Clinical trials are the bedrock of the medical research industry. They provide evidence to build trust with consumers and the FDA that new drugs, treatments, and devices are safe and effective. Because these trials deal with products that will be used directly on or within the human body, they must be conducted accurately and honestly. Specific protocols and regulations are put in place to make sure this happens every time.
Unfortunately, these protocols are sometimes rushed or ignored, leading to clinical trial fraud. Florida punishes anyone who intentionally disrupts the integrity of the clinical trial process with fines, a license revocation, or even prison. However, not every clinical trial fraud accusation is credible. Sometimes, people are mistakenly held responsible for fraud that was out of their control or in an attempt to shift blame from one individual to another. If you are facing clinical trial fraud accusations, the following steps can help prepare your defense to preserve your innocence.
One of the most important things to keep in mind is that an accusation is not an automatic conviction. While it’s natural to feel the gravity of a fraud allegation, keeping calm and not jumping to hasty decisions can prevent any unnecessary errors that could delay or alter the results of the case.
Even if you are certain the accusations are false, it is still recommended to consult with a criminal defense attorney. They are trained to assess the basis of any legal claim and support their client by pointing out holes to prove innocence or negotiating for a lighter punishment. They can also serve as your emotional safety net, as they’re motivated to protect you in a situation where it may seem like everyone is out to get you.
When you hear someone saying with certainty they believe you committed fraud, it can be difficult to take the back seat and not respond. However, making such comments in the public sphere has the power to backfire. You can never be too sure how the prosecution will twist your words to boost their own case. Leaving all communication up to your attorney can prevent this from happening.
The benefit of clinical trials is that there is a ton of documentation collected throughout the entire process that can help support your innocence. From patient data to consent forms and communication records, you want to collect everything you can to use as ammo for your case. Working with your attorney can help ensure the evidence is legally collected and admissible in court.
While you don’t want to share information with opposing counsel without your attorney present, it’s important to come across as cooperative when everyone is in attendance. Refusing to cooperate without citing any legal interference can give the impression there is something to hide. Ensure your attorney is present every time you engage with the other side, as they can intervene and tell you when not to respond if appropriate.
Like most Florida crimes, the penalty will vary based on how severe the crime is and its impact on the victims. Convictions can be either civil or criminal penalties. On the criminal side, anyone found guilty could face fines or imprisonment. Sentences could last anywhere from a few years to several decades, especially if the guilty party is a repeat offender. If the case is found to be a violation of civil law, the individual may have to pay back any defrauded funds and pay additional fines. There is also a chance they could lose their professional licenses that allow them to engage in clinical trials.
There are many different tactics you can take to help fight a healthcare fraud accusation. First, be sure to have all the documentation that helps to prove your innocence collected and organized. Provide this to your defense attorney as soon as you can to help build their strategy. The attorney will aim to lay out the facts that refute any of the major claims the prosecution is attempting to make their own case. Being honest with your attorney about every detail is essential, as an attorney needs to be able to act on the fly and respond to any unexpected comments or accusations during court. If there is a piece of the story they are missing, they will not be able to defend you as well as they could.
History has shown a number of different ways fraud has been committed in clinical trials. One frequent scenario is when an individual falsifies patient data enrollment numbers to “meet” any of the criteria required to make post-trial conclusions. Any evidence that the data has been manipulated to reach a trial objective, rather than the data reaching that conclusion itself, is considered clinical trial fraud. Another example is when researchers plagiarize the work of others without citing them as a reference.
Whistleblowers have played a historic role in uncovering criminal trial fraud. The Florida Whistleblower Act is designed to encourage people to come forward with any unethical conduct they witness in the workplace by protecting their careers from retaliation. Sometimes, in clinical trials, another party may witness a researcher tampering with study results or not reporting an adverse reaction to a certain drug. If the unethical individual does not self-report, a whistleblower is the next line of defense to protect the integrity of the study. However, not all whistleblower claims are valid. Because an individual could misrepresent the facts to pull focus away from their own actions, every claim needs to be evaluated and proven in court to prevent someone from unfair allegations.
If you are involved in clinical trials and have been accused of conducting fraudulent activity, you need a flawless defense strategy to demonstrate your innocence. Barry M. Wax, Attorney at Law, is proud to protect those who work in clinical trials that advance the health and safety of our local communities. Contact us today to learn how we can help you fight back against these allegations.