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Defective Cochlear Implant Leads to $7.2M Jury Award

Apr 22, 2013

A Kentucky jury has awarded the family of an 11-year-old girl $7.2 million for the injuries she endured due to a defective cochlear implant hearing aid.

The Associated Press (AP) reports that a western Kentucky jury determined that the maker of the questionable cochlear implant knowingly sold a defective product, even after it had initiated a recall of the same device two years before it was implanted in the young girl.

Breanna Sadler had her Advanced Bionics cochlear implant, sometimes called a bionic ear, implanted during a 2006 surgery. The procedure attaches a magnet to the recipient's skull and is designed to pick up sounds for the profoundly hard of hearing or deaf person. Problems arose with the device just two years later, when the young girl was found convulsing in her bedroom, rubbing her head against the floor. Her mother removed the device from her ear to stop the convulsions. A surgeon later reattached the device, however, and the problems persisted, the AP reports.

During the recently concluded trial, it was determined that the cochlear implant in Sadler's ear contained 30 percent moisture and was shocking her. A cochlear implant can only take on one-half of 1 percent of moisture and still be capable of operating safely. Sadler's device had 60 times the allowed moisture, according to the AP report.

The lawsuit against Advanced Bionics claimed that the company knowingly sold a defective cochlear implant. AP reports that the company recalled its troubled cochlear implant device in 2004 because of the same moisture problem. At the time, Advanced Bionics stopped shipping the devices in question. Between then and 2006, when the company issued another recall on cochlear implants that it hadn't yet shipped, Advanced Bionics allegedly shipped another 4,000 implants. The U.S. Food and Drug Administration determined that Advanced Bionics did not get approval for a new supplier for the part designed to prevent moisture from affecting the cochlear implant.

A total of 1,000 Advanced Bionics cochlear implants have already malfunctioned, making for a 40 percent failure rate, according to the AP report, which was based on information presented during the Kentucky trial. An attorney representing the Sadler family said that the actual failure rate could be as high as 50 percent.

The girl now "jumps out of her skin" whenever she hears anything, and has been forced to endure two surgeries to deal with the troublesome cochlear implant, her family says.

A Kentucky jury has awarded the family of an 11-year-old girl $7.2 million for the injuries she endured due to a defective cochlear implant hearing aid.

 

The Associated Press (AP) reports that a western Kentucky jury determined that the maker of the questionable cochlear implant knowingly sold a defective product, even after it had initiated a recall of the same device two years before it was implanted in the young girl. 

 

Breanna Sadler had her Advanced Bionics cochlear implant, sometimes called a bionic ear, implanted during a 2006 surgery. The procedure attaches a magnet to the recipient's skull and is designed to pick up sounds for the profoundly hard of hearing or deaf person. Problems arose with the device just two years later, when the young girl was found convulsing in her bedroom, rubbing her head against the floor. Her mother removed the device from her ear to stop the convulsions. A surgeon later reattached the device, however, and the problems persisted, the AP reports.

 

During the recently concluded trial, it was determined that the cochlear implant in Sadler's ear contained 30 percent moisture and was shocking her. A cochlear implant can only take on one-half of 1 percent of moisture and still be capable of operating safely. Sadler's device had 60 times the allowed moisture, according to the AP report.

 

The lawsuit against Advanced Bionics claimed that the company knowingly sold a defective cochlear implant. AP reports that the company recalled its troubled cochlear implant device in 2004 because of the same moisture problem. At the time, Advanced Bionics stopped shipping the devices in question. Between then and 2006, when the company issued another recall on cochlear implants that it hadn't yet shipped, Advanced Bionics allegedly shipped another 4,000 implants. The U.S. Food and Drug Administration determined that Advanced Bionics did not get approval for a new supplier for the part designed to prevent moisture from affecting the cochlear implant.

 

A total of 1,000 Advanced Bionics cochlear implants have already malfunctioned, making for a 40 percent failure rate, according to the AP report, which was based on information presented during the Kentucky trial. An attorney representing the Sadler family said that the actual failure rate could be as high as 50 percent.

 

The girl now "jumps out of her skin" whenever she hears anything, and has been forced to endure two surgeries to deal with the troublesome cochlear implant, her family says.


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