Medical equipment manufacturer LivaNova’s 3T Heater-Cooler machines are at the center of lawsuits and a $225 million settlement.
The London-based medical equipment manufacturer LivaNova has agreed to a $225 million settlement after multiple federal lawsuits followed an bacteria infection scare at two central Pennsylvania medical centers. The amount covers an estimated 75 percent of lawsuits filed throughout the United States over the company’s 3T Heater-Cooler. U.S. Middle District Judge John E. Jones III, nominated by George W. Bush, oversaw that nationwide litigation.
“These were complicated cases and the patients involved with this litigation have difficult medical histories. Protracted litigation was in no one’s interest, as the plaintiffs could benefit from settlement proceeds today,” said Sol Weiss, lead counsel for the executive committee for the Americans who sued. “We especially appreciate the guidance from U.S. District Judge John E. Jones III.”
LivaNova continues to deny there are any defects in its machines and has vowed to “vigorously defend” against the lawsuits not covered by the settlement terms.
Infection issues involving open heart surgery patients at Penn State Milton S. Hershey Medical Center and WellSpan York Hospital sparked one of the central Pennsylvania lawsuits in 2016. Patients from both facilities were told about the risks in late 2015. Edward Baker and Jack Miller, both of York County, were the plaintiffs in that lawsuit. They said faults with the 3T machines, which regulated blood temperature for those in need of open-heart surgery, exposed at least 3,600 patients to drug-resistant and potentially fatal bacteria.
Miller and Baker claimed a design flaw in the 3T machines allowed the dangerous bacteria, NTM, to grow inside. Several patients at WellSpan and Hershey were diagnosed with NTM infections and at least five died. In December 2015, the U.S. Food and Drug Administration (FDA) sent a letter to LivaNova regarding contamination concerns, and a warning was also issued to medical facilities by the Pennsylvania Department of Health.
The Miller/Baker suit sought $5 million in compensation for patients who underwent open heart surgery at WellSpan between Oct. 1, 2011 and July 24, 2015, and for patients who had the same procedure at Hershey between Nov. 5, 2011 and Nov. 5, 2015.
LivaNova USA had some problems in Georgia at the end of 2018, too. Formerly known as Cyberonics, Inc., the company agreed to pay the United States and the State of Georgia $1.87 million to resolve allegations that it violated the False Claims Act and the Georgia False Medicaid Claims Act by knowingly paying kickbacks to Georgia physicians with the intent to cause referrals for implantation of LivaNova’s medical devices. The settlement resolves allegations filed by Ashley Case, a former employee of LivaNova, under the qui tam, or whistleblower, provisions of the False Claims Act. Case received a portion of the payout.
“Healthcare providers must make recommendations about their patients’ health without respect to their own financial interests and medical device manufacturers cannot be permitted to influence that process with thinly-disguised kickback payments,” said U.S. Attorney Byung J. “BJay” Pak. “This settlement demonstrates our commitment to ensuring that the healthcare provided to our citizens, and the medical guidance given by Georgia physicians, is free from improper monetary influence.”