Attorney General Hardy Myers today filed a $16.75 million settlement agreement with Guidant Corporation of Minnesota and Indiana (Guidant), one of the world's three largest manufacturers of Implantable Cardioverter Defibrillators (ICD). The settlement resolves allegations that the company sold ICDs without disclosing that the medical devices had wiring problems that could result in potentially fatal short circuits. Named in a stipulated general judgment filed in Marion County Circuit Court is Guidant Corporation, a wholly owned subsidiary of Boston Scientific; Guidant Sales Corporation, and Cardiac Pacemakers, Inc. Guidant does not admit any wrongdoing.
"Consumers have the right to all information about products that impact their health and safety," Myers said. "Oregon will continue to aggressively pursue companies that hide important safety information from doctors and patients."
The settlement relates to the sale of one particular ICD, the Ventak Prizm 2 DR Model 1861 (Prizm ICD). An ICD is a medical device surgically implanted in a patient to monitor for abnormal heart rhythms and, if necessary, to deliver an electric shock to restore a normal rhythm. An ICD works as either a pacemaker to normalize rhythm or as a defibrillator to shock a heart back into function. If an ICD fails to deliver a shock when needed, the patient could die.
In 2000, the U.S. Food and Drug Administration (FDA) approved Guidant's application to produce Prizm ICDs. Prior to April 2002, the company learned of a wiring problem that could cause a short circuit when the Prizm ICD was called upon to deliver a life-saving shock. Guidant modified the Prizm ICD twice and successfully stopped the failure pattern but continued to sell unmodified devices until their inventory was exhausted.
The Oregon Department of Justice (DOJ) Financial Fraud/Consumer Protection Section organized a 36-state investigation of Guidant in 2005 after two cardiologists disclosed the company's sale of unmodified Prizm ICDs following the company's discovery of the wiring problem. At least one individual is known to have died as a result of failure of an unmodified Prizm ICD sold after November 2002.
The states' investigators found that Guidant did not inform physicians or the public about the modifications until May 2005 and that it had continued to sell unmodified Prizm ICDs in 2002 and 2003.
Under the settlement, Guidant agrees to establish a patient safety advisory board consisting of independent experts to evaluate data concerning ICD performance and to establish a patient safety officer position. The board will be staffed by a physician whose primary responsibility is to advance ICD patient safety.
Myers believes creation of the advisory board and the public safety officer position will provide an "institutional conscience that will make the type of decisions Guidant made in the past impossible."
Guidant also agrees to:
Clearly disclose and disseminate to the public certain specific information on a quarterly basis about ICDs made by Guidant, including operation failure rates, probability rates on the success or failure to normalize heart rates of patients, and instructions for consumers in the event an FDA ICD recall;
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 Prizm ICDs; and,
Maintain a data system to track the serial numbers and implant and explant dates of all ICDs distributed by Guidant in the United States.
Currently, Guidant is conducting a warranty program to provide consumers who want to replace their Prizm ICDs 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 today's settlement, Guidant agrees to extend this warranty program for an additional six months. As lead state in the case, Oregon is responsible for administering an additional $1 million in warranty program reimbursements for expenses consumers incur beyond $2,500.
Oregon's share of the remaining $15,750,000 of the settlement is $815,000, which will be placed in the DOJ Consumer Protection and Education Fund.
Consumers wanting more information about this agreement and consumer protection in Oregon may call the Attorney General's consumer hotline at (503) 378-4320 (Salem area only), (503) 229-5576 (Portland area only) or toll-free at 1-877-877-9392. DOJ is online at www.doj.state.or.us.
Jan Margosian, (503) 947-4333 (media line only) firstname.lastname@example.org