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.

Published In: Administrative Agency Updates, Civil Procedure Updates, Criminal Law Updates, Health Updates, Science, Computers & Technology Updates

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

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »