The case of the former associate general counsel of GlaxoSmithKline (GSK) has taken an unexpected turn.
Lauren Stevens, a former employee of the British pharmaceutical company, won dismissal without prejudice of an obstruction and false statement indictment last month.
She has been reindicted, according to the Department of Justice (DoJ), and charged with one count of obstruction of justice, four counts of making false statements and one count of falsifying and concealing documents related to GSK’s promotion of an anti-depressant drug for weight loss – a use that had not been approved by the US Food and Drug Administration (FDA).
GSK, however, has not been charged.
‘The case has lessons for company lawyers who deal with federal government agencies,’ says Dick Cassin, lawyer and principal writer of the FCPA Blog. ‘That includes those handling Foreign Corrupt Practices Act (FCPA) investigations or answering compliance-related questions from the DoJ and the SEC.’
Last month, Stevens asked US District Judge Roger Titus to dismiss the case at a hearing in Greenbelt, Maryland. Titus ruled in her favour.
Stevens was accused last year of providing false statements to the FDA through a series of letters in 2003 that denied the company had been promoting a drug for unapproved use, the DoJ says. Under US law, drug companies are not allowed to promote a drug for a use not approved by the FDA.
According to Cassin, Titus ruled that Stevens was entitled to use the defence of advice of the counsel, and that the DoJ’s explanation of that defence to the grand jury was not accurate.
On the flip side, the government argued that the false statements are considered a general intent crime and that a ‘good faith reliance on advice of counsel is only a defence to specific intent crimes,’ writes Ellen Podgor, a crime research professor, on the White Collar Crime Prof Blog.
To download the first indictment in US v. Stevens, click here.