A jury has awarded a 54-year-old Washington man $40.1 million against a medical device manufacturer. Paramjit Singh went to a hospital in 2004 following a minor heart attack. The man’s heart was seriously burned during a bypass procedure at the hospital. Doctors could not get his heart to continue beating voluntarily, and couldn’t determine what was causing the problem. They eventually learned the cause of the malady. A Vigilante cardiac catheter designed to monitor Singh’s blood flow overheated, reaching more than 500 degrees and melting into his heart. After the operation seared his heart, Singh couldn’t be awakened from the anesthesia. He was then placed on life-support and remained in a coma until a matching heart was found and transplanted nearly three months later.
Ever since the botched surgery, which was not the fault of the doctors or the hospital, Singh has faced a barrage of medical problems. The drugs he takes for his heart have left him susceptible to cancer and he is at constant risk of kidney failure. Doctors believe he will someday require another heart transplant. The manufacturer, Edwards LifeSciences, accepted all responsibility for the faulty monitor at trial, leaving the jury to determine damages. Extensive evidence of the manufacturer’s pattern of negligence with the machine going back more than half a decade was presented during the trial. From all accounts, the evidence was devastating for the manufacturer.
Rather than recall the defective product, the corporation simply fixed the machines one-by-one as they were sent back for maintenance. Neither the hospitals that used the monitors nor the FDA were ever informed of the problem or the company’s response to it. Only after the Singh incident in 2004 was the issue reported to the FDA – and that was only after the agency just happened to find out during a visit to the manufacturer’s plant. The FDA was on the premises at Edwards on another matter when they found out what had happened to Singh.
The FDA then conducted a full investigation and in July 2006 thousands of the Vigilante monitors were recalled. One of the doctors who performed Singh’s surgery testified it was “unconscionable” that Edwards had not reported the problem and allowed surgeries to proceed with faulty machines. The doctor had been told the machines were perfectly safe. The FDA investigation turned up thousands of documents establishing that Edwards was having problems with the monitor going as far back as 1998. A piece of computer code discovered that year, called “Layout Six,” had been added to the machines to allow the flexibility to add additional features. The code subsequently caused the monitors to crash.
Edwards had originally blamed the hospital, and specifically the two doctors who carried out the procedure, for Singh’s problems. The hospital sued Edwards for attorneys’ fees and other damages, claiming fraud and breach of contract. The hospital was awarded $100,000 in punitive damages on its claim. Paul Luvera, a very good lawyer from Seattle, Washington, represented the Singh family and did an exceptional job in the case. Do you think that this case would be a pretty good argument against federal preemption? After all, the FDA approved the defective medical device.
Source: Florida Lawyers Weekly
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