Bracker & Marcus LLC is pleased to announce that Advanced Bionics LLC, a California-based manufacturer of cochlear implants, agreed to pay the government nearly $13 million to resolve a complaint brought by our client, David Nyberg.
Mr. Nyberg was Advanced Bionics’ principal electrical engineer for Radio Frequency (RF) research and development from December 2010 to August 2017. During that time, he became aware of what he later realized was a scheme to mislead federal healthcare programs about the RF emissions generated by some of Advanced Bionics’ cochlear implants.
Read more about this case and contact a whistleblower attorney if you spot fraud in the workplace.
Engineers improperly tested cochlear implants
When Mr. Nyberg came to us, he was concerned because he knew that the cochlear implants being manufactured by Advanced Bionics (AB) could not pass emissions testing and had never been able to do so.
Instead, he alleged, AB engineers had “cheated” the tests by shielding the parts that emitted RF energy, turning the devices down to very low levels, and in one case, even turning the device off when it was supposed to be on for testing.
Even though this was clearly fraudulent behavior, and even though Mr. Nyberg was in a perfect position to know about the cheating and relate the story to the government, it was still a long road from our first conversation with Mr. Nyberg to filing the complaint. There were several reasons for this, both practical and legal.
The long road to results: Jargon, materiality, & a pandemic.
To begin, I had to understand the science at a level that would enable me to explain the fraud to the government. In fact, the relator had documents that he assured me proved the fraudulent testing had occurred—but most of them were totally unintelligible to anyone who was not already an RF engineer.
From a legal point of view, we also had the problem of materiality. As readers of this blog likely know, that is always a concern in a False Claims Act case, but here, we had multiple government agencies to convince.
First, there was the agency that had approved the faulty equipment based on lies – the Food and Drug Administration (FDA).
Second, many other government agencies paid for these faulty devices based on FDA approval (such as Medicare, Medicaid, VA, and more). We didn’t know whether any of those agencies would be concerned about whether the device violated standards set by yet another agency, the Federal Communications Commission – regulations that the other agencies likely would not easily understand.
Even after filing, Mr. Nyberg and I spent many months working together. We did so with an outside expert in RF and testing protocols to understand some very complicated science. From there, we’d go over it with the government team.
Unusually, we had four or five interviews with Mr. Nyberg after the initial meeting, where we walked the lawyers and agents through the test documentation. The goal was to show the team how the tests themselves proved that the correct standards could not be met unless basic protocols were disregarded.
Not to mention, the bulk of the investigation occurred during the pandemic. While we were able to hold these meetings over WebEx or Zoom, agents were unable to do “door knocks” for witnesses, which seriously impacted their ability to investigate.
Finally, after a lot of hard work, the government was convinced that emissions testing had been frauded up and—a harder thing to do—was also persuaded that the testing fraud was material to the decisions to both approve the devices and to pay for them.
The government intervened, settling the case for nearly $13 million. There were many questions raised by government attorneys and potential co-counsels about the materiality of our claims.
However, we took the case because of our firm’s philosophy that when a relator like Mr. Nyberg has witnessed deliberate, egregious fraud, it should be brought to the government’s attention. And we achieved an amazing result!
This settlement would not have happened without the work of a lot of government folks that we were privileged to assist. The lead attorneys who coordinated the efforts were DOJ Senior Trial Counsel Daniel Spiro of the Civil Division’s Commercial Litigation Branch, Fraud Section, and Assistant U.S. Attorney Lauren DeBruicker for the Eastern District of Pennsylvania.
We were very lucky to have such tenacious attorneys on our side, and we spent a lot of time coming up with analogies for RF interference. They were terrific to work with—a good thing in such a difficult case.
We would also like to thank Jason Zuckerman of Zuckerman Law, who referred the case to us way back in the beginning and then steadfastly supported us through all of its twists and turns.
Thanks also to local counsel Daniel R. Miller of Walden Macht & Haran LLP.
Is your employer cutting corners in the quest for FDA approval? Contact Bracker & Marcus LLC.
To say the least, Mr. Nyberg is pleased with the result, even though it took so many years.
As he says, “Cutting corners to save time and money doesn’t always yield the results you expect. Do the right thing. You’ll sleep better.” We couldn’t agree more!
If you have been asked to fraud up testing or other information during the FDA premarket approval process, we urge you to call Bracker & Marcus LLC for a free evaluation. We can help you figure out if you have an FCA case and what the best course of action is for you.