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# Attorneys Analyze Vascular Solutions Acquittal
- URL: https://www.fdaweb.com/attorneys-analyze-vascular-solutions-acquittal/
- Published: 2016-05-02T12:00:00.000Z
- Updated: 2026-09-14T20:58:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135546

> In a 4/29 Washington Legal Foundations *Legal Backgrounder*, attorneys from King & Spalding examine the recent *U.S. v Vascular Solutions* acquittal and analyze the government’s shift in strategy as the courts come to terms on the importance of First Amendment protections with regar its regulatory and enforcement efforts. Vascular Solutions and its CEO **Howard Root** were [found not guilty](http://www.fdaweb.com/login.php?sa=v&aid=D5135102&searchWords=Vascular%20Solutions&cate=S&stid=%241%244b0.5q2.%24B.b5jMgSupIMKzaRAY6SW0) earlier this year on all federal charges concerning alleged off-label promotions of the Vari-Lase Short Kit. This was a significant loss for the government and FDA because it was hailed as an escalation in enforcement for holding company executives responsible for corporate wrongdoing. The case stemmed from a 2014 Department of Justice [indictment](http://www.fdalawblog.net/VSI%20Indictment%20%2800033302%29.pdf?ref=fdaweb.com) charging Vascular Solutions and Root with selling unapproved medical devices and conspiring to defraud the government by concealing the allegedly illegal sales activity. The government charged Root and the company with one count each of conspiracy and eight counts of introducing adulterated and misbranded medical devices into interstate commerce.  
>  
> In the [Legal Backgrounder](http://www.wlf.org/upload/legalstudies/legalbackgrounder/042916LB%5FBucholtz.pdf?ref=fdaweb.com), the attorneys say the key is now whether promotion is false or misleading, not whether it is “off-label.” During the case, the government “consistently sought to sidestep the First Amendment issues,” they write. “At the motion-to-dismiss stage, the government represented to the court that it did not intend to rely at trial on truthful promotion and instead would rely only on false or misleading promotion... Closer to trial, the government sought to moot a second defense motion concerning the First Amendment by going beyond its earlier promise to rely only on false or misleading speech and representing that in order to ‘eliminate any possibility that the misbranding offenses criminalize promotional speech,’ it ‘does not plan to use promotional speech to doctors to prove the intended use of the devices for perforator ablation.’”  
>  
> The attorneys write that the approach taken by the government in this case “illustrates its latest effort to avoid First Amendment scrutiny or impact on its enforcement theories.” The government alleged that the company engaged in misleading sales tactics — by continuing to promote the Vari-Lase device for treating perforator veins after FDA failed to clear a supplemental 510(k) for that use, by failing to disclose results from a clinical trial related to that use, and by providing misleading reimbursement information — and conspired to defraud the agency by concealing these sales practices. “But the government failed to persuade the jury that any such fraud had actually occurred,” they say.  
>  
> The attorneys note that as the government’s losses accumulate, “it is becoming clearer that the key battleground in off-label promotion investigations is the truth or falsity of the alleged promotion. Shifting the enforcement focus in this way leaves less room for future First Amendment challenges to government enforcement, but also significantly heightens the government’s evidentiary burden. This acquittal post-*Caronia* confirms that fraud in the context of medical device and drug promotion is much easier to allege than to prove.”