Employees Of Research Lab Convicted For The Role In Fraudulent Clinical Trials

Clinical trials are important to the practice of medicine, but they are also important to the practice of law.  Every time you have taken a prescription drug, it had to go through clinical trials before getting FDA approval so that your doctor could legally prescribe it.  Likewise, the recommendation your doctor follows about the dosage, indications, and contraindications for the drug are based on clinical trials.  From a legal standpoint, in Daubert and other cases, the U.S. Supreme Court has ruled that expert witnesses in civil and criminal court can only cite published research about medical science if that research is based on clinical trials; animal studies, case reports, and in vitro studies do not carry the same legal weight.  Since people’s health and, in some cases, their freedom depends on the results of criminal trials, intentional misrepresentations of data in clinical trials is a serious offense.  There is a whole corner of the Internet dedicated to tales of academic misconduct, but most of it does not warrant criminal prosecution; you can lose your job for paying to get your name listed as an author of a study or for paying a journal to publish a poorly written paper, but these types of academic misconduct are not crime.  Falsifying criminal trials, however, is fraud.  If you are being accused of criminal misconduct in the context of your work as a scientific researcher, contact a Tampa white collar crime lawyer.

The Case of the Non-Existent Study Participants

Eight people affiliated with Tellus, a research lab in Miami, have been accused of fraud, money laundering, and other financial crimes.  For several years leading up to 2016, employees of the lab defrauded the companies that hired them to perform clinical trials on pharmaceutical drugs and treatment protocols they were developing.  The studies included clinical trials on opioid use disorder therapies and medications to treat irritable bowel syndrome (IBS) and diabetes-related kidney disease.

For example, the money that Tellus received from the companies included enough to pay a certain number of patients for their participation.  The Tellus staff recruited far fewer participants than the companies requested.  Several employees of the company filled in made-up data as if the studies had more participants than they did.  Sometimes they used the identifying information of people they knew.  They even impersonated the phantom participants when recording voice memo diaries about their symptoms.

Duniel Tejeda, Nayade Varona, Eduardo Navarro, Analay Rico, and Daylen Diaz pleaded guilty for their roles in the fraud and received prison sentences of several years.  Navarro received the longest sentence, namely 46 months.  Martin Valdes, Fidalgo Font, and Julio Lopez pleaded not guilty, and their cases are still pending.

Contact Tampa Criminal Defense Attorney Bryant Scriven

A criminal defense lawyer can help you if you are facing criminal charges for fraud or making false statements in a healthcare or research setting.  Contact Scriven Law in Tampa, Florida to schedule a consultation.

Sources:

outsourcing-pharma.com/Article/2022/10/20/medical-study-coordinators-jailed-for-falsifying-clinical-trial-data

cbs4indy.com/news/florida-women-plead-guilty-to-role-in-falsified-clinical-trials/