RF emissions generated by cochlear implants can potentially interfere with other devices in the area, including telephones, televisions, alarms and radios.
When Advanced Biologics submitted their implants for market approval to the FDA, they allegedly lied about the results of their RF emissions testing, did not test to stringent-enough standards, and altered the devices to fool the tests. Advanced Biologics told the FDA that their Neptune and Naida implants complied with international standards, when they indeed did not.
Advanced Biologics then sought Medicare, Medicaid and other federal funds for the implants.
In the settlement, the company will pay $11.36 million to the U.S. government and an additional $1.24 million to Medicaid states.
The lawsuit was brought by a former Advanced Biologics engineer, David Nyberg, who sued the company under the whistleblower provision in the False Claims Act. As a result, Mr. Nyberg will receive $1.87 million in the settlement.
“The United States expects device manufacturers to provide accurate information when they claim that their devices meet certain tests or standards,” Brian Boynton, principal deputy assistant attorney general, said in the report. “The integrity of our healthcare system depends on the government being able to rely on the information provided by manufacturers when they apply for permission to market their devices.”
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