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# Device Lawyers Urge SCOTUS to Hear Off-Label Appeal
- URL: https://www.fdaweb.com/device-lawyers-urge-scotus-to-hear-off-label-appeal/
- Published: 2024-05-09T12:00:00.000Z
- Updated: 2026-09-14T14:30:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156954

DuVal & Associates has submitted an *amicus* brief to the Supreme Court urging it to hear the appeal of two former Acclarent executives from a 1st Circuit Court of Appeals decision upholding their conviction on misdemeanor charges of distributing misbranded and adulterated medical devices.

The appellate judges upheld the convictions of the former CEO and vice president of sales for Acclarent. Previously, former CEO **William Facteau** and sales vice president **Patrick Fabian** were [acquitted](https://fdaweb.com/login.php?sa=v&aid=D5136240&cate=&stid=%241%24X20.UM5.%24FUa.hDqBNo3Ke1pWprU5o%2F&ref=fdaweb.com) in 2016 of felony charges that they illegally marketed a medical device for off-label use, but were found guilty of misdemeanor charges of introducing adulterated or misbranded medical devices into interstate commerce.

On appeal, their attorney had argued that their convictions violated their free speech and due process rights under the U.S. Constitution, according to a Reuters [report](https://www.reuters.com/legal/government/former-medical-device-execs-jj-unit-lose-appeal-convictions-2023-12-14/?ref=fdaweb.com).

A Justice Department official told the news service the appeals court ruling upheld the “central legal theories” of the case. “These issues are fundamental to the work that FDA does every day to protect patients and ensure that they receive safe medical devices,” he said.

The prosecution said the two oversaw the launch of the Reliva Stratus MicroFlow Spacer that was intended to be used to deliver steroids, a use FDA declined to approve. The device was cleared in 2006 to deliver saline to keep sinuses open after surgery. Prosecutors said the two supervised the illegal distribution of Stratus as a steroid delivery device.

Facteau and Fabian were found guilty in 2016 and after a four-year delay were sentenced in 2020 to fines of $1 million and $500,000 respectively. The appeals court rejected their attorney’s arguments and upheld the convictions.

DuVal says it filed the brief on behalf of **Howard Root**, the former president and CEO of Vascular Solutions, who was indicted and acquitted on charges similar to those in the Facteau case. The firm [says](https://www.duvalfdalaw.com/resourcesClientAlerts.html?ref=fdaweb.com) its brief argues that FDA’s authority to regulate truthful and non-misleading speech must yield to the First Amendment and such speech cannot and should not be prosecuted as adulteration and misbranding under the Federal Food, Drug, and Cosmetic Act.