LivaNova – Sorin 3T Heater-Cooler
The Claim: This certified class action is brought 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 were contaminated with M. chimaera bacteria, a subspecies of Nontuberculous Mycobacterium (NTM), which put patients at risk of serious infection or death.
The claim is brought on behalf of every person in Canada who underwent an open chest 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, (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 body 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 particular 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. chimaera was present, clinical and academic researchers sought to determine the cause of these unique infections. In August 2014, M. chimaera 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 10 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 suffered infections, including the Estates and dependants of those who have died.
The Class: If you fall within the class definition, then you are automatically included as a class member. The class definition is:
Every person in Canada, who underwent open chest cardiac surgery during which the Sorin 3T Heater-Cooler System was used at one of the institutions listed below after January 1, 2010 and before the end date listed for that institution here.
Our Partners: Flaherty McCarthy LLP
May 21, 2021: This action was certified as a class proceeding. 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.
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.
This action is funded by the Class Proceedings Fund. The Class Proceedings Fund provides 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.
- Frequently Asked Questions
- Long Form Notice of Certification
- Short Form Notice of Certification
- Certification Order
- Fourth Amended Statement of Claim
- Statement of Defence
- Counsel Presentation About Sorin 3T HCU Class Action
- Press Release: Class Action Certified Regarding Sorin’s 3T Heater-Cooler Unit
- CBC Article: Contaminated medical devices used in open heart surgery caused severe infection in patients
What is a class action?
A class action is a special form of lawsuit in which one plaintiff brings a claim against one or more defendants based on allegations which are common to a group, or class, of people. In order for the action to become a class action, it must proceed through a stage known as “certification”.
Who brings a class action lawsuit forward?
A statement of claim is issued on behalf of a “representative plaintiff”. The representative plaintiff’s role is to work with class counsel to bring the action forward and to represent the class members in court.
What is certification?
In order for an action to proceed on behalf of the entire class, a judge must decide (among other things) whether the members of the proposed class have common issues, and whether a class action is the preferred way to resolve the issues. The process to decide these issues is known as the “certification motion”. If the judge is satisfied that the case meets all of the requirements for certification, he or she will issue an order which certifies the action as a class action.
Do I have to do anything to “join” the lawsuit?
No. If the lawsuit is certified, and you are included in the class as defined, you are automatically included in the lawsuit.
Once I am part of the class do I have to do anything?
No. We will work primarily with the class representative.
What if I do not want to be included in the lawsuit?
Those who do not wish to remain in the class will be given the option to opt-out by sending an opt-out form at the appropriate time to us.
What are the benefits of proceeding as a class action?
Certification as a class action will enable us to prove the facts in a single lawsuit rather than in numerous individual lawsuits. This has obvious benefits to the class members and to the courts.
How long does it take for a class action to be resolved?
There is no timeframe. We will move the case forward diligently but it can take a considerable period of time to reach trial.
Can a class action lawsuit be settled without going to trial?
Many class actions settle and thereby remove the need for a trial. However, we cannot predict with any certainty whether or not there will be a settlement in a given action.
What are the chances of winning the action?
The chances of “winning” can never be accurately predicted.
Will be liable for any costs or legal fees?
Class action lawsuits are typically brought on a contingency fee basis. This means that the lawyers will only be paid if the action is successful at trial or results in a settlement in favour of the plaintiffs. Legal fees would then be paid out of the settlement or judgment proceeds as approved by a judge.
Disbursements (i.e. out-of-pocket expenses, including expert reports) may be dealt with in one of two ways.
Most commonly, the lawyers will absorb the cost of disbursements. The lawyers may seek funding assistance from the Class Proceeding Fund, which may provide funding for disbursements if granted.
In some cases, disbursements may be funded by the class members, including the class representative. This typically occurs in smaller class actions brought on behalf of an organization or network of individuals where each member of the class is easily identifiable and known to the representative plaintiff. If the class action is successful, amounts advanced for disbursements are re-paid from the proceeds of any judgment or settlement to class members (and others).
Will I be liable for costs of the action if it is unsuccessful?
Only the class representative may be liable for costs of the common issues portion of the action if it is unsuccessful.
When can I expect to receive a payout from this class action?
A “payout” or an award for damages is never certain.
The action may settle or it may proceed to trial, at which time a judge will determine the amount of damages, if any, to which the class members are entitled to. Regardless, the amount of “payout” cannot be predicted, and we cannot predict when the action may settle or when the trial will conclude.
How will counsel keep me updated on the progress of the case?
If the lawsuit is certified as a class action, you will receive a formal notice from the court explaining the nature of the case and providing you with the opportunity to opt out if you wish. General information about the lawsuit will be posted on Sotos LLP’s website at https://www.sotosclassactions.com.
Where can I send any documents that I have that may be relevant to a class action?
We ask that you keep a copy of any documents, correspondences, records, invoices, receipts, etc. that you feel might be relevant to your individual claim in the class action. If there is a “payout,” this documentation may be required in order to support your claim for compensation.
It is not required that you send any documents to us at this time.