The FDA, Centers for Disease Control and other health experts recently warned that the 3T Heater-Cooler System used to control blood temperature during heart surgeries may contain contaminated water, and therefore pose risks for deadly infections such as mycobacterium chimaera (M. chimaera).
For years, experts have identified a risk of M. chimaera infection in patients undergoing heart surgeries. However, the connection wasn't identified until 2015, when the bacteria was discovered in the production line and water supply at the 3T manufacturing plant.
Although the manufacturer, LivaNova/Sorin, issued a 3T Heater-Cooler Recall and instructions for hospital staff in July 2015, many of these devices remained in use.
The CDC has warned that around 150,000 heart bypass surgeries in the United States each year were performed using the defective 3T Heater-Cooler systems, and that nearly all 3T patient warming systems were contaminated with M. chimaera bacteria.
M. chimaera is a type of nontuberculous mycobacterium (NTM) infection that can be serious and life threatening. If discovered early, it can be treated with antibiotics. However, if left undiagnosed, there is a significant risk of death. Since M. chimaera may take between 2 weeks and 4 years to develop, patients at risk must constantly monitor for symptoms.
In recent months, at least 16 hospitals in 10 states have confirmed NTM infections in patients exposed to the heater devices, and hospitals have notified thousands of others that they may be at risk and require close monitoring.
Lawyers believe the makers of these devices are liable to victims since they failed to monitor the safety of their products or properly warn about the risks. They're now helping those affected file lawsuits.
Anyone who underwent heart surgery where a blood temperature monitor was used may have a potential claim. Those who've received hospital notification that they may be at risk of infection, or those diagnosed with infection may certainly qualify and should speak with a lawyer as soon as possible.
Patients who underwent heart surgery and are having the following symptoms should definitely seek medical and legal help:
It costs nothing to learn if you qualify or file a case. Simply contact DrugNews to talk with a lawyer today.
Yes. Lawyers have filed a class-action lawsuit for those patients who underwent heart surgery with a 3T Heater-Cooler and are concerned about the risk of infection and necessary monitoring, but have not yet been diagnosed with an infection.
For the more serious cases involving patients who've suffered infection or death, individual cases are being filed against the manufacturer in several different federal court districts.
Due to the increasing number of these cases, lawyers have asked the Joint Panel on Multidistrict Litigation to consolidate them into one central multidistrict litigation (MDL) court for faster resolution. MDL courts have most of the benefits of a class action, but give plaintiffs more control over things like picking a lawyer and deciding whether or not to settle. Also, MDL cases usually return higher compensation to victims than class action lawsuits.
It's difficult to estimate an exact value for these cases at this time, since it is early in the litigation and no settlements or verdicts have been awarded. Also, every heater-cooler lawsuit has its own value, depending on factors like the date of surgery, patient's age, the severity of infection, whether repeat surgery is necessary, and whether the victim has died.
However, lawyers do expect that many of these lawsuits will seek compensation into the millions of dollars, based on the severe infections, complications and deaths caused by defective surgical heater-coolers so far.
The first step is to speak with a lawyer who will ask a few questions to see if your case qualifies for further investigation. You can do this today at no cost by contacting DrugNews.
If your case qualifies, and once you have agreed to let a lawyer represent you, they will begin gathering important evidence such as medical records and recall notices to file a formal lawsuit. It can then take a year or longer before the court sets a trial and settlement conference date.
It is important to remember, however, that you probably won't have to leave home for any of the case events or hearings, and the whole process costs you nothing unless you receive a settlement or verdict in your favor.
This class action blood heater lawsuit was filed in the South Carolina District federal court on January 24th, alleging that the makers of the 3T Heater-Cooler, LivaNova and Sorin, sold dangerous and defective devices for use in the majority of heart surgeries.
The 3T Heater-Cooler class action lawsuit was created for those patients at risk of infection due to a recent heart surgery, who have not yet been diagnosed but still require medical monitoring for infection symptoms. The case anticipates hundreds of thousands of patients may fit this criteria.
This 3T Heater-Cooler lawsuit was recently filed by Duane Eisenberg, a South Dakota man who alleges he developed a severe M. chimaera infection after undergoing heart surgery with a contaminated blood heater-cooler.
After having aortic valve replacement surgery in June 2015, Mr. Eisenberg developed symptoms of infection over the next few months. In November 2016, he was diagnosed with M. Chimaera infection. He had to undergo a second aortic valve replacement, and also suffered organ failure, weakness, and kidney dialysis.
This case was filed in August 2016 in the Southern District of Iowa federal court by the widow of a man who died of severe infection after undergoing a heart valve replacement surgery. Mr. Prescott initially had heart surgery in October 2012. In February 2014, he began complaining of muscle pain, sweating, dry cough, fatigue and persistent fever.
Mr. Prescott was eventually diagnosed with a multiple-organ inflammatory disease caused by an M. chimaera infection. The combination of powerful antibiotic treatment and the infection led to nerve damage, pain, kidney disease, pancreatitis and hearing loss.
In January of 2016, the University of Iowa Hospitals and Clinics finally notified Mr. Prescott and his wife that his NTM infection may be due to the 3T heating and cooling device used at their facility during his surgery. Unable to undergo another operation to battle the infection due to his failing health, he passed away in May 2016 at the age of 59.
This case was filed by 39 year old Marisa Karamanoogian, a school board member in New Jersey who developed a deadly bacterial infection called nontuberculous mycobacterium (NTM) after undergoing cardiac bypass surgery in February 2016.
Mrs. Karamanoogian's infection was diagnosed 6 weeks after her surgery following complaints of severe pain and fatigue. She required several repeat surgeries and has had to take antibiotics through an IV to fight the disease.
This lawsuit was recently filed by 60-year-old Robert Gerngross, an electrical engineer from Pennsylvania. Mr. Gerngross underwent an open-heart aortic valve replacement surgery in February of 2015, during which a 3T Heater-Cooler was used.
Within 15 months of his surgery, Mr. Gerngross developed symptoms of the deadly bacterial infection nontuberculous mycobacterium (NTM). He had to have repeat surgery to replace his mechanical heart valve, and has required potent IV antibiotics.
Sensing that the growing number of lawsuits against it may be consolidated into a multidistrict litigation court (MDL), LivaNova files an opposition with the Joint Panel on Multidistrict Litigation. The company argues that combining the cases isn't appropriate because they are all slightly different.
A pre-published report in the CDC IED Journal estimates that bacterial infections may be more prevalent than thought, with almost 90% of operating room devices being affected. Also warns that M. chimaera bacteria were discovered on nearly all 3T Heater-Cooler systems.
A 3T Heater-Cooler class action lawsuit filed in South Carolina seeks to compensate patients who have not yet been diagnosed with infection for the costs of constant medical monitoring required to ensure early detection.
The most recent warning by the FDA concerning heater-cooler infections provides hospitals and physicians with additional recommendations on how to prevent the spread of infection.
The U.S. Centers for Disease Control and Prevention (CDC) issue a Health Alert Network warning over the risk of M. Chimaera infections caused by blood heater-coolers used in heart surgeries. The CDC advises that around 60% of the 250,000 heart bypass procedures performed annually use the contaminated 3T Heater-Cooler systems.
The FDA assembles an expert panel to examine the connection between serious infections and open heart procedures performed with blood heater-cooler systems.
The FDA first warns consumers about a link between surgical heater-cooler devices used in heart procedures and NTM infections, after the agency receives 32 Medical Device Reports (MDR) about patients who developed the infections.
After M. chimaera bacteria is discovered in the production line and water supply for the 3T Heater-Cooler manufacturing plant, health officials identify a link between NTM infections and the contaminated devices. LivaNova/Sorin provide "corrective action" materials to health providers, which the FDA later classified a 3T Heater-Cooler Recall. However, the devices remain in use in most hospitals.
Case study published in the Journal of Clinical Microbiology details two heart surgery patients who developed M. chimaera infections years apart after undergoing their procedures. Sadly, a link is not made with the 3T heater-coolers used in both operations.
If you've been notified that a defective surgical heater was used during your heart surgery, or you have developed an infection following heart surgery in the past 5 years, it is important to speak with a lawyer about your legal options.
Lawyers believe the makers of the 3T Heater-Cooler patient warming systems will be liable for substantial compensation to those affected, and are now filing lawsuits. However, there is a limit on the time you have to file a case.
LivaNova/Sorin has issued corrective instructions on the 3T Heater-Cooler to doctors and hospitals and the FDA and CDC have both warned of severe infection risks. However, the company did not properly warn patients or protect them from the risks.
Serious infection can lead to the need for repeat heart surgery, as well as pain, kidney damage, nerve damage, pancreatitis, hearing loss and even death.
DO NOT SIGN anything from companies involved in your heart surgery before first speaking with a lawyer, as doing so may terminate your rights to compensation.
Choosing the right lawyer may also have an effect on your case. Lawsuits for serious injury from defective medical devices are typically joined together in special MDL courts, not in your local court venue. They can also be more complicated and specialized than normal personal injury cases.
Therefore, we recommend that you choose an attorney with significant experience fighting medical device injury cases nationwide, instead of a local attorney or someone advertising on television.
The right law firm should offer to come to your location for an initial meeting. They will also collect all essential medical records and evidence for you, and appear on your behalf when possible for required court events, so you won't have to travel.
Most importantly, you should not be responsible for any costs or attorney's fees unless your lawyer prevails in getting you a settlement or verdict award.
DrugNews works only with law firms that satisfy these criteria, and have handled thousands of these lawsuits. Contact us today to speak with a lawyer at no charge.