A federal court jury in Kentucky has awarded 11-year-old Breanna Sadler and her parents $7.24 million in damages after an improperly manufactured cochlear implant – a surgically implanted medical device that allows profoundly deaf individuals to hear sounds – severely shocked her and caused her to have violent convulsions. The verdict included $994,000.00 in compensatory damages and $6.2 million in punitive damages. The jury found that Advanced Bionics knowingly sold the defective cochlear implant to be used in Breanna’s surgery when she was only 4 years old.

After the child was shocked two more times, the device had to be removed from her skull and replaced with a competitor’s model in an open-head surgery that took more than seven hours. Breanna’s parents sued the manufacturer, Advance Bionics of Valencia, Calif., accusing the company of continuing to sell the device after executives knew it was defective. About 4,000 of the devices have been implanted worldwide, and about 1,000 have failed.

Evidence at trial showed that the company was aware as early as 2004 that moisture was accumulating in the devices at an alarming rate, yet they took very few meaningful steps toward resolving the problems and warning the public of the potential dangers. Dr. Mark Severtson, the Louisville surgeon who implanted the device in Breanna, testified that he never would have done so if he had known about the defect.

The company announced a voluntary recall of its HiRes 90K device in February 2006, about six weeks after Breanna got her implant. In 2008 it paid a $1.1 million civil penalty to the U.S. Food and Drug Administration to settle allegations it failed to notify the agency that it was using a new supplier for one of the implant’s components, which the FDA said exposed patients to “unnecessary health risks.” The company’s then-CEO, Jeffrey Greiner, agreed to pay an additional $75,000.

The device used in Breanna’s surgery was later tested and found to have moisture levels 60 times greater than the acceptable limits. The company was also cited by the FDA for using unapproved component suppliers for the implants and was fined $1.8 million as a result in 2008.

Ron Johnson of Schachter, Hendy & Johnson in Covington, Ky. and Tim Edwards and Ed Wallis from Glassman, Edwards, Wyatt, Tuttle & Cox, located in Memphis, Tenn., were the lawyers representing the plaintiffs. They did a very good job for the Sadler family.

Source: Courier-Journal News

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