A staff writer with the Pharmaceutical Business Review cited the recent FDA settlement between the FDA and Advanced Bionics. As noted within that article:
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.
