Class Actions

LivaNova Class Action —

This proposed national class action is brought on behalf of individuals who underwent cardio-pulmonary surgery since January 1, 2010 during which a Sorin Stockert 3T Heater-Cooler unit was used. These individuals may have been exposed to a deadly M. chimaera bacteria in the Sorin Stockert 3T Heater Cooler system, which is manufactured and distributed by LivaNova / Sorin.

Case Overview

Waddell Phillips PC is co-counsel with the law firm of Flaherty McCarthy LLP (www.livanovaclassaction.com) in respect of a proposed class action against Sorin Group Deutschland gmbh and LivaNova Canada Corp. The claim alleges the Defendants were negligent in the design and manufacture of the Sorin Stockert 3T Heater-Cooler Systems, which put patients at risk of serious infection or death from an M. chimaera bacteria, which is a subspecies of Nontuberculous Mycobacterium (NTM).

The claim is brought on behalf every person in Canada who underwent surgery during which the Sorin 3T Heater-Cooler System (the “HCU”) was used, during the period between January 1, 2010 and the date the last HCU at each hospital or cardiac surgery facility was equipped with vacuum canister modifications or was taken out of service at the hospital or cardiac surgery facility where the surgery took place, (the Patient Class) and their close family members.  The last unit was repaired or taken out of service on October 19, 2018.

The Sorin 3T System is used to regulate the temperature of fluids during surgical procedures – including, in particular, open-heart surgeries. The System is widely used in Canadian hospitals.

Beginning in 2010 (and perhaps earlier), a peculiar type of NTM (M. chimaera) was identified in post-surgical patients who underwent open-heart procedures. Following patient deaths in Europe and the United States in which M. chimeara was present, clinical and academic researchers sought to determine the cause of these unique infections. In August 2014, M. chimera was identified on the production line at a facility at which the Sorin 3T Systems were manufactured.

The US Food and Drug Administration (FDA) began an investigation and issued safety warnings about the Devices and issued multiple safety communications about the Devices.

In October 2016 and again on February 17, 2017, Health Canada issued a Medical Device Recall for the Devices, advising that there is a potential risk of NTM infections with the Devices.

At least 8 people have died from an M. chimaera infection in Canada, and others have suffered serious injuries and illnesses.

This proposed class action seeks damages from the manufacturers and distributors of the Devices for class members who were exposed to a potentially fatal risk of NTM infection. In addition, the proposed class action seeks redress for those class members who actually developed infections, including those who may have died as a result.

Did you undergo a surgery during which the Sorin 3T System was used and would you like to speak with a member of our Team?

If you believe that you or someone you care about underwent surgery in a Canadian hospital during which time the Sorin 3T System was used, please contact us.

If you complete our online form, we will respond to your inquiry, typically within one business day. Or you can contact us at:

reception@waddellphillips.ca

(t) 647-261-4486
(f) 416-477-1657

36 Toronto St., Suite 1120, Toronto, ON, M5C 2C5, attn.: LivaNova Class Action

Case Overview

Waddell Phillips PC is co-counsel with the law firm of Flaherty McCarthy LLP (www.livanovaclassaction.com) in respect of a proposed class action against Sorin Group Deutschland gmbh and LivaNova Canada Corp. The claim alleges the Defendants were negligent in the design and manufacture of the Sorin Stockert 3T Heater-Cooler Systems, which put patients at risk of serious infection or death from an M. chimaera bacteria, which is a subspecies of Nontuberculous Mycobacterium (NTM).

The claim is brought on behalf every person in Canada who underwent surgery during which the Sorin 3T Heater-Cooler System (the “HCU”) was used, during the period between January 1, 2010 and the date the last HCU at each hospital or cardiac surgery facility was equipped with vacuum canister modifications or was taken out of service at the hospital or cardiac surgery facility where the surgery took place, (the Patient Class) and their close family members.  The last unit was repaired or taken out of service on October 19, 2018.

The Sorin 3T System is used to regulate the temperature of fluids during surgical procedures – including, in particular, open-heart surgeries. The System is widely used in Canadian hospitals.

Beginning in 2010 (and perhaps earlier), a peculiar type of NTM (M. chimaera) was identified in post-surgical patients who underwent open-heart procedures. Following patient deaths in Europe and the United States in which M. chimeara was present, clinical and academic researchers sought to determine the cause of these unique infections. In August 2014, M. chimera was identified on the production line at a facility at which the Sorin 3T Systems were manufactured.

The US Food and Drug Administration (FDA) began an investigation and issued safety warnings about the Devices and issued multiple safety communications about the Devices.

In October 2016 and again on February 17, 2017, Health Canada issued a Medical Device Recall for the Devices, advising that there is a potential risk of NTM infections with the Devices.

At least 8 people have died from an M. chimaera infection in Canada, and others have suffered serious injuries and illnesses.

This proposed class action seeks damages from the manufacturers and distributors of the Devices for class members who were exposed to a potentially fatal risk of NTM infection. In addition, the proposed class action seeks redress for those class members who actually developed infections, including those who may have died as a result.

Did you undergo a surgery during which the Sorin 3T System was used and would you like to speak with a member of our Team?

If you believe that you or someone you care about underwent surgery in a Canadian hospital during which time the Sorin 3T System was used, please contact us.

If you complete our online form, we will respond to your inquiry, typically within one business day. Or you can contact us at:

reception@waddellphillips.ca

(t) 647-261-4486
(f) 416-477-1657

36 Toronto St., Suite 1120, Toronto, ON, M5C 2C5, attn.: LivaNova Class Action

The Third Amended Statement of Claim has been issued and served on the Defendants.

The Defendants have delivered a Statement of Defence.

The parties attended a mediation on December 5, 2019, but no resolution of the claim was reached. Therefore, the litigation is proceeding.

The Plaintiff and Defendants are completing their records for the certification motion, including the exchange of several expert reports, and they will then be conducting cross-examinations.  The Plaintiff anticipates that the certification motion will be scheduled to be heard by the end of 2020.

In the interim, additional patients with confirmed M chimaera infections continue to be identified.  If you have been diagnosed with an M chimaera infection, or are concerned that you may have been infected, then please contact us so that we can add you to the list of interested and affected class members to ensure that you will get direct notice of significant steps in the proceeding as the case progresses.

An application for funding for this action was heard by the Class Proceedings Fund on March 18, 2018. The funding application was successful. The Class Proceedings Fund will provide some funding for the costs of disbursements incurred in prosecuting the case, and will provide an indemnity to the plaintiff for any adverse cost awards made by the court. In exchange, the Fund will be entitled to receive 10% of the net proceeds of any judgment or settlement achieved for the class.

Further updates will be posted as the case progresses.

We review every inquiry we receive and will respond promptly to case specific inquiries.

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