Med tech execs strike back at FDA regulation for off-label device marketing

Vascular Solutions CEO Howard Root

Two med tech execs are pushing back at the FDA's regulation of device marketing, claiming that the agency violated their constitutional right to free speech by restricting off-label marketing for certain products.

As The StarTribune reports, former Acclarent sales executive Patrick Fabian and current Vascular Solutions ($VASC) CEO Howard Root are trying to uncover secret grand jury hearings that could potentially undermine their indictments for off-label marketing, saying in court filings seen by the newspaper that they had a First Amendment right to make marketing statements in emails and company presentations. The cases echo a recent precedent, as in August a judge ruled on the side of pharma company Amarin ($AMRN) and said that the company's off-label marketing of its fish oil pill was protected under free speech.

In 2013, grand jurors in a San Antonio, TX-based court charged Root with conspiracy and illegal promotion of its Vari-Lase Short Kit. The device was approved to treat varicose veins near the surface of the skin, but Root allegedly told sales teams to market the product for short vein segments deeper in the leg, according to the StarTribune story.

Last year, a Boston grand jury indicted Fabian and his alleged accomplice, former Acclarent CEO William Facteau, for illegally marketing the company's Stratus device, a small surgical balloon that can be inflated inside the nose to keep nasal passages open following surgery. The device has tiny holes that can release a liquid drug, but the product was never approved as a drug delivery device. Acclarent execs told the FDA that the holes were intended to let saline seep out and moisten tissues.

But according to a court indictment seen by the StarTribune, Fabian and Facteau marketed Stratus as a drug delivery device anyway. "The primary Stratus promotional brochure, which is a piece of labeling under the (Food, Drug and Cosmetic Act), had a picture of Stratus inflated with a milky white substance that looks like Kenalog-40, not like clear saline," the indictment says, as quoted by the newspaper.

Still, both Fabian and Root have pled not guilty to charges and are battling it out in court. And Root is taking his defense beyond free speech, accusing prosecutors of coaching key witnesses to sway their grand jury testimony. Root also asked a judge to throw out the case all together, claiming prosecutors incorrectly told grand jurors that any off-label use for its Short Kit was illegal, which was "simply wrong," according to a motion seen by the StarTribune.

The two cases could have implications on other med tech courtroom battles, as company leaders strike back at the FDA's marketing oversight. The incentives for executives to fight are different than companies themselves, defense attorney Tom Beimers told the newspaper, as companies often opt for a settlement and an individual chooses to fight claims.

"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," Beimers said, as quoted by the StarTribune.

- read the StarTribune story