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.
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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
“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.”
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Etienne Nichols is the Head of Industry Insights & Education at Greenlight Guru. As a Mechanical Engineer and Medical Device Guru, he specializes in simplifying complex ideas, teaching system integration, and connecting industry leaders. While hosting the Global Medical Device Podcast, Etienne has led over 200...