Jury Says “Not Guilty” to Off-label Charges in Medical Device Case

March 3, 2016 – As the FDA fails to update or further clarify its policy regarding off-label promotion, the courts continue to hear cases that are being decided in favor of allowing.S. District Judge Royce Lamberth has entered an order dismissing the case; it is not subject to appeal. companies to share truthful and non-misleading information about the off-label uses of their products. Following pro-industry outcomes in the Amarin Pharma Inc. and Pacira Pharmaceuticals Inc. cases, last week a jury in the Western District of Texas returned a unanimous verdict of not guilty against Vascular Solutions Inc. and its CEO regarding the alleged off-label promotion of the Vari-Lase Short Kit.

Vascular Solutions and CEO Howard Root were charged in a criminal case of misbranding their medical device because they promoted it for treating varicose veins, an off-label use. U.S. District Judge Royce Lamberth has entered an order dismissing the case; it is not subject to appeal.

“This verdict should add to the growing pressure for the government to address the fundamental issue of what role medical products companies can play in communicating information about their products,” said APCO Worldwide’s Wayne Pines. “These issues will be addressed either by the courts, by the Congress or by the FDA.”

It is clear that while the FDA considers its options regarding a policy that seems to go up against the First Amendment, the courts are setting a new precedent. Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest, explained that “this is only the latest case to demonstrate that the FDA needs to assert leadership in the off-label debate.” He added that in the absence of FDA action, “we will continue to have judges decide, on a case-by-case basis, what is and is not appropriate communications. A good place to start would be for the FDA to clarify what it means by information that is ‘truthful, accurate, and non-misleading.’”

Even though the courts appear to be siding with the First Amendment in the cases heard to date, Pines said he would “advise drug companies not to change any policies or practices aimed at complying with FDA or other requirements.” Coalition for Healthcare Communication Executive Director John Kamp concurred, stating that “while change is in the air on off-label communications, most companies are likely to not to wade into the off-label waters until the FDA sets new rules and policies.”

The FDA previously stated that it would issue draft guidance on this topic by the end of 2014. More than a year after that date, this guidance has still not materialized.