The product liability lawyers at SHOOP | A PROFESSIONAL LAW CORPORATION
continue to investigate and take on additional claims and cases related
to the recalled, Advanced Bionics HiRes90k cochlear implant. The HiRes90k
recall action was undertaken in response to multiple, confirmed instances
of device failure wherein the unit experienced a malfunction involving
a lack of hermeticity and requiring explantation. The victims of these
malfunctioning implants experienced severe pain, extremely loud noises,
as well as shocking sensations between eight and ten days post-initial
activation of the implant.
HiRes 90k Defects
The company agreed to pay over in excess of a million dollars to settle
an administrative complaint brought by the FDA. That complaint alleged
that Advanced Bionics violated numerous federal guidelines in the manufacture
of its cochlear implants. Specifically, the suit alleged that AB violated
FDA guidelines in failing to notify the agency that it had changed its
feed-thru supplier for the device which “exposed patients to unnecessary
risk,” according to the FDA.
Pursuant to the FDA's good manufacturing practice requirements, manufacturers
must have some measure of a quality system in place for the manufacturing,
designing, packaging, labeling, storing and installation and servicing
of finished medical devices before they are placed into the stream of
commerce in the United States.
The FDA further accused Advanced Bionics of failing to utilize the proper
channels to select its new vendor for the device feed-thru, which constitutes
a crucial component of the implant. The FDA also alleged that Advanced
Bionics failed to properly test the devices that featured the unapproved
What You Should Do
You may have received a letter from Advanced Bionics notifying you that
the implant you or a loved one received contains a component called a
feed-thru device which was manufactured by a "Vendor B" (an
unapproved, device-component supplier). The components manufactured by
this supplier have failed at an alarming rate due to excess moisture,
amongst other issues in our experience with this component, some feed-thrus
have separated entirely from the unit, causing catastrophic failure.
It is very important if you are a Vendor B recipient NOT to sign a release
with Advanced Bionics in exchange for nominal reimbursement. This could
potentially affect your legal rights to recover additional sums in a lawsuit
or settlement with the company.
IT IS OF CRITICAL IMPORTANCE TO CONTACT OUR EXPERIENCED TEAM AS SOON AS
YOU EXPERIENCE A FAILURE OF THIS DEVICE SO THAT WE MAY DEAL DIRECTLY WITH
The SHOOP | APLC Difference
Our law firm represents clients nationally and internationally with regard
to failed and defective cochlear implants. No other law firm has the breadth
of experience that we do, and no other law firm handles more cochlear
implant claims than we do - and we will fight to ensure you receive maximum
compensation for your loss.
If you or a loved one suffered a failure of a HiRes90k implant, it is very
important to contact our legal team immediately so that we may provide
a FREE of cost case evaluation and initial discussion of your potential claim.
SHOOP | A PROFESSIONAL LAW CORPORATION
Defective Product Lawyers with a National Presence.
We Get Results. Period.
Call us today for a FREE consultation at 866.884.1717