In another amazing story detailing the extent that medical device manufacturers are willing to go to put profits over safety, a Washington man, and his attorneys have successfully exposed a company that put millions of patients lives at risk, and defraided thousands of hospitals, by failing to disclose known risks with it heart surgery devices.
A Washington state jury awarded 40.1 million in damages to a man who needed a heart transplant after his heart was scarred, singed and burned by a malfunction involving a defective Edwards monitor and catheter.
According to the AP report, Mr. Singh had gone to Providence Everett Medical Center in October 2004 for heart bypass surgery , and the doctors used the monitor, and had placed several attached cathetrs in the man’s heart. When the physician could not remove the catheter, he pulled back some of the tissue which revealed that the catheter had overheated and burned his heart.
The doctor could not restart Singh’s heart, so he was transferred him to another hospital while his circulation was maintained with a mechanical heart pump. The patient was in a chemically induced coma until he received a a transplant several weeks later.
According to the report, the hospital blamed Edwards for failing to disclose a problem with the monitor. The company was even pordered to pay the hospital $310,000 for fraud.
According to a press release from the man’s attorneys:
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.
Even after this incident occurred, Edward continued to put profits over safety, and continued to deny any problem with the monitor and did not warn other hospitals. It took another two years for the company to finally issue a recall.