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Sorin 3T Heater-Cooler Lawsuits

Lawsuits claim the Sorin 3T Heater-Cooler System spread bacteria during heart and lung surgeries, causing serious infections and deaths. The majority of the lawsuits have been combined into a single federal litigation.

Are you suffering complications related to a Heater-Cooler device?

If you developed an infection after undergoing an operation in which a heater-cooler device was used, you may be entitled to compensation.

Sorin 3T Heater-Cooler Legal Facts
  1. Number of Lawsuits More than 70
  2. Plaintiff Injuries Infection, death
  3. Defendants Sorin Group USA Inc.; Sorin Group Deutschland GmbH; LivaNova PLC
  4. Bellwether Trial Date Date not yet set
  5. MDL Location Middle District of Pennsylvania
  6. Class-Action Status One class action lawsuit active
  7. Litigation Status MDL formed Feb. 1, 2018
  8. Top Settlement No publicly disclosed settlements at this time
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In February 2018, a federal panel consolidated nearly 40 lawsuits that claim Sorin 3T Heater-Cooler devices spread nontuberculous mycobacteria (NTM) infections during open chest surgeries. The panel transferred the lawsuits to a single federal court in Pennsylvania to streamline the proceedings.

People suing Sorin and LivaNova say they became infected or a loved one died after surgeries using the companies’ heater-cooler devices.

NTM infections can take months or years to show up. At least one other federal lawsuit, filed as a class action, demands that the devices’ manufacturer provide monitoring for people who had surgery with the devices.

Closeup image of M. fortuitum Mycobacterium
M. fortuitum is classified as a “rapidly-growing” NTM infection.

Status of Sorin 3T Heater-Cooler Lawsuits

As of February 2018, there were at least 73 lawsuits filed over injuries blamed on the Sorin 3T Heater-Cooler System. Because of the large number of surgeries performed with Sorin 3T devices — and the fact that NTM infections can take years to show up — there is the potential for dozens or even hundreds more lawsuits.

Fact
Lawsuits over Sorin 3T injuries have been consolidated in a Pennsylvania federal court.

Heater-cooler lawsuits are still in the early stages. No trial dates have been set. Lawyers are continuing to file lawsuits on behalf of people who believe a Sorin 3T Heater-Cooler device injured them or a loved one during surgery.

In February 2018, a federal panel combined 39 Sorin 3T Heater-Cooler System federal lawsuits from around the U.S. into a multidistrict litigation (MDL) in Pennsylvania federal court. MDLs allow cases to move more quickly and efficiently through the legal process.

The Judicial Panel on Multidistrict Litigation said more than 30 cases already filed in state courts could be included in the MDL in the future.

There is also an active Sorin 3T Heater-Cooler class action lawsuit that demands the devices’ manufacturer arrange for monitoring for patients who underwent surgery with the devices.

Why People File Sorin 3T Heater-Cooler Lawsuits

Sorin 3T Heater-Cooler lawsuits claim the devices spread NTM bacteria, causing a variety of infections.

People filing lawsuits say they were seriously injured or a loved one died after developing an infection caused by a Sorin 3T machine.

NTM Bacteria Infections Can Cause:
  • Abdominal abscess
  • Aortic root abscess
  • Empyema
  • Endocarditis
  • Myocutaneous thoracotomy flap infection
  • Pericardial abscess
  • Sepsis or septic shock
  • Surgical wound infections

Heater-Cooler Manufacturers Named in Lawsuits

The Sorin 3T devices were originally branded as the Stockert 3T Heater-Cooler System. The Sorin Group originally manufactured the devices.

Sorin merged with Cyberonics Inc. in October 2015 to create a new company called LivaNova.

Lawsuits have been filed against the new company as well as U.S. and German branches of Sorin.

Manufacturers named in the lawsuits are:
  • Sorin Group USA Inc.
  • Sorin Group Deutschland GmbH
  • LivaNova PLC

Accusations Against Sorin 3T Heater-Cooler Manufacturers

People who filed Sorin 3T Heater-Cooler lawsuits say the manufacturers knew or should have known the devices could spread infection. Their lawsuits claim Sorin and LivaNova did not properly warn people of the risks the devices posed.

Develop an infection after surgery involving a heater-cooler device? Get a Free Case Review

Lawsuits claim Sorin and LivaNova should have known the Sorin 3T Heater-Cooler System design or manufacturing defects made the devices “susceptible to bacterial colonization, specifically Mycobacteria, despite any cleaning and disinfections procedures utilized.”

Sorin 3T Heater-Cooler Verdicts and Settlements

Sorin 3T Heater-Cooler lawsuits are still in the early stages of litigation, and there have not been any trials or large settlements. The amount of any possible award is impossible to predict. A product liability lawyer should be able to help you determine whether filing a lawsuit could be worthwhile for you.

Sorin 3T Heater-Cooler Class Action Lawsuits

There have been at least three Sorin 3T Heater-Cooler class action lawsuits filed. Only one of them is still active.

In March 2016, Edward Baker and Jack Miller filed a lawsuit that sought class action status in federal court for the Middle District of Pennsylvania. Baker and Miller claim they and thousands of other patients were potentially exposed to bacteria during surgeries using Sorin 3T devices.

Did You Know?
A Sorin 3T Heater Cooler class action lawsuit sought medical monitoring for about 3,600 Pennsylvania patients potentially exposed to NTM.

A second class action, filed in January 2017 in South Carolina, was later withdrawn by the man who filed it. Plaintiff Steven Foster gave no reason for his decision to withdraw the lawsuit.

In May 2017, Jeri Pickrell filed the third heater-cooler class action lawsuit. Like the Baker lawsuit, Pickrell’s sought medical monitoring for people potentially exposed to infectious bacteria. A federal court in Iowa dismissed Pickrell’s class action lawsuit in January 2018, after Pickrell was unable to show she had actually been injured.

Safety Notifications About Sorin 3T Devices

In October 2016, the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration issued safety notifications about Sorin 3T devices.

The CDC reported a genetic similarity between strains of NTM found in patients and in the devices used at hospitals in Iowa and Pennsylvania. The report asserted that the devices made before Aug. 18, 2014, may have been contaminated during the manufacturing process.

The FDA has confirmed that NTM can cause infections in patients with compromised immune systems. This includes patients requiring heart or lung surgeries.

Fact
The FDA concluded that patients who had open-chest surgeries and received implanted devices were more likely to contract an NTM infection.

3T Heater-Cooler System Recall

Sorin recalled the 3T Heater-Cooler System in June 2015, citing the potential for contamination that could lead to NTM infections in patients.

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.

The FDA inspected LivaNova’s Munich manufacturing plant in August 2015 and its Arvada facility in August and September 2015. The agency later issued a notice that inspectors found conditions that did not conform to FDA standards in the Munich facility.

Please seek the advice of a medical professional before making health care decisions.

Related Pages

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10 Cited Research Articles

  1. U.S. Judicial Panel on Multidistrict Litigation. (2018, February 1). In re: Sorin 3T Heater-Cooler System Products Liability Litigation (No. II); MDL No. 2816. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2816-Initial_Transfer-01-18.pdf
  2. LivaNova. (2017, August 7). Quarterly Report filed with United States Securities and Exchange Commission. Retrieved from http://investor.livanova.com/phoenix.zhtml?c=254127&p=irol-sec
  3. U.S. Judicial Panel on Multidistrict Litigation. (2017). Sorin 3T Heater-Cooler System Products Liability Litigation; Order Denying Transfer. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2772-Denied_Transfer-03-17.pdf
  4. Terhune, C. and Jewett, C. (2016). Deadly Infections Linked To Heart Surgery Device Highlight Holes In FDA Monitoring. Retrieved from http://khn.org/news/deadly-infections-linked-to-heart-surgery-device-highlight-holes-in-fda-monitoring/
  5. Furr, L. (2015, October 19). Merged Houston Company Begins Trading Under New Name. Houston Business Journal. Retrieved from https://www.bizjournals.com/houston/news/2015/10/19/merged-houston-company-begins-trading-under-new.html
  6. U.S. Judicial Panel on Multidistrict Litigation. (2017, November 6). In re: Sorin 3T Heater-Cooler Litigation; Oral Argument Request. Retrieved from http://newyork.legalexaminer.com/wp-content/uploads/sites/196/2017/12/3t-heater-cooler-motion-11-6-2017.pdf
  7. Perriello, B. (2016, October 13). LivaNova’s Sorin Can’t Shake Heater-Cooler Lawsuit. Mass Device. Retrieved from https://www.massdevice.com/livanovas-sorin-cant-shake-heater-cooler-lawsuit/
  8. U.S. District Court, District of Iowa. (2017, May 31). Pickrell v. LivaNova PLC, et al; Complaint and Jury Demand. Retrieved from https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2017-5-31-3t-pickrell-class-action.pdf
  9. U.S. District Court, District of Iowa. (2018, January 18). Pickrell v. LivaNova PLC, et al; Order to Dismiss. Retrieved from http://www.pacer.gov
  10. U.S. Food and Drug Administration. (2017, December 4). Heater-Cooler Devices: Information for Patients. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/Heater-CoolerDevices/ucm492585.htm
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