GUIDANT RECALLS POTENTIALLY FAULTY HEART DEFIBRILLATORS

Guidant recalls potentially faulty heart defibrillators

After the death of a 21-year-old man from cardiac arrest in March 2005. Guidant Corporation, a maker of inter­nal heart defibrillators, admitted that it had known for three years that the defibrillator model implanted in his chest— and still remaining in those of an estimated 17,000 other people with heart problems—was prone to short-circuit. Guidant, however, failed to disclose this information to doctors or the public un­til May, just before the New York Times broke its story on Guidant’s potentially hazardous Ventak Prizm 2 DR Mode’ 1861. Meier, Maker of Heart Device Kept Flaw from Doctors, N.Y. Times. May 24, 2005, available at www.nytimes.com.

Defibrillators, which are small devices planted in the chest under the skin, designed to shock an erratically beating heart back into a regular rhythm. Guid­ant, the second largest defibrillator man­ufacturer, reportedly says that about 63,000 of its devices have been im­planted, with nearly 50,000 still in use. Defibrillators can cost between $20,000 and $30,000 and must be changed ever 5 to 6 years because their batteries drain. It is estimated that more than 200,000 patients will get defibrillator implants this year.

Since May, Guidant has come for­ward with information that there are 2 other cases in which the Ventak Prizm 2 Model 1861 (also known as Prizm DR) short-circuited. It also admitted that in April 2002 it fixed a wiring flaw in this model, which was produced dur­ing a two year period before mid-2002, but continued to sell the original inventory because it believed the devices were reliable. Company data reported­ly shows that nine patients at one Minnesota hospital received original Prizm 2 DR defibrillator implants from May to September 2002. Meier, Heart

Device Sold Despite Flaw, Data Shows.

N.Y. Times, June 2, 2005, available at www.nytimes.com

On the heels of this disclosure, on June 17, Guidant issued a voluntary re­call of nearly 50,000 devices after they were linked to 45 failures, including two deaths. Britt, Update: Guidant Defibrill­ators Recalled, Smartmoney, June 20, 2005, available at www.smartmoney.com. In addition to its Prizm DR model, Guidant is voluntarily recalling Contak Renewal and Contak Renewal 2 devices manufactured before August 26, 2004, for wiring problems that lead to short-circuiting and Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT, and Renewal 4 AVT, because of a memory error. Japsen, Recalls, Defects Jolt Health-Care Costs, Chi. Trib., June 19, 2005, available at www.chicagotribune.com.

Again on June 24, the company notified doctors that there were safety problems with its Contak Renewal 3 and 4 and Renewal RF implantable cardioverter defibrillators (ICDs). Contak Renewal 3 is the best selling device among Guidant’s heart failure therapies. It uses pacemaker technology to regulate the heart’s pumping function and includes a defibrillator to detect and treat cardiac arrest. Guidant warned that a magnetic switch in these devices may get stuck in the closed position, which would interfere with their ability to treat arrhythmia and could accelerate the depletion of their batteries. Meier, Guidant Issues Warning on Heart Devices, N.Y. Times, June 24, 2005, available at www.nytimes.com. Guidant stated that it received four reports of flawed switch­es in its 46,000 implanted devices. Meier, Guidant Says Flaw Is Found in More Types of Heart Units, N.Y. Times, June 25, 2005, available at www.nytimes.com.

With the rising use of defibrillators, there has been an effort to make safety information more available to doctors and patients. Critics of the current FDA reporting system complain that the FDA database is hard to access and not easi­ly understood. Moreover, FDA incident reports are of limited use to doctors be­cause they lack consistency and are an­ecdotal. A company such as Guidant may either report a product safety improvement at the time it is made or in its annual review. Guidant stated that it reported the improvement of its Prizm 2 defibrillator to the FDA in its August 2003 annual report.

At present, most information about device safety is disseminated to the public by the product manufacturers. News that Guidant withheld product safety in­formation from the public for three years has increased calls for alternative, inde­pendent avenues to obtain device safe­ty information. Several independent databases have been accumulating in­formation about defibrillators and pace­maker implants. The Minneapolis Heart Institute has collected defibrillator product information since 1999, but it is ac­cessible only to doctors. The National CMS lCD Registry went online in January and is being organized by government, academia, and business. The database, which is closed to the public, contains limited information that the Medicare system uses to assess which pa­tients are the best candidates for im­plants. Swiatek, Doctors Seek Device-Flaw Database, Indianapolis Star, May 31, 2005, available at www.indystar.com.

The Guidant recall is the second in­cident of a defibrillator recall this year. In February, Medtronic, Inc., recalled 87,000 implantable defibrillators after the company became aware of a battery