Preemption Not Issue in Advanced Bionics, per federal judge

Jan 30th, 2009 | By Ed Wallis | Category: Cochlear Implant

A federal judge ruled that a family may proceed with its lawsuit against Advanced Bionics, manufacturers of defective cochlear implants, saying preemption is not an issue in such cases because the family’s claims are based on violations of federal law. Similar lawsuits have been filed by the authors of this blog.

Scott and Pamela Purcel filed suit Sept. 27, 2007, against Advanced Bionics and Astro Seal in the US District Court for the Northern District of Texas over their son’s malfunctioning cochlear implants. 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.

Advanced Bionics was sued by the FDA, and 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.

If you believe you have been physically or emotionally injured as a result of a defective Advanced Bionics HiResolution 90k (HiRes90k), please contact attorneys Tim Edwards or Ed Wallis for a free case evaluation. You can call us at (901) 527-4673. You can email us by clicking HERE. You can visit our page on cochlear implant litigation HERE.

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