MINNEAPOLIS, March 22 /PRNewswire/ -- Robins, Kaplan, Miller & Ciresi L.L.P., filed a wrongful death and products liability lawsuit against Guidant Corp. of Indianapolis, and its subsidiary Cardiac Pacemakers, Inc., based in St. Paul, MN. The complaint, filed in the Ramsey County District Court in St. Paul on March 21, is on behalf of the wife of Allan Gohde of Birchwood, WI, who died of sudden cardiac arrest in July 2005.
“Guidant has an ethical responsibility and duty to its patients and their physicians for ensuring the safety of their implantable heart defibrillators. They admitted to hiding a life-threatening defect in these defibrillators for three years while continuing to sell them. Mr. Gohde’s death could have and should have been prevented, and this complaint serves as a notice that such conduct is not acceptable,” said Tara D. Sutton, the Robins, Kaplan, Miller & Ciresi L.L.P. partner representing Mrs. Gohde. Sutton chairs the firm’s Mass Tort, Medical Malpractice and Personal Injury Litigation Group. Also representing Mrs. Gohde is Chris Messerly, partner at Robins, Kaplan, Miller & Ciresi L.L.P.
Background
On July 28, 2005, Gohde, age 53, died of sudden cardiac arrest at his home. At the funeral home, his wife heard a loud beeping noise coming from his chest when she was giving him a last kiss and hug goodbye in his coffin. The noise was from Gohde’s Ventak Prizm 2 DR Model 1861 defibrillator, which was among the population of devices recalled by Guidant. Gohde’s defibrillator was explanted and provided to Guidant for analysis. In a report to Gohde’s physician, Guidant stated that “high voltage damage” to Gohde’s defibrillator had been found and that the beeping sound was a result of the shorted condition. Guidant also concluded that, at the time of Gohde’s death, the defibrillator detected “ventricular fibrillation,” attempted to shock and “became non-responsive during this attempt.” In an adverse event form later filed with the FDA, Guidant admitted that the defibrillator implanted in Gohde short-circuited and that this failure directly contributed to his death.
Guidant and CPI manufacture and sell the Prizm 1861 defibrillator, which is surgically implanted in the body of patients who are known to be at risk of sudden cardiac death due to an abnormal heart rhythm. It should detect abnormally fast and life threatening heart rhythms and deliver an electric shock to the heart muscle to return it to a normal rhythm. Without the shock therapy, the person may die.
In February 2002, Guidant and CPI discovered that deterioration in a wire insulator resulted in an electrical short in some Prizm 1861 defibrillators manufactured before April 2002, and knew that after the short circuit occurred, the defibrillator would, without warning, no longer work. On February 11, 2002, Gohde was implanted with a Prizm 1861 defibrillator that was later determined to be in a population of devices Guidant knew was defective. Despite making design changes to correct the flaw, Guidant and CPI chose to continue selling Prizm 1861 defibrillators that had been manufactured before April 2002, without disclosing to physicians or patients that these devices contained a serious design flaw.
After three years of not telling patients and physicians about the defect in the Prizm 1861, Guidant finally issued a recall on June 17, 2005. While they reported then that approximately 13,900 Prizm 1861 devices manufactured before the April 2002 change were implanted in patients and that at least 28 devices had short circuited because of the design flaw, including a failure that had resulted in one death, Guidant recommended that the devices not be replaced. On July 1, 2005, the FDA classified the recall as a “Class I recall,” the most serious level of product recall. Following Guidant’s recommendation, Gohde’s physician did not replace the implanted device.
Robins, Kaplan, Miller & Ciresi L.L.P. (http://www.rkmc.com) is a national law firm with offices in Atlanta, Boston, Los Angeles, Minneapolis, Naples (FL), and Washington, D.C.
Robins, Kaplan, Miller & Ciresi L.L.P.
CONTACT: Vivian Hood, +1-904-220-1915, hoodv@jaffeassociates.com, forRobins, Kaplan, Miller & Ciresi L.L.P.
Web site: http://www.rkmc.com/
