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Weitz & Luxenberg Files Lawsuits Against Cochlear Implants Manufacturer Advanced Bionics
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If you believe that you may have received an “Important Notification” letter from Advanced Bionics about your HiRes90k or Clarion II cochlear implant in either 2004 or 2006, we urge you to contact us to receive important legal information - even if your CI is working.
Many of our clients’ cochlear implants stopped working prematurely as described in the letter. If you received this correspondence, please contact us for more information via the form below. Discuss your case with a Deaf lawyer - Videophone available (VP)
Weitz & Luxenberg has filed multiple lawsuits against California cochlear implant (“CI”) manufacturer Advanced Bionics related to certain defective Advanced Bionics 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-related failure of the implanted internal component of their implant. Advanced Bionics has provided a list of potential symptoms of moisture failure. Other potential clients may have also received a letter warning them of a potential internal magnet laser-weld defect.
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 devices 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 hearing loss and Advanced Bionics’ devices.
Some 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. who is Deaf herself. 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.”
If you or your child was implanted with an Advanced Bionics HiRes90k device between July 2003 and March 2006, or believe that you or your child had or currently has a defective Advanced Bionics HiRes90k or Clarion II device, please complete the form below. A representative from our firm will contact you as soon as possible.
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