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NIH Grant Fraud

1. What are the most common types of NIH Grant Fraud?

The three broad categories of NIH Grant Fraud are: making misrepresentations in grand applications; filing false accounting, expense and cost reports; and submitting false research results, findings and data.

2. Of the three, which tends to be the more successful FCA cases?

False applications are usually the most readily established False Claims Act cases when compared to false accounting and false research cases.

3. What would be an example of NIH Fraud involving false applications?

Perhaps the most glaring example is when the principle investigator falsifies his or her academic and/or professional credentials, qualifications or experience, or those of other key personnel.

4. Are there other examples of grant application fraud?

Yes, these include falsifying the source and amounts of government and industry funding; overstating or understating the time commitment of the project’s participants; and failing to disclose grant applications being submitted to multiple agencies or reviewers. Submitting false results from prior research would be another example.

5. How do accounting frauds arise in the NIH grant context?

In the application process, the grantee might overstate his or her budgetary needs.

 

6.What is expense or cost shifting in the context of NIH grants?

Some grants are paid out over a period of time and new funds are released only when previously awarded funds have been exhausted. NIH Grant Fraud can occur when a principal investigator on paper shifts expenses from one project to a second project in order to make it falsely appear that the second project has legitimately exhausted its funds.

7. Why are NIH Grant Fraud cases alleging false research results hard to make?

By definition, the research is very complex and cutting edge. It requires substantial expertise to be able to spot and prove this type of fraud. Also, the principal investigator is usually an expert in his or her field and will be able to offer countering explanations.

8. When might a false research case succeed?

It is very helpful if the relator worked in the lab and was involved in the project at issue. Having copies of records such as lab note books and draft reports showing data, tables and graphs “before and after” the fraud can be crucial.

9.Can plagiarism form the basis of a NIH Grant Fraud case?

Without a doubt, either plagiarizing another person’s research or even recycling one’s own may give rise to a viable case. Usually, under the terms of the grant a principal investigator is supposed to do his or her own research in an identified facility and the research is supposed to be new. Submitting progress, technical or final reports that use other people’s data or one’s own data from earlier projects might constitute material misrepresentations to NIH.

10. Who investigates NIH Fraud?

The Office of Inspector General for U.S. Department of Health and Human Services.

"Tim McInnis is an amazing attorney. He is intelligent, thorough, ethical, kind and he works very strategically in order to insure the best outcome for his clients. I would trust him with my life. He is not only an excellent attorney, but he is a compassionate person."
Denise A. Romano, January 2004

"Tim McInnis is a superb lawyer for whistleblowers. As both a relator and a lawyer I worked with for more than three and a

On October 14, 2020, medical device maker Merit Medical Systems Inc. (MMSI), of South Jordan, Utah, agreed to pay $18 million to settle allegations the company helped submit false claims to the federal Medicare and TRICARE programs and numerous state Medicaid programs by giving kickbacks to physicians and hospitals to induce the purchase and use of MMSI’s durable medical equipment devices and products. NYC attorney Timothy J. McInnis was a member of the legal team that successfully represented the whistleblower in the case, Charles J. (“CJ”) Wolf, M.D., who was the former Chief Compliance Officer of MMSI.

 

According to Dr. Wolf’s complaint and the government’s settlement agreement, for over six years MMSI paid kickbacks to physicians, medical practices, and hospitals. The payments were made indirectly under the guise of free advertising assistance, practice development, practice support, and so-called “educational” grants. All of this was intended to induce the healthcare providers to purchase and use MMSI’s products, including EmboSphere devices, which are used for uterine fibroid embolization procedures, and QuadraSphere devices, which are used for other types of embolization procedures. Among other things, MMSI used local advertising campaigns to steer patients to healthcare providers as a reward for past sales and to increase future purchases of MMSI products. Dr. Wolf and the government further alleged that MMSI disregarded numerous internal warnings, including from Dr. Wolf, that MMSI’s sales practices potentially violated the healthcare Anti-Kickback Statute (AKS).

 

The lawsuit was filed in the federal court in District of New Jersey, where attorney McInnis formerly served as an Assistant U.S. Attorney. The case is captioned United States ex rel. Wolf v. Merit Medical Systems, Inc., No. 2:16-cv-01855-CCC-MF (D.N.J.). Of the $18 million MMSI is paying to settle the case, $15.21 million will be go to the U.S. Treasury, and the remaining $2.79 million will go to the approximately 30 individual states that also joined the lawsuit.

half years and his counsel and perseverance were always spot on. His work was critical to a successful settlement of the case."
Stephen B. Diamond, Esq., August, 2016

"Tim McInnis Law represented my case with the up most professionalism. He communicated with me at every turn of the case ensuring I understood the process as well what was to come next. His patience, comprehension of Qui Tam Law and persistence in getting me the highest amount possible out of the case is unmatched. I wouldn't hesitate to recommend his law firm for a minute."
Don A. Briscoe, September 2016

"Tim McInnis Law represented my case with the up most professionalism. He communicated with me at every turn of the case ensuring I understood the process as well what was to come next. His patience, comprehension of Qui Tam Law and persistence in getting me the highest amount possible out of the case is unmatched. I wouldn't hesitate to recommend his law firm for a minute."
Don A. Briscoe, September 2016

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