This case study profiles Miami-based Unlimited Medical Research, LLC (Unlimited) and two physicians, Dr. Yvelice Villaman Bencosme and Dr. Lisett Raventos.
According to FDA investigators, Dr. Bencosme and Dr. Raventos fabricated patient records. When the physicians submitted this falsified data to the pharmaceutical company, the pharmaceutical company paid them for the fake research. The defendants admitted to creating false medical data and defrauding the pharmacy.
These two physicians allowed their greed to overcome good decision-making, resulting in severe prison sentences.
Upon completion of this Case Study, participants should:
- Understand the elements of a wire fraud conviction.
- Identify ways business owners and white-collar professionals can avoid becoming ensnared in a federal criminal investigation;
- Explain how a strong, written internal compliance program and employee training programs can assist a business stay on the right side of the law.
State of the Industry
In January 2021, the U.S. Justice Department (DOJ) published a report to review prosecutions in healthcare fraud. The DOJ’s prosecution efforts identified more than $6 billion in false and fraudulent healthcare claims. The DOJ indicated the efforts in 2020 were the largest healthcare fraud enforcement action in the department’s history.
The cases involved a large variety of medical doctors, healthcare providers, medical researchers, and other individuals who unwittingly became involved in criminal activities.
Background and Analysis
According to the Justice Department, Miami-based Unlimited Medical Research, LLC (Unlimited), began operations in 2013. The company employed Dr. Yvelice Villaman Bencosme. She served as the primary researcher for clinical trials. Dr. Lisett Raventos, another medical doctor, served as the site director, director of clinical operations, and study coordinator at Unlimited.
The FDA has been a part of the Department of Health and Human Services (HHS) since Congress created the agency in 1939. The agency’s rules ensure the safety, efficacy, and security of drugs, products, and medical devices intended for human use. The primary focus of the FDA has been the enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C).
Prior to granting approval for new drugs, FDA evaluation includes a thorough analysis of clinical trial data. Reliable and accurate data is essential for such a review in order to validate the drug’s safety and effectiveness. Should the FDA make favorable decisions and grant approval for pharmaceuticals based on compromised or falsified data, the risk of harm to consumers cannot be overstated.
Bencosme and Raventos oversaw a clinical trial of children’s asthma medication. The purpose of their research was to examine the safety and efficacy of a new asthma medication designed to prevent and treat asthma in children aged 4 to 11. However, instead of evaluating the medication with real patients and conducting authentic research, Bencosme and Raventos engaged in widespread fraud by falsifying medical records for dozens of nonexistent pediatric patients. The false records suggested pediatric patients received the required doses of the study drug and were compensated for those visits. When FDA investigators began asking questions, Bencosme and Raventos admitted to investigators that they had fabricated data in the clinical trials.
As a result of the FDA’s investigation, federal prosecutors at the Justice Department brought criminal charges against Bencosme and Raventos. They charged each defendant with one count of conspiracy to commit wire fraud. A criminal conspiracy takes place when two or two or more people agree to commit an unlawful act. By submitting falsified patient records for payment, the two physicians defrauded the pharmaceutical company that commissioned the study.
Wire fraud involves the use of some form of telecommunications or the internet, including phone calls, faxes, emails, texts, or social media messaging. Wire fraud carries a possible punishment of up to 30 years in federal prison. Both defendants pled guilty to the criminal charge and admitted to their participation in the scheme.
As a direct result of their criminal behavior, Bencosme received a sentence of 63 months in prison and a forfeiture judgment of $174,000. The judge sentenced Raventos to 30 months in prison and a forfeiture judgment of $65,000. Both defendants lost their license to practice medicine. In sentencing Raventos, U.S. District Judge Beth Bloom said that if the defendants’ actions had been left unchecked, the scheme “could have negatively impacted the treatment and well-being of children with asthma throughout the country.”
The facts of this case do not reveal whether Unlimited had a compliance training system in place. We recommend that all businesses, particularly those businesses that operate in highly-regulated industries, like healthcare, implement compliance training. Those compliance training programs should include lessons in the ways that government investigations begin, and how people can make decisions on the job that bring severe consequences.
Our team at Compliance Mitigation works with people that face charges for white-collar crime regularly. Many of those people argue that they did not understand the full ramifications of their decisions; they certainly did not view their behavior through the same lens as a prosecutor.
American prisons incarcerate many business professionals that profess ignorance of the law. For these reasons, we highly recommend compliance training that helps people understand more about white-collar crime.