By: Irvin Jackson | Published: April 19th, 2013
A Kentucky girl has been awarded $7.25 million in damages as part of a cochlear ear implant lawsuit filed after she suffered violent and severe electric shocks.
The case was brought by the family of Breanna Sadler, now 11, against Advance Bionics, which manufactured a cochlear implant or bionic ear the young girl received when she was four years old.
Cochlear implants are small electronic devices that are surgically implanted to provide a sense of sound for individuals who are profoundly deaf or hard of hearing. Advanced Bionics is one of three companies that manufacturer cochlear implants approved for use in the United States, the others being Cochlear Limited and MED-EL. The devices are often implanted in children.
According to evidence introduced at trial, Sadler was born deaf and had the implant installed in 2006. In 2010, the family alleged that the implant leaked and caused the young child to suffer at least three painful and violent shocks, which caused her to fall to the ground, vomit and suffer convulsions. Sadler was reportedly screaming that her face was melting due to the cochlear implant shocks.
Following trial that ended this week in federal court in Kentucky, a jury awarded $1 million in compensatory damages and $6.25 million in compensatory damages as a result of the conduct of Advanced Bionics.
An Advanced Bionics cochlear implant recall was issued in November 2011, after reports that some patients were experiencing problems with the bionic ear, including malfunctions that resulted in severe pain, feelings of being shocked and overly loud noises.
Sadler’s case was the first trial out of about 40 lawsuits over Advanced Bionics cochlear implants, which accuse the company of withholding information about defects.
Complaints allege that Advanced Bionics HiRes90K implants contained a defective seal that allowed moisture to enter the implant and cause it to fail. In addition, plaintiffs claim that Advanced Bionics has run afoul of federal regulations and been cited for quality control problems by the FDA in recent years.
The Advanced Bionics HiRes 90k cochlear implant has been recalled twice before. The first time was in 2004 for symptoms that are similar to those that led to the more recent recall; sudden pain, loud noises, popping sounds and intermittent functioning. A second recall was issued in 2006, when the FDA notified the company that it had changed components in the device without notifying the FDA and getting approval. Advanced Bionics paid the government $1.1 million in 2008 to settle penalties resulting from that recall.
In response to the verdict, Company officials have indicated that they disagree with the decision and are considering an appeal, claiming that Sadler was not permanently injured and does not appear to even remember the incident.