Stockert Heater-Cooler System (3T) is manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH) and provides temperature-controlled water to heat exchanger devices (cardiopulmonary bypass heat exchangers, cardioplegia heat exchangers, and thermal regulating blankets) to warm or cool a patient during cardiopulmonary bypass procedures lasting six (6) hours or less. It is a Class II medical device which was approved by the U.S. Food and Drug Administration (FDA) via a 510K process in 2006. It is also called Sorin 3T.

There is the potential for Nontuberculous mycobacteria (NTM) specifically Mycobacterium chimera bacteria to grow in a water tank in the heater-cooler units. Although the water in the heater-cooler unit does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or disperse the NTM through the device's vent(s) or other small openings between the inside and outside of the water tanks into the operating room environment and the patient's open surgical cavity. Water agitation (bubbling) inside the water tanks via pumps, mixing components, return circuit water, etc., may increase the potential for aerosolization of NTM bacteria.

As per Centers for Disease Control and Prevention (CDC) report, more than 250,000 heart bypass procedures are performed in the United States every year using heater-cooler devices routinely. Estimated 60 percent of these procedures performed utilize the devices that have been associated with these infections. Available information suggests that patients who had valves or prosthetic products implanted are at higher risk of these infections. Research says infections caused by this bacteria are severe and can also cause a fatality.

Serious Alleged Injuries May Include:

• Fever Lasting For More Than One Week
• Night Sweats
• Joint Or Muscle Pain
• Difficulty In Breathing
• Redness, Heat Or Pus Around The Surgical Incision
• Nausea/Vomiting
• Persistent Cough Or Cough With Blood
• Restricted Growth Or Weight Gain In Infants

FDA Safety Warnings:

• In 2010, the FDA began receiving reports of patients developing serious infections.

• On June 15, 2015, LivaNova issued a Class 2 recall of the Stockert 3T, acknowledging the potential dangers of nontuberculous mycobacteria infections.

• In July 2015, the FDA issued a additional recall notice to help share the recall information provided by LivaNova of this device.

• On October 15, 2015, the FDA issued Safety communications, to provide recommendations to minimize patient exposure.

• On December 29, 2015, a warning letter was issued after violations were seen in actual inspections and import was restricted.

• April 20, 2018: To help mitigate cardiac surgery Mycobacterium infection risks, LivaNova issued a Medical Device Correction letter to health care facilities to announce the availability of a “deep-cleaning” service in the U.S. to clean certain 3T devices suspected of contamination and/or containing visible biofilm.

• On October 18, 2018, LivaNova issued a Medical Device Correction letter to inform customers of actions to take to reduce potential cardiac surgery infection associated with the 3T Heater-Cooler Systems. The FDA issued this communication to help share the information provided by LivaNova.

Legal Updates:

Lawsuit Allegations:

Defendants: Livanova Deutschland GmbH, f/k/a Sorin Group Deutschland GmbH; Sorin Group USA, Inc.

Defendant Law Firm: Sorin and LivaNova are represented by Linda S. Svitak of Faegre Baker Daniels LLP.

Allegations:

• Faulty device design that causes bacterial colonization and/or transmission during invasive surgical procedures.

• Manufacturing and selling the 3T system with NTM contamination that occurred at production facilities in Germany.

• Some lawsuits are linked to infections caused by M. abscessus, which is more commonly found in the Southeastern U.S.

• Failure to conduct adequate safety testing.

• Failure to provide proper cleaning and disinfection procedures for the 3T system.

• Failure to adequately warn patients or users about the risk of colonization with NTM.

• Failure to alert hospitals and patients to promptly test for NTM infection after invasive surgical procedures using the 3T system.

• Lawsuits accuse healthcare providers of recklessness and negligence, specifically over their maintenance and cleaning of the heater-cooler devices and failure to warn patients of the infection risk.

A unanimous agreement to propose a simple Leadership Group comprised of a Lead Counsel and a small Executive Committee.

Plaintiff Lead and Liaison Counsel - Sol H. Weiss – Anapol Weiss, PA

Plaintiffs Executive Committee:

• Michael K. Johnson – Johnson//Becker, PLLC,

• Karen A. Lorenzen – Hayes Lorenzen Lawyers, PLC

• Roopal P. Luhana – Chaffin Luhana LLP

• Matt Schultz – Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor,

• Steven W. Sanford – Cadwell Sanford Deibert & Garry, LLP, Sioux Falls, SD

• James L. Ward– McGowan, Hood & Felder, LLC

Lawsuit Status:

• Pennsylvania Class Action Lawsuit, February 2016: A class action lawsuit filed by two men representing thousands of others similarly affected. This class was certified in October 2017 in the U.S. District Court for the Middle District of Pennsylvania. In September 2018, the judge issued an order for both sides to appear in court by mid-November to discuss the status of the case.

• Request for the formation of MDL was filed in January 2017, which was denied in April 2017 stating that it would not be beneficial.

• South Carolina Class Action Lawsuit was filed in 2017 by Steven Foster. It was later withdrawn.

• Iowa Class Action Lawsuit, May 2017: A woman from Iowa filed a class action lawsuit for everyone in Iowa who was exposed to M. chimaera, M. abscessus, and other potentially deadly types of Non-Tuberculosis Mycobacterium (“NTM bacteria”) bacteria from a Sorin/LivaNova Stӧckert 3T heater-cooler machine. Represents more than 4,100 class members.

• In February 2018, a federal panel combined 39 Sorin 3T Heater-Cooler System federal lawsuits from 21 districts around the U.S. into a multidistrict litigation referred to as MDL No. 2816 in the Middle District of Pennsylvania court before Judge John E. Jones III. As of October 2018, nearly 135 lawsuits are filed in federal court against the manufacturer of the Stockert 3T.

• Additional lawsuits are filed in state courts across the United States with chances of consolidation.

Important Verdicts & Settlements:

• June 2018: Case Management Order Issued for 3T Heater Cooler System for setting parameters for case-specific and generic discovery over the next 120 days.
• December 2018: In a case management order issued on December 3, Judge John E. Jones III overseeing all the 3T Heater Cooler System heart infection lawsuits appointed a settlement master Randi Ellis to negotiate the settlement plans to avoid the need of jury trials for dozens of cases.
• As of January 2019, no settlement announcements have been heard.
• Three bellwether Cases Selected (Wave I, 1 Case Per Category).
• Date December 15, 2019.

Evidence:

• Usage Of Stockert 3T Heater-Cooler In Operative/Anesthesia, Medical Records
• Indications For Usage Of Stockert 3T Heater-Cooler 3T System In Operative Records
• Identification Of Post-Operative Complications/Injuries
• Severity And Treatment For Complications/Injuries

Medical Record Review and claim validation of Sorin 3T Heater-Cooler case should take approximately 4 hours in most instances; however, this approximation may vary in cases based on the volume of records.