Heater-cooler devices are necessary for use in certain surgeries, especially those involving the heart and lungs, and in bypass surgeries, which involve the temporary and intentional stopping of the heart and/or lung functioning. These types of surgeries often require the mechanical regulation of a patient’s body temperature carried out by the heater-cooler device, to make sure they do not become too warm or too cold during their surgical procedure.
LivaNova PLC (merged with Sorin Group in October 2015) is one of a handful of medical technology companies that manufactures heater-cooler devices. Its popular heating and cooling machine, the Stockert 3T, is used in over half of all heart surgeries performed in the United States. But the company recalled the device in June 2015 due to the potential for contamination that could lead to nontuberculous mycobacteria (NTM) infections in patients.
While the bacteria are found naturally occurring in the environment and are typically thought to be harmless, the Food and Drug Administration (FDA) confirmed that they can cause infections in patients with compromised immune systems, such as those undergoing surgeries involving their heart and lungs. The FDA concluded that patients who had open-chest surgeries and received implanted devices were more susceptible to contracting an NTM infection.
In these individuals, the bacteria can lead to severe lung disease and even death if left untreated. Since the infection and disease is slow-progressing, it can take months or even years for patients to realize they’ve been exposed to NTM.
The FDA discovered that the affected devices may have been distributed as late as 2014. The agency also found the first incident was reported as early as 2012, and it estimated that over a half-million patients may have been exposed to NTM.
In some surgeries using the Stockert 3T heater-cooler device, exposure led to serious infections or even patient death. Patients who developed infections and family members of patients who died later sued LivaNova and Sorin Group.
Four Variations of Lawsuits
The lawsuits in this matter include two class actions involving patients exposed to NTM during surgery but not yet showing any symptoms of infection and individual cases in which patients have become seriously ill or died as a result of NTM infections allegedly caused by exposure from Sorin’s 3T heater-cooler device used in their surgeries.
1 – Patients who became seriously ill or died as a result of NTM infections (type M. chimaera) as a result of contamination during the manufacturing process of a heater-cooler device.
2 – Patients who suffered the same injuries due NTM because non-sterile water was inserted into the machine at the hospital.
3 – A class action suit comprising patients exposed to NTM in two hospitals in Pennsylvania but who are not yet experiencing symptoms.
4 – A similar class action lawsuit on behalf of patients at two South Carolina hospitals who were exposed to NTM but have not shown any symptoms yet.
Allegations Asserted and Relief Sought
The plaintiffs assert that the defendants (LivaNova PLC and Sorin Group) “consistently under-reported and withheld information” from the FDA and the public at large about the probability that its heater-cooler device would be linked to in complications and that they misrepresented the device’s efficacy and safety.
One plaintiff’s complaint stated that the defendants “knew, and continue to know,” that certain disclosures made to the FDA and the public at large were and are “incomplete and misleading” and that the device “was and is causing numerous patients severe injuries and complications.”
Plaintiffs allege that defendants “knew or should have known” that the design and/or defects in the manufacturing of its heater-cooler device “made it susceptible to bacterial colonization, specifically Mycobacteria, despite any cleaning and disinfections procedures utilized.”
A complaint filed in late 2016 points to LivaNova’s admission that the company was in the process of redesigning its 3T device with new features, including the switch from PVC to polyethylene materials in its tubing “to limit biofilm formation” (the process of microorganism attachment and growth on a surface) as well as the introduction of plugs in the water circuits “to prevent standing water.”
This admission is said to have come during an FDA panel during which the agency noted 90 percent of Medical Device Reports (MDRs) received between January 2010 and February 2016 and citing device contamination and resulting patient infection were attributed to the 3T heater-cooler device.
Plaintiffs claim that due to defendants’ actions they have suffered injuries including:
- Pain, swelling and drainage at the surgical incision site
- Contraction of NTM infections (types M. chimaera and M. abscessus)
- Additional surgical procedures and medical management
- Extensive courses of antibiotic therapy, sometimes resulting in drug-related toxicity
- Symptoms of infection including muscle pain, fatigue, night sweats, chills, vomiting, persistent fever, weight loss and dry cough
- Sarcoidosis (multi-organ inflammatory disease)
Who Are the Plaintiffs?
All of the plaintiffs underwent a surgery during which the use of a heater-cooler device was necessary for the re-warming and cooling of their blood. Most of the surgeries involved heart-related bypass procedures, while others involved organ transplants.
During their surgical procedures, the plaintiffs alleged they were exposed to bacteria from the contaminated heater-cooler devices, specifically the 3T system manufactured by the defendants, and most developed infections resulting in injuries, serious illness, other treatment-related complications, additional surgeries and even death, in some cases.
The affected plaintiffs filed lawsuits in various districts nationally, including Iowa, North Carolina, South Carolina, Pennsylvania and South Dakota. It can take some time (months or even years) for an NTM infection to develop causing apparent symptoms. Accordingly, more plaintiffs are expected to come forward, either joining one of the class action suits or filing an individual legal action.
The plaintiffs include:
Earl and Laura Gilstrap
On February 27, 2013, Earl Gilstrap underwent a coronary artery bypass grafting procedure at Greenville Health System Hospital (GHS) in Greenville, SC. A Sorin 3T heater-cooler device was used during his surgery and Gilstrap’s complaint alleged that the device exposed him to NTM.
Immediately following Gilstrap’s surgery, the complaint stated that his incision was healing well. But about three months later, Gilstrap experienced pain, swelling, tenderness, drainage and a “lump” at the incision site.
GHS readmitted Gilstrap and attempted to clean the wound. Gilstrap was also given a series of antibiotics.
Cultures taken during his subsequent hospital stay revealed that the plaintiff had contracted an NTM (type M. abscessus) infection. As a result of this finding, Gilstrap was forced to undergo additional surgical procedures.
Gilstrap and his wife sued Sorin Group in September of 2016, claiming negligence, liability and misrepresentation.
Debra Prescott filed suit against LivaNova and Sorin Group on behalf of her husband, Ronald Stanley Prescott, who died from an NTM (type M. chimaera) infection allegedly contracted from a contaminated heater-cooler device used during his heart valve replacement surgery.
On October 2, 2012, Ronald underwent a surgical procedure for a heart valve replacement at University of Iowa Hospitals and Clinics (UIHC). Over one year later, in February 2014, he went to Mary Greely Medical Center in Ames, Iowa, complaining of adverse symptoms including muscle pain, fatigue, night sweats, persistent fever and a dry cough.
The medical center found signs of sarcoidosis (a multi-organ inflammatory disease) including an enlarged spleen, elevated liver enzymes and pulmonary infiltrates (such as pus, blood or protein) in both lungs.
Ronald underwent a series of medical tests over the next several months to confirm a diagnosis of NTM infection in September 2014. The final diagnosis was determined via bone marrow and bronchoscopy (a procedure that provides a doctor access to the patient’s airway) cultures.
Following subsequent treatment with a series of “powerful antibiotics,” Ronald allegedly suffered from drug-related toxicity, including peripheral neuropathy (weakness, numbness and pain from nerve damage, usually in the hands and feet) and hearing loss. Even with continued treatment, Brenda’s complaint stated that Ronald’s monthly blood cultures still showed NTM present in his body through December 2015.
Doctors did not determine a link between Ronald’s heart valve replacement surgery and his infection until January 2016, at which time Ronald was too unstable to undergo a subsequent operation per his treating physicians’ recommendation.
According to the complaint, Ronald dropped 75 pounds, experienced chronic pain, fatigue, nausea, vomiting, chills, persistent fever, chronic kidney disease, and pancreatic and steroid-induced diabetes before succumbing to the infection in May 2016. He died at age 59, over three years following his initial heart surgery and over two years following his diagnosis of NTM infection.
The complaint stated that Ronald’s alleged cause of death was identified as “disseminated mycobacterium avium intracellular complex infection,” or NTM.
Jason and Kaye Thomason
Jason Thomason experienced injuries similar to plaintiff Earl Gilstrap after undergoing a cardiac bypass grafting procedure in March 2014, also performed at Greenville Health System Hospital (GHS) in Greenville, SC.
Approximately four months following his surgery, Thomason experienced many of the same complications as Gilstrap at his surgical incision site, including pain, swelling, tenderness and a “lump.” Thomason additionally suffered from fevers and increasing weakness. A therapist noticed Thomason’s lump as he was undergoing physical therapy and referred Thomason back to his treating physician for evaluation.
Thomason was readmitted to GHS on August 4, 2014, where he was forced to undergo repeated irrigation and debridement (I&D) procedures to clean the surgical wound. A PICC line (thin flexible tube inserted into a vein for long-term intravenous (IV) medications or blood draws) was also placed to administer a series of antibiotics.
Cultures obtained at the hospital revealed that Thomason had contracted an NTM (type M. abscessus) infection.
Van Sidney Blevins, III
Van Sidney Blevins, III, was diagnosed with end-stage liver disease. On June 11, 2015, he underwent an orthotopic liver transplant at Carolinas Medical Center-Charlotte (CMC) to treat the condition.
About one week later on June 19, 2015, Blevins returned to the hospital where he had his surgery done complaining of fever, abdominal pain and diarrhea. The hospital performed a CT scan, which showed an enlarged spleen, abdominal ascites (abnormal accumulation of fluid) and an intra-abdominal abscess (pocket of pus that collects in tissues, organs or body cavities). Cultures taken returned negative and IV antibiotics brought down Blevins’ fever. He was discharged three days later.
Blevins returned to the medical center two more times presenting with flu-like symptoms and continued spleen enlargement and intra-abdominal abscess. On September 16, 2015, cultures finally revealed NTM (type M. abscessus) growing on his abdominal wall near his liver. Blevins continued antibiotics and was monitored by home health care for his condition.
Blevins was readmitted to the hospital approximately 6 more times between October 2015 and March 2016. His lawsuit filed in November 2016 alleged that throughout the time following his initial surgery in June 2015 he suffered from a variety of injuries.
The lawsuit alleged that he suffered from:
- Severe fever
- Severe malnutrition (including feeding through a tube)
- Damage to the kidneys and liver due to antibiotic treatments
- Increased forgetfulness
- Abdominal wound cellulitis (a skin infection that occurs when bacteria spread through the skin to deeper tissues) with drainage
- Additional surgeries
- Multiple blood transfusions
Gary and Robin Crawford
On November 26, 2011, Gary Crawford underwent surgery to receive a mechanical heart pump at University of Iowa Hospital and Clinics (UIHC). The mechanical heart pump system placed in Crawford was later replaced in subsequent surgeries occurring on June 5, 2012, and July 20, 2012. Crawford then underwent an orthotopic heart transplant on December 13, 2012. All surgeries took place at UIHC.
Crawford underwent routine CT scans on March 12, 2015, that showed “spinal irregularities” and “inflammation of the bone indicative of infection.” The scan also revealed a thoracic aorta (the largest artery of the body – this portion of the artery would be located in the thorax, or chest) aneurysm and inflammation of the spleen.
Crawford was readmitted to the hospital and underwent several more procedures, including biopsies and a stent graft to treat the aneurysm, prior to being diagnosed with NTM infection (type M. chimaera) on March 14, 2016. By this time, Crawford suffered from ongoing weakness, difficulty walking, decreased appetite and weight loss of at least 25 pounds, according to the complaint filed in November 2016.
The lawsuit stated that “a UIHC physician noted… Crawford was ‘probably exposed to aerosolization from a heater-cooler device [used] during multiple vascular/cardiac [surgeries].’” The physician further noted that it would be “very difficult to cure” and that it was “associated with high mortality.”
Crawford’s complaint stated that he has since been diagnosed with abdominal ascites (abnormal accumulation of fluid) likely due to “aggressive” antibiotic treatments and that “his health is rapidly deteriorating.”
Crawford sued the manufacturer for negligence and pain and suffering, including monetary and physical and emotional damages.