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When Poor Communication Puts You at Legal Risk by Jennifer Williams

In recent case reviews, off-label promotion of medical devices and pharmaceuticals has been presented as a prime focus for government investigation. This is no doubt due to the two-fold nature of the issues surrounding off-label promotion. In the first place, off-label promotion is an illegal activity that violates federal law; secondly, it places individual employees and the corporations for which they work in jeopardy since infractions for such activities can include incarceration and heavy fines, for the employee as well as the corporate entity. Though the majority of off-label promotion cases have transpired from rather limited causes such as poor communication and inadequate corporate training programs, more than a few categories of off-label marketing complaints were observed during a legal query for this article. These included expansions to unapproved diseases, unapproved disease subtypes, and unapproved drug doses.

2nd February 2016