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Acclarent Execs Move To Appeal Off-Label Conviction

 
• By Elizabeth Orr

Attorneys for former Acclarent executives William Facteau and Patrick Fabian have filed a request that their convictions on off-label marketing charges either be set aside or that they be granted a new trial, citing other recent off-label trials and misconduct by the government.

Two former Acclarent Inc. executives said their recent false-claims convictions violated their First Amendment rights.

A Boston federal jury convicted former Acclarent CEO William Facteau and former VP of sales Patrick Fabian on 10 misdemeanor...

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Trump Taps Food And Drug Law Outsider For FDA Chief Counsel

 
• By Sarah Karlin-Smith

Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.

FDA Document Request Denied As Case Against SurModics Merger Intensifies

 
• By Elizabeth Orr

A federal court in Illinois ruled against SurModics and BC Holdings' request for FDA documents to support a proposed merger. The FTC has challenged the merger, claiming it threatens competition in hydrophilic device coatings. The ruling may indicate the FTC is likely to succeed.

Former Top OIG Attorney Gives Inside Look At Fraud Prevention

 
• By Elizabeth Orr

Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.

DME And Diagnostics In Crosshairs As DOJ ‘Follows The Money’

 
• By Elizabeth Orr

The DOJ has launched nearly 70 enforcement actions in 2025, targeting diagnostics, durable medical equipment, and telehealth fraud. Key cases involve significant fraudulent claims against Medicare, with individuals facing severe penalties.

More from Policy & Regulation

MDUFA VI Talks Begin with Familiar Priorities: Innovation, Transparency, Safety

 
• By Elizabeth Orr

At an Aug. 4 public meeting on MDUFA VI, FDA officials, industry representatives, and patient advocates outlined their priorities for the next user fee agreement, highlighting goals such as improved transparency, streamlined reviews, enhanced safety measures, and greater patient involvement.

Global Medtech Guidance Tracker: July 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

J&J’s Ethicon Issues Class I Correction For Echelon Stapler Reloads Amid Lockout Risk

 
• By Shubham Singh

The reason for the correction is that if the device momentarily activates but does not cut or staple tissue, providers can be inadvertently locked out during surgical procedures. When a lockout occurs, additional steps are required to open the device and remove it from tissue.