Cochlear Implant Lawsuit Award - Consumer Justice Foundation

Cochlear Implant Lawsuit Award

Written by Faith Anderson on April 24, 2013
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Potential Side Effects of Cochlear Implant

Cochlear implants are small electronic devices that are surgically implanted to provide individuals who are profoundly deaf or hard of hearing with a sense of sound. Advanced Bionics is one of three companies that make cochlear implants approved for use in the United States, and the company’s devices have been implanted in 4,000 people – most of them children. According to the cochlear implant lawsuit, Breanna Sadler was born deaf and had the implant surgically implanted in 2006. In 2010, the family claimed that the implant leaked and caused the 8-year-old girl to suffer at least three violent and painful electric shocks, which caused her to scream, fall to the ground, vomit and experience convulsions.

Cochlear Ear Implant Recall

A recall affecting Advanced Bionics’ cochlear ear implant was issued in November 2011, following reports that patients who received the implants were experiencing issues with the device, including malfunctions that resulted in overly loud noises, severe pain and the sensation of being shocked. Breanna Sadler’s case was the first trial of approximately 40 lawsuits filed over Advanced Bionics’ cochlear ear implants, the majority of which accuse the medical device firm of concealing information about defects affecting the implants. Among the complaints are allegations that Advanced Bionics’ HiRes 90K implants contained a defective seal that allowed moisture to enter the implant and cause it to malfunction.

Compensatory and Punitive Damages for Defective Device

The HiRes 90K cochlear implant manufactured by Advanced Bionics has been recalled twice before, first in 2004, for issues similar to those addressed in the 2011 recall, and again in 2006, when the FDA found that the company had changed components in the implant without notifying the agency and seeking device approval. In 2008, Advanced Bionics paid the U.S. government $1.1 million to resolve penalties resulting from the 2006 recall, which came only six weeks after Breanna Sadler received her implant. Following the Sadler family’s trial, which ended last week in federal court in Kentucky, the jury awarded the family close to $1 million in compensatory damages and recommended that the company pay $6.25 million punitive damages for recklessly disregarding patient safety and continuing to sell the defective device.



Posted Under: Legal
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