After months of anticipation, the trial of former GlaxoSmithKline lawyer Lauren Stevens, who was indicted for last November for obstructing an FDA probe into off-label marketing of the Wellbutrin SR antidepressant and making false statements to the agency, has finally gotten under way. And in their opening remarks, federal prosecutors says she was a "lawyer who went too far.”
“This is a case about a lawyer who put loyalty to her company above fidelity to the truth and to the law,” Patrick Jasperse, a Justice Department lawyer, charged during opening statements today in a federal court in Greenbelt, Maryland. “This is a case about a lawyer who went too far, from aggressively representing her company to breaking the law.”
To be specific, Stevens, 61, is charged with one count of obstructing an official proceeding, one count of falsifying and concealing documents and four counts of making false statements (read background here). The first two charges are punishable by a maximum of 20 years in prison while the others carry terms of as long as five years, notes Bloomberg News, which is reporting from the courthouse.
To counter the feds, Stevens attorney Reid Weingarten, told the jury she never intended to mislead the FDA and that she relied on advice of in-house lawyers at Glaxo as well as King & Spalding, a law firm that has done a lot of work for the drugmaker, in drafting responses to agency. “Everything she did in this case was utterly inconsistent with an intent to deceive the government,” he said, describing her actions as a good-faith effort to protecting her client and also answer FDA queries.
According to the indictment, Stevens told the FDA she would collect materials about the Wellbutrin promotion, but allegedly sent three false letters in 2003 to the FDA, failed to disclose Glaxo had directly encouraged the use of Wellbutrin for weight loss, gave gifts to docs to attend promotional talks, and held “special issue boards” to discuss unapproved uses.
Prosecutors also says she withheld info that Glaxo paid a Vermont doc to speak at 511 promotional events in 2001 and 2002 to discuss off-label uses and paid a Michigan doc to give 488 talks. Jasperse told the jury Glaxo paid those docs more than $1 million each for the talks. Stevens learned a Glaxo sales rep told the FDA about off-label promotions and sent a copy of slides used by the Vermont doc and a California doc promoting unapproved uses, she wrote a letter to the agency saying there may be “isolated deficiencies,” but evidence “clearly demonstrates” Glaxo didn’t promote off-label uses.
“Lauren believed this to be true when she sent the letter and believes it to be true today,” Weingarten told the jury. “There was no official corporate policy to promote this drug for obesity.”