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Prosecutor: Former GlaxoSmithKline lawyer went too far

To federal prosecutors, former GlaxoSmithKline attorney Lauren Stevens led an effort to obstruct 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.

But to her defense team, Stevens was a diligent lawyer who never intended to deceive the FDA, and sought and followed the advice of outside counsel in dealing with the agency’s inquiry into the pharmaceutical company’s marketing tactics.

The two sides squared off Wednesday morning in opening statements of a jury trial that presiding Judge Roger W. Titus expects to last four weeks in the U.S. District Court in Greenbelt.

“This is a case about lies and deception,” U.S. Justice Department lawyer Patrick Jasperse told the 12 jurors and four alternates. “This is a case about a lawyer who went too far.”

Defense attorney Reid H. Weingarten countered that Stevens, 61, cooperated with FDA investigators honestly and in good faith while zealously representing her client.

“Everything she did was inconsistent with an intent to deceive,” Weingarten said, noting that Stevens, the company’s former vice president and associate general counsel, consulted with the King & Spalding law firm in responding to FDA investigators. “That’s not a cover-up person. That’s a fixer-up person.”

At the heart of the government’s case is Stevens’ alleged knowledge that doctors retained by GSK to market Wellbutrin SR were telling audiences of fellow physicians the drug can be used for weight loss. The prosecution contends that Stevens not only declined to share this information with FDA investigators but repeatedly told them the company was not marketing the drug for weight loss.

Jasperse, the prosecutor, told the jury in his nearly hour-long opening statement that Stevens had a particular responsibility to be forthright with the FDA because she led the company’s legal team that dealt with the agency.

“There were other players on the team, but she was the quarterback,” he said.

Weingarten, the defense lawyer, rejected the contention that Stevens’ made false statements or ignored the advice of counsel. Rather, she and outside counsel made “good faith” efforts to respond to the FDA’s requests for information about the marketing of Wellbutrin SR, Weingarten added during his 70-minute opening statement.

“Lauren was no lone ranger here,” said Weingarten, of Steptoe & Johnson LLP in Washington, D.C. “Any effort to put this on her, on her alone, is a hideous distortion of what happened in this case.”

Weingarten added that doctors, even when speaking on a drug company’s behalf, may discuss a drug’s “off-label” uses — those not approved by the FDA — in response to a question about such uses. The federal government cannot prove that the doctors retained by GSK were not simply answering questions from fellow physicians when they discussed Wellbutrin SR’s well-known use in fighting obesity, Weingarten said.

He called it common for doctors to ask each other about a drug’s off-label uses.

“Doctors don’t talk FDA-speak,” Weingarten said. “Doctors don’t want to stay on label. They spoke about the real uses of the drug.”

The FDA began investigating GSK’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 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 and withheld slides used by speakers at marketing events.

The grand jury indicted Stevens in April on one count of obstructing 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 5-year prison term.