Thursday, August 30, 2007

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Attorney General Abbott Reaches Settlement with Heart Defibrillator Manufacturer

DALLAS – Texas Attorney General Greg Abbott and 35 state attorneys general today reached a $16.75 million settlement with the maker of an implantable heart defibrillator. State attorneys general took legal action against Guidant Corp. for marketing the unmodified device even after the manufacturer discovered and corrected a circuitry problem that could have caused the device to fail. Guidant learned of the problem in 2002.

The settlement involves one defibrillator, the Ventak Prizm 2 DR Model 1861, which is commonly known as the Prizm. Typically, surgeons implant defibrillators in a patient’s chest to monitor abnormal heart rhythms. If the patient’s heart stops, the defibrillator delivers a small jolt of electricity that is intended to resume normal heart functioning.

Media links
Attorney General's lawsuit against Guidant Corp.
Attorney General's final judgment against Guidant Corp.

“Texans expect the manufacturers of critical health care devices to immediately disclose serious problems with their products,” said Attorney General Abbott. “Today’s settlement ensures that Guidant will implement new measures to protect patients in the future. We will continue working to protect the health and safety of all Texans.”

Texas’ share of the settlement is $390,000. The entire $16.75 million sum compensates the states for attorneys’ fees, consumer protection enforcement, consumer health education programs or other beneficial programs permissible under state laws.

Under the terms of the settlement, Guidant is required to extend its existing warranty program to allow purchasers to repair or replace their Prizms with a new device within six months of today’s judgment. Approximately $1 million of the settlement will be set aside to reimburse consumers on a pro rata basis for direct patient costs that exceed the $2,500 warranty supplement cap in Guidant’s warranty program. Affected patients should have already been notified by their physicians if they received an unmodified device.

Guidant must also evaluate data on the products’ performance and worldwide failure rates. The company also agreed to post notices on its Web site within 30 days of any modification to correct failures in any of its defibrillators.

Guidant is a wholly owned subsidiary of Boston Scientific and is one of the world’s three largest manufacturers of implantable heart defibrillators.