Bay State Woman Sues Cochlear Implant Company for Manufacturing Faulty, Malfunctioning Devices

Lawsuit is second cochlear implant case for attorney Sigmund Schutz of Preti Flaherty

BOSTON – A Bay State woman harmed by faulty cochlear implants sued the California manufacturer Tuesday in U.S. District Court in Boston, claiming Advanced Bionics Corporation knew of defects yet continued to produce and sell the devices.

Jayne A. Badore of Whitman, Mass., suffered two successive failures of implanted medical devices – called cochlear implants – manufactured by Advanced Bionics, according to her attorney, Sigmund Schutz of Preti Flaherty.

Schutz also represents another Massachusetts woman, Marilyn Rappaport of Randolph, who earlier this year filed a similar federal lawsuit against Advanced Bionics of Valencia, Calif.

A cochlear implant is a surgically implanted electronic medical device that can help provide a sense of sound to people with severe or profound hearing loss. The device functions by electrical stimulation of the auditory nerve.

“Advanced Bionics knew that its implants were failing at an alarming and unacceptable rate as a result of water intrusion, and had been cited by the FDA for violating federal manufacturing regulation,” according to Badore’s complaint. “Yet the company intentionally and recklessly continued to produce defective implants knowing full well that it had not identified the root cause of the moisture problem, or solved that problem.”

The 12-count complaint includes allegations of negligence, deceptive business practices and breach of warranty against Advanced Bionics. Badore is seeking damages, including punitive damages, for pain and suffering as well as the permanent neurological damage resulting from her ordeal.

In late 2003, Badore underwent an initial cochlear implant surgery in Massachusetts and received an Advanced Bionics cochlear implant. By August of 2004, the cochlear implant malfunctioned and failed. She underwent reimplantation surgery to implant a replacement Advanced Bionics device in early 2005. With the second device, the suit alleges, Badore experienced severe and increasing pain, facial twitches, head pressure and burning ear tips, among other problems. By June of 2006, the second implant had to be removed. Last December, Badore underwent a second reimplantation surgery, a competitor’s device was implanted, and Badore’s hearing results improved. But she continues to suffer from permanent neurological damage caused by the failure of the Advanced Bionics implants, according to the lawsuit.

“My client has suffered immeasurably for more than four years, and continues to experience difficulties, as a result of Advanced Bionics’ sloppy quality,” said Schutz, Badore’s attorney.

In March, the FDA announced it would seek a $2.2 million penalty against Advanced Bionics and its CEO Jeffrey Greiner for violating federal law applicable to the manufacture of medical devices. In a news release, the FDA said that the implants “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…Advanced Bionics shipped [cochlear implants] in violation of the law between January 2005 and July 2006.”

In March 2006, Advanced Bionics recalled all unimplanted HiResolution 90K cochlear implants containing the Astro Seal component because some of the devices were not water proof and were failing at an unacceptable rate. The FDA estimated that 3,477 of the devices with the Astro Seal component had already been implanted at the time of the 2006 recall. Of those, an estimated 1,502 devices were implanted in children under 18 years old.

Advanced Bionics reported that 20 percent of its implants containing an Astro Seal feed-through had failed after only three years. The implants are warranted to last 10 years.

Preti Flaherty is reviewing additional cases on behalf of consumers harmed by Advanced Bionics and invites inquiries from persons interested in discussing their legal rights.

Preti Flaherty has offices in Portland and Augusta, Maine, Concord, N.H. and Boston. With more than 85 attorneys, the firm counsels clients in the areas of business law, energy, environmental, estate planning, health care, intellectual property, labor and employment, legislative and regulatory, litigation, technology and telecommunications. For more information, visit www.preti.com.

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