Video shows heart device malfunctioned before

Video shows heart device malfunctioned before

An Edwards Lifesciences heart catheter monitor is seen in Snohomish County Superior Court.

By Tracy Vedder

MOUNT VERNON, Wash. -- It should have been a life-saving surgery. Instead, because of a software glitch, a local man's heart was virtually cooked from the inside. And the KOMO Problem Solvers have obtained video evidence that the glitch happened before.

It's all part of the evidence that turned a local tragedy into a rare, multi-million dollar settlement. And it began with a Mount Vernon family facing the most difficult time of their lives.

"The hardest thing is if I go," says Paramjit Singh, "how my family, my kids you know?" Singh is a naturalized American citizen who moved here from India 26 years ago. The fact that he is even alive today is something of a miracle.

Because of that software glitch, Singh has had a heart transplant, survived cancer brought on by the transplant, he will soon need a new kidney and will likely need another heart. "Nobody know when the time coming but I pray to God all the time."

Paramjit Singh

In 2004, Singh went into Providence Everett Medical Center for a routine bypass surgery. At 50, he was otherwise healthy, with a young family, a zest for life, and expecting to be home in a few days.

"No big deal," says Singh as he talks about what his plans were, "I want to maybe go home same day, and we were laughing, you know?"

But during surgery the software in a blood flow monitor had a glitch and the catheter inserted inside Singh's heart heated up to more than 500 degrees. Doctors couldn't restart his heart.

His wife Harmeet Kaur spent anxious hours in the hospital waiting room for news that wasn't good. "It was hard, real hard," she said, still choked with tears at the memory.

Doctors kept Singh in a medically induced coma, with bypass machines keeping blood flowing through his body and transferred him to the UW Medical Center. A heart transplant was his only hope.

After six weeks, a heart became available but, as he was being prepped for the transplant, doctors warned his wife the odds weren't good.

"You could say goodbye, maybe he'll not come like that again," Kaur remembers them telling her, "you'll not be able to see him again like that."

Singh survived, but today his life is completely different. The former soccer coach now must not exert himself. While his sons play football in the back yard he can only watch from the sofa.

His three children have posted large signs around the house reminding Singh to take the 40 pills a day that keep him alive.

And work? He used to run two businesses.

"I am 26 years in United States, never get ill one day, never get sickness one day, always working," he said. Now nothing. He cannot work.

And while doctors measure his life expectancy in single digits, the whole family worries.

His daughter, Antapreet Kaur, is the oldest of the children and knows the most about their father's prognosis.

"All the side effects and the transplants he's going to need and that's just really hard to imagine what's going to happen next," she said.

Edwards Lifesciences of California made the catheter and monitor.

Two years before Singh's heart was burned, another operation was caught on videotape, in Japan. Doctors discovered the Edwards catheter smoking and burning.  (Watch video of the catheter burning during surgery)

Edwards slowly began to fix the software glitch; as monitors came in for routine repair or maintenance, they would fix the software problem. But Edwards didn't initiate a recall for the monitors and never warned hospitals or doctors.

The Singh's sued. Their attorney Paul Luvera says, "this company was drug here kicking and screaming into this courtroom."

The videotape and the software glitch went unreported until, Luvera says, the FDA inadvertently discovered them two years after Singh's surgery. "The evidence in this case shows the company knew about dangerous harm, studied it, and buried it in a filing cabinet in their corporate offices."

Edwards Lifesciences would not do an on-camera interview, but did provide a few written answers to e-mailed questions. And in court, their trial attorney Steve Fogg told jurors, "this is not a malicious or despicable decision."

Edwards eventually recalled the monitors in 2006. In closing arguments, attorneys Fogg and Terry Sullivan said no one at the company believed patients were at risk. And they added, Singh's injury was the only patient injury reported out of millions of uses of their monitors.

"What you have here is a series of errors," Fogg told jurors, "there's no evidence that this was done for a profit reason."

But the Snohomish County jury voted unanimously to award the Singhs $40 million. And in a rare move for a Washington court, $8.3 million of that award is in punitive damages - punishment for Edwards' behavior.

The money buys security for Singhs's family, but it can't buy what they really need. "My life, my life back," says Singh, "I need only my life."

An Edwards spokesman tells the Problem Solvers that the company believes Singh should be fairly compensated for his injury, but adds they have strong grounds to appeal the verdict for punitive damages.
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