LOUISVILLE, KY—A jury here awarded $7.24 million to a family from Vine Grove, KY, after concluding that Advanced Bionics, a cochlear implant manufacturer, had knowingly sold a defective device that caused severe harm to 6-year-old Breanna Sadler. In their verdict, reached on April 17 in federal court in Louisville, the jury awarded the Sadlers $6.25 million in punitive damages and $994,000 in compensatory damages.
The amount is believed be the largest ever assessed against a manufacturer of hearing devices. The Swiss-based Sonova Group, which now owns Advanced Bionics, immediately released a statement in response to the verdict in which it said, “Sonova will carefully review the verdict and consider an appeal.” Sonova, which also owns Phonak, Unitron, and several other hearing-related companies, purchased Advanced Bionics in 2009—well after the incident that led to the Sadlers’ suit.
According to an article by Brett Barrouquere of Associated Press, which was published by BusinessWeek.com and many other publications, the Sadlers sued Advanced Bionics in 2011. That was about three years after moisture that had seeped into Breanna’s implant made her ill and sent her into convulsions. She was 6 at the time and had been wearing the device for about two years.
Ronald Johnson, the attorney for the plaintiffs, said that when Breanna’s device malfunctioned, her mother heard her screaming with pain and having convulsions. Not until she disengaged the magnet from her daughter’s device did the convulsions stop. When a doctor reactivated the implant, the pain and convulsions resumed. Six weeks later, the Advanced Bionics device was surgically removed and another brand implanted.
According to Johnson, Breanna, now 11, is still suffering from the effects of the faulty implant and the additional surgeries that were required. He said, “Anytime she hears anything, she jumps out of her skin.” He said that she has become a “very, very fearful little girl.”
RECALLS IN 2004 AND 2006
Advanced Bionics became aware in 2004 that there were problems with moisture getting into its devices. It voluntarily conducted a limited, six-week recall and quit shipping the devices. However, it resumed shipping the devices until 2006, when it recalled all those that hadn’t already been implanted. By then, Breanna’s already had her implant.
In 2007, the Food and Drug Administration cited Advanced Bionics for failing to get approval for a new supplier of a component to keep moisture from getting into its implants. The FDA and Advanced Bionics settled the charges in 2008 for $1.1 million.
Johnson, who specializes in medical device litigation, accused Advanced Bionics of “the worst conduct I’ve ever seen by a corporation, especially when dealing with such a vulnerable population.”
In its statement, Sonova noted that the recall of the Advanced Bionics products was completed before Sonova bought AB in 2009. It added that today’s HiRes 90K implant “is the most reliable device ever manufactured by Advanced Bionics leading the industry with a 99.8% reliability rate.”