Morgan Law Firm, Ltd. (312) 327-3386
Suffering the devastating effects of a cochlear implant failure can be overwhelming. A loss of hearing can adversely impact relationships, lead to problems at work, cause developmental setbacks and may lead to feelings of isolation and depression, among other things.
You likely have many concerns, including the daunting prospect of undergoing corrective surgery. You wonder how the corrective surgery will go. What replacement implant should you choose? How will you pay for unexpected medical expenses? For young children, quick action is necessary since acquiring language and communicative skills is an ongoing, everyday process. You likely have other concerns too. Your concerns may contribute to feelings of anxiety.
Attorney Scott Morgan has practiced law for more than 25 years and, since 2011, has successfully pursued cochlear implant claims for clients across the U.S. , including through litigation. Scott readily understands the issues that cochlear implant failures cause and is focused on getting the best result for you. Ask any lawyer how many cochlear implant cases they've resolved... nobody has resolved more than Morgan Law Firm, Ltd. Experience counts - let Scott, and the lawyers he works with, help you successfully resolve your claims against Advanced Bionics.
Advanced Bionics sold defective cochlear implants that have caused injuries to cochlear implant recipients across the country. It violated the basic principle of biomedical engineering that excessive moisture is to be avoided in electronic devices implanted in the human body. The defective implants cause, among other things, a deterioration in hearing performance resulting in surgery to remove the defective implant.
According to investigations by NZZ am Sonntags, the first problems with the HiRes Ultra and HiRes Ultra 3d were discovered back in the summer of 2019. However, Advanced Bionics did not withdraw the product from the market then because the number of defective implants was "very low", the Swiss media writes. Still, Advanced Bionics waited until March, 2020 to implement a recall? The renowned Hannover Hearing Center reports that 50% of the 349 patients studied had defective cochlear implants manufactured by Advanced Bionics. Compare that to the expected failure rate of implants being less than 1%. Advanced Bionics, a global corporation, must be held accountable for failing to protect their unsuspecting customers and subjecting those same customers to unnecessary risks.
The problem is moisture and it's not the first time that moisture caused cochlear implants manufactured by Advanced Bionics to fail. Advanced Bionics has a long history of failed implants due to moisture.
Advanced Bionics is no stranger to the FDA. In 2001, the FDA issued a Form 483 to Advanced Bionics finding deficiencies in its supplemental reports relating to prior generations of cochlear implants.
In 2004, the FDA Inspected Advanced Bionics and issued another Form 483 identifying non-conformities and weaknesses in Advanced Bionics' quality system and listed 23 observations that an FDA inspector determined were in violation of federal regulations, moistly relating to moisture in its HiRes™ 90K cochlear implants that caused them to fail. Thereafter, Advanced Bionics initiated a recall due to the potential presence of moisture in the cochlear implant's internal circuitry which could cause device failure.
In 2005, the FDA issued a Warning Letter to Advanced Bionics for violations of federal regulations, including poor manufacturing processes that may cause excessive moisture levels in its cochlear implants. In 2006, Advanced Bionics recalled its HiRes™ 90K cochlear implants because moisture was causing cochlear implants to fail. In 2007, the FDA conducted an inspection of Advanced Bionics and issued another Form 483 to Advanced Bionics because of improper practices that caused excessive moisture in its cochlear implants. In 2008, the FDA sought a $2.2 million penalty against Advanced Bionics for violations of manufacturing standards. Advanced Bionics paid a $1.1 million fine and its CEO paid a $75,000 fine.
On September 28, 2018 the FDA conducted another inspection of Advanced Bionics resulting in another Form 483. On May 8, 2019, the FDA conducted yet another inspection of Advanced Bionics. In early 2020, Advanced Bionics recalled its HiRes™ Ultra and HiRes™ Ultra 3D cochlear implants after moisture caused lower impedances, decreased hearing performance and failures in the implants - sound familiar?
ADVANCED BIONICS CHEATS THE REGULATORS/GOVERNMENT AGAIN
On December 20, 2022, United States Attorney Jacqueline C. Romero and the Justice Department announced that Advanced Bionics, LLC will pay more than $12 million to resolve alleged False Claims Act violations for misleading federal healthcare programs regarding the radio frequency (RF) emissions generated by some of its cochlear implant processors. The United States Government alleged that in submitting pre-market approval applications to the U.S. Food and Drug Administration for its Neptune and Naida cochlear implant processors, Advanced Bionics made false claims regarding the results of its RF emissions tests. These tests measure the extent to which cochlear implant systems generate RF that can interfere with mobile phones, alarm and security systems, televisions and radios.
The government alleged that Advanced Bionics represented that its processors satisfied an internationally recognized emissions standard when, in fact, they did not. The government also alleged that Advanced Bionics manipulated testing conditions to obtain passing test results by not testing processors in “worst case” configurations and improperly shielding certain emissions generating components of the cochlear implant system during emission testing - all contrary to the standard’s requirements.
According to the U.S. Attorney, “The settlement in this case demonstrates our commitment to hold responsible any medical device manufacturer that skirts rules and seeks FDA approval of a device it knows is not as effective as represented. The consumers who use these devices, and the federal programs that pay for many of them, deserve better.”
The types of claims that you can make depend on various factors relating to the laws in the state where you reside and the particular circumstances of your injury. Mr. Morgan will review your particular situation to determine the amount of compensation you may claim, including:
Contact us for a free phone consultation if your Advanced Bionics cochlear implant is losing frequencies, is failing to meet specifications, you have been advised that the device failed or is failing, your doctor has recommended corrective surgery or your device has already been removed. Let us help you figure out your best options relating to your particular situation. It will cost you nothing to find out what might be done to help you. Morgan Law Firm only receives a fee if there is a recovery on your behalf. Don't wait to contact us. Statutes of limitations limit the time available for you to pursue a claim. Failure to timely pursue your claims will forever bar them. Therefore, time is of the essence. Call Scott Morgan today at (312) 327-3386 or email him at firstname.lastname@example.org
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