By CBS News Investigative Intern Dana Sherne
In an unusual move, the Department of Justice has indicted a former top corporate lawyer for the pharmaceutical giant GlaxoSmithKline.
The indictment charges Lauren Stevens with obstructing justice and making false claims about the unapproved promotion of a drug for weight loss purposes. The indictment did not identify Stevens's employer or the drug in question, but GlaxoSmithKline spokeswoman Mary Ann Rhyne confirmed that Stevens worked for the company's U.S. legal department and is now retired. She also confirmed that the drug in the indictment is Wellbutrin, an antidepressant.
According to the indictment, Stevens was aware that GlaxoSmithKline had paid doctors to promote the drug's unapproved use as a weight loss drug, yet signed letters to the FDA denying the company had done so.
According to the Justice Department document, Stevens in fact knew of 28 doctors paid by Glaxo who promoted the drug as a weight loss drug, including a Michigan doctor Glaxo paid to speak at 511 promotional events, and a doctor from Vermont Glaxo paid to speak at 488 events.
Stevens also allegedly withheld these doctors' slide presentations from the FDA after it requested all such material in October 2002.
In March of 2003, the indictment alleges, Stevens received a memo from other lawyers at GlaxoSmithKline analyzing the pros and cons of turning over the slides to the FDA. One of the cons listed in that memo was that turning over the slides would provide "incriminating evidence about potential off-label promotion of [the drug] that may be used against [the corporation] in this or in a future investigation."
A sales representative later turned over some of these slides to the FDA.
"Criminal charges are appropriate when false statements such as those alleged here are made to the FDA," said Tony West, Assistant Attorney General for the Civil Division of DOJ, in a press release. He also said that the Justice Department will pursue individuals responsible for illegal behavior when the law allows. In the past, the DOJ has generally prosecuted corporations for off-label marketing.
Stevens is charged with one count of obstruction of an official proceeding, one count of falsifying or concealing documents, and four counts of false statements. A combined sentence for the charges could be up to 60 years.
"Billions of dollars in fines has done nothing to change behavior in the pharmaceutical industry," said Paul Thacker, an investigator with the Project on Government Oversight. "But the possibility of jail time will cause executives to think twice before engaging in illegal activity or hiding data or documents from the federal government," he said.
Brien O'Connor, a lawyer at one of the firms representing Stevens, said in a written statement that she is not guilty of obstruction or of making false statements.
"Lauren Stevens is an utterly decent and honorable woman," he said. "She looks forward to the day when a judge and jury can hear the true facts in this case, which will show that she has done absolutely nothing wrong."
GlaxoSmithKline declined to comment on the indictment.