Sorin, which merged last year with Cyberonics to form LivaNova (NSDQ:LIVN), must face a lawsuit brought by cardiac bypass surgery patients alleging that they contracted an infection from the Sorin 3T heater-cooler system used during their procedures.
Plaintiffs Edward Baker and Jack Miller alleged that they were exposed to the nontuberculous mycobacterium at a pair of hospitals in Pennsylvania that later said a collective 3,600 patients were exposed to NTM via their 3T devices. Sorin (LivaNova was dismissed as a defendant from the case) moved to dismiss the case, arguing that the plaintiffs failed to prove their medical monitoring claim and asking Judge John Jones III of the U.S. District Court for Middle Pennsylvania to toss the claim for a judgment of defectiveness.
Jones instead dismissed Sorin’s motion in its entirety, finding that the plaintiffs met the minimum standard of plausibility for the medical monitoring claim and declining to dismiss the defectiveness claim.
“Contrary to defendants’ assertion, plaintiffs have alleged sufficient factual matter in their amended complaint to support each element of a plausible claim for medical monitoring,” Jones wrote, according to court documents. “Additionally, we find that the defendants have not offered any persuasive reason to decline exercising our discretionary power to entertain a declaratory judgment action.
“First, plaintiffs alleged an exposure greater than normal background level by pointing to the exposure announcements from [the hospitals], the fact that the exposure occurred during open heart surgeries, and the colonization of the bacteria which is then aerosolized through the 3T system’s exhaust vent,” he wrote. “While plaintiffs recognize that NTM ‘occurs naturally in the environment,’ the allegations that the 3T systems aerosolized this bacteria into the operating room during an invasive surgery plausibly supports that plaintiffs were exposed to a greater amount of NTM than naturally occurring background levels.”
In related news, the FDA today released updated guidance on preventing the spread of infections via the 3T device, as well as new information about Mycobacterium chimaera infections associated with the use of the 3T in cardiothoracic surgery patients.