Some Insignia and Nexus pacemakerspacemakers
Contak Renewal TR and TR 2 cardiac resynchronization pacemakers
Ventak Prizm 2, Vitality, and Vitality 2 ICDs (implantable cardioverter defibrillators)
Guidant recommends replacing the implanted devices like its a minor inconvenience. In a July 18, 2005, Dear Doctor Letter, Guident said it will provide "a replacement device at no charge for pacemaker-dependent patients and other patients deemed by their physicians to be best served by replacement, provided the replacement occurs prior to the normal appearance of elective replacement indicators. "
Experts say, its not quite that simple. On March 30, 2006, a New York Times headline read: "Replacing Heart Device Found Risky; It may be safer to leave possibly defective defibrillators in patients, studies show."
The research in JAMA found that one out of every 50 patients needed to have the replacement defibrillator removed because of severe postoperative infections.
One of the study's lead authors, Dr Andrew Krahn, of Canada's University of Western Ontario, said the overall complication rate was three to five times higher than expected.
Experts say, patients need to consider all the risks when deciding whether to replace or retain a defibrillator recalled by its maker.
Additionally, the Dear Doctor letter said, "Guidant will reimburse patients up to $2,500 for medical expenses remaining after Medicare and/or health insurance coverage, including device replacement or additional follow-up procedures." According to SEC filings, Guidant had a $113 million charge in last year's second quarter for the cost of replacing the recalled defibrillators.
However, Boston had better start putting money aside to pay for the damages because lawsuit are already being filed to force the company to pay up. According to the January 30, 2006, Lawyers Weekly article, "New York State and the city of Bethlehem, Pa. are suing Guidant for reimbursement of medical costs involved in replacing the devices."
"The bulk of the liability damages sought are for either the cost of explant and replacement surgery or the cost of medical monitoring, which includes periodic evaluation by a physician to test the reliability of devices that remain implanted," says Attorney Victoria Davis, a partner in the product liability group of Alston + Bird LLP in Atlanta, in the May/June issue of Medical Device Link.
"So obviously the financial implications are huge," she told Medical Device, "whether you are talking about the cost of defending the growing number of lawsuits or the cost of any payments made to plaintiffs and their lawyers, which could be in the millions if the plaintiffs prevail."
Even before it acquired Guidant, Boston had its own quality control problems. According to the March/April 2006, issue of Medical Device Link, "just hours after Boston Scientific Corp. (Natick, MA) bested rival suitor Johnson & Johnson Inc. (J&J; New Brunswick, NJ) and nailed down its $27.2 billion bid, the company learned that, in addition to cleaning up the problems at Guidant, it now has to get its own house in order."
In a warning letter from FDA, Boston was notified of "serious regulatory problems" with medical devices produced at its facilities in Natick, MA; Maple Grove, MN; and Spencer, IN. The letter also referred to three earlier warnings regarding the company's production plants in Watertown, MA; Glens Falls, NY; and Quincy, MA.
According to the FDA, Boston's inability to address these issues in a timely manner indicated a "systemic problem with the entire corporate quality management system."
FDA official, Daniel Schultz, MD, said the warning was only the third time in the FDA's history that the agency had issued such a broad-based warning to a medtech company. The letter called on Boston "to resolve these serious violations promptly, and to do it not as it relates to specific products, but rather on a corporate wide basis."
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