$5 Million Lawsuit Points to Reusable Heart Device Risks

A class action lawsuit against a British device maker claims that thousands of patients were exposed to a potentially fatal infection through an open-heart surgery device. The lack of timely tracking of infections echoes problems outlined in duodenoscope litigation.

Nancy Crotti

Updated February 24, 2016

LivaNova's Sorin 3T heater-cooler system, used to regulate blood temperature during open-heart surgery, exposed two men to dangerous nontuberculous mycobacterium (NMT) during surgery, according to a federal lawsuit filed in Pennsylvania.

Filed February 12, 2016 in U.S. District Court for the Middle District of Pennsylvania by two men who had been treated with the device, the suit claims that, "LivaNova knew or should have known that design and/or manufacturing defects in its Sorin 3T heater-cooler system causes bacterial colonization, to which patients are exposed during surgery, thus posing a significant risk of bodily injury or death."

"We're in the early stages of reviewing the lawsuit and plan to defend, as they say, vigorously," said Gregory Browne, senior vice president of finance for LivaNova.

Last fall, WellSpan York Hospital and Penn State Milton S. Hershey Medical Center, where the men's surgeries took place, announced that 1300 and 2300 of their respective patients had been exposed to NTM between 2011 and 2015. Seven of 11 patients identified as having the infection have died as a result of that exposure, according to reports by the York (PA) Daily Record.

Heater-cooler devices are commonly used during cardiac surgical procedures to warm and cool a patient's blood during cardiopulmonary bypass, according to the Centers for Disease Control. NTM are slow-growing bacteria found in surface water, tap water, and soil.

Recent reports have suggested an association between heater-cooler devices and NTM infections among patients undergoing cardiac surgery "potentially through the aerosolization of bacteria from contaminated water used in these devices," CDC continued. "Identifying infections related to the use of heater-cooler devices can be challenging."

Symptoms of NMT, which can take years to manifest in patients, may include a combination of fever; pain, redness, heat, or pus around a surgical incision; night sweats; joint pain; muscle pain; weight loss; and fatigue; as well as failure to thrive in infants, according to CDC.

FDA issued a warning letter to LivaNova December 29, 2015, citing multiple deficiencies the agency found during an inspection last August at the company's Munich, Germany, plant. It pronounced the 3T Heater-Cooler device made at that plant "adulterated" and cited the company for failure to file for a PMA when it changed the label to reflect new cleaning recommendations.

FDA said it was "taking steps to refuse entry of these devices into the United States" until the violations are corrected.

The company has issued updated cleaning instructions to customers over the years and includes them on its website. LivaNova does not plan to recall the heater-coolers, but expects to respond formally to FDA's warning letter by the end of March, Browne said.

The difficulty of keeping reusable devices clean and of reporting problems associated with those devices has also plagued makers of duodenoscopes. A U.S. Senate report issued in January faulted major duodenoscope maker Olympus and FDA for failing to alert the U.S. public, even as hundreds became infected with potentially deadly superbugs.

Incorporated in England and Wales, LivaNova has a corporate office in Milan, Italy, and a U.S. presence in Arvada, CO. Italy-based Sorin SpA, which makes cardiovascular devices, merged last year with neuromodulation device-maker Cyberonics to form LivaNova with a combined equity value of $2.7 billion.

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