With images of Edward Snowden or Karen Silkwood in their minds, it’s scary for most people to consider being a whistleblower in the workplace. However, while fraud in the clinical trial industry is extremely rare, as in any other profession, it has its occasional bad actors who subvert regulations either through carelessness or malice.
That’s where Shauna Itri, MA, JD, shareholder at Berger & Montague PC, comes in. “I think a lot of times, people [who come to us] are experiencing some sort of fraud” internally or externally, “or they know there’s unfair competition because their competitors are” committing fraud, she says. “I don’t think people know of [laws like the False Claims Act] and that there’s an option out there for them to come forward and receive a reward for doing the right thing.”
Maybe one out of 100 people will experience fraud that rises to the level of bringing a False Claims Act suit, but it does happen, Itri says. Often peppered with questions after she speaks on the subject, she says a few of her cases have begun when an attendee reaches out to her after the session is over.
Under the False Claims Act, a whistleblower does not have to show the alleged abuse is harming them directly, Itri says. “You can stand in the shoes of the government, and it’s a very different type of law than anything else out there because with normal litigation and other statutes, you have to be the person that is harmed—you’re the one that’s hit by a car, for example.”
Updates on Fraud, Waste, and Abuse in Clinical Research and the False Claims Act
Join us at ACRP 2019 for a primer on the False Claims Acts in clinical research, and dive into fraud enforcement trends and various related “hot button” issues. Presenter Shauna Itri will discuss how non-compliance compromises the financial and operational viability of current trials, as well as potential loss of funding, risks of fines and penalties, settlement costs and more.
Clearly, however, there are several pros and cons for the would-be whistleblower to carefully consider.
“A pro is you feel like you’re doing the right thing,” Itri says. “Number two, you might have a great reputation [for being honest] if it comes out from under seal and you filed this case. Three, you might get an award, which is a huge pro because a lot of these cases [can involve] hundreds of millions of dollars, and it results in huge rewards.”
It’s the cons that merit especially close consideration. For example, the case might not be successful. “Then you’re outed as a whistleblower and I think it might be hard to get a job [anywhere else] in the healthcare industry,” Itri says. “I always have to work very closely with clients in advising them about these cons. If it’s a younger client, they’re just getting started and they love the healthcare industry, and the case is like 50/50, I might say ‘Hey, I don’t know if this is in your best interest.’”
In a different scenario, where the potential whistleblower is older and nearer retirement or leaning toward exiting the healthcare field, Itri suggests “they might want to take a little bit more of a risk if the case is a really good one.”
Finally, Itri says to be wary of how lawyers set their fee structure if they take your case. Avoid lawyers who want to bill hourly, she advises. Her firm pays all the costs and gets a piece of the settlement only if the client wins the case, she explains.
Author: Michael Causey