3 min read

Sorin 3T Heater-Cooler Lawsuits Combined into Single Federal Court

A federal panel (The Judicial Panel on Multidistrict Litigation) has decided to transfer a number of lawsuits, claiming that LivaNova's Sorin 3T heater-cooler system caused serious injuries and infections, to a single federal court in order to move them through the legal process more quickly. Lawsuits against the Sorin 3T have more than doubled in the last year alone.

On February 1, 2018, the Panel consolidated 39 lawsuits against the heater-cooler units into a multidistrict litigation (MDL) in Pennsylvania. Research suggests that another 33 state cases from all around the country may be included in the new MDL, which claims that the Sorin 3T heater-cooler units spread bacteria during (mostly open heart/chest) surgical procedures, leading to serious infections and even deaths in some cases. The U.S. Food and Drug Administration (FDA) has been investigating these devices and their potential links to infections, specifically Nontuberculous Mycobacteria (NTM), since 2010. Italian manufacturer Sorin Group originally produced the devices, however, they merged with Cyberonics, Inc. in 2015 forming the current company called LivaNova.

 

The Majority of Bypass Surgeries in the U.S. Involve Sorin Heater-Coolers

Heater-cooler units are used in virtually all open-heart, open chest bypass surgeries, and in recent years more than 60% of those surgeries included a Sorin 3T device.

Heater-cooler devices are necessary for these types of procedures because bypass operations require the surgeon to temporarily stop a patient's heart or lungs, causing body temperatures to dangerously fluctuate with no self-regulation. Heater-cooler devices regulate the patient's body temperature by heating or cooling heart-lung machines and surgical blankets.

The Sorin 3T devices could have potentially been used in up to 750,000 surgeries prior to regulators discovering their link to infections. Since the type of infections involved (mainly NTM) can sometimes take years to show symptoms, there could likely still be hundreds, if not thousands more lawsuits filed and included into the MDL.

 

Sorin Heater-Cooler Patients Potentially Exposed to Bacteria and Are at Risk of Infection

In 2015, the FDA issued a "Safety Communication" warning that Nontuberculous mycobacteria (NTM) could potentially grow inside the water tanks of Sorin 3T devices. The FDA stated on their website, "Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient."

Symptoms of NTM are very similar to other lung conditions which often makes diagnosis difficult, but what makes this particularly challenging is that NTM can cause permanent lung damage in some cases. This dynamic makes the entire case far more complex.

In 2010, the FDA began receiving reports of patients developing serious infections following bypass surgeries, but not until 2015 did the FDA discover the likely link between the deadly infections and Sorin's 3T heater-cooler units.

 

Lawsuit Consolidation for Sorin 3T Heater-Cooler Claims Previously Denied

When plaintiffs for the Sorin 3T Heater-Cooler lawsuits requested that a federal panel combine their cases into one mass tort case roughly a year ago, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ruled in March 2017 that there was no need for consolidation.

At the time, just 16 lawsuits had officially been filed, of which 10 had been combined into a single court. But by January 2018, the number of cases more than doubled and began to pop up all over the country.

Facing a steadily growing influx of new cases, LivaNova's attorneys requested that the JPML combine the lawsuits. The device manufacturer faced actions filed in 21 federal districts and multiple states across the country. More than 70 patients had filed suit and were represented by a multitude of different law firms.

The JPML released a "Transfer Order", stating that "there are now a significant number of related state court actions; and informal coordination of these actions no longer is practicable."

*MDL's, for those who are unfamiliar, allow several similar lawsuits to be managed more efficiently through the legal process, eliminating the duplication of pre-trial proceedings. In an MDL, individual plaintiffs are still represented by their own lawyers, but panels of attorneys guide the consolidated cases through the MDL process.