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<< Previous   of   Next >> Dan Bates / The Herald  (click to enlarge) Paramjit Singh underwent bypass surgery at Providence Everett Medical Center in 2004, but faulty software caused an equipment malfunction that left him in need of a heart transplant.   ADVERTISEMENT   How a heart catheter works See an animated graphic showing what happened when a catheter inserted in Paramjit Singh's heart overheated.   Related Stories • Jury awards man record $40 million for destroyed heart 3/10/08   CONTACT THE HERALD Robert Frank, City Editor frank@heraldnet.com   Published: Monday, February 11, 2008 Man sues after medical device destroys his heart By Jim Haley and Sharon Salyer Herald Writers EVERETT -- After a small heart attack, Paramjit Singh went for bypass surgery to Providence Everett Medical Center, one of the top cardiac care hospitals around. As he surrendered to the anesthesia, Singh fully expected to wake up that afternoon. That's not what happened. About six weeks passed before he opened his eyes. Friends and family were crowded around his hospital bed, praying for his life. He started to understand what they were telling him. He was in a different hospital, in a different city. And he needed a new heart. The Mount Vernon man's problem began with what was supposed to be a relatively routine procedure at Providence. The bypass surgery, on Oct. 11, 2004, was successful. When the operation was over, the surgeon couldn't get Singh's heart to resume beating on its own. Doctors learned that a catheter inserted into his heart to monitor blood flow had overheated, reaching temperatures approaching 500 degrees, and then melted. The heat cooked Singh's heart from the inside. The surgeons kept him on a machine that kept his blood circulating until he could get a transplant. New heart, new problems The tragedy has left Singh with a shortened life expectancy. He now battles cancer caused by the drugs he must consume. He's at risk for kidney failure and possibly another heart transplant. What happened to Singh now is being recounted in front of a jury in Snohomish County Superior Court. Singh and Providence have filed suit against the manufacturer of the device that burned his heart, Edwards Lifesciences of Irvine, Calif. The company has accepted responsibility for Singh's life-threatening injury. What's being decided in the trial is how much money Edwards should pay to Singh and his family, and whether Providence shoulders any of the blame. After Singh's heart was destroyed, he was put on life-support and kept in a medically induced coma. The hope was that a matching heart could quickly be found. More than 11 weeks later, Dec. 28, 2004, Singh got his new heart at University of Washington Medical Center in Seattle. 'I can't help' Since then, Singh, now 54, says he continues to face life-threatening challenges. Singh, who was born in India and was a track star for the Indian army, running the 440-yard dash, now watches as his 11-year-old daughter and 7-year-old son do yard work. "I want to help (but) I can't help," Singh said. He tires easily. He takes 35 or 40 pills a day, mostly anti-rejection drugs, which weaken his immune system. The man who played field hockey in his youth and helped coach his children's soccer teams can do little but pass the time sitting. Singh used to visit his 96-year-old father in his native India every other year. "My father tells me, 'Come see me now, before I go,'" Singh said. But Singh's immune system is so compromised that he dares not travel abroad. He's stayed away from the courtroom where his case is being heard for fear of catching a cold from someone or being overly stressed. The lawsuit could result in the Singh family getting millions of dollars in compensation. Singh's lawyers allege that Edwards knew of the possible danger associated with the device and that the company's actions were so outrageous that a jury should award punitive damages. Singh used to operate a restaurant and motel in Oak Harbor and a truck stop in Mount Vernon. He no longer runs those businesses. Both Singh and his wife, Harmeet Kaur, 40, are naturalized citizens. He said he chose to live in the United States after visiting ports around the world as a member of the Merchant Marine. According to testimony, Singh has battled one round of cancer, a form of lymphoma that has been directly attributed to his anti-rejection medications. Doctors say he's at risk to get cancer again. Singh's lawyer, Paul Luvera, has told the jury that there's an even chance the medications eventually will cause him to require kidney dialysis or a kidney transplant. Doctors say Singh's life will be shortened by a kidney transplant, maybe by 8 to 13 years, lawyers said. And if he lives long enough, he will need a second donated heart as the one he has wears out, Luvera said. Faulty computer code The lawsuit centers on a piece of computer code that was written into the program for the Vigilance monitor, which controlled the catheter that melted. Both the catheter and monitor were made by Edwards, a leading producer of products to treat cardiovascular disease with nearly $1.4 billion in sales in 2006. Singh's lawyers allege the company knew about a software error that caused the catheter to overheat. Edwards didn't warn hospitals of potential hazards, they say. They also allege that the company "rolled the dice" with people's lives by not recalling the devices when the software problem was discovered as early as 1998. A fix for the problem was developed in 1999. By March 2003, Edwards knew that the computer code served no purpose and could only cause harm or kill a patient, Singh's lawyers said in court papers. Edwards maintains that it didn't believe there would be a danger to patients. The company released this statement regarding Singh's case: "Our Vigilance monitor has been used safely and successfully over the last 15 years to help millions of patients with life-threatening ailments. This is the only reported injury related to the use of this device." However, Sigh's case is not the first time problems were reported with the monitor. Jurors have already seen a video of a 2002 heart operation in Japan where the catheter overheated. At the time, the filament was outside the patient's heart, but jurors saw it beginning to smoke. It eventually charred and fell apart. The hot end was cut off. The patient in Japan was not injured. Thousands of Vigilance monitors nationwide were recalled in July 2006, some 21 months after the injury to Singh, and four years after the catheter charred in Japan. An Edwards lawyer, Steve Fogg of Seattle, said the 2006 recall was "entirely voluntary." He told jurors that it took until 2006 before the exact cause of the malfunction was pinpointed. Singh lawyer Joel Cunningham of Seattle told jurors that the U.S. Food and Drug Administration forced the recall after reviewing records at Edwards. Edwards also faces claims from Providence. The hospital is suing Edwards, alleging that it has spent hundred of thousands of dollars on the court case and on trying to find out what went wrong with the Vigilance machine that was in the hospital's operating room. Paula Bradley, director of organizational quality at the hospital, said she went to the operating room immediately after being told of the problem. "Obviously, the first thing is taking care of the patient, then finding out what happened, why it happened and what we can do to prevent it from happening again," she said. The hospital's investigation stretched over three years, said Dr. Lawrence Schecter, Providence's chief medical officer. Schecter said he and other hospital staff checked on Singh and visited with his family several times while he was being treated at the University of Washington. "We have dedicated ourselves to what we perceive is justice and that it will never happen again," Schecter said. "Our hope is that justice will compensate for the devastating injury." How much to pay? Edwards accepts responsibility for Singh's injury but maintains that the hospital shares part of the blame because it used a defective cable to connect the catheter to the monitor. Its lawyers also argue that Providence had no procedure in place in 2004 to regularly inspect and replace defective cables. The damaged cable and the faulty computer code were critical, but they were just two things in an unusual sequence of events that led to the filament's overheating, tests showed. Fogg told the jury late last month that Edwards is willing to pay "fair and reasonable" compensation. Fogg said the company shouldn't have to pay a blockbuster verdict. "Edwards feels tremendous regret, tremendous regret for what happened to the Singh family," Fogg told jurors. Singh's attorneys and Providence lawyer Cathy Cochran want the jurors to believe that the company is the "evil empire," Fogg said. However, the scientists and engineers who knew about the software flaw "to a person believed that no patient would be harmed." They were wrong. 'Upside down' Being dependant is something Singh struggles to accept. "I'm a healthy guy all my life," he said. "I never had any problems." Now he depends on his wife and other family members. His children posted a sign outside his room reminding him to take his medication. There is little he can do around the house. "I'm always a very happy guy, you know," he said. "Now everything is upside down. I want to help. I can't help." "What happened to me," he added, "I don't want to see happen to anyone again. I'm suffering." Reporter Jim Haley: 425-339-3447 or jhaley@heraldnet.com.

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