Guidant Corp. has reached a settlement with a group of state attorneys general who claim one of the company's implantable cardioverter defibrillators is unsafe.
The company will pay almost $17 million to the 35 states, plus the District of Columbia, for consumer education and stronger consumer protection.
"We have a responsibility to the citizens of our state to protect them from less-than-responsible corporate behavior, and I believe this settlement makes a positive contribution towards that protective effort," Florida Attorney General Bill McCollum said.
Guidant is a wholly owned subsidiary of Boston Scientific and is one of the top three ICD manufacturers in the world. The device monitors a patient's heart for abnormal rhythms, then delivers a jolt of electricity if the heart stops.
The attorneys general heard complaints that one of Guidant's brands of ICD had a wiring problem that would not deliver the jolt when it was needed. After Guidant failed to correct the problem in the Prizm line, it still sold them, the attorneys general said.
Currently, the Guidant is providing Prizm customers with a new device if it is requested and are reimbursing consumers for up to $2,500 each for expenses incurred during the replacement. The program will be extended an extra six months, per the settlement.
Also stipulated in the settlement is the creation of a $1 million fund that will cover consumers' expenses should they reach more than the allotted $2,500.
Other aspects of the settlement, according to a release from McCollum, call for Guidant 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 information including worldwide failure data, survival probability estimates and current information in the event of a recall of any ICD;
-Post a notice on the company's 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 distributed by Guidant in the United States.
In a multi-district litigation case in federal court in Minnesota, Guidant is facing 221 complaints.