National Association of Attorneys General
Thirty-six Attorneys General Settle With Guidant
Thirty-six Attorneys General1 reached a settlement with Guidant Corporation, a manufacturer 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 the 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.
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 settlement 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.
1Alaska, Arizona, Arkansas, California, Connecticut, District of Columbia, Florida, Hawaii, Idaho, Illinois, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, 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