The parents of a young girl who suffered severe shocks as a result of a defective HiRes90K cochlear ear device sued the manufacturer, Advance Bionics, and were recently awarded $7.25 million in damages. Advance Bionics was found to have exhibited negligence in the design of an unreasonably dangerous and defective product.
Breanna Sadler, an eight year old girl, was born deaf and received a cochlear ear device implant in 2006. Four years later, moisture had seeped into the device, resulting in an electrical short which shocked her so severely that it threw her to the ground, convulsing and vomiting. Breanna was shocked twice more before the device was disconnected. It was later removed in an eight hour, open-head surgery, and replaced with a model from a competitor but in the six-weeks between the disconnection and the surgery, she had to wait in complete deafness.
Evidence presented at the trial indicated that executives for the company postponed disclosing the defect in an effort to sell more of the cochlear ear devices and make more money when selling the company. Advanced Bionics’ lawyers argued that Breanna suffered minimal injuries. Her parents, however, stated that one of the incidents was so severe that they had to call an ambulance when Breanna screamed, saying it felt like her face was melting.
According to Advanced Bionics, the device failure was caused by moisture which leaked through the “feed-through” component, which carries electronic signals to the inner ear. Though the company attempted to shift the blame to the part’s supplier, suppliers are immune, according to the Judge’s ruling.
Advanced Bionics paid a civil penalty of $1.1 million in 2008 to the federal Food and Drug Administration. The payment settled allegations that the company did not notify the FDA of the fact that a new supplier was being used for one of the components of the HiRes90K. According to the FDA, the new component posed “unnecessary health risks” to patients. A voluntary recall of the HiRes90K was announced in February, 2006.
Worldwide, around 4,000 of the Advanced Bionics devices have been implanted and around one quarter of those devices have already failed, resulting in personal injury and pain and suffering for many individuals. Of those 1,000 failed devices, 40 lawsuits are currently pending.