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LivaNova Objects to Consolidation of Heater-Cooler Lawsuits

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At the end of January 2017, plaintiffs involved in heater-cooler lawsuits filed a petition with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all federally filed cases into one court for pre-trial proceedings. They argued that all the current lawsuits share common questions of fact that consolidation would help reduce the risk of duplicative discovery and conflicting rulings, and would increase the efficiency of the proceedings. They suggested the District of South Carolina as the best location for the Multidistrict Litigation (MDL).

Now, the defendants in the litigation—LivaNova, formerly the Sorin Group Deutschland GMBH, the manufacturers of the Stockert 3T heater-cooler units—have filed a reply opposing centralization. On February 17, 2017, they asked the panel to deny the plaintiffs’ petition to consolidate, stating that consolidation would not “promote the just and efficient conduct of these actions.” A second group of plaintiffs also filed a reply to the petition seeking JPML consolidation in which they argued against consolidation.

Life-Threatening Infections Traced to Contamination on Heater-Cooler Units

In the plaintiffs’ petition to centralize, they stated that in all pending cases, patients were infected by a type of nontuberculous mycobacterium (NTM) during open-heart surgery.

The source of the contamination was the heater-cooler units, which are used during these types of surgeries to maintain patient body temperature. Though the units themselves and the water contained in them never come into direct contact with the patient, the units are designed with an exhaust vent and fan. Studies have reported that the bacteria from inside the device can become aerosolized, and then pushed into the surgical room via these vents and fans, where they can enter the patient’s exposed surgical site and lead to infection.

The Centers for Disease Control and Prevention (CDC) has informed surgeons and hospitals of the potential risks associated with heater-cooler units, noting that they had received information indicating that some LivaNova heater-cooler devices could have been contaminated during manufacturing, putting patients at risk for life-threatening infections.

While the plaintiffs assert that all cases concerning heater-cooler units share common questions of fact, the defendants disagree, stating that plaintiff-specific questions “will substantially predominate over common questions.”

Defendants Argue Cases are Too Different to Warrant Centralization

The defendants argue that centralization is unwarranted because of the complex issues in each case. There are questions that are hospital-specific, bacteria-specific, and plaintiff-specific, and the cases also involve different legal issues and procedurally the pending heater cooler cases have progressed to different stages of litigation. In some of the cases, for example, plaintiffs were infected by the M. abscessus bacterium, while in others, they were infected by the M. chimaera bacterium. Though these are both in the same class of bacteria, the defendants argue they are not the same.

In addition, the defendants argue that some plaintiffs weren’t infected at all, but seek damages for the costs of medical monitoring only. Indeed, because of the link between heater-cooler units and life-threatening infections such as these, many hospitals have begun sending letters to patients who underwent open-chest surgeries to inform them of the risk for NTM infections. These patients should watch carefully for any symptoms of such infections, which can include drenching night sweats, muscle aches, weight loss, fatigue, and unexplained fever.

According to the defendants, centralization will not make litigation more convenient because a majority of the pending cases have already been consolidated for pretrial discovery purposes. Any further transfer and consolidation, they argue, would not improve the pre-trial proceedings.

The JPML is scheduled to hear arguments on the potential consolidation of heater-cooler lawsuits on March 30, 2017. Though there are only 15 cases pending now, it is expected that more will be filed in the future.