Skip to main content

False 510(k) Notices to Avoid Class III Premarket Approval Process

Increasingly, the United State Department of Justice is cracking down on medical device makers who fraudulently obtain FDA approval for their products. DOJ is particularly interested in those companies who mis-characterize their medical devices as Class II devices, solely for purpose of obtaining FDA approval through the lenient 510(k) approval process. By fraudulently inducing the FDA to approve their products, the manufacturers are potentially liable under the federal False Claims Act. (In addition, the companies may be subjected to additional False Claims Act liability when they then promote their Class II-approved devices for unapproved Class III uses.)

Fraudulent 510(k) submissions are incentivized, in part, by the different FDA approval paths for medical devices. Indeed, the differences in the level of regulatory review required for Class II and Class III medical devices are quite substantial. Class III devices are subject to a pre-market approval process, which is the most stringent level of device regulation imposed by the FDA, usually requiring the manufacturer to conduct costly clinical studies to demonstrate the safety and effectiveness of the device. Class II devices, on the other hand, are subject to a less arduous process, commonly known as § 510(k) certification.

The lowered approval hurdles for Class II devices provide an easy end-around for dishonest medical device companies, who misrepresent in their 510(k) notices that their devices were intended for Class II uses when in fact they were intended for Class III uses. For example, companies may make false statements and omit material information regarding their devices’ classification, type, predicate devices, substantial equivalence, intended use, appropriate labels, and risk to patients. Importantly, if the device makers were truthful about their devices’ intended use, they would be required to complete the pre-market approval process for Class III devices. Thus, the companies obtain market clearance of their devices through fraud.

Such deceit potentially violates Medicare Fraud statutes, and the federal False Claims Act’s “false statements” liability provision, §3729(a)(1)(B),  under a so-called “fraudulent inducement” theory of liability. Applying this well-established theory of liability to fraudulent 510(k) submissions, the device makers’ false statements to the FDA would be material to false or fraudulent claims because those statements induced the federal government to clear the devices for introduction into interstate commerce, which is a prerequisite for reimbursement by government health care programs, such as Medicare. Importantly, the underlying principle of the fraudulent inducement theory is that the initial fraud taints all future claims presented, whether or not they are literally false or fraudulent.

Thus, for example, in the classic example of a government contractor who procures a government contract by fraud, the fact that the contract itself was procured by fraud creates FCA liability for every claim for payment made under the contract, even if all of the claims the contractor makes are otherwise free of falsity or fraud. The same application of the False Claims Act can be utilized by whistleblower lawyers to reach those device-makers who abuse the 510(k) approval process to sidestep pre-market approval for Class III devices.

REAL PEOPLE making real change Medical Equipment Fraud Wins

Kathleen Hawkins

Dignity Health
$37 million

Kathleen Hawkins, RN MSN, had been employed by Defendant, Catholic Healthcare West (CHW) for approximately 6 years when she decided she had had enough of trying to change the hospital system from within.

CHW, a California not-for-profit corporation that operated hospitals in California, Arizona, and Nevada, was at the time the eighth largest hospital system in the nation and the largest not-for-profit hospital provider in California.

READ MORE

Joe Strom

Johnson & Johnson
$184 Million

Joe Strom contacted us in 2005. We were very grateful that he did. We immediately formed an all-star legal team and a process to stop a very harmful pharmaceutical marketing strategy. It was this process we set into motion that ultimately returned hundreds of millions of dollars to the U.S. Treasury, and a portion of that, very well-deserved, into Joe’s bank account.

Joe told us a very troubling story about the off-label promotion of a pharmaceutical drug for patients who already suffered from chronic heart failure.

READ MORE

Description
Description

“I collaborated with Nolan, Auerbach and White on a broad variety of cases where whistleblowers stepped forward to disclose tactics employed by large companies to influence physicians' medical decision-making in patient care. They and their medical consultants, have consistently leveraged biomedical research and best medical evidence to advance patient safety, optimize clinical outcomes, and control precious resource utilization.”

— Fred Polsky M.D.,, Former Medical Director, CMS Zone 7 Integrity Contractor

Any Questions?

Am I potential whistleblower that matches up well with our firm?

We only want to represent amazing people.

How much will I make?

We cannot guarantee anything, but we will deliver on this promise: we will give you feedback and a prognosis within 48 hours of your submission of all details to us. We are the first healthcare fraud qui tam law firm, and have been doing only healthcare fraud whistleblower lawsuits for decades-so you can expect as accurate a picture as is possible.

Are my communications with you confidential?

They are 100% confidential. If we do not take your case, your information becomes inaccessible. We have no interest in it. Besides, it is protected by the attorney-client privilege under our lawyer regulations, and we would lose our license if we were to disclose one iota of information about you or your potential case.

    Contact Us

    Contact Us

    The more detailed the response, the more likely it is that we will be able to evaluate and determine if your potential False Claims Act case falls within our case requirements. IF IT DOES, WE WILL RESPOND TO YOU WITHIN 24 HOURS. (Names of potential defendants are not necessary at this point, should you feel more comfortable omitting them.) By law, all communications to us are 100% confidential.

    No. of Employees at the Company?
    Please read the following statement and then click "Send Form":

    Any response to your e-mail will be solely to communicate about our possible representation of you under the qui tam provisions of the False Claims Act. All e-mails submitted to us, whether we take your case or not, are 100% confidential. If we do not respond to your e-mail, then you have communicated information which we cannot address because it appears to fall outside of the False Claims Act or our case requirements.

    Back to top