April 11, 2008 (Boston, MA) – Preti Flaherty amended the complaint filed
against Advanced Bionics Corporation in United States District Court for the
District of Massachusetts for providing Marilyn Rappaport of Randolph,
Massachusetts with a faulty cochlear implant. The amended complaint refers
to the U.S. Food and Drug Administration’s March 28, 2008 press release
announcing that it is seeking a $2.2 million penalty against Advanced Bionics
and its CEO Jeffrey Greiner for violating federal law applicable to the
manufacture of medical devices. This is the maximum fine available under
federal law for violations adjudicated in a single proceeding.
The FDA announced 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.”
A cochlear implant is a medical device that provides a sense of sound to
people with severe or profound hearing loss by electrical stimulation of the
auditory nerve.
The amended complaint also names Advanced Bionics, LLC, Advanced Bionics
Holding Corporation, and Astro Seal, Inc. of Riverside, California as
defendants. According to Advanced Bionics, Mrs. Rappaport’s implant failed
because water leaked into the implant through a defective component supplied by
Astro Seal.
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.
Mrs. Rappaport’s device, unfortunately, had already been implanted by the time
of the recall.
The FDA estimates 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 reports that 20% of its implants containing an Astro Seal
feed-through have failed after only 3 years. The implants are warranted to
last 10 years. Advanced Bionics has referred publicly to Astro Seal only
as “Supplier B.”
Advanced Bionics’ internal and federally-approved specification for moisture
content is 0.5 percent, yet Mrs. Rappaport’s failed implant contained 44.6
percent water. Once water entered Mrs. Rappaport’s implant it damaged the
electronics, the device stopped working properly, and she suffered excruciating
electric shocks. Mrs. Rappaport underwent a 7 ½ hour revision surgery to
remove and replace the failed implant. Mrs. Rappaport has asked for a jury
trial.
Mrs. Rappaport is a retired teacher, business owner and advocate for the hard
of hearing. Born on April 2, 1940, Marilyn graduated from Boston State
Teacher’s College. She is co-founder of the South Shore Chapter (at
Cardinal Cushing Hospital in Brockton, MA) of Self Help for Hard of Hearing
People, Inc. (“SHHH”) (now known as the Hearing Loss Association of America), a
non-profit devoted to helping people with hearing loss by providing information,
education, support and advocacy. She served as president of her SHHH
chapter for 4 years. She served as a member of the Governor’s Advisory
Council to the Massachusetts Commission for Deaf and Hard of Hearing. She
is also founder of a hearing equipment supplier, Marilyn Electronics / Rappaport
Communications (http://www.marilynelectronics.net/).
According to attorney Sigmund D. Schutz of Preti Flaherty, “For Advanced
Bionics to sell an electronic device meant to be implanted in the human body
without making sure that it is water proof is to invite disaster. That is
exactly what befell Mrs. Rappaport and many others. I applaud the FDA for
taking action against Advanced Bionics for violating federal law. Mrs.
Rappaport is determined to hold Advanced Bionics and Astro Seal
accountable.”
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.
About Preti Flaherty
Preti Flaherty has offices in Portland and Augusta, Maine, Concord, NH and
Boston, MA. 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.
###
Click here to view the FDA's warning letter to Advanced
Bionics
Click here to view the FDA's complaint against Advanced
Bionics
Click here to view the FDA press release
