A March 1 article in Bloomberg BNA’s Pharmaceutical Law & Industry Report quotes life sciences senior counsel Alan Bennett (Washington, D.C.) on how device maker Vascular Solutions Inc. and its chief executive officer were found not guilty in an off-label criminal case accusing them of illegally promoting a device used for treating varicose veins.
Mr. Bennett explains that while many cases involving medical manufacturer speech are settled, those that do go to trial often do not turn out well for the government because juries are reluctant to convict for alleged speech violations where there is an individual defendant and no allegation of patient harm. He points out that the U.S. Food and Drug Administration will eventually have to accept judicial findings that its current system of regulating speech is inconsistent with the First Amendment.
Reproduced with permission from Pharmaceutical Law & Industry Report, 14 PLIR 319, (March 4, 2016). Copyright 2016 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com
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