SEATTLE – Attorney General Rob McKenna today announced a $16.75 million multistate settlement with Guidant Corporation that extends a replacement program for certain heart defibrillators built prior to November 2002.
Guidant Corporation, a wholly owned subsidiary of Boston Scientific, is 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 again.
A version of the company’s Ventak Prizm 2 DR Model 1861 defibrillator was found to have faulty wiring that could potentially cause the unit to fail to deliver a life-saving shock to a patient’s heart when needed. According to the states’ investigation, Guidant made changes in 2002 to correct the problem but continued to sell unmodified units until 2003.
“Today’s settlement is important because it gives patients and doctors additional time to consider whether a patient should undergo additional surgery to replace one of these defibrillators and assures that Guidant picks up those costs,” McKenna said. “Guidant also agrees to implement certain safety programs and to publicly report safety information about its products.”
Thirty-six states signed onto the settlement. Washington’s version of the settlement was filed today in King County Superior Court.
States began investigating Guidant when they learned that the company had modified the ICDs. The states alleged that the company violated consumer protection laws when it continued to sell the earlier version of the units without disclosing the existence of the newer, modified units.
Guidant denied any wrongdoing in agreeing to the settlement terms. The company claimed that failure rates were within normal limits, and that when the older units were sold the company hadn’t yet confirmed that the modifications fixed the problem.
In 2005, Guidant notified patients and doctors that the units manufactured prior to Nov. 13, 2002, had been recalled and patients were eligible for free replacements. According to a company letter dated June 17, 2005, nearly 14,000 devices were being used by patients at that time. There had been 28 reports of failure including a March 2005 report involving a patient’s death. Guidant wrote that the company “expects only a limited number of additional reports of failures,” but also acknowledged that failures and deaths may be under-reported.
Guidant advised that physicians should make the final determination on a case-by-case basis as to whether a replacement was warranted.
Pursuant to the settlement, Guidant agreed to extend the warranty program for an additional six months. The company will provide a free replacement device and reimburse patients up to $2,500 for out-of-pocket medical expenses. In addition, the states will use $1 million of the $16.5 million provided by the settlement to reimburse patients for expenses they incurred beyond the $2,500.
Guidant also agreed to do the following:
- 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 the company distributes in the United States.
Washington will receive $390,000 of the settlement funds for investigative costs and attorneys’ fees.
Washington 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 to request reimbursement.
Under the settlement, Guidant will provide a free replacement device and reimburse patients up to $2,500 for out-of-pocket medical expenses. Doctors and patients will be able to find information about the warranty program at www.bostonscientific.com. UPDATE: Patients and physicians can call 1-800-227-3422, ext. 22401 to request a form to apply for reimbursement refunds.
Consumers who apply for reimbursement for those expenses and whose requests are rejected wholly or in part by Guidant may be eligible for additional money through a program administered by the states. The states will use settlement funds to reimburse patients for out-of-pocket expenses not covered by Guidant, including medical co-payments and travel expenses to appointments. Indirect costs such as missed work days will not be covered.
Guidant Consent Decree
- 30 –
Media Contacts: Kristin Alexander, Media Relations Manager – Seattle, (206) 464-6432
Bob Lipson, Assistant Attorney General, (206) 389-2513