Advanced Bionics Settlement with FDA
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:
Certain of the company's HiRes90K cochlear implants, according to the FDA website, "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."
According to the FDA's revised April 8, 2008 FDA News Release, "the complaint alleges that the company failed to comply with the FDA's current Good Manufacturing Practice (GMP) requirements for devices. GMP requires that companies manufacturing medical devices for sale in the United States establish and follow quality systems procedures to assure the safety and quality of their products."
Weitz & Luxenberg has come to be known for helping victims and family members confront what is an emotionally, financially and legally trying situation.
Together, we work with clients to understand their perspective, represent only their interests, and act as a guide during an uncertain and legally complicated time.
Weitz & Luxenberg brings a simple, unwavering philosophy to the work we do: to give only the very best to each client that we work for. We want our decades-long legacy of success, experience and knowledge to work for 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 complete the form below. A representative from our firm contact you as soon as possible.
see also:
FDA & Advanced Bionics
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Research Center
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