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Seven Things To Know When You Receive A Notice Of Investigation From The Department Of Health

Jury Finds Miami Clinical Drug Trial Company Not Guilty in Research Fraud Case

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

On May 19, 2023, jurors rendered a verdict to federal prosecutors in a trial against executives from a Miami clinical drug trial company and a local doctor. The CEO of Tellus Clinical Research and one employee were found not guilty on all charges related to an alleged plot to falsify research and deceive drug manufacturers. A third defendant, a Florida doctor, was also acquitted of conspiracy, fraud, and money laundering; however, he was found guilty of making false statements.


The History of Allegations.

Prosecutors accused employees of Tellus of falsifying lab results and medical records to gain more money from study sponsors from 2013 to 2016. According to the indictment, the fraud continued until a clinical trial sponsor alerted the U.S. Food and Drug Administration (FDA) about allegedly irregular patterns in the company’s data.

The indictment further alleged that the defendants knowingly enrolled subjects in clinical trials who did not meet the eligibility criteria, manipulated laboratory results, fabricated medical records, and falsely represented that test subjects were taking the drugs when they were not.
For further information on the defendants and the charges, read the press release issued by the U.S. Attorney’s Office, Southern District of Florida.

The Aftermath of the Alleged Scheme.

Before the trial in Miami federal court, several individuals also indicted in February 2021 for their roles in the scheme had already pled guilty. For example, an ex-Tellus study coordinator is serving two-and-a-half years in prison for conspiracy to commit mail and wire fraud charges. Read more here.

Despite this history of plea deals and testimony by three convicted cooperating witnesses during the trial, the not guilty verdict for these defendants was still allegedly shocking to prosecutors.

Learn additional information and view the original indictment in full here.

Important Lessons to Be Learned From This Case.

There are several important lessons that healthcare professionals can learn from this case.

1.    If you are innocent and have the resources to defend yourself, then you must go to court and defend yourself. For a doctor, professor, academic, or health professional, taking a guilty plea has so many adverse consequences, we cannot detail them all here. Needless to say, your career and usually your ability to practice your profession will be over if you do. Prosecutors are not omniscient and are often fed a line of bull***t by investigators and other academicians. We are seeing more and more jury verdicts coming back in favor of doctors over the last five years.

2.    It is better to say nothing at all rather than say something false or incorrect to investigators or prosecutors. The Fifth Amendment is a very important right and it is there for a reason. Any false or misleading statement you make to a federal investigator or federal official is a felony under 18 U.S.C. Section 1001. It is better to say nothing at all rather than say something that a prosecutor is going to later argue was a knowingly false or misleading statement.

Don’t Wait. Obtain Legal Counsel Before It’s Too Late.

Clinical research fraud allegations are common. Medical and clinical researchers, whether in an academic community or a practice setting, may be accused of research misconduct, altering data, falsifying results, misrepresenting data, or other forms of research misconduct. The researcher must obtain experienced legal counsel to represent them in such matters. An accusation, even if later proven unfounded, may unfairly tarnish the personal and professional reputation of the researcher, cause them to lose grants, bonuses, and promotions, and may even lead to termination of employment. Many additional, more severe, and far-reaching consequences may also result.

Find out what can happen if you don’t retain legal counsel from an experienced attorney.

Contact Health Law Attorneys Experienced in Clinical Research Fraud and Misconduct.

The Health Law Firm and its attorneys have experience in representing researchers, investigators, academicians, and clinicians who are the subject of clinical research fraud and misconduct. The Health Law Firm and its attorneys also have experience representing students, employees, researchers, investigators, and “whistle-blowers” who report such matters, including those who become the victim of reprisals and retaliation by the person against whom the report is made.

If you are facing research misconduct or research fraud accusations, please visit our website for more information at www.TheHealthLawFirm.com or call The Health Law Firm at (407) 331-6620 or toll-free (888) 331-6620.

Sources:

Weaver, Jay. “Miami prosecutors lose medical fraud case alleging ring ran ‘fake’ clinical drug trials.” Miami Herald. (May 19, 2023). Web.

Clough, Craig. “Jury Clears Miami Drug Trial Co.’s CEO Of Fraud Charges.” Law360. (May 19, 2023). Web.

Department of Justice. “Study Coordinator Charged in Scheme to Falsify Clinical Trial Data.” U.S. Food & Drug Administration. (May 11, 2021). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.


Current Open Positions with The Health Law Firm. The Health Law Firm always seeks qualified individuals interested in health law. Its main office is in the Orlando, Florida, area. If you are a current member of The Florida Bar or a qualified professional who is interested, please forward a cover letter and resume to: [email protected] or fax them to (407) 331-3030.

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