CHICAGO (CN) – In a federal class action, a father claims Cochlear Limited’s ear implants failed inside his young daughter one month before the FDA recalled them for a manufacturing defect.
Wyly Wade sued Cochlear Limited, of Australia, for its “Nucleus CI500 range of cochlear implant medical devices,” which were recalled in September 2011.
“Cochlear holds itself out as ‘The leading global hearing solutions company,'” Wade says in the complaint.
A cochlear implant is a surgically implanted medical device that provides deaf people with a sense of sound by processing sound into electrical impulses that are sent to the brain.
Wade says his daughter, K.W., was deaf in both ears.
“As a toddler, K.W. was medically evaluated for cochlear implants and determined to be an excellent candidate to receive cochlear implants,” the complaint states.
In June 2011, she was fitted with Cochlear Limited’s implants in both ears. By September 2011, both of K.W.’s implants had failed and had to be surgically removed.
“On or about September 14, 2011, the Australian government issued an urgent medical device recall and hazard alert in connection with the recalled devices,” the complaint states.
“The stated reason for the Australian governmental recall was that it followed a recent increase in the number of failures of CI512 cochlear implants in the Cochlear Nucleus CI500 range. According to the recall, the information available to the Australian government’s Therapeutic Goods Administration was that less than one percent of the recalled implants had failed.”
In October 2011, the FDA issued a recall for the Cochlear Nucleus CI512 Implant: “According to the FDA’s recall, the reason for the recall was that the recalled devices may shut down and cease to function.”
In December 2011, Cochlear Limited’s CEO Chris Roberts released a letter, stating: “Variations in the brazing process have resulted in a limited number of implants being more susceptible to developing microcracks in the braze joint during subsequent manufacturing steps. These microcracks allow water molecules to enter the implant resulting in the malfunction of specific electronic components,” the complaint states, quoting the letter.
In a follow-up letter, Roberts said that “as of January 31, 2012, the overall proportion of Nucleus CI500 series devices that has been reported as failed is 2.4 percent of registered devices globally,” according to the complaint.
The brazing process connects the external components of the cochlear implant with its internal electrical components, which must be waterproof.
Wade claims that “microcracks in the braze joints of K.W.’s cochlear implants allowed water molecules to enter each of K.W.’s cochlear implants and cause a malfunction of certain electronic components contained in each of K.W.’s cochlear implants.”
He seeks class damages for three forms of strict product liability: defective manufacturing, design defect, and defect due to nonconformance with representations. He also seeks damages for failure to warn, negligence, breach of warranty, misrepresentation, constructive trust, and unjust enrichment, and medical monitoring for class members.
At least 25,516 recalled cochlear implants have been implanted, according to the complaint. A 2.4 percent failure rate would produce 612 defective implants.
Wade is represented by Scott Morgan of Scott Morgan & Associates.