LAWFUEL – The US Law Newswire

~ Company is one of the world’s top three manufacturers of implantable
cardioverter defibrillators ~

TALLAHASSEE, FL – Attorney General Bill McCollum today announced that Florida and 34 other states as well as the District of Columbia have reached a settlement with Guidant Corporation regarding a particular brand of implantable cardioverter defibrillators (ICD). Pursuant to the settlement, Guidant has agreed to implement certain ICD safety programs and publicly report important safety information about the potentially life-saving heart devices manufactured by the company. The company, a wholly owned subsidiary of Boston Scientific and one of the world’s top three ICD manufacturers, will also pay more than $16.75 million to the states for consumer education and enhanced 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,”
said Attorney General McCollum.

ICDs are medical devices which are surgically implanted 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. McCollum and other State Attorneys General began investigating Guidant after learning that the Ventak Prizm brand of ICDs had a wiring problem significant enough to cause the unit to short circuit. The damaged devices could have then failed to deliver the necessary jolt of electricity to restart a patient’s heart when needed. The investigation revealed that even after making two separate changes to correct the Prizm wiring problem in 2002, Guidant continued to sell unmodified Prizms for two years, but did not inform physicians or the public until May 2005 that unmodified devices had been sold.

In response to the issue of the faulty Prizms, Guidant is currently conducting a warranty program to provide Prizm customers with a new device if requested and reimburse consumers up to $2,500 for out-of-pocket expenses they may incur with this replacement. The settlement requires Guidant to extend this warranty program for an additional six months.
Additionally, up to $1 million of the $16.7 million will be used to reimburse warranty program participants for expenses beyond $2,500.
Florida’s share of the remaining funds will be used to fund general consumer education and promote enforcement of consumer protection laws in the state.

In addition to the warranty program and payment to the states, Guidant must adhere to the following guidelines:

– 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.

A copy of the multistate settlement, which is currently pending approval by the Court, is available online at:$file/GuidantSettlement.pdf

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