An ex-GlaxoSmithKline Plc attorney accused of covering up the company’s improper marketing of its antidepressant drug Wellbutrin SR is a “lawyer who went too far,” a federal prosecutor said as her trial began.
Lauren Stevens, former vice president and associate general counsel for London-based Glaxo, is charged with impeding an inquiry in 2002 and 2003 by the U.S. Food and Drug Administration into the marketing of the drug for uses not approved by the FDA.
“This is a case about a lawyer who put loyalty to her company above fidelity to the truth and to the law,” said Patrick Jasperse, a Justice Department lawyer, during opening statements today in Greenbelt, Maryland, federal court. “This is a case about a lawyer who went too far, from aggressively representing her company to breaking the law.”
Stevens, 61, of Durham, North Carolina, is charged with one count of obstructing an official proceeding, one count of falsifying and concealing documents and four counts of making false statements. 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.
Stevens’s attorney, Reid Weingarten, told the jury that she never intended to mislead the FDA and that she relied on the advice of in-house lawyers at Glaxo as well as its outside law firm King & Spalding in crafting her company’s responses to the agency.
“Everything she did in this case was utterly inconsistent with an intent to deceive the government,” Weingarten said. Stevens made a good-faith effort to respond to the government while properly protecting her client, he said.
Glaxo hasn’t been charged with crimes related to the Wellbutrin investigation, prosecutors said.
The FDA contacted Glaxo in October 2002, seeking information after receiving allegations that the company had promoted Wellbutrin for unapproved uses, specifically weight loss, according to the indictment.
Stevens told the FDA she would collect materials about Glaxo’s promotion of the drug, which was approved only for a single use, “the treatment of a major depressive disorder in patients age 18 or older,” according to the indictment.
Stevens sent three false letters between February 2003 and May 2003 to the FDA, failing to disclose that Glaxo had directly encouraged the use of Wellbutrin for weight loss, that it gave gifts to doctors to attend promotional talks, and that it held “special issue boards” to discuss unapproved uses, the indictment said.
Stevens withheld that the company paid a Vermont physician to speak at 511 promotional events in 2001 and 2002 to discuss off-label uses and also paid a Michigan doctor to give 488 talks, prosecutors said. Jasperse told the jury Glaxo paid the two doctors more than $1 million each for the talks.
In March 2003, Stevens got a memo from lawyers at King & Spalding that discussed the pros and cons of handing over the promotional materials gathered. One benefit of disclosure, it said, was that it “potentially garners credibility with FDA,” the indictment said.
The negatives, it said, were that it potentially demonstrated “lack of control” over sales representatives and physician speakers and could provide incriminating evidence against the company “in this or a future investigation.”
Stevens didn’t turn over the materials and said the company only promoted the drug for approved uses, according to the indictment.
When Stevens learned that a Glaxo sales representative told the FDA about off-label promotions and sent a copy of slides used by the Vermont doctor and a California physician touting unapproved uses, Stevens wrote a letter to the agency saying that while there may be “isolated deficiencies,” the evidence “clearly demonstrates” Glaxo didn’t engage in off-label promotions.
“Lauren believed this to be true when she sent the letter and believes it to be true today,” Weingarten said. “There was no official corporate policy to promote this drug for obesity.”
Stevens was charged in November. U.S. District Judge Roger Titus dismissed the indictment last month after finding prosecutors misinformed the grand jury about a key element of Stevens’s defense.
Prosecutors secured a new indictment against Stevens on April 13.
The case is U.S. v. Stevens, 10-cr-694, U.S. District Court, District of Maryland (Greenbelt).