Cochlear Implant Lawsuits

FDA Recalls and Warnings

Cochlear ear implants were recalled because of moisture problems caused by defective seals. The Food and Drug Administration (FDA) has posted several cochlear ear implant recalls and warnings including:

• Posted HiRes 90K Cochlear Implant Device Recall in 2010
• Warned educators that cochlear implants do not make hearing “normal” in 2009
• Warned of the life-threatening risk of bacterial meningitis (a potentially fatal swelling of the brain and/or spinal cord) in patients, especially children, with cochlear implants in 2002, 2003, 2006 and 2007
• Advanced Bionics voluntarily recalled CLARION® and HiResolution® cochlear implants in 2004
• In February 2020, Advanced Bionics recalled its HiRes Ultra and HiRes Ultra 3D cochlear implant models due to reports of hearing degradation. The defects, discovered during device failure analysis, were linked to fluid ingress at the electrode, leading to stimulation interruption. Defective devices may need to be surgically removed and replaced.

Cochlear Implant Lawsuits

In 2007 the FDA’s Center for Devices and Radiological Health sued Advanced Bionics and its President and CEO Jeffrey Greiner saying that the HiRes 90K cochlear implants were “adulterated devices.” The FDA’s complaint lists how Advanced Bionics failed to get premarketing approval for a new “feedthru assembly” component that caused an excessive moisture problem.

The excessive moisture exposed patients to the risk of device failure and associated risks of surgical intervention and potential permanent loss of hearing. Although Advanced Bionics recalled the devices, the implants were still shipped and implanted after the recall. The case was settled in 2008 for over $1 million to be paid by Advanced Bionics and $75,000 to be paid by Greiner.

A Kentucky jury awarded a $7.25 million verdict to a little girl and her family against Advanced Bionics. The little girl had a cochlear device implanted when she was four years old. Four years later the device had an electrical short that shocked her so severely she went into shock and was thrown to the ground vomiting and convulsing. Before the device was removed and replaced 13 months later, she was shocked two more times. Her open-head surgery to remove the device from her skull took more than seven hours. The jury awarded punitive damages because it found that Advanced Bionics delayed revealing the defect so they could sell more devices. That should tell you something.

A deaf girl’s father filed a class action lawsuit against Australian medical device company Cochlear Limited. The girl received Cochlear Limited’s Nucleus CI500 cochlear implant. The devices failed in both ears by September 2011 and had to be surgically removed. In September 2011 Cochlear issued a voluntary recall based on a manufacturing flaw that created small cracks in the medical devices that allowed water to enter the device and short the electric components. According to the lawsuit, at least 25,000 patients worldwide received the potentially defective cochlear implants. The class action is seeking medical costs associated with removing the failed devices and corrective surgery, punitive damages, attorneys’ fees, and a medical monitoring program for the impacted class members.

In 2010 Cochlear had to pay a fine of $880,000 as part of a settlement with the US Department of Justice for violating anti-kickback statutes by offering physicians discounts, gifts, trips and other incentives to implant their devices…. I think you get the point by now. This company was chasing profits hard instead of trying to do the right thing with this life-changing – for good and bad, apparently – medical device.

Some estimates put the rate of failure of these devices at about 25% of the approximately 4,000 implanted worldwide. Plaintiffs lawsuits in these cases alleged that Advanced Bionics failed to disclose to doctors and patients that unacceptable levels of moisture had been reported with the Hi Res 90K cochlear implant.

Still, Advanced Bionics continued to distribute the Hi Res 90K despite evidence that the unacceptable moisture levels might cause these implants to fail. There are also allegations that Advanced Bionics did not tell doctors and patients that its cochlear implant program was not in compliance with the federal regulations for medical devices. These deficiencies were later underscored by an FDA’s warning letter on February 1, 2005.

Potential Side Effects

There are many known cochlear implants side effects and risks from the surgery. These include:

• total loss of natural hearing due to damaged cochlea cells
• bacterial meningitis
• tissue death in the skin surrounding cochlear implants
• injury to the facial nerve during surgery
• cerebrospinal fluid leakage as a result of the surgery
• perilymph fluid leak as a result of the surgery
• skin wound infection
• blood or fluid collection at the surgical site
• attacks of dizziness or vertigo
• tinnitus (ringing or buzzing sound)
• taste disturbances from nerve damage during surgery
• numbness around the ear
• reparative granuloma (localized inflammation if the body rejects the implant)
• general anesthesia risks

If you or a loved one have a cochlear implant, you should watch for the following signs that the implants are failing:

• loss of sound
• discomfort or pain
• intermittent functioning
• sudden loud noises or popping
• Children crying or unwilling to use headphones

Other Risks from Use of Cochlear Implants

In addition, the FDA warns of the following risks associated with cochlear implants:

• May hear sounds differently than “normal hearing”
• May lose residual hearing.
• May not hear as well as others who have had successful outcomes with their implants
• May not be able to understand language well
• May not be able to upgrade their implant when new external components become available
• May not be able to have some medical examinations and treatments such as MRI imaging, neurostimulation, electrical surgery, electroconvulsive therapy and ionic radiation therapy
• Will depend on batteries for hearing. For some devices, new or recharged batteries are needed every day
• Replacing damaged or lost parts may be expensive
• Will have to use it for the rest of life. During a person’s lifetime, the manufacturer of the cochlear implant could go out of business. Whether a person will be able to get replacement parts or other customer service in the future is uncertain.
• May have lifestyle changes because their implant will interact with the electronic environment. An implant may set off theft detection systems set off metal detectors or other security systems, be affected by cellular phone users or other radio transmitters, have to be turned off during takeoffs and landings in aircraft and interact in unpredictable ways with other computer systems
• Will have to be careful of static electricity
• May hear strange sounds caused by its interaction with magnetic fields, like those near airport passenger screening machines.

Example Cochlear Implant Lawsuits

1. Advanced Bionics LLC:
   • Background: Advanced Bionics, a major manufacturer of cochlear implants, faced multiple lawsuits related to its HiRes90k implants. Plaintiffs claimed that the implants were prone to moisture infiltration, leading to device failure and the need for additional surgeries. This company has had a lot of issues.
   • Case Example: Advanced Bionics settled a series of lawsuits alleging that its implants were defectively designed and manufactured, resulting in electrical malfunctions. The company paid significant settlements to resolve these claims.
2. Cochlear Limited:
   • Background: Cochlear Limited, another leading manufacturer, was involved in several legal cases regarding its Nucleus cochlear implants. Issues included device failure and complications requiring further surgical intervention.
   • Case Example:  Cochlear Limited faced a lawsuit from a plaintiff who experienced multiple device failures, leading to recurrent surgeries and significant distress. The court awarded damages to cover medical expenses and pain and suffering.
3. Med-El Corporation:
   • Background: Med-El Corporation has also faced legal actions related to the performance and safety of its cochlear implants. Some users reported adverse effects and device failures shortly after implantation.
   • Case Example: One plaintiff claimed that Med-El’s implant failed within a year of surgery, resulting in loss of hearing and requiring a risky revision surgery. The case was settled out of court with undisclosed terms.

Cochlear Implant Malpractice Lawsuits

Cochlear implants are sometimes be the subject of medical malpractice claims.  You do not see them often but hese lawsuits often arise when the implantation procedure or the device itself causes harm to the patient.

Common issues include surgical errors such as improper placement of the electrode, damage to the facial nerve, or failure to follow proper sterilization protocols leading to infections.

Plaintiffs typically claim that healthcare providers failed to meet the standard of care, either through surgical errors or inadequate follow-up care, resulting in significant harm and additional medical expenses. These lawsuits seek to hold both the medical professionals and, sometimes, the device manufacturers accountable for the injuries sustained by patients due to negligence or defective products.

2024 Update: This litigation mostly resolved in 2013 and our firm is no longer reviewing cochlear implants lawsuits.

Cochlear Implant Verdicts & Settlements

Below are settlements and verdicts involving cochlear implants. These include both product liability cases involving alleged defects in the implants, as well as medical malpractice cases.

$152,000 Settlement (Missouri): Plaintiff J.W., a 7-year-old female deaf from the age of three, said she underwent surgery to install a cochlear implant device, manufactured by defendant Advanced Bionics Corporation. The plaintiff claimed that she began experience hearing loss four years after the installation procedure and underwent a revision surgery to remove the implant manufactured by the defendant and install a new cochlear implant device. The plaintiff contended the implant was defective and improperly manufactured.

$500,000 Settlement (Florida): Plaintiff, a minor, underwent a cochlear implant surgery. During the surgery, a blood vessel was punctured causing subdural hematoma resulting in brain damage. The brain damage left her with neurological defects and they brought a medical malpractice lawsuits alleging that the implant was not properly installed.

$7,246,236 Verdict (Kentucky): Plaintiff, a minor female, reportedly experienced at least three shocks to the inside of her head resulting in falls, vomiting, seizures and emotional distress that allegedly were caused by a defective cochlear implant device manufactured by defendant Advanced Bionics. The minor reportedly underwent open cranial surgery to remove the failed device after the shocks, and after the device was removed, it was allegedly determined that the device contained a manufacturing defect in a moisture seal component that allowed moisture to enter the device. The plaintiffs claimed the defendant was negligent and breached its duty of reasonable care by incorporating a defect into the design of the device, failing to manufacture the device within the standard of care, failing to properly test, validate and qualify the device, and failing to warn the plaintiffs of the risk that the device would not be sealed and free of excessive moisture.