April 29, 2019

“Nothing short of criminal.”

That’s how one juror described the U.S. government’s relentless prosecution of Howard Root, the CEO of a medical device company who in 2016 found himself facing three years in prison and the destruction of the company he worked so hard to build.

In a new video, the Goldwater Institute examines why the government targeted Root and how, ultimately, he and his company were acquitted of all charges. The video follows a report by Goldwater national investigative journalist Mark Flatten, who uncovers Root’s story and the implications it has for all Americans.

Root is the founder and former CEO of Vascular Solutions (VSI), a Minneapolis-based company producing medical devices to treat vascular disease. One day he was notified that federal prosecutors were investigating him and his company for what they deemed criminal activity: Some VSI sales representatives, against Root’s orders, had discussed potential off-label uses for one of the company’s medical devices, the Vari-Lase short kit. But while it’s legal and extremely common for doctors to prescribe treatments off-label (that is, for a condition different from the one it was approved by the FDA to treat), it is not legal, in the government’s view, for treatment manufacturers to talk about those off-label uses with doctors. Numerous federal courts have ruled otherwise, finding that drug and medical device manufacturers have First Amendment free-speech rights to honestly discuss the off-label uses of their products.

This government ban on sharing of truthful information is truly damaging: It hurts patients, limiting their ability to make the most informed choices about their care in concert with doctors. When it comes to making choices regarding their healthcare, “people need to have more information so that they can make informed decisions—not less,” explains Goldwater Institute Executive Vice President Christina Sandefur. “What the FDA is doing is taking important information away from doctors and away from patients.”

And being unable to communicate about treatments’ off-label uses not only chills the speech of drug and medical device manufacturers—it also has bigger consequences for innovation and the development of new medical breakthroughs. In VSI’s case, money that could have been spent on research and development was instead spent on its fight with the government. “It’s not like products are pulled off the market, it’s that products are never developed,” Root says.

After years of battling the government, Root and VSI were acquitted of all criminal charges by a jury in February 2016. But no medical device CEO should have to go through what Root experienced, especially when patient care can be improved by changing the law. With that in mind, the Goldwater Institute developed the Free Speech in Medicine Act, which would protect the free-speech rights of pharmaceutical companies to speak freely with doctors about truthful information regarding their products’ uses. Arizona and Tennessee have already passed laws protecting free speech in medicine, and other states are considering passing their own similar legislation based on the Goldwater model.

You can watch Root tell his story in a new Goldwater Institute video above. And to learn more about him and about Free Speech in Medicine, read Mark Flatten’s recent report, Gagged: Feds Use Criminal Charges, Threats to Silence Drugmakers.

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