Health Care Providers are Facing Increased False Claims Act Liability: False Data in Clinical Research Investigations New Theory

Monday, July 2, 2012

By Miles Indest and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A recent "whistle-blower case" filed under the False Claims Act (FCA) has emphasized the indispensability of fact verification when submitting claims, grant applications or other information to the federal government. Health care providers may face FCA liability for false records or mediocre research methods when seeking research grants from a federal agency.

Click here to view the False Claims Act.

Research Grant Recipients Allegedly Falsified Their Reports.

In U.S. ex rel. Jones v. Brigham and Women's Hospital, __ F.3d ___, 2012 WL 1571232 (1st Cir. May 7, 2012), a whistle-blower alleged that the defendants submitted a false application for a research grant to the National Institute on Aging (NIA), a federal agency. To see the decision in Jones, click here.

The defendants pursued the NIA grant in order to continue their research on MRI scans that could potentially anticipate the commencement of Alzheimer's Disease. According to the allegations of Jones, who was himself a research team member, the defendants collected research data that was not from a typical "blind study" as they had claimed in their grant application. Instead, the whistle-blower insisted, the data was "cherry picked" and "manipulated."

Appeals Court Remands Case;  Issue Concerns Intentionally Falsifying Scientific Data.

The trial court dismissed the case. However, the appeals court remanded the dispute, claiming that the heart of the case was "not about resolving which scientific protocol produces results that fall within an acceptable range of accuracy." Instead, the case concerned whether the defendants "falsified scientific data by intentionally exaggerating the re-measurements to cause proof of a particular scientific hypothesis."

Thus, there was a triable issue whether the defendants had made "a false record or statement to get a false or fraudulent claim paid or approved by the Government" in violation of the FCA.

Researchers Should Ensure the Accuracy of All Materials Submitted to the Government.

As demonstrated in the Jones case, clinical investigators, medical researchers and academic research centers need to be extremely cautious when collecting or submitting information for federal research funding. Every fact on every document submitted should be thoroughly verified to ensure accuracy and to avoid False Claims Act violations, qui tam cases by whistle-blowers and even possible criminal prosecution.

For more information on clinical research fraud, click here to see our previous blog post.

Website Tracks Allegedly Fraudulent Investigations.

The Department of Health and Human Services (DHHS) Office of Research Integrity (ORI) maintains a list of all individuals who have been accused of clinical research misconduct and fraud. The names of these individuals are included in the Public Health Service (PHS) Administrative Action Bulletin Board. Click here to see the PHS Administrative Action Bulletin Board.

The Food and Drug Administration (FDA) maintains separate bulletin boards that list the names of individuals who it has debarred or has placed restrictions on. Click here to see the FDA's debarment list.

Click here to see our web page on clinical investigation fraud and misconduct.

Contact Health Law Attorneys Experienced with False Claims Act Cases.

The Health Law Firm represents physicians, scientists, researchers, research assistants, universities, laboratories, and other clinical research organizations in matters involving research misconduct and fraud. If you have been accused of research misconduct or committing False Claims Act violations, contact an experienced health law attorney immediately.

For more information on clinical research misconduct and fraud defense, click here.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sources Include:

Giuliana, Antonia F. "The Evolution of the False Claims Act and Anti-Kickback Allegations." FCA Alert. (Mar. 8, 2012). From:
http://www.fcaalert.com/2012/03/articles/the-evolution-of-the-false-claims-act-and-antikickback-allegations/

Holloway, James P. "Federal Research Grant Recipients Face False Claims Lawsuit." JD Supra. (June 1, 2012). From:
http://www.jdsupra.com/post/documentViewer.aspx?fid=88868338-ab35-464a-8202-458c6afb976b

Renner, Richard. "Whistleblower Kenneth Jones Wins Appeal and Forces Harvard to Trial for Research Fraud." Whistleblowers Protection Blog. (May 8, 2012). From: http://www.whistleblowersblog.org/2012/05/articles/whistleblowers-tax-fraud/whistleblower-kenneth-jones-wins-appeal-and-forces-harvard-to-trial-for-research-fraud/

U.S. ex rel. Jones v. Brigham and Women's Hospital, __ F.3d ___, 2012 WL 1571232 (1st Cir. May 7, 2012)

Tag words: False Claims Act, FCA, qui tam suits, federal research grants, clinical research, research grant application, falsified data, falsified reports, clinical research misconduct, clinical research fraud, federal research grant recipient, whistleblower, whistle blower protection, clinical investigation fraud misconduct defense, clinical research fraud defense, clinical research misconduct defense, medical investigation misconduct defense, medical investigation fraud defense, medical research misconduct defense, clinical studies

7/2/2012

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