FDAnews Device Daily Bulletin

Preemption Not Issue in Cochlear Implant Suit, Judge Says

Aug. 26, 2008

A federal judge ruled that a family may proceed with its lawsuit against device manufacturers, saying preemption is not an issue in this case because the family’s claims are based on violations of federal law.

Scott and Pamela Purcel filed suit last Sept. 27 against Advanced Bionics and Astro Seal in the U.S. District Court for the Northern District of Texas over their son’s malfunctioning cochlear implants.

“We understand why the court would make that ruling, but what the plaintiffs are claiming is not true, and we will be able to prove that is not true,” Jeff Goldberg, Advanced Bionics senior vice president of regulatory affairs, said.

Goldberg said the parents’ allegations stem from an administrative claim filed against Advanced Bionics by the FDA last November. The claim, which was amended in March, accused the company of using components from an unapproved supplier. The company settled with the FDA in July by agreeing to pay a $1.1 million fine, the maximum the FDA can impose on an individual or company. As part of the settlement, Jeffery Greiner, Advanced Bionics’ president and co-CEO, agreed to pay a $75,000 fine. Initially, the FDA had sought a $1.1 million fine from him in addition to the company’s fine.

“But that suit was settled without us ever admitting any liability,” Goldberg said.  

According to the district court order, the Purcels’ suit centers around a single component of the HiRes90k — a feed-thru manufactured by Astro Seal — that was used to connect the device’s internal electrical circuitry to external components. Advanced Bionics issued a voluntary recall of all nonimplanted HiRes90k devices containing Astro Seal feed-thrus in September 2004 because moisture could get into the internal circuitry, which could cause the device to fail.