A man has filed a lawsuit alleging a cardiac heater-cooler unit caused him to develop an aortic valve replacement infection.

Plaintiff John G. says he underwent the open-heart procedure in June 2015. During the operation, a Sorin 3T Heater-Cooler System was allegedly used to keep his blood and organs at normal temperature.

John alleges that M. chimaera bacteria from the Sorin 3T reached the surgical site on his body and caused him to develop a devastating infection that went undetected for months.

John alleges he made periodic visits back to the hospital in late 2016 and early 2017 because of pain that started in his sternum and spread out to his neck, head and shoulders. In late February 2017, he says doctors at the hospital told him that a bacterial infection might have been causing his symptoms.

By March 18, 2017, John allegedly returned to the hospital with a lump on the upper part of his sternum. Two days later, he says he went back to the hospital with further problems related to that lump, and doctors admitted him.

Due to the aortic valve replacement infection, John allegedly endured a re-do sternotomy, re-do aortic valve, extension of left coronary artery, re-do ascending and partial arch replacement.

According to the lawsuit, John “went into acute liver and renal failure, acute respiratory failure, and post-operative shock, among other complications.”

John says he was released from the hospital in late April 2017 with instructions to continue dialysis treatments and to keep taking antibiotics, which allegedly led to hearing loss.

Heater-Cooler Device and Aortic Valve Replacement Infection

In May 2017, tests confirmed that John’s infection was caused by M. chimaera bacterium, which is the same bacteria allegedly found to thrive in the Sorin 3T Heater-Cooler Systems.

According to John’s lawsuit, “[t]he Sorin 3T was defective because its design allowed bacteria, including mycobacteria, to collect and multiply and to form biofilm in the device.”

Although the patient’s blood and organs do not come into contact with the Sorin 3T’s water, the machine emits water vapor, which allegedly carries contaminants into the air. These aerosolized contaminants can settle into an open surgical wound where seeds of infection fester for months, and sometimes years, before becoming a full-blown, symptomatic infection.

In 2011, the U.S. Food and Drug Administration (FDA) inspected the Sorin manufacturing facility and allegedly saw problems related to the cleaning and disinfecting of the Sorin 3T. Also in 2011, the European Centre for Disease Prevention and Control reported cases of infection caused by M. chimaera in patients who had open-heart surgeries in seven European countries.

In January 2014, a hospital notified Sorin that at least one patient had acquired an infection after undergoing open-heart surgery where a Sorin 3T was used. When the hospital tested all of its Sorin 3T devices, all of them were found to be contaminated with bacteria.

In August 2014, Sorin’s own investigation found mycobacteria in Sorin 3T units at the manufacturing plant.

The FDA has issued recommendations for using any heater cooler device—including the Sorin 3T system—and warns of the potential for bacteria to grow in the water tanks, leading to infection, especially in those undergoing open-chest surgery.

Though the FDA maintains that for most patients, the benefits of the heater cooler temperature controlling system outweigh the risk of infection, hospitals should still be cautious and aware of the risk.

LivaNova (formerly known as Sorin Group) has announced that it’s making a “deep-cleaning” service available for affected heater-cooler systems that are less than 10 years old. Devices that are given priority for this service are, in order:

• 3T heater-cooler devices either known or suspected of being contaminated
• 3T heater-cooler devices manufactured prior to September 2014
• 3T heater-cooler devices manufactured after September 2014 (and not known/suspected to be contaminated)

Contaminated devices have the potential to affect a great number of patients—indeed, more than a quarter million heart bypass procedures are performed each year that use heater cooler devices, according to the Centers for Disease Control and Prevention. The CDC notes that in approximately 60 percent of these procedures, devices associated with the infections were used.

If you or someone you love has developed an aortic valve replacement infection after undergoing open-heart surgery, you could be eligible to participate in this Sorin 3T Heater-Cooler System investigation.

Filing a lawsuit cannot undo the pain and suffering caused by an open-heart surgery infection, but it can at least help to alleviate the financial burden incurred by medical expenses and lost wages. Litigation can be a daunting prospect, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney.

Consulting a lawyer can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.

The Aortic Valve Replacement Infection Lawsuit is Case No. 2:18-cv-07504-GW-KS in the U.S. District Court for the Central District of California.