A Kentucky jury found that Advanced Bionics, maker of implantable hearing aids, knew it was selling a defective device.
The device shocked then-six-year-old Breanna Sadler, sickening the girl and sending her into convulsions, said The Associated Press (AP). The jury awarded the girl’s family a $7.2 million verdict: $6.25 million in punitive damages and $994,000 in compensatory damages.
The Sadler family filed the lawsuit against Advanced Bionics in 2011, three years after the device made Breanna ill after moisture seeped into the cochlear implant, the AP explained. Sonova, parent company of Advanced Bionics, wrote that it will consider an appeal. Court records indicate that the company stated that the devices were in compliance with federal regulations and recalls were appropriately issued.
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, said the AP. Tests on the device revealed that the implant had over 30 percent moisture, significantly greater than the allowable .5 percent, the AP noted.
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, said the AP.
The 2004 and 2006 recalls involved the Clarion 1.2, Clarion II / CII and HiRes90k cochlear implants. In 2007, the US Food & Drug Administration (FDA) filed a civil action against Advanced Bionics alleging that the company sold and manufactured adulterated cochlear implants. Advanced Bionics settled that lawsuit, paying $1.1 million dollars on behalf of the company and $75,000 on behalf of then-CEO, Jeff Greiner.
In 2010, Advanced Bionics recalled its HiRes 90K cochlear implant after two patients suffered from severe pain and overly loud sounds about eight to 10 days after its implantation.
As with most implanted medical devices, there is a risk of some serious side effects when using cochlear implants. These may include:
- Total loss of natural hearing due to damaged cochlea cells (this damage can occur during device implantation).
- Bacterial meningitis, a life-threatening inflammation of the brain and/or spinal cord. In 2007, the FDA warned that children with cochlear implants faced a higher risk for developing bacterial meningitis, a potentially deadly infection, and must be fully immunized against the disease. The warning came after two children with the devices died due to bacterial meningitis.
- Tissue death in the skin surrounding cochlear implant(s).