Anniversary of FDA Settlement

Approximately one year ago, Advanced Bionics, the US manufacturer of cochlear implants, settled a civil suit brought by the U.S. Food and Drug Administration (FDA) based on the HiRes90k cochlear implant device. It is expected over 25% of the vendor B HiRes90k devices (implanted in most part through March 2006) will fail. While public relations campaigns may tell you Advanced Bionics settled to “move on,” you have the option to not “move on” until the company addresses the difficulties you faced in life following a failed medical device.

If your HiRes90k failed, and you sustained emotional or physical injuries, lost wages, medical bills, travel expenses, or any other costs, you may be entitled to recovery from the company and possibly the manufacturer or the defective component (a feedthru manufactured by Astro Seal).

If you received the defective cochlear implant recall letter, you may be entitled to relief.

If you want more information on filing a lawsuit against Advanced Bionics, a cochlear implant manufacturer, you can contact me below.

If you or your child has an Advanced Bionics HiRes90k device that was implanted prior to March 2006 (or was implanted with a Clarion II / CII device) and you or your child is experiencing difficulties with the implant or the device has failed, please email me, call me, or complete the form below. I will contact you as soon as possible:

Ed Wallis
Glassman, Edwards, Wade & Wyatt, PC
26 N. 2nd Street
Memphis, TN 38103
(901) 527-4673
ewallis@gewwlaw.com

Or fill out this form today for a free case evaluation:

Failed cochlear implant? We may be able to help.

If you or a loved one has endured medical bills, doctor visits, or simply frustration from a failed cochlear implant, we may be able to help. We are attorneys that are working to provide relief to those recipients of failed cochlear implant devices.

There is no upfront cost.

There is no cost if you do not prevail.

We may be able to seek relief for you to compensate you for your pain, your time away from work, your doctor’s bills, and more.

Please contact us if you would like to discuss your rights and how we may be able to help you:

Ed Wallis
Glassman Edwards Wade & Wyatt
26 N. 2nd Street
Memphis, TN 38103
(901) 527-2125
(901) 275-0600 (after hours / weekends)
ewallis@gewwlaw.com

Or please fill out this form, and we will immediately contact you.

Cochlear Implant Lawsuits

Tim Edwards and Ed Wallis have filed two lawsuits on behalf of minors against cochlear implant (“CI”) manufacturer Advanced Bionics related to certain defective HiRes90k cochlear implants.  The two attorneys are currently investigating numerous other cases and are willing to provide any interested persons a free case evaluation. Additional lawsuits will be filing in the coming months to protect the rights of both innocent children and adults.

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, including popping or crackling sounds, shocking, intermittent sound, and the device turning on/off without effort.

Tim Edwards and Ed Wallis are investigating claims on behalf of a variety of clients, including (1) young children who were forced to endure unnecessary surgery (some multiple times) and who lost out on a critical period of their life for linguistic and speed development and (2) adults who have endured the frustration of deafness and medical complications after being told their cochlear implant would better their lives.

We are 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. We provide our direct office lines, cellular telephone numbers and email addresses to our clients so that they or their families can contact us at any point they need help.

Tim Edwards’ grandson was born deaf and received at 12 months of age a HiRes90k cochlear implant, now part of the recall group. While Mr. Edwards’ grandson’s device has not yet failed, he and Mr. Wallis understand the importance these devices play in the lives of their clients.

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” and also referenced in the public domain as “vendor 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. It is believed that the feedthrus in HiRes90k vendor B devices fail or otherwise are permeable to moisture. A failed device must be explanted, and medical attention should be sought if you or your loved one fears a failed device.

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. You can read more about the lawsuit by visiting our COCHLEAR IMPLANT RESOURCE on our blog.

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. You can read the settlement agreement by CLICKING HERE.

“Children and adults alike may have experienced pain and suffering as a result of Advanced Bionics’ conduct, which is particularly disturbing,” says attorney Ed Wallis, who is counsel for several children in already filed cases and is investigating others. “Advanced Bionics was entrusted with manufacturing this life-changing device using the federal government’s rules and regulations as basic building blocks to ensure safety and effectiveness of the device. If the company failed to follow those rules and regulations, they should be held accountable.”

If you or your child has an Advanced Bionics HiRes90k device that was implanted prior to March 2006 (or was implanted with a Clarion II / CII device) and you or your child is experiencing difficulties with the implant or the device has failed, please complete the form below. I will contact you as soon as possible:

Ed Wallis
Glassman, Edwards, Wade & Wyatt, PC
26 N. 2nd Street
Memphis, TN 38103
(901) 527-4673
ewallis@gewwlaw.com

Or fill out this form today for a free case evaluation: