White Collar and Health Care Enforcement Defense Alert: In-House Counsel Indicted in Responding to Government Inquiry


Having investigated and prosecuted, sometimes unsuccessfully, pharmaceutical and biotech companies and their executives for years, the government this week has turned its might on a pharmaceutical company’s associate general counsel. Lauren Stevens, a former in-house attorney for GlaxoSmithKline, was charged with one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and four counts of making false statements to the Food and Drug Administration (FDA), for arguably doing her job. Her indictment spotlights the importance of being extremely cautious when responding to governmental inquiries and investigations and the need for “gatekeepers”—those deemed to be responsible for ensuring that a company acts legally—to be especially careful. Every statement to the government must now be evaluated with this in mind.

According to the indictment, Stevens coordinated the company’s response to an FDA investigation into whether the company had engaged in or encouraged off-label promotion of its anti-depressant drug, Wellbutrin. In the course of the company’s internal investigation, Stevens allegedly obtained materials used by speakers hired by the company. Those materials allegedly indicated that the speakers had engaged in off-label promotion of the drug.

Please see full alert below for more information.

LOADING PDF: If there are any problems, click here to download the file.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Mintz Levin - Health Law & Policy Matters | Attorney Advertising

Written by:


Mintz Levin - Health Law & Policy Matters on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.