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Heart Surgery Heater-Cooler Lawsuits

Lawyers helping those affected by infection following heart surgery.

THE LITIGATIONLATEST UPDATES

Did you undergo heart bypass surgery?

FAQs About Heart Surgery Heater-Cooler Litigation

1. Why are patients filing lawsuits against the makers of the 3T Heater-Cooler?

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.

Due to the failure of the manufacturer to monitor the safety of their product or properly warn patients about the deadly risks, lawyers are helping those affected and their families file lawsuits.

2. How do you qualify for a Surgical Heater-Cooler Lawsuit?

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.

However, 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.

  • Night sweats
  • Muscle aches
  • Weight loss
  • Fatigue
  • Unexplained Fever

It costs nothing to learn if you qualify or file a case. Simply contact DrugNews to talk with a lawyer today.

3. Is there a 3T Heater-Cooler Class Action Lawsuit?

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.

However, 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.

These cases will likely be consolidated into a centralized federal multidistrict litigation (MDL) court for expedited handling. MDL courts offer many advantages of a class action case, however, victims have more control over their case. For example, they can select their lawyer and decide whether or not to settle. Also, MDL cases usually result in greater awards to victims than class action lawsuits.

4. How much are Surgical Heater-Cooler Lawsuits worth?

Like all lawsuits, each heater-cooler claim has its own un ique value. This may depend on specific facts such as the date of surgery, the age of the patient, the degree of side effects or infection, whether the patient has undergone repeat surgery or whether they have passed away.

Based on the severe infections, complications and deaths caused by these defective surgical heater-coolers, lawyers expect the lawsuits will seek compensation into the millions of dollars.

5. How long does it take to file a surgical heater-cooler lawsuit? What is involved?

You can talk directly with a lawyer today at no charge. It only takes a few minutes to review and qualify your case. After you retain a lawyer, they will gather your medical records to investigate and file your claim. It can take a year or more to prepare your case for trial or settlement. However, the chances are slim that you will have to travel anywhere and it costs you nothing unless you receive compensation.

SURGICAL HEATER LAWSUITS: A DETAILED LOOK

Foster, et al. v. LivaNova, PLC, et al. (Class Action)

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, LivaNona 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.

Eisenberg v. LivaNova, PLC, et al. (South Dakota)

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.

Prescott, deceased v. LivaNova, PLC, et al, Case 4:16-cv-00472-JAJ-SBJ Filed 08/22/16 U.S. Dist. Ct. for the Southern District of Iowa

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.

KaraManoogian v. LivaNova, PLC, et al. (New Jersey)

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.

Gerngross v. LivaNova, PLC, et al. (Pennsylvania)

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.

Assistance is available. Speak with a patient advocate today.

SURGICAL HEATER LAWSUITS: THE TIMELINE

1

MARCH 2017

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.

24

JANUARY 2017

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.

13

OCTOBER 2016

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.

13

OCTOBER 2016

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.

24

JUNE 2016

The FDA assembles an expert panel to examine the connection between serious infections and open heart procedures performed with blood heater-cooler systems.

1

OCTOBER 2015

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.

7

JULY 2015

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.

12

JUNE 2013

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.

CHOOSING THE RIGHT SURGICAL HEATER LAWYER

If you or a loved one underwent heart surgery of any kind over the past 5 years and has developed infection, it is important to speak with a lawyer to determine your legal rights. Lawyers are now pursuing lawsuits against the makers of the 3T Heater-Cooler patient warming systems due to contamination and defects that can cause severe infection or death.

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.

If you are contacted by the manufacturer or claims representatives about this device used in your surgery, it is important that you DO NOT SIGN anything before first speaking with a lawyer.

In addition, the lawyer you choose may significantly affect your case. Defective medical device injury lawsuits are usually filed in special federal multidistrict courts, not in your local court. Therefore, it is recommended that you choose a lawyer with extensive experience in these cases, rather than a local attorney.

The right law firm will offer to meet with you at your home, take care of gathering all necessary medical records, and appear at all necessary events on your behalf, so you never have to leave home or appear in court.

DrugNews works only with law firms that specialize in medical device and pharmaceutical injury lawsuits, and have handled thousands of these cases across the country. Contact us today to speak with a lawyer at no charge.

view sources

Scutti, S. Heart surgery patients at risk for deadly infection, CDC warns. CNN. (October 14, 2016). Retrieved from www.cnn.com

Svensson, E. Mycobacterium chimaera in Heater–Cooler Units in Denmark Related to Isolates from the United States and United Kingdom. CDC IED Journal. (March 2017). Retrieved from wwwnc.cdc.gov

Foster, et al. v LivaNova PLC, et al., 3:17-cv-00218-BHH Date Filed 01/24/17; (U.S. Dist. Ct. for the District of South Carolina, Columbia Division). Retrieved from www.aboutlawsuits.com

FDA Safety Communication. Heater-Cooler Devices: FDA Safety Communication - Use of Devices Associated With Nontuberculous Mycobacteria Infections. (October 15, 2015). Retrieved from www.fda.gov

Centers for Disease Control. CDC Advises Hospitals to Alert Patients at Risk from Contaminated Heater-Cooler Devices Used during Cardiac Surgery. (October 13, 2016). Retrieved from www.emergency.cdc.gov