Advanced Bionics HiRes Cochlear Implants
The Claim: In February 2020, Advanced Bionics issued a recall of its unsold HiRes Ultra and HiRes Ultra 3D cochlear implants because body fluids can enter into the electrode array, causing malfunctions in the device. Many patients have had to undergo invasive and painful revision surgeries to replace the defective devices, or are living with impaired hearing from faulty cochlear implants.
This proposed class action is against Advanced Bionics and Sonova-related companies for their role in designing, manufacturing, distributing, and marketing the defective devices, and failing to issue timely warnings about the defect.
On February 17, 2020, Advanced Bionics sent an “Urgent Field Action Notification” to healthcare providers informing them that Advanced Bionics had detected an increase in the number of devices being explanted or the potential of being explanted due to performance issues, which included reports of hearing performance degradation, amongst other things. Since then, the devices have continued to fail.
The Advanced Bionics Cochlear implants are intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
These device failures were reported by Advanced Bionics as resulting from fluid ingress at the electrode leading to interruption of stimulation.
Health Canada posted the Advanced Bionics Recall on April 17, 2020. According to Health Canada: “The defect was discovered during the device failure analysis on an explanted device in March 26, 2019.”
Defective devices may require surgical explantation and replacement.
Over 1/3rd of one institution’s patient population underwent explant surgery. According to the Laryngoscope Journal, “Advanced Bionics HiRes Ultra and Ultra 3D Series Cochlear Implant Recall: Time Course of Anomalies”, published in May 2022: “Of the 349 devices implanted at this institution, 181 showed anomalies in accordance with the special failure mode and for this reason, 120 implants were already explanted.”
In the Journal of Otology and Neurotology, “Voluntary Field Recall of Advanced Bionics HiRes Cochlear Implants: A Single-Institution Experience”, published on October 6, 2022, the authors concluded: “Hearing performance degradation is significant in AB Ultra device failures and seems to be linked to the basal-most electrodes in the array. Revision outcomes have been robust, necessitating continued monitoring of affected patients and support for reimplantation procedures.”
The largest single demographic for cochlear implants in Canada are children. The Canadian Agency for Drugs and Technologies in Health reported:
- Since the approval of these devices by Health Canada in 1990, there has been a steady increase in the number of implantations across all age groups in Canada
- Up until 2007, 4,244 Canadians had received implants; 2,534 adults and 1,710 children
- As of May 2011, approximately 2,100 to 2,350 children between the ages of zero and 18 years have received cochlear implant surgery in Canada
- These devices are implanted most frequently in children under the age of eight
- Several jurisdictions indicated the age ranges of 12 to 18 months and 12 to 24 months as the most common ages for surgical implantation
The Class: All persons who were implanted in Canada (excluding Quebec) with the HiRes Ultra CI HiFocus MS Electrode, HiRes Ultra CI HiFocus SlimJ Electrode, HiRes Ultra 3D CI with HiFocus MS Electrode and HiRes Ultra 3D CI with HiFocus SlimJ Electrode (collectively, the “Cochlear Implants”), or any of the Cochlear Implant components including electrode arrays (the “Implant Patients”); and
All other persons why by reason of his or her relationship to an Implant Patient have standing pursuant to s.6191) of the Family Law Act, R.S.O. 1990, c. F.3, or equivalent legislation in other provinces and territories (the “Family Law Claimants”).
Our Partners: Gluckstein Lawyers, Trudel Johnston & Lesperance
- The Plaintiff has delivered his materials in support of the motion for certification. The Defendants materials are due in mid-2025. The certification motion is scheduled for April 8 – 10, 2026.
- There is a companion action in Quebec, Dingwell v. Advanced Bionics, which is proceeding to an unopposed authorization
- Amended Statement of Claim
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.