Miami Clinic Charged with Falsifying Clinical Data

According to a Department of Justice press release dated March 8, 2021, a doctor, a clinic owner, and staff have been charged with falsifying clinical data.

Dr. Martin Valdes, 64, of Coral Gables, Florida, Fidalgis Font, 53, of Miami, Julio Lopez, 54, of Miami, and Duniel Tejeda, 35, of Canon City, Colorado, were charged in a six-count indictment with conspiracy to commit mail and wire fraud. Valdes and Font were also charged with money laundering and Valdes was further charged with making a false statement to inspectors with the U.S. Food and Drug Administration (FDA).

Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division said of the crime, “The public must be able to rely on the accuracy and honesty of clinical trial data, which is essential to ensuring the safety of drugs approved for patient use. The defendants undermined that process and put patients at risk. The Department of Justice will pursue and prosecute those who put personal profit before public health.”

The defendants allegedly fabricated clinical data while working at Tellus Clinical Research, a medical clinic in Miami. Allegedly, they enrolled subjects in clinical trials while knowing they were ineligible and falsified the subjects’ medical records. They falsified subject laboratory results and falsely represented that subjects were taking the drugs being studied, according to the indictment.

Catherine A. Hermsen, FDA Assistant Commissioner for Criminal Investigations expressed the importance of accurate clinical data and said, “Reliable and accurate data from clinical trials is the cornerstone of FDA’s evaluation of a new drug. 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.”