Doctor and Staff Charged with Falsifying Data in Clinical Drug Trials

In an indictment unsealed today, a federal grand jury in the Southern District of Florida charged a medical doctor and two staff members of a medical research center for their roles in an alleged scheme to falsify data in clinical trials of prospective new drug treatments. A third staff member was also charged in a criminal information.

According to the indictment, Dr. Jaynier Moya, 49, of Southwest Ranches, Florida, Luis Montano, 55, of Hialeah, Florida, and Yuniarka Garcia, 41, of Plantation, Florida, were charged for allegedly engaging in misconduct in clinical trials conducted at Pines Care Research Center LLC (Pines Care), in Pembroke Pines, Florida. Alexandra Olivera, 38, of Hialeah, Florida, was separately charged in a criminal information with participating in the alleged scheme. As alleged in court documents, Moya co-owned Pines Care and served as principal investigator for the research studies. Montano, Garcia, and Olivera were clinical research coordinators.

Beginning no later than 2019, the defendants allegedly fabricated testing data and falsified other records while conducting clinical trials sponsored by a pharmaceutical development company. The trials were designed to test prospective new drugs to evaluate their safety and efficacy for potential approval by the FDA. As alleged in the charging documents, the defendants falsified records to make it appear that human subjects had taken the study medications and undergone testing to evaluate the study medications' effects as called for in trial protocols, when, in fact, they had not. The defendants allegedly used identification documents from people - who did not actually participate in trials - to create false records purporting to show those individuals participated and generated test results. The indictment also alleges that the scheme caused the falsified test data to be submitted into the clinical trial database systems used for evaluating prospective new drugs.

Each defendant is charged with conspiracy to commit wire fraud. Moya, Montano, and Garcia are each also charged with three counts of substantive wire fraud. If convicted, each defendant faces a statutory maximum penalty of 20 years in prison for conspiracy to commit wire fraud. Moya, Montano, and Garcia also face a statutory maximum penalty of 20 years in prison per count upon conviction of substantive wire fraud.

Assistant Attorney General A. Tysen Duva of the Justice Department's Criminal Division and Acting Special Agent in Charge Juan Berrios of FDA's Office of Criminal Investigations Miami Field Office made the announcement.

The FDA's Office of Criminal Investigations Miami Field Office is investigating the case.

Trial Attorneys Andrew Crawford and Brianna Gardner of the Criminal Division's Health and Safety Unit are prosecuting the case.

The Health and Safety Unit within the Department's Criminal Division works with law enforcement partners to investigate and prosecute violations of federal laws designed to protect public health and safety. The unit focuses on corporations and individuals who make and sell dangerous drugs, food, and other consumer products that could cause significant harm to Americans. For more information, see https://www.justice.gov/criminal/criminal-fraud/health-safety-unit.

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