Responding to Government Requests for Information: Lessons Learned from the Indictment of A Former In-House Counsel.

Transcription

1 Responding to Government Requests for Information: Lessons Learned from the Indictment of A Former In-House Counsel Attorney Advertising Prior results do not guarantee a similar outcome Models used are not clients but may be representative of clients 321 N. Clark Street, Suite 2800, Chicago, IL January 4, 2011 Pamela Johnston, Foley & Lardner LLP Heidi Sorensen, Foley & Lardner LLP

2 2 Overview of discussion Indictment of Lauren Stevens Types of requests for documents or information Practical tips for responding Lessons Learned from the Stevens Indictment

3 Indictment of Lauren Stevens: 3 Former Assoc GC at Glaxo Indicted November 2010 allegations that she withheld information/documents requested in FDA investigation of off-label promotion of Wellbutrin Allegations that she had a memo prepared for her laying out pros and cons of producing requested documents. Her lawyer: utterly decent and honorable woman. Everything she did was consistent with advice provided by a nationally prominent law firm. How did this happen? Stevens had direct contact with the FDA and made promises about producing responsive documents

4 Types of Requests for 4 Information CMS contractors ask for documents or information Agencies ask for access, documents, or testimony Letters/Immediate Access OIG subpoenas (documents and/or testimony) Prosecutors ask for documents or testimony HIPAA/AID subpoenas CIDs Grand Jury subpoenas

5 EXAMPLE: Letter from CMS Contractor 5

6 6 EXAMPLE: OIG Subpoena

7 7 EXAMPLE: Grand Jury Subpoena Rule 6

8 Why does Government issue 8 RFIs? Investigations often begin with subpoenas to corporation Cannot tell what the purpose is Stated purpose can omit additional purposes Doesn t mean individuals are off the hook Truly searching for facts Encourages subject to hire an attorney Gives government someone to negotiate with

9 Scoping the response to the 9 request Suggested approach: If certain it is a simple issue, keep the approach simple If not certain or cannot tell Brainstorm with outside counsel Assume it could lead somewhere bad, until you know with certainty that it won t Proceed as though the company is a subject of an investigation (could go criminal) Assume the govt will get information from other sources too you are not alone

10 A few things to keep in mind 10 about criminal investigations No approval sought or received for GJ subpoenas Recipient s status may change at any time Even after charges have been brought Other people, entities have received RFIs Have provided information your client has May be cooperating against your client

11 11 What to know Responding is more than just producing documents First call -- opportunity to learn from investigator What the govt thinks and where they are going Client s status (witness/subject/target) Scope of investigation Civil, criminal, both

12 Consequences of making a 12 mistake in production Civil Can be corrected Might result in a fine Criminal Converts responder into a target Charges for obstruction, contempt Additional liability for company, individual, in-house attorney, outside counsel Requestor = same person determining punishment

13 13 What to ask Contact the person issuing the RFI If an agent, find out who the prosecutor is I can t confirm or deny whether there s an investigation... Civil or criminal? Make no promises or representations in first call Documents only? Narrow: don t want to inconvenience recipient Broad: can it be narrowed? Early vs. late stage of investigation

14 14 Practical tips Again scope the matter Involve outside counsel if it is anything other than routine You want the buffer The govt usually views outside counsel as being more independent of the client so errors in production are not usually viewed as acts of obstruction

15 15 Practical tips for production Impose a litigation hold on relevant documents Do not send documents without explaining them If in doubt, explain the client s efforts to comply with RFI Bates label documents For some agencies, magic words to avoid FOIA disclosure

16 16 Practical tips (cont d) Cover letters responding to RFIs Avoid categorical representations: Here is every responsive document to Request No. 1. If needed, provide a detailed description of the process used and the results of that process Describe in detail any agreements or revisions to the original RFI

17 17 Practical tips (cont d) Never produce documents without also learning the story behind them Do they match client s story? Do they cover the universe? Have you made all reasonable efforts to comply? Are you turning your client into a subject or target? Try to avoid invoking advice of counsel defense at an early stage

18 18 Practical tips (cont d) Collecting documents in a forensically sound manner Use vendors for larger cases Consider specialized software for narrowly tailored RFIs Cost-effective option In all cases, attorneys will need to provide direction to ensure relevant data has been captured

19 19 Practical tips (cont d) Maintaining the database Create a new database for documents provided to government At a minimum, internally segregate within master client database Use unique Bates numbers and prefix for government productions Memorialize every step in responding to RFIs

20 Lessons Learned from the Stevens Indictment the Allegations 20 FDA requested information regarding promotional programs Stevens made assurances that she would gather all responsive documents, including those held by some doctors Stevens gathered documents from the doctors, including some that were incriminating

21 Lessons Learned from the Stevens Indictment the Allegations 21 Stevens held back these extra documents and did not produce them because they were not responsive done after getting input from outside counsel Stevens told the govt that the company was in compliance with the law Charged with obstruction of justice and making false statements

22 Lessons Learned from the Stevens Indictment Take Aways Don t promise anything at the beginning Don t promise to produce documents from third parties Don t promise that the client did not violate the law If you change approach, be transparent about that Use outside counsel as a buffer, not just as lawyers providing advice Be cautious in potentially big-ticket cases 22

23 23 Questions? Pamela Johnston Foley & Lardner, LLP 555 South Flower Street, Suite 3500 Los Angeles, CA Heidi Sorensen Foley & Lardner, LLP 3000 K Street, N.W., Suite 600 Washington, DC pjohnston@foley.com hsorensen@foley.com