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Weitz & Luxenberg cautions public about potentially defective Advanced Bionics cochlear implants
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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 HiRes90k 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:
The U.S. Food and Drug Administration (FDA) is seeking a $2.2 million penalty against Advanced Bionics, the California manufacturer of cochlear implants.
Certain of the company's HiRes90K cochlear implants, according to the FDA website, 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."
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."
The FDA's revised News Release also states that the "alleged GMP violations include the failure to sufficiently evaluate and select a new vendor as the supplier of a critical device component and the failure to adequately validate the continued safety and effectiveness of the cochlear implant by testing lots under actual or simulated use when the unapproved vendor's component was used...[and] that Advanced Bionics shipped cochlear implants in violation of the law between January 2005 and July 2006. Two cochlear implants shipped and implanted after a March 2006 recall contained the component from the unapproved vendor."
If you were a recipient of an Advanced Bionics HiRes90k Cochlear Implant or earlier Clarion model, and have suffered physical or emotional injuries due to a malfunctioning implant, please complete the form below. A representative from our firm will contact you as soon as possible.
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