May 7, 2013 by Brad Perriello
The jury in the lawsuit, filed in the U.S. District Court for Western Kentucky, found that Advanced Bionics didn't properly test the implant before it hit the market and never told the FDA that it had switched the manufacturer of a key component to a vendor called AstroSeal.
Brian and Michelle Sadler sued Advanced Bionics in August 2011 on behalf of their daughter Breanna, alleging that Advanced Bionics was liable for the 2009 failure of Breanna's HiRes 90k implant because it knew about problems with the device at the time.
"Advanced Bionics failed to warn plaintiffs, Breanna's surgeon, or the medical facility at which Breanna's operation was performed that this device was manufactured and marketed after Advanced Bionics knew that it had added AstroSeal as a feed-thru supplier without FDA approval, that Breanna was receiving an untested, invalidated and unqualified device with an AstroSeal feed-thru, or that Breanna was receiving an "adulterated" and experimental device as that term is defined by FDA regulations," according to court documents. "Advanced Bionics knew that its devices contained water above specifications at an alarming and unacceptable rate and that patients were, as a result, experiencing device failure at an excessive rate and suffering hearing loss and surgery to remove the failed devices."
Testing of the device explanted from Breanna Sadler later found "a staggering 38.5668% water/vapor," well in excess of the 0.5% moisture rating mandated by the FDA. The device's failure allegedly subjected Breanna Sadler to 3 separate bouts of shocking, causing convulsions and vomiting.
"Breanna at that point was too afraid to sleep, eat, wear her glasses, wear her hearing aid or connect the external processor to her skull," according to the documents. "Breanna experienced severe emotional distress as a result of the failure. This is particularly true as she will still today approach her father at times and say, 'Shock?' and look at him while holding her device before placing it on her head."
The jury awarded Breanna Sadler $996,000 for physical & mental pain and suffering, medical expenses, lost wages, and travel costs and $6.3 million in punitive damages, according to the documents.