Two plead guilty in connection with alleged scheme to falsify clinical trial data

FLORIDA — Two Florida women pleaded guilty last week in connection with their participation in a conspiracy to falsify clinical trial data, the U.S. Department of Justice has announced.

According to court documents, Analay Rico, 37, of Fort Lauderdale, and Daylen Diaz, 44, of Miami, worked as study coordinators at a clinical research site called Tellus Clinical Research. As part of their plea agreements, Rico and Diaz admitted that they agreed with others to defraud clients paying for clinical trial work intended to evaluate treatments for various medical conditions, including opioid dependency, irritable bowel syndrome, and diabetic nephropathy.

Among other things, Rico and Diaz admitted they falsified data to make it appear as though subjects were participating in the trials when, in truth, they were not, the Department of Justice (DOJ) said in its statement.

“Clinical trials are the foundation of the drug approval process,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division.

“The Justice Department will continue to work with its law enforcement partners to prosecute those who falsify clinical trial data for personal profit.”

According to the DOJ, Duniel Tejeda, 36, of Clewiston, Florida, Eduardo Navarro, 53, of Miami, Florida, and Nayade Varona, 51, of Port St. Lucie, Florida, previously pleaded guilty and were sentenced to 30 months in prison, 46 months in prison, and 30 months in prison, respectively, for their roles in the scheme.

A trial is set for Sept. 27 in the case of three other defendants: Dr. Martin Valdes, 66, of Coral Gables, Florida, Fidalgis Font, 55, of Miami, and Julio Lopez, 55, of Hialeah, all charged by indictment in connection with Tellus, the DOJ said.

FDA-OCI is investigating the case.

Trial attorneys Lauren M. Elfner, Joshua D. Rothman and Wandaly Fernández García of the Civil Division’s Consumer Protection Branch are prosecuting the case. The U.S. Attorney’s Office for the Southern District of Florida has provided critical assistance.

An indictment is merely an allegation, and all defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law.