Vascular Solutions CEO 'Outraged' by Federal Prosecution

Brian Buntz

March 4, 2016

3 Min Read
Vascular Solutions CEO 'Outraged' by Federal Prosecution

Recently acquitted of off-label promotion of medical devices, the attorney and device executive Howard Root has penned an op-ed in the Star Tribune decrying his "malicious" federal prosecution.

Brian Buntz

Howard RootVascular Solutions CEO Howard Root is angry. For more than five years, he has been at the receiving end of a Department of Justice trial. Recently acquitted, Root had been accused of orchestrating a scheme of selling one of the company's products treat perforator varicose veins rather than saphenous varicose veins. In the end, Root and his company had been charged with one count of conspiracy and eight counts of introducing adulterated and misbranded medical devices into interstate commerce.

But the conspiracy charge against Root--a felony--was especially unfair, he writes, because the device in question--the Vari-Lase "short kit" --had been cleared by FDA for use in all varicose veins and the product was not a part of its core product line. "[O]ver two-thirds of our salespeople never sold even one unit of it," he explains, adding that "sales constituted only 0.1 percent of our total sales and not a single patient was harmed."

"Why would federal prosecutors spend five years pursuing something so wrongheaded and so insignificant?" he asks.

Root claims that the federal prosecution began after one of members of its sales staff became enraged that he wasn't promoted. "So he quit and filed a baseless complaint with the U.S. attorney's office in San Antonio, alleging a multitude of offenses to try to justify a $20 million claim," he said. The former employee then stood to receive 20% of any proceeds from the lawsuit.

That lawsuit would lead the plaintiff to subpoena more than two million pages of the company's documents and interviews with more than 60 of its customers and employees.

Root says that prosecutors used highly questionable tactics to obtain evidence from witnesses:

[In conversation with our lawyers, they called conflicting statements by witnesses "a line of sh*t." They referred to one employee as "a poor f***er" who needed to return "on bended knee" to "fix" his testimony. They told a female employee to think about what would happen to her firstborn son if she were indicted because she refused to "cooperate." And by "fix" and "cooperate," I mean retract their prior testimony and support the government's case.]

Root reasons that the federal prosecutors were desperate to convict because they are rewarded based on them rather than exonerations.

The company ultimately hired a substantial team of attorneys from 10 different lawfirms at a final price tag of $25 million. Because the lawsuit was in San Antonio as opposed to Minnesota where the company is based, the company hired local attorneys as well.

"In the end, after I endured four weeks sitting in a San Antonio courtroom while still running Vascular Solutions in Minnesota, the jury rejected each and every allegation," he writes. "And that was without hearing from any of our 20 witnesses, since we made the decision to rest immediately after the government finished its case. So the government's own witnesses proved our innocence -- simply stunning."

In the end, Root is calling for Minnesota's U.S. senators, both of whom are on the Senate Judiciary Committee, to remove the prosecutors involved this case.

Having founded Vascular Solutions in 1997, Howard Root boasts that his company has since developed more than 100 medical devices used for vascular disease applications and has created more than 500 jobs in the process.

The company ultimately pulled to product at the heart of the lawsuit from the market and paid $520,000 to resolve a civil whistleblower lawsuit alleging off-label marketing of the device.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz. 

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