Weitz & Luxenberg Informs the Public of Potentially Defective Advanced Bionic Cochlear Implants; To Investigate Possible Lawsuits
Get a Free Cochlear Implants Lawsuit Review When You Complete the Form Below. Firm Attorney Fluent in ASL.
April 8, 2008, New York, NY—The Food and Drug Administration (FDA) announced that it is seeking a $2.2 million penalty against California-based cochlear implant manufacturer Advanced Bionics, LLC, for violations of federal law, including manufacturing standard violations and the failure to notify the FDA of a change in an outside supplier or vendor, which may have exposed recipients of certain Advanced Bionics devices to unnecessary health risks.
According to the FDA, certain Advanced Bionics HiRes90K cochlear implants may "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."
“What is particularly disturbing in this case is that Advance Bionics, which has been entrusted with assisting young children and later-deafened or prelingually deaf adults, may have violated that trust by its failure to follow applicable federal laws,” said Teresa Curtin, an attorney with Weitz & Luxenberg P.C.
Curtin, who is Deaf and fluent in American Sign Language (ASL), has taken on many issues related to the Deaf community. These include acting as co-counsel in a class-action lawsuit involving Deaf inmates’ access to Americans with Disabilities Act accommodations. Curtin works on a wide variety of the firm’s litigations involving defective drugs and medical devices, including the Vioxx and Ortho Evra birth-control patch litigations. Curtin is a Phi Beta Kappa graduate of Princeton University and an NYU Law School Root Tilden Scholar.
For more information:
View the Amended FDA Complaint and the FDA's updated News Release.
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 complete the form below. A representative from our firm contact you as soon as possible.
see also:
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Advanced Bionics
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