(Washington, DC) - District of Columbia Attorney General Linda Singer today announced the District and 35 states have resolved allegations against Guidant Corporation that it continued to sell heart defibrillators without disclosing its introduction of a modified version that corrected a potentially fatal defect in the product.
The settlement is in the form of consent judgments that are being filed in the states’ courts and in DC Superior Court, where a formal complaint also is being filed.
Guidant Corporation, a wholly-owned subsidiary of Boston Scientific Corporation, is one of the world’s three largest manufacturers of Implantable Cardioverter Defibrillators (“ICD”s). These are medical devices that doctors surgically implant in a patient’s chest to monitor for abnormal heart rhythms. If an abnormal rhythm develops, the ICD delivers a small jolt of electricity to restore normal heart rhythm. Pursuant to the settlement, Guidant has agreed to implement certain ICD product safety programs and to publicly report important safety information about its ICD products. Guidant also has agreed to make a $16.75 million payment to the states, of which up to $1 million will be used to supplement consumer medical expenses incurred in replacing implanted defibrillators.
Singer and other attorneys general began investigating Guidant when they learned that Guidant made product modifications in 2002 to correct a design flaw in the wiring of one specific ICD model. The flaw could cause the unit to short-circuit, resulting in its failure to deliver a life-saving electrical charge to a patient’s heart when needed.
The complaint filed in Superior Court alleges that despite making two separate changes in 2002 to correct the wiring problem, Guidant continued to sell, until May 2005, unmodified versions of this model at the same time it was shipping corrected versions without informing physicians, patients, or the public that it was doing so.
Guidant does not admit to any wrongdoing, but in settlement of the states’ concerns has agreed, among other matters, to:
- Establish a Patient Safety Advisory Board of independent experts to evaluate ICD performance and risk assessment data;
- Establish a Patient Safety Officer position, staffed by a physician whose primary responsibility would be to advance ICD patient safety;
- Clearly disclose and disseminate to the public on a quarterly basis specific information about its ICD products, including worldwide product failure data, device survival probability estimates, and information in the event of an FDA recall of an 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.
Under its Warranty Supplement Program, Guidant has provided consumers with replacement ICD devices at no cost, and has provided up to $2,500 for unreimbursed medical expenses incurred in the replacement. Pursuant to the settlement announced today, Guidant has agreed to extend this replacement program for an additional six months, and the states will use up to $1 million of the settlement funds to reimburse consumers for medical expenses they incurred beyond the $2,500 Guidant allowance. The ICD products covered by the extended replacement program are the VENTAK PRIZM 2 DR Model 1861, the CONTAK RENEWAL Model H135, and the CONTAK RENEWAL 2 Model H155 devices.
The District of Columbia’s share of the multistate settlement is $390,000, which will be used to fund consumer education and continued enforcement of the District’s consumer protection laws.