Breanna Sadler, of Vine Grove, Kentucky, was born deaf seven years ago. At the age of four she had a cochlear ear device implanted in her head. Approximately four years later, an electrical short from the device shocked the young girl so violently that it actually threw her to the ground, causing her to vomit and convulse.
She was subsequently shocked again two more times, resulting in the removal of the device from her skull. She was then implanted with a replacement from a competitor, in a 7-hour open-skull surgery.
A cochlear implant is a small, complex electronic device that helps children and adults with little or no hearing pick up sounds – including human voices, music and environmental noises, says Johns Hopkins cochlear implant surgeon John Niparko.
Cochlear implants have been used since the early 1980s in adults. More recent scientific advances have been made so they now can be implanted into less fully formed skulls of babies and toddlers. In addition, researchers have recently found that placing implants in both ears (the protocol had previously been one ear), as well as using combo cochlear implant/hearing aids, appears to drastically improve a deaf person’s ability to hear more nuanced sounds, Niparko says. These implants are more effective when they are implanted as early as possible in children born deaf because a developing brain is better at adapting to the flow of new information. That is, when the implants perform properly.
Breanna’s parents sued the manufacturer, Advance Bionics of Valencia, California, accusing the company of continuing to sell the device after executives knew it was leaking and was defective.
On Tuesday, a U.S. District Court jury in Louisville agreed, awarding Breanna, who is now 11-years-old, and her parents $7.25 million in damages.
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.
Evidence was presented showing Advance Bionics executives deliberately delayed disclosing the defect in order to sell more devices and get more money when the company was sold.
It was alleged that approximately 4,000 of these devices have been implanted worldwide, about 1,000 of which have failed. It was contended that dozens of patients in the Louisville area have these devices implanted in their heads and potentially can experience failure of the devices.
The victim’s father, Brian Sadler, said he and his wife, Michelle, filed the lawsuit “so other parents will know what is going on.”
“We didn’t want this to happen to anyone else,” he said.
In a statement, Cheryl Garma, a spokeswoman for 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 that the company denies that executives took any action designed to enhance their payments.
In court, the company tried to blame the defect on a supplier. They also argued that Breanna’s injuries were minimal.
Advance Bionics, now owned by Swiss-based Sonova Holding AG, sells implants in 50 countries and described itself on its website as “a global leader in developing the most advanced implant systems in the world.”
The company announced a voluntary recall of its HiRes 90K device in February 2006 about six weeks after Breanna received her implant.
In 2008, it paid a $1.1 million civil penalty to the U.S. Food and Drug Administration (FDA) 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 CEO at that time, Jeffrey Greiner, agreed to pay an additional $75,000.
Breanna’s parents said in their suit that she was shocked three times and that 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 implant a new version, which was manufactured by a competitor.
Advance Bionics claimed that the device failed due to moisture leaking 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.
Breanna did not testify at trial, but her deposition was played for the jurors to hear.
Louisville surgeon, Dr. Mark Severtson, 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 the implant in February 2010, and Dr. Mary Burton, director of audiology at the Heuser Hearing Institute in Louisville.
The jury deliberated for 3 ½ hours before finding the company’s HiRes 90K was negligently designed, defective and unreasonably dangerous. The jury 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 her medical expenses, $750,000 for pain and suffering and about $10,000 to recover the couple’s lost wages and travel expenses. Brian works as a pipefitter and Michelle a stay-at-home mother.
It is time these companies put the safety and well-being of the patient before their profit. Do you feel that this was a fair verdict?
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