Who Pays $520,000 for a Speeding Ticket When they Claim They Don’t Have a Car? VSI & CEO Howard Root Acquitted of Criminal Charges but Not Innocent
February 26, 2016
Who pays $520,000 for a speeding ticket when they claim they didn’t even have car?
July 2015, Vascular Solutions (VSI) settled a civil case with the government, in which VSI paid $520,000 “to resolve allegations that it caused false claims to be submitted to federal health programs by marketing a medical device for the ablation (or sealing) of perforator veins without FDA approval and despite the failure of its own clinical trial.” The Department of Justice (“DOJ”) obtained criminal charges from a grand jury sitting in the United States District Court for the Western District of Texas against Vascular Solutions, Inc. (“VSI”) and Howard Root, VSI’s CEO, for off-label promotion of the company’s Vari-Lase devices. The Indictment alleges a conspiracy to defraud the U.S. government, along with distributing adulterated and misbranded medical devices. FDA Law Blog
Today, a jury acquitted Root and VSI on criminal charges, which to be clear is not innocent of all charges. It just means the jury wasn’t presented with enough information to convict criminally but there was federal civil action taken against the company, where Root is CEO. Root desperately tried shielding his crimes behind the First Amendment, not unlike two other federally indicted former Johnson & Johnson, Ethicon, Acclarent executives, William (Bill) Facteau and Patrick (Pat) Fabian, but there’s no mention of the First Amendment aiding in the acquittal during Root’s hubris-filled manifesto. Logic dictates that if you’re hiding behind something, you’re hiding something, and when it comes to medical devices, that’s tragic for patients. And when was the last time anyone paid $520,000 for a speeding ticket when they claimed didn’t even have a car? It’s inconsistent & contradictory language to action for VSI, where Root, as CEO, to knowingly & willingly pay to resolve false claims on a medical device then imply innocence in the criminal trial, which is a manipulation of facts without recognizing the rights of others, without shame, remorse, guilt or accountability while playing blame, in this case on taxpayers and those that represented the taxpayers (Assistant U.S. Attorneys General) Note: The one Root doesn’t use the word is innocent.
Not Guilty means exactly that, found not guilty, of the crime (innocent). Acquitted means what there wasn’t enough evidence to prove, beyond reasonable doubt, guilt, therefore, the defendant is acquitted of all charges.
“The company and I are vindicated by today’s verdict, but outraged by the obscene legal process we were forced to endure,” StarTribune
Wow, vindicated but he/the company paid the civil fine of $520,000 because DOJ had them dead-to-right; that’s not vindicated that’s an admission of wrongdoing, no matter how you slice it.
Root and the corporation were charged in November 2014 in a nine-count grand jury indictment alleging company executives conspired to sell their Vari-Lase Short Kit to doctors for medical procedures not approved as safe by the U.S. Food and Drug Administration. Prosecutors said the company defied explicit warnings from the FDA not to promote the device for treatment of veins deep in the legs. StarTribune
“We are appalled by the malicious behavior and lack of substantive oversight of the government officials who pursued this matter – in particular Assistant U.S. Attorneys Bud Paulissen and Christina Playton of the Western District of Texas, Consumer Protection Branch Trial Attorneys Timothy Finley and Charles Biro, and FDA Special Agent George Scavdis. There simply is no excuse for abusive and dishonest conduct in any U.S. governmental agency, much less in the Department of Justice and our law enforcement agencies.” “We greatly appreciate the jury’s complete rejection of the government’s false allegations.” Qmed
“Government’s False Allegations?” What? Root still paid a civil fine. Wow, you know who should be appalled? Federal taxpayers everywhere because this unrepentant, abusive, and dishonest CEO, who also happens to be an attorney, is encouraged that his company only paid a civil fine, where he’s free to replicate and reward this unethical and illegal behavior on behalf of the company.
The judge, in fact, instructed the jury in Root’s case that it is “not a crime for a device company or its representatives to give doctors wholly truthful and non-misleading information about the unapproved use of a device.” Qmed
The First Amendment protects truthful speech, but as the Supreme Court pointed out in Illinois v. Telemarketing Associates, it “does not shield fraud.”
Senior U.S. District Judge Royce Lamberth likely wasn’t familiar with that ruling since it wasn’t carved on stone tablets when he was appointed in 1987 and served in the Litigation Division of the Office of the Judge Advocate General of the Army at the Pentagon from 1971 to 1974. This is part of what’s wrong with our legal system, from SCOTUS on down, there’s a naturally diminished capacity after a certain age; and, these are the people we have making decisions on things they couldn’t possibly understand.
Judge Lamberth stated it’s “not a crime for a device company or its representatives to give doctors wholly truthful and non-misleading information about the unapproved use of a device.” If you’ve been injured by any medical device be sure and let Judge Lamberth know that his ruling is telling companies it’s acceptable to lie to doctors who unknowingly lie to patients causing them harm.
Judge Lamberth failed the medical device industry where employees will now be forced to sell off-label and he’s failed the patients, that will be harmed, by bending the law for profits. I’m still not sure the First Amendment saved Root more than the jury couldn’t prove fraud. Criminal cases are much harder to prove than civil; and, it didn’t help that Judge Lamberth contradicted the law during jury instruction.
Unchecked unethical and illegal behavior will escalate until it’s forced accountable. I’m sure Assistant U.S. Attorneys Bud Paulissen and Christina Playton of the Western District of Texas, Consumer Protection Branch Trial Attorneys Timothy Finley and Charles Biro, and FDA Special Agent George Scavdis along with myself in the cheap seats will keep an eye on this, because it’s not a matter of “if” we read about VSI and their CEO again, it’s “when.”
Just because a jury could not or did not convict on criminal charges is not the same as innocent, something the public tends to not fully understand, and when people like Root, later try and imply innocence by manipulating the facts in a misguided press release, I for one, won’t forget or forgive. This is enough information for me to know I would never work with Howard Root or VSI nor as a consultant would I recommend any clients work with Howard Root or VSI. It’s up to each person reading this to understand the facts and apply the facts, however is best for them personally and or professionally.
USA v. Facteau et al Massachusetts District Court, Case No. 1:15-cr-10076 (a countdown clock is at the bottom of this page), Facteau’s attorneys also claim First Amendment protection, but according to the indictment:
Stay tuned…
Derek Stocker
In addition to age related diminished capacity there are many other factors. Did the Judge have a few too many the night before, a sleepless night, family strife, medications etc., we know it should remain outside the court and chambers but human nature makes that darned difficult.
Some countries have a panel of three Judges, a fairer system? You judge the Judges.
Melayna Lokosky
That’s a great point Derek, and I like the idea of a panel of three to judges; but, I believe that’s what our jury system is supposed to do. However, when you have a judge, whose never worked in the industry, saying people can say “wholly truthful & non-misleading” statements about off-label, but doesn’t understand that reps are lied to, who in turn lie to doctors who in turn lie to patients (as was the case with myself and peers at Johnson & Johnson’s Ethicon’s Acclarent), we’ll allowing the companies to place blame without taking accountability. Unless studies are done to verify what’s being said, then it can’t be the “company’s truth and then the truth, there is only one truth, and this judge’s instructions to the jury set the stage to allow the company off from criminal accountability, even though they agreed they were civilly accountable. I’m not sure if the AG’s can appeal in this case, but I hope that if they can, they do, it’s too important for the safety of employees, consumers, patients, and taxpayers.
Lisa Jorgensen
You are wrong about this case. I don’t believe you were there. I was.
Melayna Lokosky
You were there how, as a juror? Root’s attorney? Just because you were there doesn’t me you’re correct. I wasn’t there but just worked in the industry for 13 years. So, I’ll trust my applied knowledge from the facts about the industry over that of a stranger who offers no facts to support their claims.
Helge Sandve
It is obvious who pays $520,000 for an unjustly-issued speeding ticket: somebody who would have to pay many times that amount in legal bills to fight the speeding ticket. But you already knew that.
Melayna Lokosky
What my experiences have taught me is that once a Grand Jury indicts it’s usually for just cause. Perhaps they were mischarged (too broad or not broad enough) meaning where there’s smoke there’s fire, but something was done unethically and or illegally. The “speeding ticket” wasn’t unfairly issued which is why they paid they fine. However the idea that you’ve taken the time to comment in defense of fraud says more about your own personal lack of moral integrity thereby invalidating your comment to ethical readers.