LivaNova has been hit with another cardiac heater-cooler lawsuit, the California plaintiff alleging a contaminated device led to serious infection after heart surgery.

The plaintiff, Elizabeth K., alleges she underwent heart surgery on Dec. 17, 2015—an aortic valve replacement (AVR). A cardiac heater-cooler system was used during her surgery to regulate her body temperature. The specific system used during Elizabeth’s surgery was the Sorin 3T Heater-Cooler from LivaNova.

According to the lawsuit, Elizabeth began suffering from infection after heart surgery. She says she called the cardiac surgery department that performed the operation just months later, in February 2016, over concerning symptoms, and on several occasions thereafter through 2016 and into 2017. Elizabeth reported sharp pain in the left side of her chest, headaches, pain in her ear, distorted vision, slurred speech, heart palpitations, congestion back pain.

During these months, Elizabeth was given medications for individual symptoms. But in July 2017, after a liver biopsy, findings allegedly showed that Elizabeth may have been exposed to nontuberculous Mycobacteria chimaera in December 2015, leading to serious infection after heart surgery.

Indeed, she says that a few weeks later, she was diagnosed with an M. chimaera infection, and now lives at a skilled nursing facility to care for her through these health problems. According to the lawsuit, Elizabeth’s infection after heart surgery has led complications necessitating bone marrow biopsies, antibiotic therapy, and surgical procedures.

The lawsuit alleges that Elizabeth’s injuries and infection after heart surgery were caused directly by exposure to a contaminated heater-cooler system during her 2015 cardiac surgery.

The cardiac heater-cooler lawsuit was filed on multiple counts, including negligence, manufacturing defect, design defect, and failure to warn. Elizabeth’s husband, Ken, also filed on one count of loss of consortium.

Basics of Heater-Cooler Devices

Essentially, cardiac heater-cooler devices are commonly used during heart surgeries in order to regulate a patient’s body temperature, warming and cooling the blood as necessary.

Unfortunately, these devices have been linked with major complications. Indeed, there is a risk of the water becoming contaminated, and patients may be exposed as the water vaporizes and moves through the device’s exhaust vent.

Exposure to contaminated water from a heater-cooler device can result in side effects including Mycobacterium chimaera infection. According to researchers, contaminated devices may lead to hundreds of cases of Mycobacterium chimaera infection annually, around 80 of which affect U.S. patients.

Patients may not even develop symptoms of this serious infection after heart surgery for months or even years after the initial exposure. Reports show that the average cardiac surgery patient linked with heater-cooler contamination failed to show symptoms of infection after heart surgery for 1.5 to 3 years.

A person who undergoes heart surgery with the use of one of these heater-cooler devices will likely not even consider an infected device as one of the possible causes of infection since they see the effect months or years later.

Filing a Lawsuit Over Infection After Heart Surgery

If you or someone you love has suffered from an infection after heart surgery with the use of a heater-cooler device like the Sorin 3T System, you may be able to file a lawsuit against the device’s manufacturer.

While filing a lawsuit cannot take away the effects of such a serious infection after heart surgery or bring a loved one back to life, it can help to alleviate the financial burden caused by medical expenses and lost wages.

The Infection After Heart Surgery Lawsuit is Case No. 8:18-cv-00512-AG-KS, in the U.S. District Court for the Central District of California.