Implanted defibrillator maker Guidant (Indianapolis) is facing hundreds of class actions and liability lawsuits related to the malfunctions of its devices, but a case filed Tuesday in Ramsey County, Minnesota, certainly is the most unique - and perhaps the most emotionally distressing to the victim's family.
In July 2005, Allan Gohde was to be buried, the victim of an apparent heart attack days earlier at the age of 53, struck down at his home in front of his wife Kathleen.
At the funeral home a few days later, his widow leaned into the coffin to give him a final kiss and a good-bye hug and heard a noise. A loud, beeping sound. And it was coming from the chest of her dead husband.
The noise was the sound of his defibrillator, a Ventak Prixm 2 DR Model 1861 ICD from Guidant. It had not been explanted, with Kathleen and other members of the family apparently considering Allan's death an unavoidable cardiovascular failure.
That all changed, of course. The device was then explanted from his body and sent to Guidant for evaluation.
To the company's credit, it provided a thorough explanation of what had happened.
According to the family's attorneys, Guidant acknowledged in a report to Gohde's physician, that “high-voltage damage“ to Gohde's defibrillator had been found and that the beeping sound that his wife heard at the funeral home was a result of the shorted condition.
Guidant also concluded that, at the time of Allan Gohde's death, the defibrillator had detected “ventricular fibrillation“ and that it attempted to provide a shock, but that it had become “non-responsive during this attempt.“
The company then filed an adverse event report which said that the defibrillator implanted in Gohde short-circuited and that this failure directly contributed to his death.
This week, the law firm of Robins, Kaplan, Miller & Ciresi (Minneapolis/Washington) filed a wrongful death and product liability suit vs. Guidant and its Cardiac Pacemakers (St. Paul, Minnesota) subsidiary.
“Obviously the product was defective,“ Tara Sutton, one of two attorneys from the firm in its Minneapolis office, told Medical Device Daily, citing various news reports and disclosures by the company itself, including Guidant's own report concerning the device implanted in Gohde. She additionally noted this week's lengthy report of an investigation into these problems by an independent panel of experts established by the company itself (MDD, March 22/ March 23, 2006).
Sutton further charged that Guidant was “hiding a life-threatening defect“ for three years but continued to sell the devices before the problems were revealed.
She noted that the Gohde case would appear to stand out sharply from all others being filed.
“We think our case is unique in that Guidant had an opportunity to interrogate the device and determine what was going on in Mr. Gohde's heart at the time of his death,“ Sutton said.
The case appears to underline a general contention that there has been under-reporting of malfunctions because of situations similar to Gohde's, but Sutton declined to make any assertions of what the extent of this under-reporting might be. “I can't really say,“ she said, but added: “I think that's certainly a question that we all have.“
She said that there had been “settlement discussions“ with Guidant, but failing to reach any agreement with the company, the firm filed the wrongful death suit. Sutton and a colleague on the case will “push for as early a trial as possible,“ she said.
Guidant and other companies in the industry have argued that the malfunctions of the defibrillators were within acceptable statistical limits, but Sutton said that defense won't fly. “Certainly they have been using statistics as part of their defense,“ she said, “but statistics have very little to do with the loss of human life. Even a single death is enough to trigger a company's obligations to disclose that information to people.“
Sutton chairs the Mass Tort, Medical Malpractice and Personal Injury Litigation Group of Robins, Kaplan, Miller & Ciresi. Also representing Kathleen Gohde is Chris Messerly, a partner at the firm.