If you have undergone open heart surgery in recent years, you may be at risk of a life-threatening infection linked to a medical device used during the operation. According to the Centers for Disease Control and Prevention (CDC), patients who have had valve implants or prosthetic product implants are at risk of infection with a bacterial species of nontuberculous mycobacterium (or NTM). It is estimated that 600,000 patients are at risk, and there have been confirmed infections in 28 heart surgery patients in the U.S.
The product associated with these infections is a heater-cooler device that is commonly used during open-heart surgery. The CDC reports that more than 250,000 heart bypass procedures are performed every year in the U.S., and of these operations, 60% use the problem device. At least 12 patient deaths have been reported worldwide, according to the Food and Drug Administration.
Unfortunately, these infections are occurring close to home. Pennsylvania’s Department of Health has confirmed 21 cases of infections related to the machines, and the infection is now linked to least seven deaths in the state.
WellSpan reported in October that about 1,300 patients who had open-heart surgeries at their York Hospital between October 1, 2011, and July 24, 2015, may have been exposed to the infection — and this was likely a contributing factor in five deaths. Penn State Milton S. Hershey Medical Center admitted that about 2,300 patients who had open-heart surgery there between November 5, 2011, and November 5, 2015, may have been infected. Two deaths are possibly linked to the machine.
When unfortunate situations like this occur, the patient and family suffer terrible consequences. If you or someone you love has experienced infections after having open-heart surgery, you should seek legal representation. The experienced medical malpractice attorneys of Rieders, Travis, Humphrey, Waters & Dohrmann have spent decades honing their skills and successfully representing Pennsylvania families who have suffered injury due to medical negligence. Our deep sense of loyalty to each client drives us to pursue each claim vigorously and get you the compensation you deserve.
What Created the Problem?
The source of a potential infection has been identified as the Stöckert 3T heater-cooler device, produced by LivaNova PLC. These devices are commonly used during cardiac surgical procedures to regulate a patient’s temperature by warming and cooling blood and organs. The problem arises if devices become contaminated with nontuberculous mycobacterium, usually during manufacture. During surgery, bacteria can escape from the exhaust vents and blow onto a patient, causing infection.
What are Symptom of Infection?
Symptoms of infection with NTM include:
- Joint pain
- Weight loss
- Death, in serious cases
- Loss of energy
- Heat and/or pus around the surgical incision
- Night sweats
- Joint and/or muscle pain.
Unfortunately, symptoms following exposure through surgery may take months or years to develop, so a diagnosis can be missed or delayed. Diagnosis is difficult because there is no test to determine exposure to the bacteria; it is necessary to have the bacteria cultured in a laboratory. The bacteria grow slowly, so the CDC says it can require up to two months to rule out infection.
NTM infections can usually be treated successfully once diagnosed. However, it can take more than a year of antibiotic treatment to cure the infection.
Class Action Lawsuits
In February 2016, a class action complaint in Pennsylvania was filed against LivaNova PLC, the company that produces the device. Patients in the suit had open heart surgeries at WellSpan York Hospital and Penn State Milton S. Hershey Medical Center. There have been additional similar lawsuits against LivaNova for procedures performed at these hospitals, as well as at Greenville Health System Hospital in Greenville, SC. The cases in Greenville are not counted in the number of cases identified by the CDC since they have not been conclusively linked to the device.
The class-action lawsuit is seeking aggregate damages in excess of $5 million. Also, two York County residents have filed the lawsuit in federal court against LivaNova PLC. The plaintiffs want the devices declared unsafe and LivaNova held responsible for the cost of monitoring the patients.
Currently, both hospitals are offering free screening and treatment to exposed individuals. The hospitals claim they have replaced all of the devices, but the plaintiffs say that other hospitals in Pennsylvania continue to use them. LivaNova has issued revised cleaning and disinfecting protocols for the device
Contact Us For Help
Medical malpractice law is highly regulated by a complex body of rules. Whether in settlement negotiations or pursuing a favorable trial verdict, the experienced Pennsylvania medical malpractice attorneys of Rieders, Travis, Humphrey, Waters & Dohrmann are familiar with the law and thoroughly prepared and committed to achieving a just outcome. With our sizeable staff, we offer strength in numbers while providing top-notch personal service.
If you or your loved one has suffered from infections contracted at a hospital or other medical facility, do not delay. Consult Cliff Rieders at Rieders, Travis, Humphrey, Waters & Dohrmann by calling 800–326–9259 for a free consultation, or use our online contact form.
Based in Williamsport, we serve clients throughout the state of Pennsylvania, offering a free consultation on all injury matters. More than that, we offer you experience, knowledge, compassion, and a long history of results.