Speak with a Deaf Attorney in ASL About Your Potential Lawsuit Involving Advanced Bionics Cochlear Implants

According to an article on April 14, 2008, in the FDAnews Device Daily Bulletin, the Agency is reiterating that it is seeking $2.2 million in fines from Advanced Bionics and its president, alleging the company made significant cGMP violations, including shipping a recalled product, cochlear implants for the Deaf.

Those products that are defective may ultimately yield lawsuits from implant patients.

Advanced Bionics shipped cochlear implants that posed “a significant public health risk” and exposed patients to device failure and possibly further hearing loss, the FDA said last month.

The Agency originally filed its complaint last November and amended it in March.

The complaint will be heard before an administrative law judge at the FDA in a procedure similar to federal court proceedings, an FDA spokeswoman said.

The FDA can initiate an administrative proceeding to impose civil fines of up to $1.1 million per individual or corporate entity.

Advanced Bionics shipped cochlear implants illegally between January 2005 and July 2006, according to the complaint.

Two implants shipped and implanted after a March 2006 recall contained a component from an unapproved vendor, the FDA said.

If you were a recipient of Advanced Bionics HiRes90k Implantable Cochlear Implants, and have suffered physical or emotional injuries due to a malfunctioning implant, please complete the form below. A representative from our firm contact you as soon as possible.

Click To Talk To Us Online

see also:

Deaf Lawsuit Some Cochlear Implants for the Deaf Found Faulty--Free Lawsuit Info
Speak with a Deaf Attorney Fluent in ASL--Cochlear Implants Lawsuit

Cochlear Implant Lawyer Has your cochlear implant failed? Discuss your situation with a lawyer
Speak to a lawyer about your malfunctioning cochlear implant (ASL)