Florida doctor, staff charged with allegedly falsifying clinical trial data

A Florida physician and three staff members at a medical research center have been charged in an alleged scheme to falsify clinical trial data, the Justice Department announced.

A federal grand jury in the Southern District of Florida unsealed an indictment charging Dr. Jaynier Moya, 49, of Southwest Ranches; Luis Montano, 55, of Hialeah; and Yuniarka Garcia, 41, of Plantation, with conspiracy to commit wire fraud and three counts each of substantive wire fraud. A fourth defendant, Alexandra Olivera, 38, of Hialeah, was separately charged in a criminal information with participating in the alleged scheme.

Moya co-owned Pines Care Research Center LLC in Pembroke Pines and served as principal investigator for the studies, according to court documents. Montano, Garcia and Olivera worked as clinical research coordinators at the facility.

Prosecutors allege the defendants began fabricating testing data and falsifying records no later than 2019 while conducting clinical trials sponsored by a pharmaceutical development company. The trials were designed to evaluate the safety and efficacy of prospective new drugs for potential FDA approval.

According to the indictment, the defendants falsified records to make it appear that human subjects had taken study medications and undergone testing required by trial protocols when, in fact, they had not. The defendants allegedly used identification documents belonging to people who did not participate in the trials to create fraudulent records showing those individuals had enrolled and generated test results.

The indictment further alleges that the falsified data was submitted into clinical trial database systems used to evaluate prospective new drugs for potential approval.

Each defendant faces a statutory maximum sentence of 20 years in prison on the conspiracy count if convicted. Moya, Montano and Garcia each face an additional statutory maximum of 20 years per count if convicted on the substantive wire fraud charges.

The announcement was made by Assistant Attorney General A. Tysen Duva of the Justice Department’s Criminal Division and Acting Special Agent in Charge Juan Berrios of the FDA Office of Criminal Investigations’ Miami Field Office, which is investigating the case. Trial Attorneys Andrew Crawford and Brianna Gardner of the Criminal Division’s Health and Safety Unit are prosecuting the case.

An indictment or criminal information is merely an allegation. All defendants are presumed innocent until proven guilty beyond a reasonable doubt.