A Louisiana resident whose lawsuit against LivaNova (NSDQ:LIVN) was thrown out will have another chance to plead his case.
A federal appeals court in Pennsylvania ruled last week that a Louisiana district court must reconsider the case of Kyle Hamer. Hamer underwent open-heart surgery at Children’s Hospital-New Orleans in 2017 using LivaNova’s 3T Heater-Cooler device. He developed an infection in the incision, which his physicians suspected stemmed from a non-tuberculosis mycobacterium (NTM), Mycobacterium abscessus, according to the appeals court opinion.
Although Hamer’s treatment team never isolated NTM from any of the swabs or cultures, his physician informed him that the lack of a positive NTM culture did not mean that he hadn’t had an NTM infection, according to the appeals court ruling. Hamer alleges that his treatment caused him lasting injuries, including potential long-term hearing loss.
Hamer sued LivaNova in the Eastern District of Louisiana in 2018, asserting claims under the Louisiana Products Liability Act (LPLA) for failure to warn and inadequate design, among other violations. His case was folded into multi-district litigation with others alleging damages
from the NTM infection outbreak caused by the 3T System. On March 19, 2020, the court dismissed Hamer’s claims with prejudice on the basis that Hamer lacked proof of an NTM infection — a requirement for being part of the multi-district case.
LivaNova’s 3T Heater-Cooler device has been implicated in a number of unexpected, severe patient infections. In 2016, the FDA warned patients and doctors about the risk of a type of bacterial infection posed by the device. Later that year, the U.S. Centers for Disease Control & Prevention warned of the risk of serious bacterial infection in open-heart surgery patients using the 3T Heater-Cooler.
In 2017, a report emerged suggesting that a dozen children who underwent cardiac procedures at Children’s Hospital New Orleans earlier were infected with myobacterium previously linked to LivaNova’s 3T Heater-Cooler. LivaNova said in 2019 that it inked a deal to settle approximately 75% of lawsuits it faced in the U.S. related to its 3T Heater-Cooler device, expecting to pay up to $225 million to settle the claims.
Hamer claims that the dismissal of his suit with prejudice hobbled his ability to proceed in any court. The appeals court agreed with Hamer, saying that his case may have merit under Louisiana law even if it can’t be part of the multidistrict case. In particular, Hamer alleges that older versions of the 3T device suffered from design defects that made them unreasonably dangerous and that newer models accommodated a safer disinfection system that was not used in Hamer’s surgery.
“Under the LPLA, these facts might state a prima facie case for defective design,” wrote Judge Jane Richards Roth for the three-judge panel. “In sum, Hamer presents alternative and potentially redressable theories of injury against LivaNova.”