the other Attorneys General began investigating Guidant when they learned that Guidant made changes in 2002 to correct a Prizm wiring problem 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. Guidant continued to sell unmodified Prizms even after making two separate changes to correct the wiring problem. Nixon said Guidant did not inform physicians or the public until May 2005 that it had continued to sell unmodified Prizms in 2002 and 2003.

Because of the potential problems with the unmodified ICDs, Guidant currently is conducting a warranty program to provide consumers who want to replace their Prizms with a new device at no cost, and to reimburse consumers up to $2,500 for their out-of-pocket expenses. Under the settlement with the Attorneys General, the warranty program will be extended for an additional six months, and the states will use up to $1 million from Guidant to reimburse warranty participants for expenses beyond $2,500.

The settlement also addresses Guidant’s failures in its patient safety decision-making processes. Nixon said Guidant will be required to establish an independent patient safety advisory board and the position of a patient safety officer.

The patient safety advisory board will consist of independent experts to evaluate data concerning ICD performance, with expertise in cardiac electrophysiology, bioethics, engineering, statistics and risk management. At least one member of the board will represent the interests of patients. The patient safety officer must be a physician and will act as a liaison with the patient safety advisory board.

Guidant also will clearly disclose and publicly disseminate specific information regarding ICDs on a quarterly basis; post a notice on its Web site, www.bostonscientific.com, within 30 days of any modification to correct a failure pattern in any of its ICDs; and maintain a data system to track pertinent information about its ICDs.

Inquiries from consumers should be directed to consumer@ago.mo.gov or 1-800-392-8222 (from within Missouri) or 573-751-3321 (outside Missouri).

All media inquiries should be directed to Press Secretary John Fougere.

E-mail      Phone: 573-751-8844         Fax: 573-751-5818