A federal judge sentenced a medical clinic owner and a pharmacy technician for their involvement in a clinical trial fraud scheme that included the falsification and fabrication of clinical trial data, the Justice Department announced.
Miguel Angel Montalvo Villa, 53, of Miami, and Ivette Maria Portela Martinez, 53, also of Miami, were convicted by a jury on Sept. 5 of one count of conspiracy to commit wire fraud and one count of wire fraud. Montalvo Villa also was convicted of making a false statement to a regulatory investigator with the U.S. Food and Drug Administration (FDA). On Nov. 30, U.S. District Judge K. Michael Moore sentenced Montalvo Villa to 71 months in prison and Portela Martinez to 46 months in prison.
According to court documents and evidence presented at trial, Montalvo Villa was a co-owner, president and CEO of AMB Research Center Inc. (AMB), a medical clinic located in Miami that conducted clinical trials of new drugs for pharmaceutical companies and sponsors. Portela Martinez was an employee who served as recruiter, site manager, data entry specialist and pharmacist. The evidence showed that Montalvo Villa and Portela Martinez used the names and personal information of individuals without their knowledge or consent and listed them as enrolled subjects in a clinical trial for a drug that was being developed to treat Clostridium difficile-associated diarrhea (CDAD), a moderate to severe form of diarrhea. The trial evidence further showed that the defendants enlisted and used the names of family members and friends who purportedly participated as eligible subjects in the CDAD clinical trial – but no subject fully participated in that clinical trial, as required by the protocol.
The trial evidence showed that Montalvo Villa and Portela Martinez falsified, at a minimum, hundreds of pages of documents and entered that information and data into the clinical trial’s electronic databases to make it appear as though the purported clinical trial subjects were fully participating in the clinical trial. The trial evidence also showed that as part of the conspiracy, Montalvo Villa submitted falsified and fraudulent invoices for AMB to receive payments for conducting the clinical trial that totaled $277,920.
“Accurate clinical trial data is critical to the evaluation of new drug treatments,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Justice Department will continue to work closely with its agency and law enforcement partners to uncover and prosecute clinical trial fraud.”
“The cornerstone of FDA’s evaluation of a new drug is reliable and accurate data from clinical trials,” said FDA Assistant Commissioner Justin D. Green of Criminal Investigations. “Compromised clinical trial data could impact the agency’s decisions about the safety and effectiveness of the drug under review. We will continue to monitor, investigate and bring to justice those whose actions may subvert the FDA approval process and endanger the public health.”
The FDA’s Office of Criminal Investigations, Miami Field Office, investigated the case.
The Civil Division’s Consumer Protection Branch prosecuted the case. The U.S. Attorney’s Office for the Southern District of Florida provided critical assistance.
Additional information about the Consumer Protection Branch and its enforcement efforts can be found at www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Southern District of Florida, visit www.justice.gov/usao-sdfl.