In an indictment unsealed yesterday, 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 announced.
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).
According to the indictment, from at least September 2015 through at least March 2018, the defendants fabricated clinical trial data for profit while working at AMB Research Center Inc., a medical clinic based in Miami. 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. 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.
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.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Southern District of Florida, visit its website at https://www.justice.gov/usao-sdfl.
An indictment is merely an allegation. All defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law.
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Florida Medical Clinic Owners and Staff Charged With Falsifying Clinical Trial Data - Department of Justice
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