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In 2003, Advanced Bionics Corporation released for sale the HiRes90k, also known as the HiResolution cochlear implant system, to help deaf persons learn to hear. The device is tabbed by some as a “miracle,” but lawsuits filed have alleged that Advanced Bionics failed to place patient safety at the highest level of priority. In fact, lawsuits have been filed on behalf of injured persons across the country alleging wrongdoing by Advanced Bionics.

TO GET A FREE COPY OF THE REPORT ENTITLED “TEN THINGS EVERY PERSON EXPERIENCING AN ADVANCED BIONICS COCHLEAR IMPLANT FAILURE SHOULD KNOW” PLEASE FILL OUT THIS FORM:

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Possible signs of failure of the HiRes90k include:

• Discomfort
• Ear pain
• Loss of sound
• Cracking, hissing and popping noises
• Humming
• Sudden loud noises
• The device stops working

If you believe you have sustained any injuries, please seek medical help IMMEDIATELY. If your child is not showing proper development advances, and you suspect his or her cochlear implant is malfunctioning, please seek medical help IMMEDIATELY.

After seeking medical help, call us or email us for help. You are not alone in your situation, there are others just like you who have gone through device failure and replacement surgery. We can walk you through the troubling times ahead and help try and make something good out of a bad.

Some prior entries we have written about this defective medical device include:

• Ten Things Every Person Experiencing an Advanced Bionics Cochlear Implant Failure Should Know
• Cochlear Implant Injury Recall Attorneys Offering Help to the Injured
• Memphis attorneys accepting cases for defective Advanced Bionics cochlear implants
• Anniversary of FDA Settlement
• Cochlear Implant Lawsuits

For help, call Ed Wallis:

BUSINESS HOURS: (901) 527-2125

AFTER HOURS: (901) 275-0600

EMAIL: click here

FILL OUT THIS FORM FOR A FREE CONSULTATION:

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Scott and Pamela Purcel filed suit Sept. 27, 2007, against Advanced Bionics and Astro Seal in the US District Court for the Northern District of Texas over their son’s malfunctioning cochlear implants. According to the district court order, the Purcels’ suit centers around a single component of the HiRes90k—a feed-thru manufactured by Astro Seal—that was used to connect the device’s internal electrical circuitry to external components. Advanced Bionics issued a voluntary recall of all nonimplanted HiRes90k devices containing Astro Seal feed-thrus in September 2004 because moisture could get into the internal circuitry, which could cause the device to fail.

Advanced Bionics was sued by the FDA, and the company settled with the FDA in July by agreeing to pay a $1.1 million fine, the maximum the FDA can impose on an individual or company. As part of the settlement, Jeffery Greiner, Advanced Bionics’ president and co-CEO, agreed to pay a $75,000 fine. Initially, the FDA had sought a $1.1 million fine from him in addition to the company’s fine.

If you believe you have been physically or emotionally injured as a result of a defective Advanced Bionics HiResolution 90k (HiRes90k), please contact attorneys Tim Edwards or Ed Wallis for a free case evaluation. You can call us at (901) 527-4673. You can email us by clicking HERE. You can visit our page on cochlear implant litigation HERE.

The FDA asserted that Advanced Bionics should have made a formal submission five years ago before using a second vendor for a particular component in its cochlear implant system.

The component, called a feedthru, contained a hidden weakness that allowed a very slow leak of water molecules into the implanted devices containing this vendor’s feedthru’s while blocking the passage of much smaller helium and nitrogen gases.

Until this situation, such a condition was universally believed to be impossible. After an extended period of one year or more, the slow leakage led to device failures, a product recall, and a termination of the second vendor.

Advanced Bionics responded to FDA’s complaint asserting that it had tested the component with state-of-the-art processes and equipment, which demonstrated that gas molecules much smaller than water molecules were completely blocked from passage; until this hidden weakness was observed, the industry standard testing was considered sufficient to ensure hermeticity.

Although the FDA did not accept these arguments, Advanced Bionics believes them to be true and denies that it violated the law. Nevertheless, rather than continuing a protracted and costly legal process that would likely harm its relationship with the FDA, Advanced Bionics has decided to settle this issue and move on.

In doing so, Advanced Bionics has agreed to pay the FDA $1.1 million and the CEO has agreed to pay $75,000.

For more information, read HERE.

If you believe you have been injured as a result of a defective Advanced Bionics HiResolution 90k (HiRes 90k) cochlear implant, and would like more interest in filing a lawsuit on your behalf or on behalf of a loved one, please call Ed Wallis at (901) 527-4673, or send an e-mail by clicking HERE.

In 2004, Advanced Bionics issued a recall for the Clarion HiResolution 90k (HiRes90k) bionic ear system. It appears Advanced Bionics kept shipping these devices across the country, and eventually, the Food and Drug Administration (FDA) approached Advanced Bionics about numerous deficiencies with the development, manufacturing, design, testing, and sale of the HiRes90k cochlear implant. After there was a nearly 20% failure rate for Supplier B HiRes90k implants, Advanced Bionics issued a second nationwide recall for all unimplanted cochlear implants.

The FDA eventually filed a complaint against Advanced Bioncs seeking $2.2 Million in fines, plus additional fines from the company’s CEO. The complaint accused Advanced Bionics of failing to follow pre-market approval procedure, failing to properly test the HiRes90k, supplier B, and failing to comply with numerous other FDA requirements. The HiRes90k cochlear implant was alleged by the FDA to “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 Settlement

Advanced Bionics has settled the Complaint with the FDA, agreeing to pay $1.1 Million Dollars in fines for alleged wrongdoing. The company’s CEO has also agreed to pay a $75,000.00 fine.

Why file a lawsuit?

Advanced Bionic’s failure to follow FDA regulations and guidelines shows a conscious disregard for the safety of patients. Causes of action may exist for design defects, breach of warranty, consumer protection, negligence, intentional wrongful and more.

Symptoms

Possible symptoms of injuries include:

• Discomfort
• Ear pain
• Loss of sound
• Cracking, hissing and popping noises
• Sudden loud noises

If you believe you have sustained any injuries, please seek medical help IMMEDIATELY. If your child is not showing proper development advances, and you suspect his or her cochlear implant is malfunctioning, please seek medical help IMMEDIATELY.

The Authors’ Connection

Tim Edwards, an author of this blog, has a personal connection to cochlear implants and this specific allegation of wrongdoing by Advanced Bionics. Tim’s grandson was born completely deaf, and at twelve months of age, he was implanted with an Advanced Bionics HiRes90k cochlear implant. While Tim’s grandson today has experienced no symptoms of a failing device, he is a part of the recalled group, and must live day by day never knowing when his implant might fail.

Tim has a strong, personal connection to these cases, and is passionate about seeing that justice prevails for his clients.

For More Information

Attorneys Tim Edwards and Ed Wallis are currently representing injured persons who received the HiRes90k cochlear implant and stand ready to discuss your case with you. 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 call us today at (901) 527-4673 or send an e-mail immediately for a FREE CASE EVALUATION.

If you have already settled with Advanced Bionics, CALL US OR E-MAIL US TODAY as there may be means to address wrongdoing by Advanced Bionics.

Astro Seal allegedly made the feedthrus for the Advanced Bionics Clarion HiResolution 90k (HiRes90k) cochlear implant bionic ear system.

On July 7, 2003, Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Implant. Worth noting, a cochlear implant is classified as a Class III medical device by the FDA, and Class III medical devices are the most stringent regulatory category for devices.

The FDA alleged that Advcanced Bionics failed to comply with the FDA’s current Good Manufacturing Practice (GMP) requirements for devices. In a sense, the GMP requires a company 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 alleged (among others) that Advanced Bionics:

1. Failed to sufficiently evaluate and select a new vendor as the supplier of a critical device component of the HiRes90k implant and further failed to validate the continued safety of the HiRes90k when an unapproved vendor’s component was used.
2. Shipped cochlear implants in violation of the law between January 2005 and July 2006, specifically that two cochlear implants shipped and implanted after a March 2006 recall contained the component from the unapproved vendor.
3. Failed to file required supplements with the FDA.

So, in a nutshell, Advanced Bionics got pre-market approval (PMA) from the FDA to sell the HiRes90k using Vendor A as a supplier. After obtaining PMA, Advanced Bionics added Vendor B as a supplier. Allegedly, Advanced Bionics never received approval to use Vendor B.

And there, in a short version, is why the FDA sued Advanced Bionics.

If you believe you have been physically or emotionally injured as a result of the Advanced Bionics clarion HiRes90k cochlear implant, please call Tim Edwards or Ed Wallis at (901) 527-4673, or SEND US AN E-MAIL today.

You can also click HERE for more information.

You can visit the FDA’s website and read the report by clicking HERE.

If you believe you have been physically or emotionally injured as a result of the Advanced Bionics clarion HiRes90k cochlear implant, please call Tim Edwards or Ed Wallis at (901) 527-4673, or SEND US AN E-MAIL today.

You can also click HERE for more information.

One way to address whether you have a case is to contact us. We will review the facts of your case in detail with you, and will also review the facts of your case with an expert. We will study applicable law, and discuss with you the road that lies ahead. Then, at that point, the decision can be made if you have a case against Advanced Bionics.

We stand ready to discuss your situation. Simply call Tim Edwards or Ed Wallis today at (901) 527-4673, or SEND US AN E-MAIL.

The News Report:

Information on the FDA’s recent announcement of intent to fine Advanced Bionics
Apr 7, 2008

Many of you have heard about the FDA’s intent to fine Advanced Bionics.  This announcement is about events that happened years ago. It’s old news. We’re trying to reach resolution with the FDA, but the process is complex and takes time. What you should take from these events is the following:

1. The fine is principally related to judgments the FDA is making about our quality system as it existed in 2003 — five years ago.

2. We are actively participating with the FDA to try and resolve these matters.

3. The process is complex and takes time.

4. The fine proposed by the FDA has no impact whatsoever on the ability of Advanced Bionics to operate its business.

5. The HiRes 90K is extremely reliable and, together with the Harmony, is the most durable implant system on the market.

If you would like more information, please VISIT THE COCHLEAR IMPLANT PAGE or email us today by clicking HERE. You can also call Tim Edwards or Ed Wallis at (901) 527-4673.

Example jurisdictions where we can file a lawsuit to protect you from problems and injuries associated with your Advanced Bionics HiRes90k cochlear implant include:

• Memphis, Tennessee
• Nashville, Tennessee
• Little Rock, Arkansas
• St. Louis, Missouri
• Dallas, Texas
• Atlanta, Georgia
• Chicago, Illinois
• New York, New York
• Boston, Massachusetts
• San Francisco, California
• Los Angeles, California

Attorneys in our firm are licensed in numerous states, and we are prepared to associate counsel to file your lawsuit close to your home so you are not inconvenienced. In a sense, in most cases, we will come to you if we are retained as your counsel to represent you in your case against Advanced Bionics.

You may have questions about the association process, if we elect to associate local counsel to assist us, and if so, we invite you to EMAIL US TODAY.

Note, however, that you will not be charged for having lead counsel and local counsel. Instead, this is an added benefit in that you have more lawyers to fight for justice for you.

For more information on cochlear implants, please CLICK HERE.