3T Heater Recall: Background and Product Liability Lawsuits

Legally Reviewed and Edited by: Terry Cochran

The 3T Heater recall has resulted in several product liability suits filed under state law throughout Michigan and elsewhere. The product liability claims are filed by people exposed to and developing a bacteria infection after surgery. Medical malpractice attorneys have filed class action suits to obtain compensation for patients who suffered infections.

Product Liability Law

Product liability law protects people from dangerous products and allows them to recover damages in the event of harm. Often plaintiffs file class action lawsuits due to general product defects. There could be design defects or manufacturing defects. Sometimes the parent or subsidiary companies may be in breach of warranty.

In a product liability case, Sometimes there is a finding of strict liability, which assesses no fault, such as negligence, but rather lability due to the inherent danger posed by the defect. This can be anything from suffering third degree burns due to the defect, to serious injuries while undergoing a medical procedure as a result of a product fault.

The 3T Heater

LivaNova PLC manufactures the Stockert Heater-Cooler System (3T), also known as the Sorin 3T. The device controls the temperature of water used in heat exchanger devices that warm or cool patients during specific procedures.

Hospitals routinely use heater-coolers in over 250,000 bypass operations performed in the United States annually. Doctors use the 3T during operations lasting six hours or less to keep patients from becoming too warm or too cold during an operation.

The Food and Drug Administration (FDA) approved the device in 2006.

Bacteria Problem

Studies have shown the potential for a Nontuberculous mycobacteria (NTM) called Mycobacterium chimera to propagate inside the heater-cooler water tanks.

The 3T tanks do not come in contact with the patient. However, the 3T machines may disperse the NTM through the vents or other small openings. The agitation of the water due to the pumps and water circulation can increase the potential for the bacteria to become airborne.

The bacteria could contaminate the operating room environment and enter the patent’s open surgical cavity. Patients with valves or other prosthetic implants may be particularly susceptible. Infections caused by NTM cause extremely severe reactions and may be fatal.

Types of Operations

Surgeons often use the 3T in cardio bypass operations. Other operations in addition to bypass surgery and heart valve surgery where a 3T is commonly used include:

• Lung, esophageal and mesothelioma procedures.
• Chest reconstruction.
• Benign tumors in the lung, esophagus, or chest wall.
• Lung and heart transplants.

Other surgeries may also use the machine.

Symptoms and Side Effects

Specific patient symptoms or complications after common surgeries where the hospital used a 3T machine may have been exposed to NTM as a direct result of using the devices.

The symptoms experienced include:

• Persistent cough or coughing up blood
• Pain and fever
• Difficulty breathing
• Pus, redness, or heat at the site of the incision
• Pus, redness, or heat at the site of the incision
• Nausea and vomiting
• Sepsis
• Weight loss
• Night sweats
• Muscle or joint pain

FDA Safety Warnings

Four years after approval of the 3T, the FDA began receiving reports of patients developing severe infections after operations where a 3T was used.

The FDA investigations determined by 2015 that heater-cooler devices caused the problem and in 2016 specifically linked the infections to the 3T.

Class 2 Product Recall

LivaNova issued a Class 2 recall of the machines in June 2015.

A Class 2 Recall, is defined by the FDA as:

A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Companies can voluntarily issue a recall, which happened in this case, or the FDA can order a recall.

Product recalls are an important component in a product liability lawsuit.

Additional FDA Action

In July 2015, the FDA also issued a 3T recall notice to inform a wider audience and followed up the recall notice with a Safety Communication that included recommendations to limit patient exposure.

The safety notice included the advisory that most cardiopulmonary bypass patients in the United States utilize these heater-cooler devices, which were distributed up until 2014.

The FDA inspected two LivaNova facilities, one in Germany and one in the United States in 2015. As a result of the inspections, the FDA issued LivaNova a Warning Letter.

The Warning Letter stated that the FDA investigators determined the procedures used by LivaNova for manufacturing, packing, storing, and installing the devices did not conform to standard quality control procedures used in the manufacturing sector.

Final Thoughts

If you experienced an infection or harm after surgery involving the use of a 3T heating-cooling unit, or a loved one died due to bacterial-related complications where a 3T was used, call Eileen Kroll, a registered nurse and personal injury trial attorney, at Cochran, Kroll & Associates, P.C. at 866-MICH-LAW for a no obligation case evaluation. Our law firm never charges a fee unless a recovery is made.

Disclaimer : The information provided is general and not for legal advice. The blogs are not intended to provide legal counsel and no attorney-client relationship is created nor intended.