Guidant Sold Faulty Defibrillators After New Ones Were AvailableJun 3, 2005 | ST. PAUL PIONEER PRESS
it kept selling the old devicesThe fallout from Guidant Corp.'s handling of its potentially defective Prizm 2 defibrillator intensified Thursday. Even as Guidant was being sued by a patient for allegedly selling a defective product, the company acknowledged that after the corrected version was available.
"I don't understand why they continued to sell them it must be a flaw in their decision-making process," said Jan Wald, a securities analyst at A.G. Edwards.
Wald said that when he was working for Guidant, his former employer alerted doctors of all potential problems, no matter how small. Given the recent disclosures, Wald admits he has "lost a little faith in them."
The Indianapolis-based company's division that developed the Prizm 2 device is based in Arden Hills.
At least nine patients at Abbott Northwestern hospital in Minneapolis, possibly more, received the potentially defective devices even though new ones were ready, said Dr. Robert Hauser, a cardiologist at the Minneapolis Heart Institute. It was Hauser's patient, Joshua Oukrop, a 21-year-old Grand Rapids, Minn., man, who died of a heart attack after his device failed to give his heart a needed jolt.
Several "high risk" patients like Oukrop recently have had their potentially defective devices replaced at the Minneapolis hospital, Hauser said Thursday.
Meanwhile, a Pennsylvania man who was implanted with the device sued Guidant on Wednesday. John Brennan, 74, alleges the company sold a defective product, and accuses it of breach of warranty, fraud and negligence. He is asking the court for class action status so that up to 24,000 other patients who received the flawed device can join the suit. The company declined comment on the lawsuit Thursday.
Since the issue came to a head a week ago, officials with the Food and Drug Administration, which regulates medical devices, have met with Guidant executives. But a spokeswoman for the federal regulators said Thursday that the agency is not quite ready to go public with comments on the case.
For the most part, there appears to be little the FDA can do besides criticize Guidant's actions. The device's reported defects did not reach the threshold where the agency can order a recall, and it appears to have limited enforcement options, Wald said.
"The FDA is a relatively weak enforcement agency it has come down to depending on trial lawyers to hold corporations accountable," said Steven Miles, a professor at the Center for Bioethics at the University of Minnesota.