Overview: Letter Inquiry & Stevens GlaxoSmithKline (GSK) received a letter inquiry in 2002 from the Food and Drug Administration (FDA) related to one of its drug products. Lauren Stevens, GSK V.P. and Associate General Counsel for U.S. Legal Operations, was put in charge of responding to FDA’s requests. She was assisted by a team of lawyers – at least 5 additional counsel including law firm counsel. 4
Overview: Internal Investigation After receipt of letter, Stevens confirms with agency what is being sought: –Company promises to investigate and make good faith effort to obtain 3 rd party physician presentation materials and will inform about inability to secure materials. Internal Investigation ensues. Company obtained some physician presentation materials from 3 rd parties Company asked outside counsel for pros-cons of producing materials 5
Overview: Pro – Con Memorandum Pros Responds to FDA’s request 5(a) for copies of all materials presented by individuals identified in response to item 3 and relating to Drug X Potentially garners credibility with FDA Cons Provides information that appears to promote off-label uses of Drug X for weight loss Potentially demonstrates Company’s lack of control over sales reps Potentially demonstrates Company’s lack of control over physician speakers Provides incriminating evidence about potential off label promotion 6 March 18, 2003 Memorandum from outside counsel to Stevens on pros and cons of submitting physician presentations on Drug X:
Overview: Response Does not Include Physician Presentations –Physician Presentation Materials were not produced. –Company responded with letter that made statements that were perceived to contradict what was within the materials, and indicated it was their “final” response. –Stevens received advice of counsel and worked shoulder to shoulder with counsel to respond to the inquiry. –Company intended to speak with the FDA about the production, during which time it would discuss the withheld physician presentations. –Outside counsel drafted memorandum of speaking points relating to the reasons why presentations were not produced. 7
Overview: Alleged altered document –Agency also requested information related to compensation of physicians in connection with promotional events for Drug X. –Company appended an Event Spreadsheet to a response letter, which displayed this information, however, a column listing entertainment was removed from the original sheet. –Letter stated that the Event Spreadsheet was being created for the purpose of responding to the letter. 8
Overview: Stevens prosecuted for response Stevens signed the letters. No certification, merely a signature. Government contends that statements within the 2003 letters were untrue and misleading. The statements, the failure to produce presentation materials, and the altering of the Event Spreadsheet formed the basis for the indictment. Seven years later, Steven was the only one prosecuted. 9
Overview: the Indictment In Nov. 2010, Stevens was indicted for –Two Counts of Obstruction of Justice: Maximum penalty: 20 years and $250K in fines –Four Counts of False Statements: Maximum penalty - 5 years and $250K in fines Charges could apply to response to any federal agency – not just the FDA. Stevens was acquitted of all charges on May 10, 2011 10
Obstructing an Official Proceeding: 18 U.S.C. § 1512(c)(2) The government must prove each of the following elements beyond a reasonable doubt: 1.The defendant obstructed, influenced, or impeded, or attempted to do so; 2.an official proceeding; 3.with corrupt intent.
Concealing and Falsifying Documents to Influence the FDA: 18 U.S.C. § 1519 The government must prove each of the following elements beyond a reasonable doubt: 1.An investigation or other matter within the jurisdiction of a department or agency of the U.S. must have been pending or contemplated by such department or agency of the U.S.; 2.The defendant must have been aware of the pending or contemplated matter or investigation; and 3.Knowingly altered, concealed, mutilated, or destroyed something with the intent to impede, obstruct, or influence the pending or contemplated matter or investigation, or any matter in relation to the pending or contemplated matter or investigation.
False Statement to Federal Official: 18 U.S.C. § 1001 The government must prove each of the following elements beyond a reasonable doubt: 1.the defendant made a false statement in a matter within the jurisdiction of the federal agency; 2.the defendant acted willfully; that is, deliberately and with knowledge that the statement was untrue; and 3.the statement was material to the activities or decisions of the federal agency; that is, it had a natural tendency to influence, or was capable of influencing, the agency’s decisions or activities.
Available Defenses No false statement Bona Fide Practice of Law Defense Advice of Counsel “Defense” 14
Bona Fide Practice of Law Defense The Bona Fide Practice of Law Defense is available as a defense to all obstruction of justice charges: “This [obstruction of justice] chapter does not prohibit or punish the providing of lawful, bona fide, legal representation services in connection with or anticipation of an official proceeding.” 18 U.S.C. §1515(c).
Advice of Counsel “Defense” The elements are: 1.before taking action, 2.a defendant in good faith sought the advice of competent attorney, 3.for the purpose of securing advice on the lawfulness of her possible future conduct, 4.and made a full and accurate report to her attorney of all material facts which the defendant knew, and 5.acted strictly in accordance with the advice of her attorney who had been given the full report. United States v. Cheek, 3 F.3d 1057, 1061 (7th Cir. 1993). 16
Issues for Discussion How can corporate counsel be protected? How does this case affect how a company should conduct an internal investigation? Who should sign communications to the government that reveal findings related to an internal investigation? Is there any assurance that advisory communications with clients remain protected by the attorney-client privilege? Is there a different standard of completeness in responding to a voluntary request for information versus a subpoena? How can attorneys avoid “over committing to government agency negotiations”?
Lessons and Considerations Corporate employees should consider involving the company’s law department and work “shoulder to shoulder” with counsel on responses. –Enables the use of the Bona-Fide Practice of Law defense –Enables the use of the Advice of Counsel “Defense” 20
Lessons and Considerations Carefully consider who is the right person to sign any submission –Many participated in the drafting of the response letters, but only the signatory for the letters was indicted –The person signing should feel completely comfortable with the representations within the letter.
Lessons and Considerations Responsibly state limitations to answers that foreclose arguments that you are omitting material information –Frame the scope of what you intend to provide in advance of the submission –Ensure that you adhere to the scope
Lessons and Considerations Keep the dialogue civil when addressing government entities –Be a zealous advocate, yet be cordial – don’t give them a reason to look for problems. –Know it is not a fair fight, the government has the ability to charge you with obstruction and making false statements
Lessons and Considerations Be aware that attorney client communications may become public –Court may force disclosure under the crime fraud exception (privilege will not apply if you consult an attorney for the purpose of furthering a continuing or ongoing crime or fraudulent scheme) –Company can waive privilege in order to utilize an advice of counsel “defense” –Document may be inadvertently disclosed –Pick up the phone for extra sensitive communications 24
Questions Kwamina Thomas Williford Holland & Knight LLP 2099 Pennsylvania Ave., NW Washington, D.C. 20006 (202) 828-1857 25
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