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1st Circuit Rejects Convicted Former Medical Device Executives’ Off-Label “Free Speech” Theory

By Michael J. Podberesky, Royce DuBiner & Allyson M. Maur on January 18, 2024
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A federal appeals court recently upheld misdemeanor convictions of two former Acclarent Inc. executives for commercially distributing an adulterated and misbranded medical device by misleading the U.S. Food and Drug Administration regarding the device’s intended use.

Read on for details about the decision, which rejected claims that their off-label promotion amounted to constitutionally protected commercial speech.

Photo of Michael J. Podberesky Michael J. Podberesky

Michael Podberesky, a former federal prosecutor in the U.S. Department of Justice’s Civil Fraud Section, is a partner in the firm’s nationally recognized Government Investigations and White Collar Litigation Department and co-chair of the False Claims Act Investigations, Litigation and Enforcement team. Employing…

Michael Podberesky, a former federal prosecutor in the U.S. Department of Justice’s Civil Fraud Section, is a partner in the firm’s nationally recognized Government Investigations and White Collar Litigation Department and co-chair of the False Claims Act Investigations, Litigation and Enforcement team. Employing his extensive experience with False Claims Act cases in the healthcare and defense sectors, Michael represents clients confronting high-stakes government investigations and litigation arising from allegations of healthcare and procurement fraud and also counsels clients regarding compliance issues.

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Photo of Royce DuBiner Royce DuBiner

Royce practices food and drug law with a focus on advising pharmaceutical, medical device, cannabis, dietary supplement, tobacco, food and beverage companies as well as investment firms on a range of regulatory matters. He is presently the lead of the Cannabis, Hemp, and…

Royce practices food and drug law with a focus on advising pharmaceutical, medical device, cannabis, dietary supplement, tobacco, food and beverage companies as well as investment firms on a range of regulatory matters. He is presently the lead of the Cannabis, Hemp, and CBD industry team.

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Photo of Allyson M. Maur Allyson M. Maur

Allyson advises on regulatory issues affecting diagnostics developers, biopharma manufacturers, and clinical laboratories, including CLIA/CLEP and FDA regulatory advice, MLR and MRC review of marketing and promotional materials, clinical studies, global data privacy issues, ethics & compliance, commercial contracting, commercial litigation and more.

Allyson advises on regulatory issues affecting diagnostics developers, biopharma manufacturers, and clinical laboratories, including CLIA/CLEP and FDA regulatory advice, MLR and MRC review of marketing and promotional materials, clinical studies, global data privacy issues, ethics & compliance, commercial contracting, commercial litigation and more. Allyson’s healthcare regulatory work ranges from clinical bioethics and informed consent issues to counseling on compliance with U.S. federal fraud, waste, and abuse laws such as the Anti-Kickback Statute, Stark Law, Sunshine Act, and their state law equivalents, as well as HIPAA, state healthcare privacy laws, change of ownership and state licensing requirements for various healthcare and healthcare adjacent entities.

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  • Posted in:
    Corporate Compliance, International
  • Blog:
    Subject to Inquiry
  • Organization:
    McGuireWoods LLP
  • Article: View Original Source

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