FDA Seeks $2.2 Million Fine against Cochlear Implant Maker for Violations
NEW YORK– LAWFUEL – Legal Newswire –The Food and Drug Administration announced on Friday that it is seeking a $2.2 million penalty against California-based cochlear implant manufacturer Advanced Bionics, LLC, for manufacturing violations that may have exposed recipients of its cochlear implants to unnecessary health risks.
According to the FDA, the Advanced Bionics Implantable Cochlear Stimulators pose a danger due to excessive moisture, thus exposing patients to the risk of device failure, including possible explant surgery and additional hearing loss. Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator in 2003. This surgical implant includes an electrode array which, when inserted into the inner ear, stimulates the cochlear hearing nerve directly.
“What is particularly reprehensible in this case is that Advance Bionics, which has been entrusted with assisting young children and later-deafened or prelingually deaf adults, may have violated that trust by allowing the use of defective devices which may cause irreparable harm to the cochlear nerve and prevent later successful use of a cochlear implant,” said Teresa Curtin, an attorney with Weitz & Luxenberg P.C.
Curtin, who is Deaf and fluent in American Sign Language (ASL), has taken on many issues related to the Deaf community. These include acting as co-counsel in a class-action lawsuit involving Deaf inmates’ access to Americans with Disabilities Act accommodations. Curtin works on a wide variety of the firm’s litigations involving defective drugs and medical devices, including the Vioxx and Ortho Evra birth-control patch litigations. Curtin is a Phi Beta Kappa graduate of Princeton University and an NYU Law School Root Tilden Scholar.
A complaint filed by the FDA against the manufacturer alleges that Advanced Bionics failed to notify the Agency of changes made to the devices that affected their safety and effectiveness. The Agency also stated in its complaint that Advanced Bionics failed to sufficiently evaluate a new vendor that was entrusted with being a supplier of the implant. It then failed to validate continued safety and effectiveness of the cochlear implants by doing checks on the lots.
This is also not the first time Advanced Bionics has failed to meet manufacturing standards. According to the FDA, two cochlear implants shipped and implanted after a March 2006 recall contained the component from the unapproved vendor.
Implant patients who have experienced adverse events after being implanted with an Advanced Bionics HiRes90k Implantable Cochlear Stimulator, or who have suffered physical or emotional injuries due to a malfunctioning implant, can visit the law firm’s website at www.weitzlux.com for more information or to communicate with Ms. Curtin.
About Weitz & Luxenberg, P.C.
Weitz & Luxenberg, founded in 1986, is one of the leading plaintiffs’ law firms in America. The firm has also played leading roles in national and local litigations involving asbestos, DES, silicone breast implants, medical malpractice, and general negligence, among others. A forerunner in the legal fight against environmental polluters, Weitz & Luxenberg has worked with clients harmed by MTBE and mercury, among other toxins. The firm has won numerous cases involving dangerous pharmaceuticals, including Vioxx, achieving a $13.5 million verdict against Merck & Co. The firm’s other active pharmaceutical litigations include actions against the manufacturers of Bextra, ReNu, Celebrex and Ortho Evra.