A California court recently awarded $40 million to a man whose heart monitor device malfunctioned and burned his heart – causing him to have a heart transplant. The verdict is thought to be one of the largest in the state.

The case

According to news reports, Paramjit Singh, a 54 year old man, used a heart monitor device by Edwards Lifesciences Inc. Singh had been admitted to the hospital for heart bypass surgery in 2004. During the surgery, his heart monitor malfunctioned, effectively shutting down safety devices within the monitor and caused a catheter inside his heart to reach a temperature of nearly 500 degrees.

Singh had to have a heart transplant and sued the manufacturer. A California jury awarded him $40 million after evidence revealed that the manufacturer knew that the device could malfunction but did not warn consumers or recall the product. The jury award is thought to be one of the largest on record.

Manufacturers often delay recalls

Many medical device manufacturers delay recalls because they don’t want to lose consumers’ confidences. However, delaying recalls often ends up injuring consumers. While the U.S. Food and Drug Administration (FDA) becomes involved in some recalls, it simply doesn’t have the manpower to effectively monitor every medical device on the market. That leaves little incentive for manufacturers to do the ‘right thing’.

Neil Overholtz, a Florida attorney whose firm represents clients injured by medical devices, explained that, “When the FDA classifies something as a recall, it sends out a pretty scathing letter. An official Class I* recall comes with a letter that becomes a very important exhibit in fighting the liability of the case and any pre-emption issues. It describes the product as ‘violative’, forces the manufacturer to comply with the terms of the recall and reserves the right to raid the manufacturer’s premises and forcefully seize the product.”

*The FDA classifies medical device recalls into three classes:

• Class I: The most severe classification where there is a potential for serious injury or death.
• Class II: A less severe classification where there is a lesser potential for major injuries or death, but where there is still the possibility of serious enough adverse events to have irreversible consequences.
• Class III: The least severe classification where there is an unlikely potential for adverse health consequences, but there is still a chance and therefore the product is being recalled.

(Source: FDA)

If you’ve been injured due to a defective or unreasonably dangerous medical device, contact an attorney whose practice focuses in this area of law to discuss your situation. Consultations are free, without obligation and are strictly confidential. For a consultation with a qualified attorney, please click here. We may be able to help.