A California couple is filing legal action against Sorin Group USA Inc., alleging a deadly infection after heart surgery occurred due to the company’s cardiac heater cooler devices.

According to the cardiac heater cooler lawsuit, the husband allegedly developed an infection after heart surgery due to Sorin’s 3T Heater Cooler System used during the surgery. Plaintiffs Hayes G. and Maria G. are filing the cardiac heater cooler lawsuit.

Hayes had allegedly undergone open heart surgery on Sept. 10, 2014, wherein a Sorin 3T cardiac heater cooler system was used to help regulate his body temperature. Hayes appeared fine not long after the surgery, but began visiting his doctors between late 2016 and early 2017 for worsening back pain.

In early February 2017, his doctors suspected that a bacterial infection may be the cause of his symptoms and quickly ordered him to be asses for possible M. chimaera bacteria infection.

Hayes was ultimately diagnosed with this condition on Feb. 27, 2017, and began a stringent antibiotic regiment and other treatment therapies to combat the deadly bacterial infection. Hayes continues the antibiotic treatment to this day, and is reportedly still suffering from the M. chimaera bacterial infection.

This M. chimaera infection after heart surgery has been reported by numerous patients and hospitals, with the CDC reporting on 12 patients dying from the occurrence.

Overview of Cardiac Heater Cooler Infection Allegations

M. chimaera (Mycobacterium Chimaera) bacteria are typically found in ground water and are usually not harmful to humans, but they can become potentially deadly under certain circumstances. An inspection at a manufacturer’s facility revealed that M. chimaera bacteria may have contaminated the Sorin 3T Heater Cooler System during the device manufacturing process.

These devices are manufactured in Germany; the contamination was discovered during testing in September 2014. The contamination was reportedly resolved in July 2015 when the facility was tested again, with the FDA stating that no infection after heart surgery occurrences have been linked to 3T heater cooler devices manufactured after September 2014.

However, both the FDA and CDC have issued safety warnings regarding potential cardiac heater cooler infections, with health officials warning that bacterial cells in the contaminated devices can potentially aerosolize and come into direct contact with the patient.

The most recent cardiac heater cooler warning came from the FDA on Oct. 13, 2016, which provided health officials recommendations on how to prevent infection from spreading. While M. chimaera bacterial infection after heart surgery is rare, doctors warn it can take months or years to develop.

According to the CDC, there have been a total of 28 confirmed infections and 12 deaths, with occurrences reported in Iowa, Michigan, and Pennsylvania. Even though M. chimaera infection after heart surgery can be potentially fatal to patients, Sorin allegedly failed to warn the general public against this possibility.

Hayes and Maria allege the company either knew or should have known about potentially deadly bacterial infection, and that Hayes would not have agreed to use of the device if he had known. Hayes and Maria are filing this cardiac heater cooler lawsuit for multiple damages, including negligence and failure to warn.

This Cardiac Heater Cooler Lawsuit is Case No. 2:17-cv-7802, in the U.S. District Court for the Central District of California.