Archive for January 2009

Why we think the FDA sued Advanced Bionics

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

I’ve been asked by several persons, “Why did the Food and Drug Administration sue Advanced Bionics?” The answer, as concise is possible, is as follows.
On July 7, 2003, Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Implant. Worth noting, a cochlear implant is classified as a Class III medical device by the [...]



Vendor/Supplier B of the Advanced Bionics HiRes90k

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

Who is the “supplier B” for HiRes90k cochlear implants. The company is Astro Seal, Inc. of Riverside, California.
Astro Seal allegedly made the feedthrus for the Advanced Bionics Clarion HiResolution 90k (HiRes90k) cochlear implant bionic ear system.
If you believe to have been injured as aa result of a HiRes90k cochlear implant, please contact us. We are [...]



Is your Advanced Bionics cochlear implant failing?

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

The Facts.
The Food and Drug Administration (FDA) estimates that 3,477 HiResolution90k (HiRes90k) cochlear implant bionic ear system devices with the Astro Seal component (vendor B) had already been implanted at the time of the 2006 recall. Of those an estimated 1,502 devices were implanted in children under 18 years old. Advanced Bionics has raised these figures [...]



Per blog, ASL Enhances Spoken English Acquisition

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

A nice read can be found HERE from a blog promoting the American Sign Language (ASL) connection to cochlear implant devices. The post finds that the author’s son advanced by utilizing ASL in his learning to speak with a cochlear implant.
Nice story, and further fitting on why companies like Advanced Bionics should be held accountable [...]



Advanced Bionics FDA Settlement

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

We are attorneys who are assisting clients around the globe as to issues with their HiRes 90k Advanced Bionics cochlear implant. A staff writer with the Pharmaceutical Business Review cited the recent FDA settlement between the FDA and Advanced Bionics. As noted within that article:
The FDA asserted that Advanced Bionics should have made a formal [...]



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 [...]



FDA vs. Advanced Bionics, Complaint

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

For those interested, you can read the original complaint filed by the U.S. Food and Drug Administration (FDA) against Advanced Bionics and its CEO Jeffrey Greiner by clicking HERE.
We are lawyers who are accepting nationally FREE case evaluations related to the Advanced Bionics HiRes90k cochlear implant. This device has also been referred to as the [...]



Answer, FDA vs. Advanced Bionics

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

For those interested, you can read the Answer of Advanced Bionics in the lawsuit filed by the U.S. Food and Drug Administration (FDA) against Advanced Bionics and its CEO Jeffrey Greiner by clicking HERE.
If you believe you have been physically or emotionally injured as a result of a defective Advanced Bionics HiResolution 90k (HiRes90k), please [...]



Answer of CEO Jeffrey Greiner, FDA vs. Advanced Bionics

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

For those interested, you can read the Answer of Advanced Bionics CEO Jeffrey Greiner in the lawsuit filed by the U.S. Food and Drug Administration (FDA) against Advanced Bionics and its CEO Jeffrey Greiner by clicking HERE.
If you believe you have been physically or emotionally injured as a result of a defective Advanced Bionics HiResolution [...]



Woman blinded in LASIK procedure

Jan 30th, 2009 | By Ed Wallis | Category: LASIK

The wife of a professor at at the University of La Verne has been diagnosed as partially blind in her right eye following laser vision corrective surgery, LASIK. The patient, an attorney, blames a rushed schedule and lack of communication by the doctor for the injuries. “The doctor never explained to me what to expect [...]