FDA Seeks Civil Penalties from Cochlear Implants Maker.
Our Defective Medical Devices Lawyers Will Review Potential Cases.
If you were the recipient of a faulty Advanced Bionics cochlear implant, you have a right to seek counsel with one of our lawyers.
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:
March 28, 2008, amended April 8, 2008--The U.S. Food and Drug Administration (FDA) today announced it is seeking a $2.2 million penalty against a California cochlear implant manufacturer 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 recipients of certain devices to unnecessary health risks.
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."
The agency's complaint, originally filed this past November and amended on March 17, seeks penalties against California medical device manufacturer Advanced Bionics, LLC and its president and co-CEO, Jeffrey H. Greiner.
According to the FDA's revised 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 "[t]he 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 hearing aid by testing lots under actual or simulated use when the unapproved vendor's component was used...[and] that Advanced Bionics shipped devices in violation of the law between January 2005 and July 2006. Two devices 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, and have experienced 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.
see also:
Discuss a case in ASL
Discuss Your Advanced Bionics Implant Case With a Deaf Lawyer--ASLSeeking a deaf lawyer to discuss your case in American Sign Language?
Cochlear Implants Lawyers
Lawyers to Review Cases on Some Advanced Bionics Cochlear Implants Have your cochlear implants failed? Talk with one of our lawyers
Our Press Release
Some Advanced Bionics Cochlear Implants a Health Risk--Lawsuit InfoLawsuit info: Some people may have Cochlear Implants that have failed
