Jeffrey L. Bornstein

Jeffrey L. Bornstein

K&L Gates LLP

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Corporate Responses to Investigative Requests by the Federal Government

In light of these new realities corporations face, the first step a company should take is to establish internal guidelines addressing interaction with government agents. Companies should have a response policy in place and...more

9/4/2014 - Best Management Practices Government Investigations Investigations Policies and Procedures

Off-Label Marketing Questioned as a Viable Criminal Theory – But Stay Tuned

On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label...more

12/17/2012 - FDA FDCA First Amendment Marketing Misbranding Off-Label Promotion Off-Label Use Pharmaceutical

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