Cochlear Implant Lawsuits Filed Over Advanced Bionics HiRes90K

A growing number of Cochlear implant lawsuits are being filed by individuals who say they have experienced problems as a result of problems caused by defective bionic ear implants. 

In recent months, at least four product liability lawsuits have been filed in four different states against Advanced Bionics over problems with the HiRes90K implant.

Advanced Bionics issued a cochlear implant recall last November for the bionic ear following reports of patients experiencing malfunctions that resulted in severe pain, feelings of being shocked and overly loud noises.

A cochlear implant is an electrionic device that is surgically implanted to provide a sense of sound for individuals who are profoundly deaf or hard of hearing. Advanced Bionics is one of three companies that manufacturer cochlear implants approved for use in the United States, the others being Cochlear Limited and MED-EL.

Lawsuits filed against Advanced Bionics since July 2011 in federal district courts in Kentucky, Oklahoma, Pennsylvania and Texas all contain similar allegations that plaintiffs were forced to undergo “lengthy and risky open-head surgery” to remove and replace the devices after they failed.

According to the complaints, the Advanced Bionics HiRes90K implants contained a defective seal that allowed moisture to enter the implant and cause it to fail. In addition, plaintiffs claim that Advanced Bionics has run afoul of federal regulations and been cited for quality control problems by the FDA in recent years.

The Advanced Bionics HiRes 90k cochlear implant has been recalled twice before. The first time was in 2004 for symptoms that are similar to those that led to the more recent recall; sudden pain, loud noises, popping sounds and intermittent functioning. A second recall was issued in 2006, when the FDA notified the company that it had changed components in the device without notifying the FDA and getting approval. Advanced Bionics paid the government $1.1 million in 2008 to settle penalties resulting from that recall.

In 2004, the FDA identified 23 violations of federal regulations in connection with Advanced Bionics cochlear implants, resulting in a recall of some of its Clarion implants, also due to moisture problems.

In 2005, the FDA issued a warning letter to the company identifying 18 significant deviations from federal standards. The warning letter led to an internal investigation by Boston Scientific, which was the parent company at the time, that revealed a number of problems. However, the FDA said many of the problems went unaddressed and the agency issued a corporate-wide warning letter to all Boston Scientific subsidiaries; only the third time in history the agency has issued such a broad-based warning letter.

According to the lawsuits, Advanced Bionics should be held liable for problems caused by their implants as a result of the company’s negligence in manufacturing a defective product, breach of warranty and fraud. The lawsuits seek both compensatory and punitive damages.

Another Cochlear bionic ear recall was issued in September 2011 by Cochlear Limited for their entire Nucleus 5 implant series, after an increasing number of customers complained about implant failures.

Cochlear Limited launched an investigation into the cause of the problem and discovered failures in one or more diodes were being caused by moisture entering the implant through a defective seal, similar to the Advanced Bionics implants, which can disrupt the transfer of information and power from the sound processor, causing the ear implant to shut down. 

Photo via Wikimedia Commons, public domain work of the National Institutes of Health