FLORIDA — The owners of a Florida medical clinic and an employee of the clinic are accused by the U.S. Department of Justice of falsifying clinical trial data, the Department of Justice said in a statement.
In an indictment unsealed last week, a Miami grand jury charged three defendants for their roles in an alleged scheme to fabricate and falsify clinical drug trial data, the Department of Justice (DOJ) announced.
According to the DOJ, Miguel Montalvo, 52, Bernardo Garmendia, 58, and Ivette Portela, 52, all of Miami, were charged in a three-count indictment returned by a federal grand jury on Sept. 13. Each defendant was charged with conspiracy to commit wire fraud and one substantive count of wire fraud.
In addition, Montalvo was charged with making a false statement to a regulatory investigator with the Food and Drug Administration (FDA), the DOJ said in its statement.
According to the indictment, from at least September 2015 through at least March 2018, the defendants are alleged to have fabricated clinical trial data for profit while working at AMB Research Center Inc., a medical clinic based in Miami, the DOJ said.
The indictment alleges that the defendants knowingly enrolled subjects in a clinical trial even though those subjects failed to meet eligibility criteria, falsified subject laboratory results, falsified subject medical records, and falsely represented that subjects were taking the drug being studied when, in fact, they were not, the DOJ said.
According to the DOJ, Montalvo and Garmendia were co-owners of AMB Research Center, where Montalvo also served as a lead study coordinator, and Garmendia served as a study coordinator.
Portela worked at AMB Research Center and was a pharmacy technician, the DOJ said.
Trial Attorneys Karla-Dee Clark and Jessica C. Harvey of the Justice Department’s Consumer Protection Branch are prosecuting the case.
The U.S. Food and Drug Administration’s Office of Criminal Investigations, Miami Field Office, investigated the case, and the U.S. Attorney’s Office of the Southern District of Florida has provided critical assistance.
An indictment is merely an allegation. All defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law.
