You run a clinical research site. Maybe you're a study coordinator handling patient data. Maybe you're the principal investigator signing off on trial results. The pharmaceutical company sends the grant money. You enroll patients. You submit data. The FDA reviews the application. The drug gets approved. Everyone moves on to the next study.
Except for the part where some of that data wasn't entirely accurate.
The DOJ is prosecuting clinical trial fraud as a federal crime - and they're getting serious prison sentences.
The Department of Justice Consumer Protection Branch has made clinical trial fraud a top enforcement priority. Not administrative action. Not FDA warning letters. Criminal prosecution with wire fraud charges, identity theft charges, and sentences that would shock anyone who thought this was just a regulatory compliance issue. Welcome to Spodek Law Group. We handle federal defense for clinical investigators, study coordinators, and research site owners facing DOJ prosecution. If you've been contacted by FDA Office of Criminal Investigations or received any indication of federal interest in your research site - this article explains exactly what you're facing.
The DOJ Made Clinical Trial Fraud a Priority
For the past two years, the DOJ Consumer Protection Branch has treated clinical trial fraud as a top enforcement priority. Not the FDA sending warning letters. Not regulatory slaps on the wrist. Federal prosecutors seeking prison time.
The sentences are real. In the Tellus Clinical Research case out of Miami, the clinic owner - Miguel Montalvo Villa - recieved 71 months in federal prison. Dr. Martin Valdes, the clinical investigator, got 60 months. Eduardo Navarro, a study coordinator, was sentenced to 46 months plus ordered to pay $2 million in restitution. Ivette Portela Martinez got 46 months. Multiple other study coordinators recieved 30-month sentences.
What did they do? They ran a clinical research site that enrolled children ages four to eleven in asthma medication trials. The pharmaceutical sponsor paid for the research. The data was submitted to support drug approval. The problem: the children never actualy participated. The visits were fabricated. The lab results were falsified. The pharmaceutical company paid for research that never occured.
These weren't career criminals. They were doctors. Clinic owners. Study coordinators with medical backgrounds. People who had built careers in clinical research. People who thought they were cutting corners on paperwork - not committing federal felonies. The DOJ thought otherwise. And federal judges agreed.
How One Study Creates Dozens of Federal Charges
The federal government dosent need a special clinical trial fraud statute. They use existing fraud laws - and those laws let prosecutors stack charges in ways that create massive sentencing exposure.
- Wire Fraud (18 U.S.C. § 1343) - up to 20 years per count
- False Statements to Federal Agencies (18 U.S.C. § 1001) - up to 5 years per count
- Aggravated Identity Theft (18 U.S.C. § 1028A) - mandatory +2 years consecutive
- Health Care Fraud (18 U.S.C. § 1347) - up to 10 years per count
Every email containing falsified data is a potential wire fraud count. Every electronic invoice submitted for fabricated patient enrollment is another count. Twenty phantom patients enrolled using real peoples identities? That could be twenty aggravated identity theft charges - each one adding a mandatory two years consecutive to whatever other sentence you recieve.
The government dosent have to prove the drug was dangerous. They dont have to prove anyone was hurt. The Tellus case involved asthma medication trials. Nobody was injured. The drug wasnt pulled from the market. Just fabricated data submitted to a pharmaceutical sponsor. Just phantom patients who never actualy showed up for there visits. Thats enough for 71 months in federal prison.
And prison isnt were the consequences end. The FDA issued a permanent debarment order against Dr. Valdes effective March 2024. Permanent. He can never again provide services in any capacity to anyone with a pending or approved drug product application. His career in clinical research is over. Forever.
Then theres restitution. The pharmaceutical company gets there money back. Through you. Eduardo Navarro: 46 months prison, then a $2 million restitution order to the pharmaceutical sponsor he defrauded. The company keeps the drug approval. You serve the sentence. You pay them back.
The People Inside Your Organization Can Destroy You
The False Claims Act allows private citizens to file lawsuits on behalf of the government when they know about fraud involving federal funds.
Whistleblowers recieve 15-30% of whatever the government recovers. Duke University paid $112.5 million to settle allegations that researchers falsified data in grant applications. The Athira Pharma settlement was $4.07 million. The whistleblower in that case - Andrew Mallon - received $203,434 for reporting the misconduct.
Your lab technician knows what data looks like before and after its modified. Your former study coordinator knows which patients actualy showed up for visits. The employee you terminated last month might have copies of original records. Every one of them has a financial incentive to report you to the government. And False Claims Act complaints are filed under seal - the investigation happens in secret. You won't know it exists until federal agents show up at your facility.
Jessica Palacio was charged in 2025 for her role as a study coordinator at Unlimited Medical Research in Miami. She allegedly participated in a scheme to falsify records showing pediatric subjects made scheduled visits, received physical exams, and took study drugs as required. None of which actualy happened. Study coordinators. Not executives. Not principal investigators. Coordinators are getting indicted.
The government dosent need the principal investigator to cooperate first. They work up the chain. Start with the study coordinator. Get cooperation. Move to the physician. Then the clinic owner. Conspiracy charges mean everyone who touched the fraudulent data is a potential defendant. Everyone who knew and didnt report it. The circle expands.
What Happens When The Investigation Starts
FDA inspectors show up at your site. Or agents from the FDA Office of Criminal Investigations. Or attorneys from the DOJ Consumer Protection Branch. Your instinct is to explain. To cooperate. To demonstrate good faith and show them you're not the kind of person who commits fraud.
That instinct destroys people.
18 U.S.C. § 1001 makes it a federal crime to make false statements to investigators. Up to 5 years per count. It's a seperate crime from the underlying fraud - and its frequently charged alongside wire fraud and identity theft. People who thought explaining would help ended up with additional charges for what they said during the "cooperative" interview.
If FDA or DOJ contacts you:
- Don't destroy any documents. Document destruction is obstruction and creates additional charges.
- Don't alter any records. Modification after notice of investigation is spoliation.
- Don't discuss the matter with colleagues who might be involved. Those conversations can become evidence.
- Don't consent to searches without counsel present.
- Contact a federal defense attorney immediately. Before you say anything.
Todd Spodek has represented individuals facing DOJ Consumer Protection Branch investigations into clinical research practices. The timing matters enormously. Early intervention - before statements are made, before cooperation becomes self-incrimination - can mean the difference between a negotiated civil resolution and a multi-count federal indictment.
When Your Ready
If you're involved in clinical research and you've recieved contact from FDA investigators or DOJ - or if you're concerned about practices at your site - Spodek Law Group can help you understand your exposure and your options.
The consultation is free. What you'll get is an honest assessment. Not best-case scenarios or wishful thinking. Realistic analysis of where the investigation stands, what charges are possible, and what paths exist for resolution.
Call us at 212-300-5196. The DOJ Consumer Protection Branch has made clinical trial fraud an enforcement priority. They're actively pursuing these cases. They're getting convictions. They're getting prison sentences. Early counsel isn't just helpful - it's critical. Were here when you need us.
