September 1, 2007
Medical device manufacturer Guidant has agreed to settle a multi-state lawsuit over its Implantable Cardioverter Defibrillator medical device for $16.7 million. The devices were recalled in 2005.
The settlement resolves allegations that Guidant failed to disclose to the medical community wiring failures in Guidant-made ICDs called the Ventak Prizm 2 DR Model 1861. It also resolves allegations that after making modifications to correct the wiring problems in 2002, Guidant continued to sell the original, unmodified devices into 2003.
ICDs are devices that doctors surgically implant in a patients chest to monitor for abnormal heart rhythms. If a patients heart stops, the ICD delivers an electrical surge to start it again.
The Indianapolis-based Guidant is among the worlds three largest makers of ICDs. Its related corporate entities, Guidant Sales Corporation and Cardiac Pacemakers, Inc., are also party to the settlement.
Currenty, Guidant is conducting a warranty program to provide consumers who wish to replace their Ventak Prizms with a new device at no cost, and to reimburse consumers up to $2,500 for any out-of-pocket expenses they incur with the replacement.
As part of the settlement, Guidant has agreed to extend its warranty program for an additional six months. Of the total $16.7 million being paid by Guidant to the states, approximately $1 million will be used to reimburse warranty program participants for expenses they incur beyond the $2,500 threshold.
As a result of this agreement, Guidant will create the position of patient safety officer staffed by a physician, and will take other steps to ensure that patient safety is always a priority, New Jersey Attorney General Anne Milgram said. Guidant will also be more accountable concerning the performance of its products.
We want to make sure this life-saving tool is as safe as possible, and that patients and doctors get the information they need about any safety problems, added North Carolina Attorney General Roy Cooper.
Cooper and 35 other attorneys general began investigating Guidant when they learned that the company made changes in 2002 to correct a wiring problem that could cause the Prizm to short circuit but continued to sell the old model.
If the Prizm short-circuited, it could fail to deliver a life-saving jump-start to a patients heart when needed. Guidant kept selling unmodified Prizms even after making two separate changes to correct the problem, and did not tell doctors or the public until May 2005 that it sold Prizms with wiring problems in 2002 and 2003.
Under terms of the settlement, Guidant has agreed, among other things, 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;
• On a quarterly basis, publicly disclose and disseminate specific information, including worldwide failure data, survival probability estimates and current information in the event of any U.S. Food and Drug Administration recall of an ICD;
• Post a notice on its Web site within 30 days of any modification to any of its ICDs to correct a failure pattern;
• Solicit the return of out-of-service ICDs
• Maintain a data system to track the serial numbers, implant dates and removal dates of all ICDs that Guidant distributes in the United States.
