Hospitals and health care providers offering cardiac surgery or bypass that use a particular heater-cooler system manufactured by LivaNova PLC (formerly Sorin Group) should be aware of a burgeoning area of litigation.
LivaNova PLC, a German company formerly known as Sorin Group S.p.A., manufactures a Stӧckert 3T Heater-Cooler system that has been associated with patient infections with M. chimaera and M. abscessus, subspecies of nontuberculous mycobacterium (NTM). Heater-cooler devices are commonly used during cardiothoracic surgeries, as well as other medical and surgical procedures, to warm or cool a patient in order to optimize medical care and improve patient outcomes. Approximately 60 percent of heart bypass procedures performed in the United States use 3T heater-cooler devices, according to the Centers for Disease Control and Prevention (CDC).
NTM poses a significant risk to patients during open heart surgery. Such infections are generally very difficult to identify or assess in a timely fashion, as they have a latency period of months to years and have multiple clinical manifestations, including endocarditis, surgical site infection, abscess, bacteremia, hepatitis, renal insufficiency, splenomegaly, pancytopenia and osteomyelitis. Diagnosis of NTM infections requires specific laboratory testing for acid fact bacilli (AFB) and other specialized testing, and assessment is particularly difficult given the slow-growing nature of the bacteria. Risks of NTM infections, if untreated, include death. As of October 2016, the Washington Post reported that at least 28 cases of NTM infection had been identified stemming from treatment at hospitals in Iowa, Michigan and Pennsylvania.
On June 1, 2016, the U.S. Food and Drug Administration (FDA) issued a Safety Communication, updated on Oct. 13, 2016, directed to the following persons and entities:
- Health care providers who use the 3T Heater-Cooler System.
- Primary care providers who are responsible for the ongoing care of patients who have undergone cardiothoracic surgery.
- Patients who have undergone cardiothoracic surgery.
- Hospital staff that are responsible for operating and maintaining the 3T Heater-Cooler System.
- Health care facilities that perform procedures using the 3T Heater-Cooler System.
The Safety Communication was directed to cardiothoracic surgeons, cardiovascular surgeons, orthopedic surgeons, neurosurgeons, general surgeons, anesthesiologists, infection control, infectious disease physicians, pediatrics, primary care and intensive care physicians. It provided information about the M. chimaera infections associated with the 3T System, including a European study that suggested a direct link between the 3T System used in specific cardiovascular surgeries and infected patients. Additionally, the manufacturer’s testing in August 2014 found M. chimaera contamination on the production line and water supply at the 3T manufacturing facility. The 3T Systems at issue were sold worldwide through August 2014, when the company performed an extensive disinfection procedure in an effort to rectify contamination issues.
The FDA promulgated extensive recommendations in its June 1, 2016, and Oct. 13, 2016 Safety Communications, with protocols ranging from removal of 3T Systems from service, to replacing tubing and connectors and rearranging the physical layout of operating rooms utilizing the system.
At the same time that the FDA issued its supplement on Oct. 13, 2016, the CDC issued an official Health Advisory for the Stӧckert 3T System. The CDC identified the 3T System as one that put patients at risk for a life-threatening infection arising from M. chimaera bacteria. The CDC specifically advised hospitals to communicate with potentially exposed patients to seek medical care if they were suffering specific symptoms, and further, building on the FDA Safety Communication, strongly encouraged hospitals to make and execute a plan to communicate with such patients. The CDC identified two specific recommendations for health care providers, eight detailed recommendations for hospitals, three detailed recommendations for health departments, and importantly, two specific recommendations for patients advised of their potential exposure to NTM through use of the 3T System.
Widespread use of the 3T System at hospitals across the country during cardiovascular and other surgeries presents a significant litigation risk not only for the manufacturer, but for hospitals and health care providers. LivaNova/Sorin is already the subject of multiple class action and individual lawsuits filed in federal and state courts across the country. Additionally, there is a potential increasing trend of lawsuits naming hospitals and health care providers, alleging claims centered on the their alleged role in exposing patients to the NTM bacteria. WellSpan, a hospital system in Pennsylvania, is currently the subject of multiple lawsuits.
A significant number of hospitals and hospital systems have taken steps to review the FDA/CDC recommendations and to get ahead of any potential litigation. As of October 2016, the six hospitals that had identified cases of NTM infection had notified in excess of 13,000 patients who had undergone surgical procedures between October 2011 and July 2016 with the potential for infection. Other hospitals and hospital systems, including the Mayo Clinic, Minneapolis Veterans Affairs Health System, University of Iowa, Penn Presbyterian Medical Center, Mercy Medical Center in Iowa and University of Alabama at Birmingham Hospital, have sent letters to potentially exposed patients.
Plaintiff’s firms are already actively seeking clients and have prepared websites with detailed information and background in an effort to identify potential claimants. Given the lawsuits filed against WellSpan, any inaction on the part of health care providers and hospitals significantly increases the potential for costly litigation.
Armstrong Teasdale’s Health Care and Life Sciences industry team has extensive knowledge of the 3T System issue and significant experience advising hospitals, hospital systems and health care providers on how to investigate and proactively address issues such as the NTM infections detailed above, including setting up notification and advisory protocols consistent with the FDA and CDC’s recommendations. Steps should be taken immediately to evaluate any potential exposure and to conclusively determine when and if the contaminated 3T Systems were or are currently used in any surgical setting, as well as the date of acquisition and/or installation of the equipment.
Copies of the FDA Safety Communications can be found at https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm504213.htm and https://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm520191.htm.
A copy of the CDC Health Advisory can be found at https://emergency.cdc.gov/han/han00397.asp.