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LOUISVILLE, Ky. — A federal jury has awarded $7.25 million in damages to an 11-year-old girl who suffered severe electric shocks from a defective cochlear-ear implant that has been inserted in 4,000 people — most of them children.
Born deaf, Breanna Sadler of Vine Grove, Ky., had a cochlear ear device implanted in her head in 2006, when she was 4 years old. Four years later, an electrical short shocked her so violently that she was thrown to the ground, vomiting and convulsing.
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After she 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.
Her parents sued the manufacturer, Advance Bionics of Valencia, Calif., and on Tuesday a U.S. District Court jury here awarded Breanna, now 11, and her parents the money.
In the first of about 40 lawsuits filed nationally to go to trial, the jury said the company should pay $6.25 million in punitive damages alone for recklessly disregarding patient safety by continuing to sell the device after company officials knew it was leaking and defective.
The Sadlers' lawyers presented evidence that Advance Bionics executives delayed disclosing the defect so they could sell more devices and get more money when the company was sold. They " chose to ignore risks and focus on profits," the lawyers said in a brief.
About 4,000 of the devices have been implanted worldwide, and about 1,000 have failed, according to lead plaintiff's counsel Tim Edwards of Memphis.
In an interview, Brian Sadler, a pipefitter who works in Louisville, Ky., said he and his wife, a stay-at-home mom, filed the suit "so other parents will know what is going on."
"We didn't want this to happen to anyone else," he said.
In a prepared statement, spokeswoman Cheryl Garma of Advance Bionics, said the company "respects the jury but disagrees with its verdict, particularly with respect to punitive damages," and is considering an appeal.
She said the company denies that executives took any action designed to enhance their payments.
In court, the company's lawyers tried to blame the defect on a supplier. They also argued that Breanna's injuries were minimal.
"Fortunately, she appears to be happy, well adjusted and has little or no memory of the events surrounding the device failure," the company's lawyers said in court papers.
Advanced Bionics, now owned by Swiss-based Sonova Holding AG, sells implants in 50 countries and describes itself as "a global leader in developing the most advance implants systems in the world."
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 federal 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-chief executive, Jeffrey Greiner, agreed to pay an additional $75,000.
Breanna's parents said in their suit that their daughter was shocked three times and in one incident, an ambulance had to be called because she screamed that her face was on fire and felt like it was melting.
The device was disconnected and Breanna had to wait six weeks in total deafness until an eight-hour surgery could be performed to remove the implant and install a working version from a competitor, said Ronald E. Johnson, another lawyer for the Sadlers.
"She lived in a cold, dark, deaf world while Advanced Bionics shareholders enjoyed millions of dollars in sales-based bonuses," her lawyers said in a pretrial brief.
The company unsuccessfully argued that the suit should have been dismissed because it was pre-empted by federal regulation of medical devices.
Advanced Bionics also said the device failed because moisture leaked through a component called a "feed-through" that carries electronic signals into the fluid-filled inner ear. The company tried to apportion blame to a supplier that provided the part, but U.S. Senior Judge Thomas Russell ruled that suppliers are immune.
Garma said that the company's current implant leads the industry with a one-year cumulative survival rate of 99.8%.
"The safety and well being of our recipients is the first priority of Advanced Bionics," she said.
Breanna didn't testify, but lawyers for the company played her deposition at trial.
Dr. Mark Severtson of Louisville, who implanted the device in Breanna, testified that he never would have done so if he had known about the defect. Also testifying for the family was another surgeon, Dr. Arun Gadre, who removed it in February 2010, and Dr. Mary Burton, director of audiology at Heuser Hearing Institute in Louisville.
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The jury deliberated about 3½ hours before finding the company's HiRes 90K was negligently designed, defective and unreasonably dangerous. It returned the punitive award after finding that the company acted with reckless disregard for Breanna's safety.
It awarded her parents $236,325 to pay for her medical expenses, $750,000 for pain and suffering and about $10,000 to recover the couple's lost wages and travel expenses.
Edwards said he represents clients from Miami to Oakland, Calif., in about 40 other pending cases and has settled two or three others.
About cochlear implants
What they are? An implanted electronic hearing device designed to produce useful hearing sensations by electrically stimulating nerves inside the inner ear.
What are the parts? A microphone, sound processor and transmitter system are worn behind the ear or carried in a pocket, belt pouch or harness. An implanted receiver and electrode system contains the electronic circuits that receive signals from the external system and send electrical currents to the inner ear.
Who uses them? Severely to profoundly deaf adults and children who get little or no benefit from hearing aids.
How do they work? The implant receives sound, processes it and sends small electric currents near the auditory nerve. Currents activate the nerve, which then sends a signal to the brain. The brain learns to recognize this signal and the person experiences this as "hearing." The cochlear implant simulates natural hearing, but the result is not the same as normal hearing.
When were they invented? Research began in the 1950, but the first commercial devices weren't approved by the federal Food and Drug Administration until the mid-1980s.
If you or your child have an Advanced Bionics HiRes 90K (Vendor B): The company says it supports clinician recommendations to replace affected devices and provides warranty coverage and other support to patients and centers.
Sources: U.S. Food and Drug Administration, Advanced Bionics
Jury awards $7.25M for hearing aid that severely shocked
