Weitz & Luxenberg Files Lawsuits Against Cochlear Implants Manufacturer Advanced Bionics

Weitz & Luxenberg informs the public that it has filed several lawsuits against California cochlear implant (“CI”) manufacturer Advanced Bionics related to certain defective HiRes90k cochlear implants, and is currently investigating numerous other cases.

Potential clients may have received September 2004 or/and March 2006 “Important Notification” Letters from Advanced Bionics warning them of potential moisture failures with their cochlear implants. Advanced Bionics has provided a list of potential symptoms of moisture failure.

Weitz & Luxenberg’s clients range from very young children, some whom have been implanted with more than one defective device--thus have undergone multiple cochlear implant surgeries during critical periods of linguistic and speech development--to elderly clients whose miraculous restoration of their hearing through a cochlear implant suddenly ended when their device stopped working. Weitz & Luxenberg is committed to understanding the unique circumstances surround each individual’s, or in the case of young children, each family’s, experience with their hearing loss and Advanced Bionics’ devices.

The defective HiRes90k devices in question contain an alleged defective internal component of the cochlear implant device called the “feedthru” (or “feed-through”) manufactured by Astro Seal (mentioned in some Advanced Bionics notification letters to cochlear implant recipients as “Supplier B”). Astro Seal is also named as a defendant in the lawsuits. The feedthru is the part of the implanted internal component of the implant that conducts electrical signals from the hermetically (waterproof) sealed implanted part to the electrode array implanted in the cochlear nerve.

The FDA filed a complaint in November 2006 brought under the FDCA (“Food, Drug and Cosmetic Act”), 21 U.S.C. §§321 etc. seq. as amended by the Medical Device Amendments, and its implanting regulations seeking administrative penalties against Advanced Bionics and its President and Co-CEO Jeffrey H. Greiner) related to Advanced Bionics’ violation of the FDA regulations related to Advanced Bionics’ manufacturer of its HiRes90k implants containing the Astro Seal feedthru.

After a February 2007 onsite investigation, the FDA complaint was amended on March 17, 2007 to reflect the findings of the February 2007 investigation. The amended complaint sought a $2.2 million penalty against Advanced Bionics for violating federal law, including violation of CGMP (Current Good Manufacturing Practice”) standards and failure to seek PMA (“Premarket Approval”) approval or supplement or a 30-day notice prior to distributing devices with an Astro Seal feedthru.

The FDA alleged that the design criteria and specifications of the Astro Seal feedthru components were materially different from the design criteria and specifications of the feedthru submitted to the FDA for approval, thus constituting a violation of federal law. On July 7, 2008, the FDA and the Advanced Bionics settled the Administrative Action, with Advanced Bionics agreeing to pay a $1.1 million fine (which is the maximum fine allowed in an administrative action). CEO Greiner agreed to pay a $75,000 fine personally. Advanced Bionics denied that it violated federal law and did not concede to any admission of liability in the settlement agreement.

“The cochlear implant is the first prosthesis device that actually replaces a human sense,” said Teresa Curtin, an attorney with Weitz & Luxenberg P.C. She added, “What is particularly disturbing in this case is that Advanced Bionics, which has been entrusted with manufacturing such an amazing device to be implanted in the delicate cochlear of infants, children and adults, may have may have violated that trust by its failure to follow applicable federal laws.”

For more information:

View the Amended FDA Complaint , the FDA's updated News Release, and the FDA’s July 17, 2008 Settlement News release.

If you or your child has an Advanced Bionics HiRes90k device that was implanted prior to March 2006 (or the earlier Clarion II device), please complete the form below. A representative from our firm will contact you as soon as possible.

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see also:

Our Press Release Update: Advanced Bionics Failed HiRes90k and Clarion Cochlear Implants
Get a free lawsuit review | Failed Advanced Bionics cochlear implants

Lawsuit Information Some Advanced Bionics Cochlear Implants a Health Risk. Lawsuit Info
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Advanced Bionics Certain Advanced Bionics cochlear implants cited for health risks
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