Advanced Bionics HiRes90k Recall
The attorneys at Shoop | A Professional Law Corporation continue to represent victims of failed cochlear implants, including certain of the Advanced Bionics HiResolution 90k (HiRes90k) and Clarion implant model (based on a failures in the manufacturing process and numerous FDA violations).
The product defect associated with these HiRes90k devices in question relate to a defective, internal component of the cochlear implant (CI) device called a "feedthru" (or "feed-through") manufactured by a California corporation called, "Astro Seal" (at times, Astro Seal was referenced within various Advanced Bionics notification letters to their CI recipients as "Vendor B"). The feedthru unit is the part of the implanted internal component which conducts the electrical signals from the implanted portion of the electrode array within the cochlear nerve.
Potential clients could have received either September 2004 or March 2006 "Notification" letters from Advanced Bionics warning of a failed hermetic seal and moisture-related issues within their cochlear implants. Advanced Bionics has additionally provided a list of potential symptoms for this product failure mode.
If you or your child has been implanted with a defective cochlear implant, we encourage you to contact us. Shoop | A Professional Law Corporation is committed to resolving your Advanced Bionic claim quickly and efficiently. In its representation of Advanced Bionics clients, the firm has gained valuable insight with regard to the expeditious handling and resolution of these cases and claims.
Attorneys Don Liddy and
David Shoop represent cochlear implant victims nationally and are currently investigating numerous other cases.
With regard to the substantive allegations against Advanced Bionics, the FDA filed a complaint in November 2006 brought under the FDCA ("Food, Drug and Cosmetic Act") and its medical device regulations seeking administrative penalties against Advanced Bionics (and its President and CEO Jeffrey H. Greiner) related to Advanced Bionics' violation of FDA manufacturing guidelines regarding the "Vendor B" 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 involving Astro Seal.
The FDA alleged that the design criteria and specifications of the Astro Seal feedthru components were different from the specifications of the feedthru submitted to the FDA for approval, thus rendering the device 'adulterated' and in violation of federal law. On July 7, 2008, the FDA and the Advanced Bionics settled an Administrative Action, with Advanced Bionics agreeing to pay in excess of a million dollar fine.
Shoop | A Professional Law Corporation additionally represents numerous children and adults implanted with the defective Cochlear Nucleus CI512 device. You can read additional information regarding the Cochlear Nucleus recall here.
Our firm recommends that cochlear implant victims & parents of minor victims not release any of their rights to recovery for injuries sustained and financial losses, without first consulting an attorney who has substantial experience in the investigation of defective products, and litigating cases involving defective
medical devices. If you or a family member has suffered a failure of the Advanced Bionics HiResolution 90k (HiRes90k) or the Cochlear Ltd., CI500 series implant, contact us today to speak with an experienced attorney.
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