Rooting for Free (Commercial) Speech

Howard Root is living quite the antithetic existence, at least professionally.

The Vascular Solutions Inc. founder/CEO has turned his once struggling peripheral and coronary device manufacturing firm into a thriving $145 million business mostly by purposely avoiding confrontation. In 2001, for example, when the company faced financial ruin from direct competition with St. Jude Medical Inc., Root shifted strategies and targeted smaller “niche” markets traditionally ignored by medtech OEMs.

Worked like a charm.

Yet Root can hardly be considered a shrinking violet: He’s taken another firm to task over product defamation (gaining $3.5 million in damages), frequently sparred with Minnesota journalists, and threatened to halt new product development over state-sponsored disclosure legislation he opposed (the bill eventually died). He also is notorious for his candor.

“He has a strong voice and strong opinions,” Ryan Baird, spokesman for the non-profit trade group LifeScience Alley, told MedCity News. “Not everyone loves that…”

Maybe not, but Root’s overbearing personality and iron will have served him well during personal and professional crises. Those traits also could serve the industry well as the outspoken commander-in-chief fights efforts by U.S. Food and Drug Administration (FDA) officials to regulate commercial speech by healthcare firms.

Root and former Acclarent Inc. sales executive Patrick Fabian have become part of a growing crusade challenging the FDA’s restrictions on the language used in off-label promotions. The pair are attempting to expose secret grand jury hearings and undermine the federal indictments accusing them of illegally marketing their companies’ products, arguing that prosecutors inaccurately portrayed the kind of information device manufacturers can relay to doctors and hospitals.

Fabian and former Acclarent CEO William Facteau were charged in April with conspiracy, securities fraud, wire fraud and introducing adulterated or misbranded medical devices into interstate commerce. U.S. Justice Department officials contend the pair illegally marketed the Relieva Stratus Microflow Spacer by telling the FDA that Stratus would be used to maintain a sinus cavity opening when it really was launched as a steroid delivery device. The indictment notes the FDA had specifically refused Acclarent’s request to clear the Relieva Stratus for marketing as a drug delivery product without further submissions to support that use.

A San Antonio, Texas, grand jury indicted Root and Vascular Solutions five months earlier on eight misdemeanor charges of illegally promoting a varicose-vein laser kit and a ninth felony charge of conspiring to commit, and then cover up, the illegal conduct.

The government’s 25-page indictment against Root cites internal company e-mails and sales presentations as proof that he and his cohorts knew the FDA never granted the sweeping approval suggested to doctors in sales pitches for the Vari-Lase “short kit.” Approved in June 2007 to treat varicose veins near the skin, regulators barred Vascular Solutions from selling the device as a deep vein treatment due to safety concerns, but the company ignored the FDA’s directive, prosecutors claim.

At the heart of both cases is the longstanding “right to free speech” argument. The FDA argues that public safety concerns entitle the agency to control marketing language to prevent “off-label” promotion and the sale of misbranded or adulterated medical products. Fabian and Root, on the other hand, allege such regulation denies their First Amendment right to freely market products.
“The government’s off-label promotion theory is improperly content-based because it disfavors particular messages, ‘distinguish[ing] between favored speech and disfavored speech on the basis of the ideas or views expressed,’ ” Root claimed in his mid-August motion to dismiss the indictment. “The government’s theory also facially discriminates by ‘targeting one kind of speaker’—pharmaceutical and device manufacturers—as no doctor, scientist, researcher or anyone else in the world could be prosecuted for speaking truthfully about an off-label use. The government’s off-label promotion theory thus violates the principles of content- and viewpoint-neutrality that lie at the core of the First Amendment.”

In addition to his First Amendment defense, Root accuses prosecutors of coaching several witnesses to “fix” their grand jury testimony to conform to the law enforcement’s theory of the case.

Another argument for dismissal rests with the Justice Department’s alleged distortion of the law, with Root accusing prosecutors of telling grand jurors that any off-label use of the short kit was illegal.

“In fact, the law is clear that doctors can use the Vari-Lase products to treat perforator veins, on- or off-label,” the motion states. “…Off-label use of medical devices ‘is an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.’ The government also instructed the grand jury that Medicare did not cover laser ablation of perforator veins; in fact, in many (if not all) states—including Texas—Medicare did cover this treatment, regardless of the scope of its FDA authorization.”

Historically, the U.S. Justice Department has had a fairly decent track record in winning judgements against healthcare firms accused of illegal marketing and sales, collecting at least $8 billion in settlements and plea agreements since 2010. Such past triumphs could explain the government’s stepped-up efforts to punish corporate executives.

Holding CEOs and other managers accountable for their actions, however, is significantly more difficult to prove. Some legal experts predict a sobering end to the Justice Department’s incredible winning streak.

“The incentives are different. The incentive for the individual is to fight, whereas incentives for companies are often to settle and move on,” Minneapolis, Minn.-based defense attorney Tom Beimers told the Star-Tribune. “From my perspective, so long as there is strongly defensible clinical and factual support for the off-label promotion, given the way commercial speech doctrine has developed, it is going to be difficult for the government to win these cases.”

Especially with Root as an opponent.