Suit by patient whose heart was burned by surgical device malfunction exposes company’s deceit

Singh v. Edwards Lifesciences Corp., Wash., Snohomish Co. Super., No. 05-2-12213-5, Mar. 10, 2008.

Few medical procedures are more risky than open-heart surgery. Yet the fairly routine single-bypass surgery performed on Paramjit Singh, 54, would likely have been a complete success were it not for a surgical equipment malfunction that nearly killed him.

Paramjit, who had suffered a mild heart attack, was monitored during his surgery with the help of a catheter that had been inserted into his heart and was connected to a Vigilence I monitor manufactured by Edwards Lifesciences Corporation. During the procedure, the monitor malfunctioned and, without warning, increased the temperature of the catheter to the point that it burned his heart beyond repair. Doctors quickly attached Paramjit to an artificial heart pump and kept him in a chemically induced coma to keep him alive until a donor heart became available for transplant, a procedure he underwent about 11 weeks later.

The impact the coma and transplant have had on Paramjit’s health has been cataclysmic: The changes to his immune system necessary to prevent rejection of his new heart caused him to develop cancer; he has experienced kidney damage so severe he will require dialysis and a future transplant; he suffers the effects of anoxic brain injury brought on by his coma, resulting in memory deficits; and his life expectancy is greatly reduced.

With the help of a team of attorneys led by AAJ members Paul N. Luvera, Joel D. Cunningham, and Robert N. Gellatly, all of Seattle, Paramjit, his wife, and their three minor children sued Edwards Lifesciences, claiming the Vigilence I monitor was defective in that it had a software bug that caused it to malfunction and injure Paramjit.
During the discovery process, the full extent of Edwards Lifesciences’ liability came to light. The company, it turns out, had been aware of the software bug for more than five years. Rather than inform doctors and hospitals of the problem, the company decided it would repair the problem in the monitors as they were returned to the company for routine maintenance. Consequently, only three of the 11 monitors used at the hospital where Paramjit was treated had been repaired.

Furthermore, in the course of a visit to the Edwards Lifesciences facilities on a separate matter during this time, the FDA happened upon evidence that a similar incident had occured in Japan two years before Paramjit’s surgery, and that the company had destroyed files related to the incident. The Vigilence I monitor was subsequently recalled in June 2006.

Up until one week before the Singh trial began in January 2008, Edwards Lifesciences denied liability. The company then accepted legal responsibility but claimed it should only pay “reasonable compensation.” Its other defenses included that the problems with the monitor have been solved, making additional punishment unnecessary; it did not act after the Japanese incident because it felt the chances of the circumstances repeating themselves were sufficiently remote; there had been only one injury in over two million uses over a 15-year period; and the hospital was negligent.
The company’s claims against the hospital and its doctors were dismissed by the court on motions for summary judgment. The court also held that plaintiffs’ punitive damages claim could be presented to the jury.

One of the challenges Paramjit’s attorneys faced was that many of his injuries were not obvious. His doctors did not think it would be healthy for him to sit through the trial and endure testimony about his many injuries. On their advice, he was present only for jury selection, his own testimony, and the final argument. But, says Luvera, “The evidence from medical records, doctors, and friends was much more powerful than his appearance.”

Paramjit’s injuries have impacted every aspect of his life, including his ability to practice his religion. The Singhs used to travel to Vancouver weekly for worship activities, which included large social gatherings. But Paramjit’s injuries have impaired his ability to travel. In addition, his impaired immune system has limited his ability to interact with large groups, for fear of disease. During voir dire, Luvera asked the panel whether they were familiar with the Singhs’ Sikh faith. No one was. “The biggest challenge was getting the jury to understand and identify with the enormous harm inflicted upon this family,” says Luvera. To help meet this challenge, the attorneys called a witness to explain the basic beliefs of the Sikh faith.

After a five-week trial and four days of deliberation, the jury awarded the Singh family a total of $40.1 million. The verdict includes $31.75 million in compensatory damages and $8.35 million in punitive damages. Of the compensatory damages, $24 million is for Singh, $6 million is for his wife, $750,000 is for their oldest daughter, and each of their other children will receive $500,000.

The jury also determined that Edwards Lifesciences had violated Washington’s state consumer protection act, committed fraud against the hospital, and breached its contract with the hospital. It awarded the hospital $310,000, including $100,000 in punitive damages. On May 7, 2008, the trial court denied defendant’s motion for a new trial and declined to reduce the jury’s award.

“We know from posttrial communications that this jury took its job very seriously and wanted a verdict that set standards for medical device manufacturers as well as provided justice for this family,” says Luvera.

BRIANNE KENNEDY