Some Advanced Bionics Cochlear Implants Include Possible Risk of Device Failure and Explant Surgery. Get Lawsuit Information.
Learn More About the Potential Health Risks of Certain Advanced Bionics Implantable Cochlear Implants and Get Lawsuit Resources Here.
NEWS UPDATE: Weitz & Luxenberg P.C. would like to inform the public that Advanced Bionics LLC, a California-based manufacturer of cochlear implants, will pay the Food and Drug Administration (FDA) $1.1 million, and the company’s CEO Jeffrey Greiner will pay $75,000, as part of a settlement agreement regarding alleged violations of federal law.
The cochlear implant maker denies it violated federal law and has not
conceded to any admission of liability in the settlement agreement.
The
FDA has agreed not to initiate any administrative action or refer to the
Department of Justice any criminal or civil action against Advanced Bionics
arising from the manufacture and distribution of the HiRes900k cochlear implant
that was known to the FDA on or before November 2, 2007.
However, the
Settlement Agreement is binding on the FDA only, and does not preclude any
action by any other agency or governmental entity, nor does it preclude the FDA
from taking any other action based on information unknown to the FDA at the time
of settlement or from using the evidence described in the Second Amended
Complaint in support of further actions based on additional or later
conduct.
Below is earlier information regarding the the FDA's decision
to seek a penalty against Advanced Bionics LLC:
On March 28th, 2008, updated April 8, 2008, the Food & Drug Administration issued a release stating that it is seeking a $2.2 million penalty against Advanced Bionics, a California-based cochlear implant manufacturer.
The fine is for violations of federal law, including manufacturing standards violations and the failure to notify the FDA of a change in an outside supplier or vendor,which may have exposed the recipients of certain Advanced Bionics devices to unnecessary health risks.
If you were a recipient of an Advanced Bionics HiRes90k Implantable 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:
Cochlear Implants
Cochlear Implants (CI) Help the Profoundly Deaf and Hard of HearingWere you harmed by defective Cochlear Implants (CI)? Free Legal Info
FDA & Advanced Bionics
Advanced Bionics Reaches Settlement With FDA--Free Legal Case ReviewTalk to a Lawyer: Advanced Bionics Settles with FDA
FREE Legal Review
Free Lawsuit Evaluation from Advanced Bionics Attorneys--ASLAdvanced Bionics Attorneys Offer Free Legal Review--Fluent in ASL
