Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

DOJ Manual Updated To Enhance Focus On Targeting Individual Execs

This article was originally published in The Gray Sheet

Executive Summary

The updated US Attorney’s Manual instructs government lawyers to focus on individuals from the launch of civil or criminal investigations into a company, and not to consider individual’s ability to pay a judgment in deciding whether to pursue charges.

You may also be interested in...



Unlocking Legalities: Overseas Practices, Park Doctrine Could Drive More Fraud Cases

The US Department of Justice recently announced the largest-ever civil settlement in a device-related False Claims Act case. But otherwise it was a textbook FCA case, attorneys say, and many device companies still have a lot of work to do to ensure compliance and that their executives stay out of trouble. This is the first article in an occasional series in which Medtech Insight talks to attorneys to get the best takes on hot legal topics.

Former Acclarent Execs Convicted Of Misdemeanors In Off-Label Case

Two former executives from J&J's Acclarent division were found not guilty of felony charges but convicted on misdemeanor counts. Prior to being acquired by J&J, Acclarent allegedly marketed its Relieva Stratus sinus dilation device as a steroid-delivery system, even though the FDA had cleared the device only to deliver saline.

Store Clerk Prosecution Underscores FD&C Violation Risks For Individuals

A store clerk accused of selling misbranded synthetic drugs was sentenced on misdemeanor violations of the Act. An appeals court verdict upholding the conviction could give FDA more latitude to pursue individuals responsible for violations in the drug and device space, attorneys say.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

OM002075

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel