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June 30, 2005
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| The Ventak Prizm 2 is one of 11 defibrillator models recalled by Guidant. It's associated with at least 28 malfunctions and one patient death out of 26,000 patients who have the device. (Image courtesy of Guidant Corp.) |
In his lawsuit, Otto Mormon alleges that Guidant concealed information about the defects, putting his life and the lives of other patients at risk. He spoke to Minnesota Public Radio's Lorna Benson shortly before going into surgery to have his Guidant defibrillator replaced.
St. Paul, Minn. — Otto Morman says he tries very hard not to think about the defibrillator implanted in his chest because when he does, he starts to worry.
"Thinking about this, I woke up around 2:30 this morning in anticipation of what's taking place today," says Morman. "I wasn't able to get back to sleep. So I ended up watching television since 2:30 this morning."
Morman's defibrillator is a Ventak Prizm 2. He's had it since his first heart attack more than two years ago. It was put in to correct his irregular heartbeat.
In Guidant's recall notice, the company says the Ventak Prism 2 model has short-circuited in 28 patients and is associated with one death out of 26,000 patients with that unit.
Statistically speaking, the failure rate is very low. But Otto Morman says it's too high for him.
"I'm not crazy about the idea of the fact that the next time I need this thing, it may not work. It could work, it could work fine for the next seven or eight times. But there's always that chance that it's not going to work the next time I need the charge," says Morman. "That's not a feeling I wanted to walk around with."
Morman decided to have his defibrillator replaced, even though it functioned properly a month ago when he had his second heart attack. He says the device went off seven times that day, and he believes it probably saved his life.
Still, Morman says he can't shake the feeling that something is wrong with his defibrillator. He says there's an odd flutter in his heart lately. He's says it could be the device malfunctioning, or it could be anxiety. But he says judging by Guidant's interest in his second heart attack, Morman's convinced there's a problem with his device.
"The part that makes me really wonder about Guidant is that their representative was in to see me three different times while I was in the hospital with the heart attack," says Morman. "I would stake my life they knew at the time that this was taking place that I had one of the defective units. I have nothing to prove that. But why else, within two days, would they send their representative in three different times?"
Morman's attorney, Charles LaDuca, says Guidant knew about problems with the Ventak Prizm 2 defibillator in the spring of 2002 and made some changes to the device. But he says the company still kept selling its defective inventory. Otto Morman received his unit in December 2002.
"We allege in our complaint and on behalf of Mr. Morman that Guidant knew about these defects, but concealed the facts of these defects from doctors and defibrillator recipients," says LaDuca.
Guidant officials wouldn't agree to be interviewed on tape. A company spokeswoman did say that it's Guidant policy not to comment on pending lawsuits. She referred questions about the recall to Guidant's Web site.
On the site, the company lists its recommendations on when to replace a defibrillator. In some cases Guidant says it could be riskier to replace the unit than leaving it in place.
The company is offering to replace its defibrillators for free, and provide up to $2,500 in unreimbursed medical expenses. But Otto Morman says that won't be enough to compensate him for his losses.
"I'm going to lose probably a month's wages, for one thing, because any time I had at work was taken up with my recent heart attack," says Morman. "Yeah, I am completely out of time, vacation and sick pay."
The situation has hit Guidant's pocketbook too. The company's stock is trading several dollars lower since the recall was announced. And Wall Street analysts say it could jeopardize the company's pending sale to Johnson and Johnson.
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