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Protecting Against FDA Abuses

March 4, 2019

by Rachel McPherson

March 4, 2019

At a Phoenix event last week, Goldwater Institute National Investigative Journalist Mark Flatten, former Vascular Solutions CEO Howard Root, and Goldwater Institute Executive Vice President Christina Sandefur discuss how the FDA limits free speech in medicine.

Howard Root was the head of a medical device company whose treatments improved the lives of many patients suffering from vascular disease. But thanks to overzealous U.S. Food & Drug Administration (FDA) regulators, Root spent millions of dollars fighting off criminal charges and nearly went to prison.

Root’s story is the subject of a new Goldwater Institute report released by the Institute’s National Investigative Journalist Mark Flatten. Root and his company, Vascular Solutions (VSI), were nearly brought down by, as Flatten writes, “a few rogue salespeople” who communicated with doctors about an off-label use for a “financially insignificant” VSI product, called the Vari-Lase short kit. While it’s completely lawful for doctors to prescribe a drug or treatment off-label (or for a use different from its FDA-approved use), federal regulators and prosecutors at the Department of Justice take the view that it’s not legal for drug or medical device manufacturers to communicate with doctors about those off-label uses. Federal courts have repeatedly taken a different view, ruling repeatedly that it is legal for drug and device companies to share truthful and non-misleading information about the off-label uses of their products.

Root had spent five years under federal investigation, indictment or in trial by the time he and VSI were acquitted of all criminal charges by a jury in February 2016. A conviction would have shuttered the company and sent Root to prison for three years.

Last week, following the report’s release, Root joined Flatten and Goldwater Institute Executive Vice President Christina Sandefur for a discussion of the federal government’s attempt to convict him for sharing truthful and constitutionally protected information about his company’s products—and what his story means for the future of innovation in the medical space.

Root explained that he was hit with a nine-count indictment—including one felony count of conspiracy—in 2014: “One day you get a subpoena from the federal government—you look at it and you spend the weekend in your office trying to dig into what the subpoena is for. It’s a criminal subpoena asking for records saying that you and your company are the target of a criminal investigation, and you find out they’re investigating a product that makes up 0.1 percent of your sales, has been approved by the FDA eight separate times, is being legally sold, has never had a single issue or patient complication, and they’re investigating you for the crime of a sales person for allegedly saying the wrong word.”

Root and his employees were subject to scare tactics on the part of the government, Flatten explained—to the point that some witnesses’ stories ended up changing: “Many VSI employees denied any misconduct in their initial interviews with federal investigators. As the case progressed, some of them changed their stories to align with the government’s theory of the case, after they were threatened with jail time, criminal charges, and exclusion from the medical industry.”

Root described some of the tactics used by federal prosecutors to threaten the freedom, livelihoods, and even the children of witnesses unless they backed the government’s theory of the case. “Prosecutors—who you would think are on the side of justice—are really on the side of prosecution. They get rewarded for prosecutions and convictions and large settlements, not for seeing the truth,” he said. “There has never been an employee in the Department of Justice who has gotten rewarded for an exoneration.”

Root was ultimately acquitted of all charges in 2016, but his story still stands as a warning to other medical device company CEOs. Root’s experience is not only proof that free speech is being restricted, Sandefur explained, but that limits on off-label communications end up harming patients. “It’s such a breathtaking abuse of government power because the government knows that it cannot make speech a crime and so what it does is it just intimidates and scares people so much that they self-select—they decide for themselves to muzzle themselves and to not speak the truth simply because they want to avoid those consequences,” she said. “When you think about it, that is not only violating an individual’s or a company’s free speech rights—which is something we revere in this country and in the constitution—but think about the trickle-down effect that it has on doctors, who now don’t have information that they need—the most up-to-date information to be able to treat their patients, and the patients. If the patients’ doctors aren’t armed with this information, they’re not getting the best treatment options presented to them.”

In trying to prevent what happened to Howard Root from occurring again, the Goldwater Institute drafted model legislation called Free Speech in Medicine. This law reiterates that the First Amendment does exactly what it is supposed to—it protects the right of pharmaceutical companies to share truthful, non-misleading information about off-label uses of lawful products. The law says that the sharing of that information is protected speech, as already stated by multiple court cases. Arizona and Tennessee have passed Free Speech in Medicine law, and other states expect to introduce similar legislation.

Root’s story isn’t about partisanship or politics, Sandefur concluded. “This is an issue that is about people—people like Howard and all the way down to doctors and patients. It’s also about principles—the idea that you could be punished, that you could be fined, that you could be jailed for sharing truthful information that could help people is just anathema.”

Rachel McPherson is a Ronald Reagan Fellow at the Goldwater Institute.



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