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this pageNY Attorney General Sues Guidant Over Defective Defibrillators
MANHATTAN, NY — November 11, 2005 — Guidant, a leading manufacturer of medical devices, concealed information about a serious flaw in its defibrillators, a lawsuit filed by the NY Attorney General charges (People of The State of NY v. Guidant Corporation, Supreme Court of NY, November 2, 2005). A defibrillator is a surgically implanted device that provides a shock to the heart to restore it to normal rhythm. Its purpose is to prevent cardiac arrest, a condition in which the heart stops or is unable to pump blood. However, some Guidant defibrillators may short–circuit, leading to serious injury or death, according to the lawsuit.
The complaint alleges that Guidant engaged in fraud by failing to disclose to doctors that its Ventak Prizm 2 DR Model 1861 defibrillator could short out. The company knew about this design defect in February 2002, the complaint states, and made design changes in some of the defibrillators to correct the problem. It continued to sell Prizm 1861 defibrillators in which the design flaw had not been corrected, however. Guidant did not notify doctors of the defect in the older models until three years later, the complaint continues.
“Concealment of negative facts that might influence a consumer to purchase another manufacturer’s product is the essence of fraud,” said NY Attorney General Eliot Spitzer (Press Release, November 3, 2005). “We wouldn’t permit this type of conduct in connection with the sale of cars or washing machines. It is simply unconscionable that it occurred with a critical medical device.”
The lawsuit asks for a court order that will require Guidant to fully disclose design and performance information about its medical devices to doctors and the public. It also seeks damages for Guidant insurers, government health programs, and consumers, including payment for replacement defibrillators. Guidant would also be required to give up profits from Prizm 2 DR sales made after 2002.
Guidant Defibrillators Recalled Earlier This Year
In June of this year, Guidant recalled all Ventak Prizm 2 DR Model 1861 defibrillators that were manufactured prior to April 16, 2002. These were the defibrillators that had not been redesigned (FDA News, June 17, 2005). The company also recalled two other defibrillators—the Contak Renewal Model H135 and the Contak Renewal 2 Model H155, that were manufactured before August 26, 2004. All three of these older defibrillator models were subject to short–circuiting.
The Food and Drug Administration (FDA) classified the defibrillator recalls as Class I, the most urgent recall category. If a Class I device does not function properly, it can cause severe health problems or death.
About 109,000 defibrillators in the Class I category were recalled, according to Minnesota Public Radio (November 3, 2005). Within this group, 14,000 remain implanted in patients in the United States.
What Should I Do About My Guidant Defibrillator?
The FDA has issued no advice about whether the defective Guidant defibrillators should be removed and replaced. Instead, it advises patients to have an extensive discussion with their doctors.
If you have a defibrillator, you need to know what company manufactured the device, the model name, and number. If you have one of the recalled models, your doctor should review your individual situation to determine whether removing the defibrillator is the best course of action. He or she may consider the possibility that a defibrillator may fail as well as the risks involved with replacing the device, including injury and infection.
Brayton Purcell is concerned about defective heart defibrillators and other unsafe medical devices. Please feel free to contact us if you or a loved one has suffered an injury due to a defective medical device, and would like information about your legal options. We have been handling medically–related consumer cases for over 20 years, and have represented hundreds of clients against medical device manufacturers.