## Facts

- Lauren Stevens, an in-house attorney at GlaxoSmithKline (GSK), managed GSK’s responses to an FDA inquiry into alleged off-label promotion of Wellbutrin.
- The FDA sought materials about promotional activities, including slide decks and information about speakers and events.
- Stevens worked with outside counsel in preparing productions and written responses to the FDA.
- GSK produced three slide decks, although additional slide decks related to off-label promotion existed.
- Stevens prepared an information spreadsheet responsive to the FDA request and, after consultation with outside counsel, removed certain information not expressly requested in the FDA’s letter.
- Stevens sent letters to the FDA stating that GSK did not promote Wellbutrin for unapproved uses and did not compensate speakers to promote off-label uses; the government contended internal information suggested off-label messaging occurred at some events and speakers were paid.
- The government obtained communications ordinarily protected by attorney-client privilege after a magistrate judge applied the crime-fraud exception, then indicted Stevens on obstruction-type charges.
- After the government rested at trial, Stevens moved for judgment of acquittal under Federal Rule of Criminal Procedure 29.

## Issues

1. Whether the government’s evidence, viewed most favorably to the prosecution, was sufficient for a reasonable jury to find beyond a reasonable doubt that Stevens knowingly and corruptly obstructed the FDA inquiry or made criminally false statements.
2. Whether, on this record, an in-house lawyer’s disclosure decisions and characterizations made with outside counsel’s involvement could constitute criminal obstruction or false statements rather than lawful advocacy.

## Decision

- The court granted Stevens’s Rule 29 motion and entered a judgment of acquittal on all counts.
- The court held the evidence was legally insufficient to establish the specific intent required for the charged obstruction and false-statement offenses.
- The court treated the record as showing, at most, aggressive but colorable lawyering in responding to an agency inquiry, not proof of a scheme to mislead.
- The court found the FDA requests and the alleged misstatements/omissions too dependent on interpretation to support criminal liability absent clearer proof of knowing, material falsity and corrupt intent.
- The court relied in part on Stevens’s repeated consultation with, and review by, outside counsel as undermining an inference of corrupt intent.

## Legal Principles

- A Rule 29 judgment of acquittal is required when the government’s evidence cannot support a finding of guilt beyond a reasonable doubt on each essential element.
- Obstruction and false-statement offenses require proof of the requisite mens rea; ambiguous wording, interpretive disputes, or debatable characterizations generally cannot substitute for proof of knowing, corrupt misconduct.
- In evaluating intent, a defendant’s consultation with and reliance on counsel may undercut an inference that the defendant acted knowingly and corruptly, particularly where communications and responses were vetted by lawyers.
- Criminal liability should not be premised on equivocal inferences from an attorney’s disclosure judgments and advocacy choices in responding to regulatory inquiries, absent clear evidence of intentional deception and material falsity.

## Conclusion

The court acquitted an in-house attorney as a matter of law after finding the government’s proof insufficient to show that her FDA responses—prepared and reviewed with outside counsel amid interpretive uncertainty—were knowingly and corruptly obstructive or materially false in the criminal sense.


United States v. Stevens, No. RWT-10-694 (D. Md. 2011)