Breanna Sadler of Vine Grove, Kentucky, was born deaf. She had a cochlear ear device, manufactured by Advanced Bionics, implanted in her head in 2006 when she was 4 years old. A cochlear implant is a surgically implanted electronic device that provides a sense of sound to a person who is profoundly deaf or severely hard of hearing. Cochlear implants are sometimes called bionic ears.
Advanced Bionics announced a voluntary recall of its HiRes 90K device in February 2006, about six weeks after Breanna got her implant. In 2008 it paid a $1.1 million civil penalty to the U.S. Food and Drug Administration to settle allegations it failed to notify the agency that it was using a new supplier for one of the implant’s components, which the FDA said exposed patients to “unnecessary health risks.” The company later agreed to pay an additional $75,000.
Four years after the device had been implanted in Breanna, an electrical short from the device shocked her so violently that she was thrown to the ground, vomiting and convulsing. She screamed that her face was on fire and felt like it was melting, and an ambulance had to be called.
After she was shocked two more times, the cochlear device was disconnected. Breanna had to wait six weeks in total deafness until surgery could be performed to remove the implant and install a working version made by a competitor.
Breanna’s parents sued the manufacturer, Advanced Bionics. The lawsuit claimed that the implant was defective and that the company continued to sell the device after executives were aware of the defects and hid that fact from consumers. The lawsuit alleged that 25% of the devices that have been implanted have failed. At trial, the Louisville surgeon who implanted the device in Breanna testified that he never would have done so if he had known about the defects.
There are dozens of lawsuits pending around the country against Advanced Bionics regarding the cochlear implant device. This month, Breanna’s lawsuit was the first such case to go to trial.
The jury found the device was defective and also found that punitive damages should be awarded because the company recklessly disregarded patient safety. The jury awarded Breanna’s parents $236,325 for her medical expenses, $750,000 for pain and suffering, and about $10,000 to recover the couple’s lost wages and travel expenses. The jury also found the company should pay $6.25 million in punitive damages for recklessly disregarding patient safety.
Advanced Bionics, which is now owned by Swiss-based Sonova Holding AG, sells implants in 50 countries and describes itself on its website as “a global leader in developing the most advanced implants systems in the world.” The company has already announced that it has decided to appeal the jury’s verdict. The company has also announced that it has decided to increase its provisions set aside for claims of this kind from about $50 million to about $250 million.
The implant in question was part of a voluntary recall issued by AB in March 2006. According to the company, the issue with the device recalled was related to the feed through assembly, a component provided by one of two approved. The company has said that roughly one third of 4,000 devices have since been explanted due to recall-related failures. According to a press release, it estimates ultimately up to 50% of the devices originally implanted may fail.
At Heygood, Orr & Pearson, we have extensive experience litigating defective pharmaceutical and medical device lawsuits. In fact, we recently have resolved nearly 200 claims against Johnson & Johnson relating to their defective medical products. To receive a free legal consultation and find out if you are eligible to file a case, please call our toll-free number at 1-877-446-9001, or by filling out our free case evaluation form located on this page.