Class Actions

LivaNova Class Action —

This certified class action is brought on behalf of every person in Canada, who underwent open chest cardiac surgery during which the Sorin 3T Heater-Cooler System (“HCU”) was used after January 1, 2010 and before the last day the affected HCU was taken out of service at each hospital. These individuals may have been exposed to a deadly M. chimaera bacteria in the HCU, which is manufactured by Sorin and distributed by LivaNova.

Case Overview

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

The claim is brought on behalf of 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 HCU is used to regulate the temperature of fluids during surgical procedures – including, in particular, open-heart surgeries. The HCUs are widely used in Canadian hospitals.

The claim alleges that beginning in 2010, 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 German facility at which the HCUs were manufactured.

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

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

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

This class action seeks damages from the manufacturer and distributor of the HCUs for class members who were exposed to a potentially fatal risk of NTM infection. In addition, the class action seeks redress for those class members who actually developed infections, including the Estates and dependants of those who 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 Flaherty McCarthy LLP (www.livanovaclassaction.com) in this class action against Sorin Group Deutschland GMBH and LivaNova Canada Corp. The claim alleges the Defendants were negligent in the design, manufacture, pre and after-market testing, and the distribution and sale of the Sorin Stockert 3T Heater-Cooler Systems, which put patients at risk of serious infection or death from M. chimaera bacteria, a subspecies of Nontuberculous Mycobacterium (NTM).

The claim is brought on behalf of 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 HCU is used to regulate the temperature of fluids during surgical procedures – including, in particular, open-heart surgeries. The HCUs are widely used in Canadian hospitals.

The claim alleges that beginning in 2010, 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 German facility at which the HCUs were manufactured.

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

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

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

This class action seeks damages from the manufacturer and distributor of the HCUs for class members who were exposed to a potentially fatal risk of NTM infection. In addition, the class action seeks redress for those class members who actually developed infections, including the Estates and dependants of those who 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 Fourth Amended Statement of Claim has been issued and served on the Defendants.

The Defendants have delivered a Statement of Defence.

This action was certified as a class proceeding on May 21, 2021. Everyone who meets the class definition is automatically included in the class action. Please review the Notice of Certification to find out more about this class action.

Class members who wish to opt out of this class action must do so by September 27, 2021. Please review the Notice of Certification to find out how to opt out.

While most cases of M. chimaera resulting from surgery with the HCUs have now been identified, there are reports of infections being identified as long as 5 years or more after surgery. Additional patients with confirmed M. chimaera infections continue to be identified in Canada and around the world.  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.

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.

This action will now proceed through the usual litigation steps towards a trial on the common issues.  This will be a lengthy process involving the exchange of documents, oral examinations of representatives of each party, and the preparation of expert reports.

Further updates will be posted as the case progresses.

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

Contact us below and we’ll respond shortly.

Contact Us