U.S. District Court, Maryland Case Summaries: April 3, 2011
The Daily Record (Baltimore) › April 10, 2011
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Criminal Procedure
Grand jury instructionsSee the full content of this document
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U.S. District Court, Maryland Case Summaries: April 3, 2011
BOTTOM LINE: Where grand jury was improperly instructed that the acting-on-advice-of-counsel defense was irrelevant at the charging stage of the proceeding, there was grave doubt that the grand jury's decision to indict was free from the substantial influence of the erroneous legal instruction.
CASE: United States v. Stevens, No. RWT 10cr0694 (filed March 23, 2011) (Judge Titus).FACTS: Lauren Stevens was formerly the Vice President and Associate General Counsel of GlaxoSmithKline (GSK). On Oct. 29, 2002, the FDA sent a letter to GSK stating that the FDA had recently received information indicating that GSK had possibly promoted the anti-depressant drug Wellbutrin for weight loss, a use not approved by the FDA. The FDA asked GSK to provide it with materials related to Wellbutrin promotional programs sponsored by GSK, including copies of all slides, videos, handouts, and other materials presented or distributed at any GSK program or activity related to Wellbutrin.Stevens was in charge of the response to the inquiry and led a team of lawyers and paralegals who gathered documents and information. In responding to the FDA's inquiry, Stevens was also assisted outside counsel.In November 2010, Stevens was indicted on multiple counts with regard to the FDA investigation. It was alleged that Stevens obstructed the FDA's investigation by withholding and concealing documents and other information about GSK's promotional activities for Wellbutrin, including for unapproved uses, while representing to the FDA that she had completed her response to its inquiry, and that Stevens falsified and altered documents in order to impede the investigation. In particular, it was alleged that Stevens withheld slide sets used by speakers at GSK promotional events that promoted off-label use of Wellbutrin and withheld information regarding compensation received by...See the full content of this document
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