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Vascular Solutions Not-Guilty Verdict Another Challenge To FDA Off-Label Oversight

The case against the venous device manufacturer turned on the rights of manufacturers to use truthful off-label speech to promote their products. It joins a growing body of cases in which courts have sanctioned broader off-label speech than has traditionally been allowed by FDA.

A Texas jury may have helped boost the First Amendment rights of device manufacturers on Feb. 26 by finding Vascular Solutions Inc. (VSI) and its CEO Howard Root not guilty on charges of illegal off-label marketing.

The US Department of Justice had alleged VSI and Root promoted the Vari-Lase product, which was FDA-approved for the ablation...

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