Bert Rein and John Kamp Discuss Not-Guilty Verdicts in Off-Label Device Marketing Case

March 2, 2016

Wiley Rein founding partner Bert W. Rein and consulting counsel John F. Kamp were quoted in a February 29 Bloomberg BNA article about the dismissal of a criminal case against a medical device manufacturer. The U.S. government had alleged that the company and its chief executive officer conspired to violate the Federal Food, Drug, and Cosmetic Act and sold misbranded medical devices. In unanimous verdicts, a federal jury found the defendants not guilty on both counts.

Mr. Rein and Mr. Kamp, who are members of Wiley Rein’s Food & Drug Law Practice, and have written and litigated extensively on off-label use issues, were in agreement with attorneys who said the verdicts do not bode well for future prosecutions of companies for promoting off-label uses of their medical products.

“When you get these cases before a jury, they tend to think, ‘What’s wrong with what these people did?’ ” Mr. Rein, who serves as Vice Chair Emeritus of the firm, told BNA’s Pharmaceutical Law & Industry Report. “This is a tough road because the government’s position is highly technical, and that’s hard for people to grasp.”

“This is another nail in the coffin for the FDA’s off-label promotional policies,” Mr. Kamp said. “I think the off-label promotional policies are going to be revised, and I hope fairly soon.”

Mr. Kamp also serves as Executive Director of the Coalition for Healthcare Communication, an industry group that promotes the free exchange of scientific and medical information.

The Bloomberg BNA article can be found here.