This proposed class action is brought against Advanced Bionics and others in respect of its HiRes Ultra and HiRes Ultra 3D cochlear implants, which were recalled by the manufacturer in February 2020. The defective devices have and will result in many patients requiring revision surgery to replace the defective device.
Case Overview
In February 2020, Advanced Bionics issued a recall of its unsold HiRes Ultra and HiRes Ultra 3D cochlear implants because the devices can allow fluid into the electrode area causing malfunctions. 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.
Waddell Phillips PC is co-counsel with Gluckstein Lawyers in this proposed class action against Advanced Bionics and Sonova-related companies for their role in designing, manufacturing, distributing, and marketing the defective devices, and failing to issue warnings about the defect in a timely manner.
Background
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.
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:
Case Overview
In February 2020, Advanced Bionics issued a recall of its unsold HiRes Ultra and HiRes Ultra 3D cochlear implants because the devices can allow fluid into the electrode area causing malfunctions. 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.
Waddell Phillips PC is co-counsel with Gluckstein Lawyers in this proposed class action against Advanced Bionics and Sonova-related companies for their role in designing, manufacturing, distributing, and marketing the defective devices, and failing to issue warnings about the defect in a timely manner.
Background
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.
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:
Status of Proceedings
The Statement of Claim was issued by the proposed representative plaintiff, Paul Pedersen, on April 27, 2023. The Amended Statement of Claim is posted under the “Documents” Tab.
The plaintiff will be delivering his materials in support of a certification motion by October 31, 2024.
News
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