When does an implantable defibrillator manufacturer have an obligation to inform patients and doctors of a defect? I respectfully suggest the answer is as soon as the defect is determined to exist and known to present a risk to the patient. In this report of defective defibrillators the manufacturer apparently decided otherwise.
According to recent SEC filings, Boston Scientific Corp. now faces about 477 individual and 72 class-action lawsuits over recalled Guidant defibrillators.
The first trial surrounding defective Guidant defibrillators is set to begin in Corpus Christi, Texas on September 18, 2006. The plaintiffs in this are two patients who had Guidant’s Ventak Prizm 2 defibrillator implanted 2001. While both plaintiffs are still alive, they live with the fear that the devices can fail at anytime. Many patients in their same situation have elected to have the defective devices removed and replaced with new models. The removal and insertion of these devices does require risk, making it a difficult decision for patients to decide on the best course of action.
Plaintiffs argue that Guidant knew about the defects in their defibrillators for three years before they informed doctors about the problems. The defibrillator defects didn’t come to light until the death of a 21-year-old college student was reported. The student had a Guidant defibrillator implanted because he suffered from heart disease. Guidant acknowledged that the defibrillator short circuited causing his death. The company also told his doctors that it was aware of 25 other cases in which the defibrillator had been affected by the same flaw. However, Guidant’s executives said the company did not see a compelling reason to issue an alert to physicians because the unit’s failure rate was very low and replacing the devices might pose greater patient risks.
The Guidant defibrillator recall included the following models:Guidant Prizm 2 DR, Model 1861, Guidant Contak Renewal, Model H135, Guidant Contak Renewal 2, Model H155, Guidant Prizm AVT Vitality AVT Renewal 3, Guidant AVT Renewal 4 AVT, Guidant Contak Renewal 3 and 4, Guidant Renewal 3 and 4 AVT and Guidant Renewal RF.