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.

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.

How do I join this class action?

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 below:

INSTITUTION NAME CITY & PROVINCE END DATE
BC Children’s Hospital Vancouver, BC November 29, 2017
Cardiac, Vascular & Stroke Research Institute Hamilton, ON June 29, 2018
CIUSSS Du Saguenay -Lac-Saint-Jean Chicoutimi, PQ November 2, 2017
Foothills Medical Centre Calgary, AB July 18, 2018
General Hospital Health Sciences Centre St. John’s, NL September 3, 2017
Hamilton General Hospital Hamilton, ON September 29, 2017
Health Sciences North Sudbury, ON November 15, 2017
CHU Hôpital Ste. Justine Montreal, PQ October 25, 2017
Chul et Centre mère-enfant Soleil (CMES) Québec City, PQ October 31, 2017
CHUM Hôtel Dieu De Montréal Montréal, PQ October 17, 2017
Institut de Cardiologie de Montréal Montréal, PQ August 31, 2017
Institut Universitaire de Cardiologie Québec City, PQ October 19, 2017
IWK Health Centre Halifax, NS October 16, 2017
Kelowna General Hospital Kelowna, BC December 12, 2017
Kingston General Hospital Kingston, ON March 1, 2018
London Health Sciences Centre –  University Hospital London, ON May 11, 2018
McGill University Health Centre – Glen Site Montreal, PQ July 23, 2018
McGill University Health Centre – Montreal General Hospital Montreal, PQ November 16, 2017
McGill University Health Centre – Montreal Children’s Hospital Montreal, PQ November 16, 2017
Ottawa Civic Hospital Ottawa, ON April 17, 2018
QEII Health Sciences Centre Halifax, NS January 15, 2018
Regina General Hospital Regina, SK August 31, 2017
Royal Columbian Hospital New Westminster, BC December 14, 2017
Royal Jubilee Hospital Victoria, BC December 1, 2017
Royal University Hospital Saskatoon, SK October 4, 2017
Saint John Regional Saint John, NB November 3, 2017
Sir Mortimer B Davis Jewish General Hospital Montreal, PQ October 20, 2017
Southlake Regional Hospital Newmarket, ON May 10, 2018
St. Boniface General Winnipeg, MN May 11, 2018
St. Paul’s Hospital Vancouver, BC January 16, 2018
Sunnybrook Hospital Toronto, ON March 14, 2018
The Hospital for Sick Children Toronto, ON December 14, 2017
Toronto General Hospital Toronto, ON May 14, 2018
Trillium Health Partners – Mississauga Hospital Mississauga, ON May 17, 2018
University of Alberta Hospital Edmonton, AB October 5, 2017

Do I have to pay to be in this class action?

No, there is no cost to class members to be a part of this class action. Class Counsel are working on a contingency fee basis, which means that they only get paid if the class action is successful in recovering money for the class members. The fees that Class Counsel will be paid, and the amount they will be reimbursed for the expenses incurred in running the case (disbursements), will have to be approved by the court before anything is paid to them.

How many people have been infected with M. chimaera in Canada?

This infection is very rare, and is reported to occur in between 0.1 – 1% or 0.39 cases per 10,000 patient years.  The total number of patients infected in Canada is not known, as they have not all been reported to Health Canada or other public health organizations.

How do I find out if the Sorin 3T Heater-Cooler device was used during my surgery?

There should be a notation in your hospital records indicating if the Sorin 3T Heater-Cooler device was used during your surgery. You can request a copy of your surgical records from the hospital where your surgery took place. You can also inquire with your surgeon who may be able to answer this questions for you.

Some hospitals sent a letter to patients warning about the potential risk of an M. chimaera infection after the Health Canada advisory was published in 2016.  If you received such a letter, then it is highly probable that the Sorin 3T Heater-Cooler device was used during your surgery.

What are the symptoms of M. chimaera infection?

Symptoms of an M. chimaera infection tend to develop slowly, and often do not begin to show until as much as 18 months to 5 or 6 years post-surgery.

The most common symptoms of an M. chimaera following open-chest surgery are persistent fevers, shortness of breath, and unexplained weight loss.

Other possible symptoms of the infection may include:

  • Redness, heat, or pus at the surgical site
  • Fatigue
  • Night sweats
  • Muscle/Abdominal pain
  • Nausea and/or vomiting
  • Joint pain
  • Persistent cough or cough with blood

What should I do if I am experiencing any of these symptoms?

You should contact your treating physician or surgeon if you are experiencing symptoms and inform them that you had open-heart surgery, and tell them of your concern about M. chimaera infection.

I had an infection following my open-chest cardiac surgery. Was it an M. chimaera infection?

Your medical records from the hospital or your treating physician should indicate the nature of the infection you suffered.  In most cases, the nature of the infection will be identified.  In some cases, it is possible that the doctors were unable to determine the nature of the infection.

You can request a copy of your records from the physician who treated the infection. You can also inquire with your treating physician who may be able to answer this question for you by looking at your medical records.

If your records show that you did have an M. chimaera infection, or if the source of the infection could not be determined, then please contact us.

I had open-chest surgery. Should I be concerned?

If you are feeling unwell, you should consult with your doctor. You and your doctor can then decide whether it is advisable to test for an M. chimaera infection.

My parent (or other family member) had open-chest surgery in one of the listed hospitals in the specified time frames, and died or has become incapacitated. Can I make a claim on their behalf?

Yes, the person who is the Estate’s executor or who has a power of attorney for property can take the place of a deceased or incapacitated class member.

To do so, they must produce a document such as a grant of probate, or a will and proof of death, or the power of attorney and proof of the class member’s incapacity, along with their own personal identification, and then Class Counsel, and Trilogy (the notice administrator) can update their records to name the executor or attorney as the class member’s representative.

Can I make a claim on behalf of the deceased patient’s next of kin?

Yes, the next of kin of a person who died from an M. chimaera infection are entitled to make a claim for their losses, and are included in this class action.

Should I send in my medical records from the hospital where my open-chest surgery took place?

You do not have to send us your medical records right now. If you suspect that you were infected with M. chimaera, you can request your medical records from the treating physician or hospital, in order to see if the doctors were able to identify the type of infection you suffered.  If the documents show an M. chimaera infection or no identifiable source for the infection, then please contact us, and keep your medical records in a safe and accessible place.

I learned about the contaminated HCUs from Health Canada, my hospital, or the news. I have been very anxious since then. What should I do?

If you have suffered from significant anxiety since learning of the potential of being infected by M. chimaera, you should contact your health care provider or mental health care provider to address your anxiety, if this anxiety is interfering with your mental well-being or day to day living and coping ability.

If this is the case, we would also like to hear from you about your experiences. Significant anxiety is something that is “serious and prolonged and rises above the ordinary annoyances, anxieties and fears that come with living in civil society. If your anxiety rises to this level, you might be entitled to compensation, even if there is no conclusive proof that you were infected with M. chimaera from the LivaNova heater cooler units.

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

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