Massachusetts To Receive $390,000 As Part Of 36-State Settlement With Manufacturer Of Defective Implantable Defibrillators

September 1, 2007 – 10:41 pm | posted in Cardiovascular

Attorney General Martha Coakley’s Office reached a settlement with Guidant Corporation, a wholly owned subsidiary of Natick-based Boston Scientific, and one of the world’s three largest manufacturers of Implantable Cardioverter Defibrillators (ICDs). ICDs are medical devices that doctors surgically 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. The settlement was part of an enforcement action brought by Attorney General Martha Coakley and other 35 state attorneys general due to concerns with the sale of a particular model, the Ventak Prizm 2 DR Model 1861 (Prizm), that did not work properly.

“Guidant’s conduct in selling this product could have led to serious injury, or even death, in a patient,” said Attorney General Martha Coakley. “This settlement holds the company accountable, and contains requirements that should prevent this type of behavior from occurring in the future.”

The attorneys general began investigating Guidant in 2005 after learning 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 the substandard Prizms even after making two separate changes to correct the wiring problem. Guidant did not inform physicians, patients or the public that it had sold 4,000 of the defective, older models until May, 2005.

The judgment, filed in Suffolk Superior Court, requires Guidant to implement certain ICD Safety programs, publicly report important safety information about the potentially life-saving heart devices it manufactures and pay $16,750,000 to the 36 participating states. Up to $1,000,000 will supplement Guidant’s warranty program in order to compensate consumers. Massachusetts will receive approximately $390,000 which will be used to fund local consumer programs.

Under the terms of the settlement, Guidant has agreed 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 on a quarterly basis, including worldwide failure data, survival probability estimates, 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 explant dates of all ICDs Guidant distributes in the United States.

Guidant began offering a warranty program in 2005 to consumers wishing to replace their Prizms with a new device at no cost and to reimburse consumers up to $2,500 for out-of-pocket expenses they incur with this replacement. Under the terms of today’s agreement, the warranty program will be extended for an additional six months. Massachusetts consumers must first apply through Guidant for any restitution of their out-of-pocket expenses and follow Guidant’s extended warranty process prior to contacting the Attorney General’s Office. Doctors and patients will be able to find information about the warranty program at http://www.bostonscientific.com, although exact details were not available at the time of this news release. Consumers may also contact Mary Wollenhaupt of Attorney General Coakley’s Consumer Protection Division at 617-727-2200 ext. 2051 for further information.

In addition to Massachusetts, Attorneys General from the following states are participating in today’s settlement: Alaska, Arizona, Arkansas, California, Connecticut, District of Columbia, Florida, Hawaii, Idaho, Illinois, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Mississippi, Missouri, Montana, Nevada, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin, and Wyoming.

Assistant Attorney General April English of Attorney General Coakley’s Consumer Protection Division handled this matter.

http:// www.ago.state.ma.us

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