The Recall
In 2004, Advanced Bionics issued a recall for the Clarion HiResolution 90k (HiRes90k) bionic ear system. It appears Advanced Bionics kept shipping these devices across the country, and eventually, the Food and Drug Administration (FDA) approached Advanced Bionics about numerous deficiencies with the development, manufacturing, design, testing, and sale of the HiRes90k cochlear implant. After there was a nearly 20% failure rate for Supplier B HiRes90k implants, Advanced Bionics issued a second nationwide recall for all unimplanted cochlear implants.
The FDA eventually filed a complaint against Advanced Bioncs seeking $2.2 Million in fines, plus additional fines from the company’s CEO. The complaint accused Advanced Bionics of failing to follow pre-market approval procedure, failing to properly test the HiRes90k, supplier B, and failing to comply with numerous other FDA requirements. The HiRes90k cochlear implant was alleged by the FDA to “pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss.”
The Settlement
Advanced Bionics has settled the Complaint with the FDA, agreeing to pay $1.1 Million Dollars in fines for alleged wrongdoing. The company’s CEO has also agreed to pay a $75,000.00 fine.
Why file a lawsuit?
Advanced Bionic’s failure to follow FDA regulations and guidelines shows a conscious disregard for the safety of patients. Causes of action may exist for design defects, breach of warranty, consumer protection, negligence, intentional wrongful and more.
Symptoms
Possible symptoms of injuries include:
- Discomfort
- Ear pain
- Loss of sound
- Cracking, hissing and popping noises
- Sudden loud noises
If you believe you have sustained any injuries, please seek medical help IMMEDIATELY. If your child is not showing proper development advances, and you suspect his or her cochlear implant is malfunctioning, please seek medical help IMMEDIATELY.
The Authors’ Connection
Tim Edwards, an author of this blog, has a personal connection to cochlear implants and this specific allegation of wrongdoing by Advanced Bionics. Tim’s grandson was born completely deaf, and at twelve months of age, he was implanted with an Advanced Bionics HiRes90k cochlear implant. While Tim’s grandson today has experienced no symptoms of a failing device, he is a part of the recalled group, and must live day by day never knowing when his implant might fail.
Tim has a strong, personal connection to these cases, and is passionate about seeing that justice prevails for his clients.
For More Information
Attorneys Tim Edwards and Ed Wallis are currently representing injured persons who received the HiRes90k cochlear implant and stand ready to discuss your case with you. If you were a recipient of an Advanced Bionics HiRes90k Cochlear Implant, and have experienced physical or emotional injuries due to a malfunctioning implant, please call us today at (901) 527-4673 or send an e-mail immediately for a FREE CASE EVALUATION.
If you have already settled with Advanced Bionics, CALL US OR E-MAIL US TODAY as there may be means to address wrongdoing by Advanced Bionics.
