What does the False Claims Act do, and when does it involve medical devices? In today’s episode, you’ll hear from Jonathon Tycko, an attorney who represents whistleblowers. Jonathan is a founding Partner with Tycko & Zavareei LLP, a law firm with offices in Washington, D.C., and California. His practice represents whistleblowers under the False Claims Act, along with similar statutes. Jonathon created and hosts his own podcast, The Garrulous Gavel.

In today’s conversation, we cover the history of the False Claims Act and the lifecycle of the medical device. Listen to the episode to hear what Jonathon has to say about the process of the whistleblower’s claim, best practices for companies in relation to whistleblowers, and what kinds of penalties might result from a finding of fraud.

Some of the highlights of this episode include:

• History of the False Claims Act
• The process of filing a whistleblower claim
• What happens if the whistleblower’s claim isn’t investigated
• The flow of money in whistleblower cases
• How many whistleblower cases are successful each year
• Best practices for companies in relation to whistleblowers
• Whether whistleblowers can be reintegrated into the company when they don’t have a case
• Whistleblower cases in the medical device field
• Boundaries and understanding when you’re on the hook for what you do within your company
• What the penalty for potential fraud could look like
• Definitions of profiteering and price differentiations between the government or another entity
• Advice for medical and medical device companies

Memorable quotes from Jonathon Tycko:

“The vast, vast, vast majority of the cases that the government brings is because of whistleblowers, because of that 1986 amendment.”

“This is where most companies get in trouble in the device field. It’s in the marketing of the product.”

“You don’t want to do this and get caught by the Department of Justice. It will not be worth it to you.”

“If your goal is to have a sustainable company that’s going to be around for a while, you have to accept the fact that you’re in a highly, highly, highly regulated business, and you can’t just put the blinders on when it comes to compliance.”

Links:

Jonathan Tycko LinkedIn

Tycko & Zavareei LLP

The Garrulous Gavel podcast

Etienne Nichols LinkedIn

Greenlight Guru Academy

MedTech Excellence Community

Greenlight Guru