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A federal decide sentenced two Florida girls to jail in connection with their participation in a conspiracy to falsify medical trial knowledge.
Senior U.S. District Judge Donald L. Graham of the Southern District of Florida sentenced Analay Rico, 37, of Fort Lauderdale, to 40 months in jail and Daylen Diaz, 44, of Miami, to 24 months in jail. The court docket additionally ordered Rico and Diaz to pay roughly $2.1 million in restitution.
According to court docket paperwork, Rico labored as a lead examine coordinator for a medical analysis agency based mostly in Miami referred to as Tellus Clinical Research (Tellus). Diaz was a analysis assistant and assistant examine coordinator at Tellus. As a part of their plea agreements, Rico and Diaz admitted that they agreed with others to defraud shoppers paying for medical trial work supposed to consider remedies for numerous medical circumstances, together with opioid dependency, irritable bowel syndrome and diabetic nephropathy. Among different issues, Rico and Diaz admitted they falsified knowledge to make it seem as if topics have been collaborating in the trials when, in reality, they weren’t.
“Clinical trials are essential in determining the safety and effectiveness of drug treatments,” stated Principal Deputy Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “The Justice Department will continue to work with its law enforcement partners to prosecute anyone who intentionally falsifies this critical data for personal profit.”
“It’s disgraceful when a criminal preys upon patients in a health care setting,” stated U.S. Attorney Juan Antonio Gonzalez for the Southern District of Florida. “We will prosecute perpetrators who do to the fullest extent of the law.”
“Reliable and accurate data from clinical trials is the cornerstone of FDA’s evaluation of a new drug,” stated FDA Assistant Commissioner for Criminal Investigations Catherine A. Hermsen. “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.”
Three co-conspirators beforehand pleaded responsible and have been sentenced for his or her roles in the scheme. Eduardo Navarro, 53, of Miami, was sentenced to 46 months imprisonment; Duniel Tejeda, 36, of Clewiston, Florida, was sentenced to 30 months imprisonment; and Nayade Varona, 51, was sentenced to 30 months imprisonment. Trial in opposition to three remaining defendants charged by indictment in connection with Tellus, Dr. Martin Valdes, 66, of Coral Gables, Florida, Fidalgis Font, 55, of Miami, and Julio Lopez, 55, of Hialeah, Florida, is at present set for Jan. 10, 2023.
The Food and Drug Administration’s Office of Criminal Investigations is investigating the case.
Trial Attorneys Lauren M. Elfner, Joshua D. Rothman and Wandaly Fernandez Garcia of the Civil Division’s Consumer Protection Branch are prosecuting the case. The U.S. Attorney’s Office for the Southern District of Florida is offering crucial help.
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