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Month-long trial expected for former GlaxoSmithKline lawyer

Opening arguments begin Wednesday in the trial of a former GlaxoSmithKline attorney on charges of obstructing a U.S. Food and Drug Administration probe into her company’s marketing of the anti-depressant Wellbutrin SR as a weight-loss drug, a use not approved by the FDA.

Lauren Stevens is also charged with making false statements to the FDA, including the claim that “GSK has not developed or maintained promotional plans or activities to directly or indirectly promote Wellbutrin SR for weight loss or the treatment of obesity.”

The trial in U.S. District Court in Greenbelt is expected to last four weeks, according to the presiding judge, Roger W. Titus.

Jury selection started and ended Tuesday with 12 jurors and four alternates being picked from a pool of 60 people.

Stevens, who was in the courtroom during jury selection, was actually indicted twice by federal grand juries for the crimes of which she stands accused.

Titus dismissed the first indictment in March, after finding prosecutors had inadvertently misinformed the grand jury that it could not consider Stevens’ defense that she acted on advice of counsel. Prosecutors had told the grand jury that defense could only be raised at trial.

But Titus said the grand jurors should have been permitted to consider the defense before deciding to indict Stevens.

In his dismissal order, Titus said the prosecutors could seek to reindict Stevens provided they told the grand jurors they could consider Stevens’ argument that she acted on advice of counsel.

The prosecutors did press ahead, and the grand jury reindicted Stevens on April 13.

The FDA began investigating GlaxoSmithKline’s promotion of Wellbutrin SR for weight loss in 2002. The agency asked the company for its promotional materials associated with the anti-depressant.

Stevens, then vice president and associate general counsel at GSK, was in charge of the company’s response, which included getting the materials the FDA requested.

According to federal prosecutors, Stevens signed and sent the FDA six letters containing materially false statements.

Prosecutors allege Stevens withheld slides used by speakers at some GlaxoSmithKline marketing events and failed to provide information about compensation to doctors at those events.

The grand jury indicted Stevens in April on one count of obstruction of an investigation, one count of concealing documents and four counts of falsifying statements. The obstruction charge carries a maximum 20-year sentence; the false-statement counts each carry a maximum five-year prison term.

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