As evidence that the government will make good on its recently announced intent to pursue individuals responsible for corporate acts, a federal grand jury indicted former GlaxoSmithKline (GSK) in-house counsel Lauren Stevens in November. Stevens has now moved to dismiss these charges, arguing they violate her due process rights because they fail to allege a legal requirement that she had a "specific, wrongful intent" when responding to an inquiry by the Food and Drug Administration (FDA). The defense argues that the government's theory, taken to its logical conclusion, would mean that every time a lawyer decides not to produce documents she believes privileged, she would commit obstruction of justice regardless of the good faith of her belief.
The indictment charged Stevens with:
- One count of obstructing an FDA inquiry into company-sponsored promotional programs about the weight-loss benefits from a drug approved for a single use: adult major depressive disorder
- One count of concealing documents in a federal investigation
- Three counts of false statements to the FDA
FDA's request. The indictment alleges that the FDA asked GSK for materials, including slides, videos, and handouts, from promotional programs it sponsored. It sought all materials, whether held by GSK or by healthcare providers whom GSK paid to participate in the programs.
Steven's internal investigation. The indictment charges that Stevens committed to FDA on GSK's behalf to make a good faith effort to obtain the presentation materials from others if the materials' owner consented. Stevens agreed to keep FDA informed of an inability to secure such materials. She then:
- Obtained slides of GSK-sponsored presentations from 40 of 2,700 speakers.
- Wrote to 28 of the 40 responding speakers to warn them that their slides contained information about unapproved uses of the drug and that this was contrary to FDA requirements, company policy, and their contract with the GSK.
- Learned that two physicians had repeatedly promoted the drug for unapproved uses, including weight loss—one at 488 events and the other at 511 events. She learned that GSK paid physicians to attend these events and provided some physicians gifts and entertainment there.
Steven's disclosures. Yet, knowing these things, the indictment charges that Stevens told the FDA that GSK "has not . . . maintained any activity to promote or encourage, either directly or indirectly, the use of [the drug] as a means to achieve weight loss or treat obesity . . ." and that attendees at speaking events were "not paid, reimbursed or otherwise compensated to attend . . . except for parking fees."
Internal deliberations. The indictment charges that Stevens discussed with counsel whether to produce the actual speaker slides she had gathered in GSK's final response to the FDA. The counsel summarized the discussions as :
- Responds to FDA's request . . . for copies of all materials presented by individuals identified . . . and relating to [the drug]
- Potentially garners credibility with FDA
- Provides information that appears to promote off-label uses of [the drug] for weight loss . . . ADHD, sexual dysfunction . . .
- Provides incriminating evidence about potential off-label promotion of [the drug] that may be used against [GSK] in this or in a future investigation."
Final disclosures. The indictment charges that after these discussions, Stevens produced none of the slide sets she had gathered from speakers. Instead, she wrote to the FDA, "in the final analysis, all of the information consistently and clearly points to the same conclusion – [GSK] has not developed . . .established or maintained any program or activity to promote, either directly or indirectly, the use of [the drug] to achieve weight loss or treat obesity . . .
[P]romotional materials and activities . . . are consistent with the approved Prescribing information and the supporting clinical data. . . ."
Lulling. According to the indictment, Stevens later learned a GSK employee had sent the FDA slide presentations used by two doctors on unapproved uses of the drug. Stevens then sent the FDA only the slide sets she knew the FDA had already received, calling them "isolated deficiencies," and declaring "the objective evidence clearly demonstrates that [GSK] has not . . . maintained, or encouraged . . . activities to promote, directly or indirectly, [the drug] for weight loss . . ." At the time of this statement to the FDA, the indictment charges Stevens with the knowledge that GSK sponsored likely more than 1,000 programs containing off-label information about the drug.
In sum, the indictment and Stevens' motion to dismiss bring sharply into focus a lawyer's separate obligations to disclose facts learned in an inquiry undertaken at a federal agency's request, and to assert privilege on behalf of the client in the appropriate circumstances. As this case proceeds, the picture will become more clear how these obligations competed here. In the portion of a memorandum from which the grand jury quoted, counsel did not discuss the question: Could fraud be charged when a lawyer withholds documents responsive to a federal agency request and makes statements to the agency that may contradict facts in those documents?