A Medical Device Daily Staff Report

A Snohomish Superior Court jury reported awarding a Mount Vernon, Washington man and his family $40.1 million after his heart was irreparably burned by one of Edwards Lifesciences (Irvine, California) monitors – a device the plaintiff claimed the company knew for years was defective.

The award, one of the largest of its kind, included $8.35 million in punitive damages.

Paramjit Singh checked into Providence Everett Medical Center (Everett, Washington) in October 2004 for routine surgery when a monitor manufactured by Edwards malfunctioned, causing a catheter to overheat and sear his heart.

According to Paul Luvera, founding partner of The Luvera Law Firm and one of the attorneys representing Singh, Edwards knew of the potential problem as early as 1998 but chose not to warn hospitals and other users of the potentially deadly flaw.

Singh had to undergo a heart transplant because of his injuries and faces serious life-long medical problems, including an expected kidney transplant.

The jury also awarded Providence $310,000 in damages. Providence filed suit claiming Edward’s actions damaged the hospital.

“They had the courage to do the right thing for the Singh family, and for Providence Everett Medical Center,” Luvera noted. “The jury made a thorough assessment of Singh’s injuries and circumstances and found Providence’s actions inconsequential, a victory all around.”

But Edwards said it sharply disagrees and said it plans to file an appeal.

In a statement the company said “We do not believe the award of punitive damages will withstand the scrutiny of the higher court. This was the only reported injury related to millions of uses of this device and the problem that caused the issue has been rectified. While we are certainly sympathetic to Mr. Singh and believe he should be fairly compensated for his injury, the award of punitive damages is contrary to the facts and the law and we have strong grounds for appeal.”

Singh was admitted to Providence to undergo cardiac bypass surgery. During the operation, surgeons monitored Singh with Edwards’ Vigilance I Monitor and placed several catheters in his heart tissue.

When the physician could not remove a catheter from Singh’s heart, he made an incision and found a piece of the catheter was “burned to a crisp” and the heart tissue around it was charred. He was unable to re-start Singh’s heart.

According to court documents, Edwards first became aware of a software bug in its monitors back in 1998, but ignored internal recommendations to correct the problem. In 2002, the software bug caused a similar incident in Japan — caught on video tape — but the smoldering catheter had been removed from the patient before overheating.

Despite the Japan incident, Edwards did not warn or advise healthcare professionals to stop using its monitors, court records show. Instead, the company simply began distributing re-designed products in March 2003 that no longer contained the software error.

The jury awarded Singh $24 million, his wife $6 million and their children $750,000, $500,000 and $500,000 respectively.

When Singh’s injury occurred in 2004, Edwards continued to deny any problem with its product, and made no attempt to alert other hospitals.

In 2006, almost two years after Singh’s heart was permanently damaged, Edwards issued a product recall that removed all defective monitors from healthcare facilities.

In its action, Providence claimed the company defrauded the hospital and violated the Consumer Protection Act among other actions. The jury found for the hospital in each of its claims.

The judge allowed the Singh’s and Providence to argue for punitive damages — typically not permitted in Washington court — since Edwards is based in California, a state that allows for punitive damages.

In other legalities: TriMed (Valencia, California) a developer of orthopedic fixation devices, has reported that the United States Court of Appeals has ruled in its favor and reversed a lower court’s summary judgment in its patent infringement suit against defendant Stryker (Kalamazoo, Michigan).

The appellate court found that Stryker’s accused device contains “precisely the same structure” shown in TriMed’s patent. The decision was reported Jan. 29, 2008. TriMed filed a patent infringement case against Stryker in early 2006 in the U.S. District Court, Central District of California in Los Angeles. The suit claimed infringement of its U.S. Patent No. 5,931,839, which protects the company’s Radial Pin Plate and the Ulnar Pin Plate used for the distal radius (wrist) fractures. TriMed introduced the plates in 1995 for use in reducing distal radius fractures often without a need for a post-surgical cast. The plates are particularly suited for reducing fractures involving small bone fragments, intra-articular fractures, highly comminuted and/or osteoporatic bone conditions.

Following the growing popularity of TriMed’s Radial and Ulnar Pin Plates, Stryker introduced its Radial and Ulnar Column Plates in 2003.