Panel Denies Centralized Litigation for Heater-Cooler Victims

Panel Denies Centralized Litigation for Heater-Cooler Victims

A request to centralize heater-cooler lawsuits in the United States has been denied by the country’s Judicial Panel on Multidistrict Litigation. The decision forces plaintiffs to continue their cases on an individual basis in courts around the country, rather than joining together for a single verdict.

Litigation against contaminated LivaNova heater-cooler devices has been on the rise for the last 18 months. As its name suggests, the equipment is designed to warm or cool a patient undergoing surgery, with a view to improving the outcome of the procedure.

Unfortunately, the device was recalled in 2014 and later prompted a CDC safety alert, due to the potential for contamination of its water tanks. Contaminated tanks can lead to the right environment for M. chimaera to develop, which is a dangerous form of nontuberculous mycobacterium (NTM). A European study raised the alarm and clearly linked the bacteria to one particular heater-cooler model, the 3T from Sorin, which is now LivaNova.

The nature of the infection means that there could be many NTM-related health issues out there. It is slow to develop and health issues may not be evident for months, perhaps years in some cases. By extension, this means that there could be a lot more heater-cooler lawsuits. Those patients will now be forced to pursue litigation on their own, albeit with legal experts available to evaluate any claim and assist with case development.

While informal coordination was cited in the Judicial Panel’s reasoning, the decision is clearly a win for LivaNova. The manufacturer of the affected heater-cooler devices is more likely to face down individual litigation, even if some settlements are required to do so.

Unfortunately, the decision comes at a time when the device in question is being linked to new instances of infection in the United Kingdom. 

The Scottish National Health Service has been forced to write to around 5,000 patients who underwent heart surgery in the past five years. The alert was prompted by 26 confirmed cases of infection linked to contaminated heater-coolers, of which 15 resulted in the patient’s death. An investigation into mycobacterial infections preceded the warning and uncovered the potentially fatal consequences.

While no settlements have yet been reached in U.S. lawsuits involving LivaNova, a growing sense of unease can be felt from the manufacturer and medical facilities at the center of complaints against the device.

The lack of multidistrict litigation gives them some breathing room. However,  the walls are closing in when it comes to taking responsibility for contaminated medical equipment and the health issues the problem has created for thousands of patients around the world.


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