For as long as I can remember, at every company meeting I’ve ever been to, the topic of off-label promotion is always covered. Whether it was new-hire orientation, a national sales meeting, or some other large commercial event, the dissemination of off-label information was always presented as not only a fireable offense, but something that could get you thrown in jail. C.R. Bard, Boston Scientific, Covidien, Medtronic. Everyone considers this to be extremely important. And rightfully so.
BUT, doctors use medical devices off-label all the time. If you go to any societal conference, physicians present off-label uses for medical devices on a regular basis. In fact, talk to any KOL, and they think it’s almost humorous that medical device companies take off-label promotion so seriously.
Because I’ve spent the majority of my medical device career in a sales or marketing capacity, I’ve always found this to be an interesting dynamic. Our physician customers discuss and use our products off-label all the time. But we can’t say anything? If a doctor asks a question about an off-label use, mum is the word. “Sorry Dr. Smith. I can’t answer that question. No information. Nada. Zilch.”
However, the times are certainly changing. In a recent landmark criminal case against Vascular Solutions, the actual instructions to the jury included this statement, “It is not a crime for a device company or its representative to give doctors wholly truthful and non-misleading information about the unapproved use of a device.” Wow! That’s the first time something like that has ever been uttered by the government!
In this interview with Mark Duval, President of DuVal & Associates, P.A., we learn about other recent First Amendment cases and what the outcomes mean for medtech companies moving forward.
Interview Highlights with Mark DuVal
- The 3 key takeaways from the recent criminal case against Vascular Solutions and why everyone in medtech should pay attention.
- Why the government’s focus on speech vs. conduct is so important.
- The government’s recognition that off-label promotion is legal as long as it’s “wholly truthful and not misleading”.
- New implications regarding the FDA’s interpretation of general vs. specific use.
- Other recent cases the government has lost and why there’s a significant amount of inertia for positive change.
- Mark’s advice for medtech leaders in light of the government’s losses in so many First Amendment cases.
- Mark’s favorite book, the CEO he’s closely following right now, and the advice he’d give to his 30-yr. old self.
Mark DuVal, J.D., is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally. Mark earned his Juris Doctor from the William Mitchell College of Law where he served as executive editor on the law review, and his Bachelor of Arts in Public Administration from St. Cloud State University. Mark is a frequent national speaker and writer on issues relating to product approvals/clearances; combination products, product advertising and promotion, Anti-kickback and False Claims Act (reimbursement) matters.
For as long as I can remember, at every company meeting I’ve ever been to, the topic of off-label promotion is always covered. Whether it was new-hire orientation, a national sales meeting, or some other large commercial event, the dissemination of off-label information was always presented as not only a fireable offense, but something that could get you thrown in jail. C.R. Bard, Boston Scientific, Covidien, Medtronic. Everyone considers this to be extremely important. And rightfully so.
BUT, doctors use medical devices off-label all the time. If you go to any societal conference, physicians present off-label uses for medical devices on a regular basis. In fact, talk to any KOL, and they think it’s almost humorous that medical device companies take off-label promotion so seriously.
Because I’ve spent the majority of my medical device career in a sales or marketing capacity, I’ve always found this to be an interesting dynamic. Our physician customers discuss and use our products off-label all the time. But we can’t say anything? If a doctor asks a question about an off-label use, mum is the word. “Sorry Dr. Smith. I can’t answer that question. No information. Nada. Zilch.”
However, the times are certainly changing. In a recent landmark criminal case against Vascular Solutions, the actual instructions to the jury included this statement, “It is not a crime for a device company or its representative to give doctors wholly truthful and non-misleading information about the unapproved use of a device.” Wow! That’s the first time something like that has ever been uttered by the government!
In this interview with Mark Duval, President of DuVal & Associates, P.A., we learn about other recent First Amendment cases and what the outcomes mean for medtech companies moving forward.
Interview Highlights with Mark DuVal
- The 3 key takeaways from the recent criminal case against Vascular Solutions and why everyone in medtech should pay attention.
- Why the government’s focus on speech vs. conduct is so important.
- The government’s recognition that off-label promotion is legal as long as it’s “wholly truthful and not misleading”.
- New implications regarding the FDA’s interpretation of general vs. specific use.
- Other recent cases the government has lost and why there’s a significant amount of inertia for positive change.
- Mark’s advice for medtech leaders in light of the government’s losses in so many First Amendment cases.
- Mark’s favorite book, the CEO he’s closely following right now, and the advice he’d give to his 30-yr. old self.
Mark DuVal, J.D., is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally. Mark earned his Juris Doctor from the William Mitchell College of Law where he served as executive editor on the law review, and his Bachelor of Arts in Public Administration from St. Cloud State University. Mark is a frequent national speaker and writer on issues relating to product approvals/clearances; combination products, product advertising and promotion, Anti-kickback and False Claims Act (reimbursement) matters.
