Heart surgery can save your life, but a common device used during the procedure has been making people sick. The device, known as the Stockert 3T Heater-Cooler, has caused bacterial infections in many patients, and some have died. If you have developed an infection after receiving heart surgery, you may have a claim, and we’d like to talk to you.
At John Foy & Associates, our lawyers have developed a reputation for helping people recover money for medical injuries. From our beginnings more than 20 years ago, we have always focused on helping people who have been injured, and we know how to get the big medical companies to pay. Let us give you a free consultation to discuss your injuries. Call us at 404-400-4000 and get your free consultation today.
What is the Stockert 3T Heater-Cooler Device?
The Stockert 3T Heater-Cooler device keeps a patient’s body at normal temperature during surgery. It is mostly used during cardiothoracic surgeries, including open heart surgery, coronary bypass surgery and heart valve surgeries.
The device has water tanks that provide water at a controlled temperature to external heat exchanges, heart-lung machines or warming or cooling blankets. The water travels through closed circuits so it never comes into direct contact with the patient.
Sockert 3T Heater-Coolers are an essential part of heart surgeries and used in most major hospitals and in about 60 percent of the heart surgeries in the U.S. It is estimated they are used in about 250,000 procedures per year, just in the United States. The device is manufactured by LivaNova PLC.
What problems does the 3T Heater-Cooler Have?
It appears that the water inside the devices was contaminated with bacteria during the manufacturing process. When the manufacturing facility was tested in 2014, results showed M. chimaera bacteria on the production line and in the water supply. Yet LivaNova continued making and distributing the device worldwide.
Because the contaminated water was contained within closed circuits, it could not infect patients directly. But the water from the device can aerosolize as it travels through the closed circuits. That air, filled with tiny, bacteria-containing water droplets, may be able to leak into the sterile operating room through the device’s fans, vents or other small openings. The droplets may remain suspended in the air, increasing the risk they enter a patient’s surgical cavity or contaminate a sterile instrument or implant.
Researchers have found a connection between the bacteria in the contaminated heater-cooler devices and the bacteria samples from infected patients.
Even though the manufacturing facility was tested in 2014, The Food and Drug Administration and the Centers for Disease Control and Prevention didn’t publish alerts about this risk of infection from 3T heater-coolers until 2015.
In October 2016, the CDC issued a warning. It said that in hospitals where there has been an infection, the risk of a patient getting infected is between 1 in 100 and 1 in 1000. It stressed that infections can be severe and that some patients have died.
At this same time, the FDA urged health care facilities to transition away from using 3T heater-coolers manufactured before September 2014, and to take action to minimize the risk of infections from these devices.
Unfortunately, these warnings have not come quickly enough. LivaNova has known about the bacteria in its devices since 2014, and the FDA has been receiving reports of infections since 2010. By the time specific warnings were issued, tens of thousands of patients lives were put at risk.
How do I know if I’ve been infected?
The bacteria that contaminated the heater-cooler devices, M. chimaera, is often found in soil and water. In its natural environment, it seldom causes illness. Even when patients are exposed during surgery, the infection may not show any symptoms for months, and then the symptoms may not point to anything specific. As the CDC noted in 2016, this makes it hard to diagnose the infection. Some patients have died before they knew what was wrong with them.
When diagnosis is delayed—or made inaccurately—the infection becomes even harder to treat. And unfortunately, there’s no test for M. chimaera exposure. Doctors can do a lab culture to test for infection, but the infection grows so slowly that it may take as much as two months to get results.
There are, however, symptoms that indicate you should follow up with your doctor. These include:
- Night sweats
- Muscle aches
- Weight loss
- Difficulty breathing
- Persistent cough
In addition, the infection can lead to complications even years after surgery. These include bone inflammation, bacteria in the blood, inflammation of the heart’s inner lining, abscesses and infections at the surgical site.
Can I file a lawsuit and recover money for my injuries?
If a company manufactures and sells a medical device, it has an obligation to make the device as safe as possible, and to warn doctors and the public of any potential risks. LivaNova failed in that duty and should be held liable for all the injuries its tainted device caused.
If you developed an infection from M. chimaera after having heart surgery, you may have a case. A key question is whether the Stockert Heater-Cooler device was used during your operation. You may not be sure, but our law firm knows how to get the answer and hold the manufacturer fully accountable for its irresponsible actions.
If your infection was caused by the Stockert device, you may be eligible to recover the full cost of your medical bills, time missed from your job, and other losses you may have suffered because the contaminated device made you sick.
Talk to a 3T Heater Cooler Bacterial Infection Lawsuit Lawyer
At John Foy & Associates, we have a solid history of helping our clients get the money they need, and we only charge a fee if we win you money. Let us give you a free consultation, with no obligation, to answer your questions and talk about what happened to you. Call us at 404-400-4000 or fill out the form to your right and get your FREE consultation today.