Parents Call Hearing-Aid Maker ‘Reckless’

LOUISVILLE (CN) - A "reckless" cochlear implant-maker's defective hearing aid failed, forcing three children to undergo "lengthy and risky open-head surgery," parents claim in three federal lawsuits.

The parents sued Advanced Bionics Corp., of Valencia and Sylmar, Calif.

They claim the company skirted federal law by failing to ensure that its device was moisture-free.

All three lengthy lawsuits were filed Wednesday. Citations in this article are taken from Jessica McPherson's lawsuit on behalf of her son.

"Camerron McPherson ('Cammeron' or 'Minor Plaintiff') suffered from permanent hearing loss and was forced to undergo a lengthy and risky open-head surgery as a

result of the failure of an Advanced Bionics HiRes 90k medical device (the 'Device) recalled by its manufacturer, Advanced Bionics, because it contained a manufacturing defect in a component supplied by AstroSeal, Inc., and was, therefore, not in compliance with applicable federal law, including federal device manufacturing requirements," the lawsuit states.

AstroSeal is not named as a defendant in any of the complaints.

McPherson's lawsuit continues: "Advanced Bionics violated the basic principal of biomedical engineering that moisture is to be avoided in electronic devices implanted in the human body. Advanced Bionics sold cochlear implants, medical devices used to provide a sense of sound to persons with profound hearing loss, which leaked. Advanced Bionics' specification for moisture content was 0.5%, yet minor plaintiff's failed device contained moisture far in excess of this limit. Water entered the minor plaintiff's Advanced Bionics' HiRes90k implant through a leak in an AstroSeal manufactured critical component, causing device failure and requiring explantation surgery and other related damages.

"The HiRes90k Device placed in the minor plaintiff's head was designed, manufactured, and sold in violation of federal law and in violation of Advanced Bionics' federally approved device specifications. It contained a latent defect not disclosed to the Food and Drug Administration ('FDA'), was adulterated, breached Advanced Bionics' express and implied warranties, and was defective and unreasonably dangerous for its intended use. Advanced Bionics was negligent in the design, manufacture and labeling of the Device and the AstroSeal component meant to provide a hermetic (waterproof) seal. Advanced Bionics knew that its devices were failing at an alarming and unacceptable rate as a result of moisture intrusion, had been cited by the FDA for violating federal manufacturing regulations, and yet defendants continued to produce defective devices knowing full well that it had not solved the moisture problems with its product. By October 2004 at the latest Advanced Bionics knew the HiRes 90K was leaking at the feed-thru yet did not advise clinicians or patients of the defect. Advanced Bionics violated a host of federal regulations, all of which Plaintiff makes a parallel claim for in this litigation. Advanced Bionics was, at the least, 'reckless' as that term is defined in Chesapeake & O. Ry. Co. v. Johns' Adm'x, 155 Ky. 264, 159 S.W. 822, (Ky.App. 1913)."

McPherson says in the complaint that her son "never received an optimal result with the device" and "was shocked by the defective device and suffered nerve twitching in his face and neck caused by the defective device."

"Minor plaintiff's device failed as a result of water intrusion into the device through nanocracks in the oxide layer of an AstroSeal feed-thru ... testing revealed minor plaintiff's device contained 3.8893% moisture vapor at the time of failure analysis testing."

McPherson seeks compensatory and punitive damages for negligence, product liability and fraud.

Plaintiffs in all three cases are represented by Ronald E. Johnson Jr., with Schachter, Hendy and Johnson, of Fort Wright, Ky., assisted by Glassman, Edwards, Wyatt, Tuttle & Cox, of Memphis.

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