3T Heater-Cooler Lawsuits Look To Consolidate Complaints of Bacterial Infections During Cardiac Surgery

Print

3T Heater-Cooler Lawsuits Allege Risks of Chimaera Bacterial Infections During Cardiac Surgery Due To Contaminated Heater-Cooler Units.

3T Heater-Cooler infection lawsuit cardiac surgery infectionsAfter numerous 3T Heater-Cooler lawsuits have been filed, a federal judicial panel will decide whether to consolidate all cardiac surgery infection lawsuits. The complaints filed against LivaNova PLC, (formerly Sorin Group Deutschland GmbH) are pending in federal courts nationwide. The 3T Heater-Cooler lawsuits all allege that plaintiffs contracted life-threatening infections during cardiac surgery. Blaming the contaminated heater-cooler units for the Nontuberculous Mycobacteria (NTM) infections, namely the M. chimaera bacteria or M. abscesses. The plaintiffs further allege Liva Nova failed to warn of the infection risks.

The petition, filed on January 26, asks the U.S. Judicial Panel on Multidistrict Litigation to transfer 15 3T Heater-Cooler lawsuits, as well as future lawsuits, to the federal court in Greenville, South Carolina for coordinated pretrial proceedings. Plaintiffs who filed the request to establish a multidistrict litigation (MDL) maintain the Sorin 3T Heater-Cooler system has a design and manufacturing defect, Liva Nova made “misleading and incomplete representations” to the U.S. Food and Drug Administration (FDA), and the company provided “misleading and erroneous instructions” on how to disinfect or sterilize the system. The petition also asks for U.S. District Judge Bruce H. Hendricks in South Carolina to preside over the proposed MDL because he is already assigned to 10 of the 15 cases. (In Re: Sorin 3T Heater-Cooler Litigation – MDL No.2772 )

“Consolidating cases with common allegations and factual questions promotes efficiency and is convenient for the parties and witnesses,” says Wright & Schulte.
The firm is currently offering free 3T Heater-Cooler lawsuit evaluations to those who believe they or their loved ones may have sustained a serious infection from a contaminated heater-cooler device. To learn more, please contact Wright & Schulte today by calling 1-800-399-0795 or through our information page and contact form on yourlegalhelp.com.

The 3T Heater-Cooler machines are used during open-heart surgeries to maintain patients’ blood temperature. Tanks on the units provide temperature-controlled water to external heat exchangers or warming-cooling blankets through closed circuits, according to the FDA. Patients do not come into direct contact with water in the unit. However, contaminated water can enter parts of the device or transmit airborne bacteria through the exhaust vent into the environment and to the patient.
[fda.gov/medicaldevices/safety/alertsandnotices/ucm466963.htm]

In June 2015, the Sorin Group issued a Field Safety Notice Letter that provided updated instructions on how to use and clean its heater-cooler units. Six months later, the FDA sent a warning letter to the company after the federal regulatory agency inspected Sorin’s facilities in Munich, Germany and Arvada, Colorado in August and September 2015. The FDA found several violations at the Germany facility that included a failure to adequately validate and verify procedures for cleaning and disinfecting the heater-heater-cooler machines.
[accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=138337]
[fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm479684.htm]

One of the plaintiffs seeking an MDL is a South Carolina man who said he contracted M. abscessus after undergoing an aortic valve replacement and bypass grafting surgery in May 2014. About a month after the procedure in which a Sorin 3T Heater-Cooler device was used to cool and rewarm his blood, the plaintiff began running a high fever, became weaker and developed pneumonia, according to the complaint. In addition, a rash, swelling and fluid buildup around the incision site caused the plaintiff to undergo another surgery to clean the site. It was during this surgery that doctors discovered the plaintiff had an M. abscessus infection. (Case No. 8:16-cv-02688, U.S. District Court, District of South Carolina)

About Wright & Schulte LLC And Filing A 3T Heater-Cooler Lawsuit

Wright & Schulte LLC, an experienced personal injury firm with experience in representing clients in such cases as 3T heater-cooler lawsuits. The firm is dedicated to the belief that America’s legal system should work for the people. Every day, the attorneys of Wright & Schulte LLC stand up for the rights of people across the country who have been injured by medical devices and defective products. To learn more, please contact the 3T Heater-Cooler Lawsuit Attorneys at Wright & Schulte today by calling 1-800-399-0795 or through yourlegalhelp.com.

Contact:
Wright & Schulte LLC
865 S. Dixie Dr.
Vandalia, Ohio 45377
1-800-399-0795
www.yourlegalhelp.com

This entry was posted in Wright & Schulte Lawsuit News. Bookmark the permalink.