A lawsuit brought against Advanced Bionics just ended in favor of the plaintiff with the jury awarding a Kentucky couple more than $7.2 million.
The award included about $6.3 million in punitive damages over defects in the HiRes 90K cochlear implant manufactured by Advanced Bionics, according to Mass Device. The lawsuit was filed in the U.S. District Court for Western Kentucky. The jury found that Advanced Bionics did not conduct appropriate testing on the now-recalled implant prior to its release to market and never advised the U.S. Food and Drug Administration (FDA) that it had changed the maker of a critical component to AstroSeal, Mass Device reports.
We’ve been following the case in which the HiRes 90K cochlear implant shocked then-six-year-old Breanna Sadler, sickening the girl and sending her into convulsions. Breanna’s parents, Brian and Michelle Sadler, initiated the lawsuit against Advanced Bionics in August 2011 and alleged that the device maker was liable for the failure of Breanna’s device because the device maker was aware of the problems at the time Breanna’s device shocked her in 2009, according to Mass Device.
“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,” court documents also indicated, wrote Mass Device.
Upon testing of the Advanced Bionics device removed from Breanna’s body, “a staggering 38.5668% water/vapor,” was discovered, significantly more than the 0.5 percent FDA-mandated moisture rating. Allegations include that the implant’s failure caused Breanna to suffer three incidents of shocking, which led to convulsions and vomiting, according to the Mass Device report. “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,” the documents indicated. “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.”
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. Unlike hearing aids, the cochlear implant does not amplify sound, but works by directly stimulating any functioning auditory nerves inside the cochlea with electrical impulses. External components of the cochlear implant include a microphone, speech processor, and transmitter.
Breanna was four years old when she was implanted with the device in 2006. The cochlear implant malfunctioned on December 29, 2008, causing Breanna to suffer from convulsions. Her mother removed the magnet from the device; however, when a physician re-attached the magnet, Breanna suffered more convulsions and required revision surgery to remove the Advanced Bionic implant and undergo re-implantation with a different device, according to a prior AP report.
In 2004, when Advance Bionics became aware of the implant’s problems, it implemented what the AP described as a “limited, six-week recall.” The recall involved a cease in shipment; however, devices that weren’t implanted were recalled in 2006 due to excessive moisture seeping into the implant. To date, more than 1,000 of the recalled implants have malfunctioned, representing a 40 percent failure rate.