McGrath: State Settles with Defibrillator Manufacturer
HELENA – Montana Attorney General Mike McGrath said today that Montana and 35 other states have reached a settlement with Guidant Corporation regarding a type of “implantable cardioverter defibrillator” or ICD.
McGrath said Montana’s share of the settlement is $390,000 and the funds will be used for consumer protection and education. The total settlement to the states is $16.75 million. There are separate class action lawsuits dealing with restitution to consumers who had the device.
The settlement announced Thursday involves a specific defibrillator known as the “Prizm.” An ICD is implanted into a patient’s chest to monitor heart rhythms. If the heart stops, the ICD delivers a small jolt of electricity to restart the heart.
The device had a wiring problem that could cause it to short circuit and prevent it from jump-starting a patient’s heart. McGrath said that in 2002, Guidant made changes to correct the problem in the Prizm, but the unmodified Prizms remained on the market. The company did not notify physicians or the general public of the changes until May 2005.
Under the terms of the settlement, Guidant will:
- Establish an safety advisory board 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 release to the public specific information on failure data, survival probability 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 removal dates of all ICDs Guidant distributes in the United States.
If consumers wish to replace Prizms, Guidant is offering a new ICD at no cost. The company is also offering to pay up to $2,500 to reimburse patients’ expenses related to the replacement. Consumers with questions about replacing their ICD and the risks associated with it should consult their physicians.
Guidant did not admit to any wrongdoing in the settlement.