The Department of Justice (DOJ), Civil Division announced in a March 8, 2021 press release that it had charged four individuals who allegedly falsified clinical trial data.  The charges include conspiracy to commit mail and wire fraud, mail fraud, money laundering, and making false statements to Food and Drug Administration (FDA) inspectors.  DOJ alleges that, while working for Tellus Clinical Research in Miami, the physician serving as the primary investigator for clinical trials, the business owner, and two senior employees conspired to falsify data in pending clinical trials.  

According to DOJ, the defendants allegedly allowed subjects to be enrolled in clinical trials despite knowing that the patients did not meet the criteria to be eligible for the clinical trials.  The defendants also allegedly falsified lab results, medical records, and clinical trial data.  And the defendants allegedly said that patients were being administered drugs that were the subject of clinical trials despite the defendants knowing that the patients were not, in fact, being administered those drugs.  The FDA Assistant Commission working on the investigation reiterated the importance of accurate and reliable data to ensure the safety and efficacy of new drugs and treatments.

In convicted, the individual defendants face potentially decades in prison.  The severity of the punishment demonstrates the importance of providing accurate data when participating in a clinical trial.  It is imperative that physicians, nurses, and all other individuals assisting in clinical trials ensure the accuracy of the information being reported to manufacturers and the FDA.  Indeed, those administering clinical trials face far stiffer consequences from the FDA than from the manufacturer of a new drug or device.  Providing inaccurate clinical data could result in significant fines and prison time for individuals that provide false information.

The attorneys at Chilivis Grubman represent clients of all types and sizes in connection with government investigations, including white collar criminal investigations.  If you need assistance with such a matter, please contact us today.