In their ongoing quest to save former GlaxoSmithKline lawyer Lauren Stevens from serving jail time, her attorneys may have succeeded in convincing a federal judge to toss the indictment. Why? They raised doubts about the extent to which federal prosecutors correctly portrayed her defense to a grand jury, according to court documents. And so US District Judge Roger Titus will issue a ruling in which he may instruct the feds to issue a new indictment and begin new grand jury proceedings.
You may recall that Stevens, who was indicted for obstructing an FDA probe into off-label marketing of Wellbutrin SR, indicated in recent court filings that she received advice from other Glaxo lawyers, including the King & Spalding law firm that regularly works for the drugmaker. She wants to offer what is known as ‘advice of counsel’ defense, although prosecutors argue this should not be permitted (back story here, here and here). The prosecutors argue this would confuse a jury.
At a hearing yesterday, grand jury proceedings were unsealed and discussed, because the Stevens legal team charged that prosecutors failed to accurately answer a question from a juror. The juror asked the prosecutors whether it mattered that Stevens had been "getting direction from somebody else about how to handle" the FDA inquiry, according to court documents. Prosecutors responded by saying Stevens was required to disclose everything she knew to the FDA, not just rely on advice.
In their filings, the Stevens lawyers charged the prosecutors misinformed the grand jury. "In response to a grand juror's specific inquiry, the prosecutors instructed the grand jury that Ms. Stevens' reliance on counsel was not to be considered by the grand jury. This instruction was plainly contrary to applicable law and severely prejudiced Ms. Stevens...The erroneous instruction was clearly a substantial factor in the grand jury's decision to charge" Stevens with a crime, according to documents (see here).
And so at the hearing, Titus asked prosecutors about their response to the grand jury and left open the possibility the indictment may be tossed when the hearing resumes on March 25. "The question is whether the answer was correct, and if not, what's the remedy?" he asked, according to Reuters. One prosecutor, Patrick Jasperse, maintained they fulfilled their duty before the grand jury and it would be "extreme" to toss the indictment. "Could the answer have been more articulate and complete? Absolutely," he said. "But the government basically got it right."
The King & Spalding team, by the way, was headed by Mark Brown, as well as Sherrie Shade and Doug Snyder, according to court documents. And Glaxo sent six letters to the FDA between December 2002 and November 2003 that purportedly addressed the FDA inquiry, described Wellbutrin promotional efforts and disclosed "several instances of non-compliance with corporate policies" for marketing. "King & Spalding attorneys drafted, edited and reviewed each of these letters," her filings state (read this).






9 Comments
Better to issue a new bullet-proof indictment against Stevens than risk letting her walk on a technicality.
If I have the facts straight, she was told to turn over everything they had, slides included, to the FDA. She did not. She is guilty. I may be wrong on this one, but Ms. Stevens, nor anyone else, does not get to determine what to send to the FDA, and what not to send. Not sending in the slides is a very clear obstruction of justice. Am I wrong here?
It's curious that the other attorneys inside Glaxo were not included in the indictment when they too were responsible for the decision to hold onto the documents. Is it because these lawyers are ex-FDA officials? And as ex-FDA, it's reasonable to assume they knew the regulations more intimately than Stevens.
Curious is dead on.
This is absolutely absurd! Corporative executives frequently break the law and always walk, but if a teen steals a candy bar, they could do jail time.
I think it is the United States where you are innocent until proven guilty? Did I miss something here?
Paul is correct. If Ms Stevens is fortunate enough to get a jury of her peers she may well be found not guilty.
I'm confused.
As I read the brief, it looks like Stevens is saying that all decisions were by consensus. So, if the other two GSK attorneys are indicted for conspiracy or some other offense, they could also claim that they relied on each other, including Stevens, in reaching consensus as to what to say to the FDA? And if the outside lawyers are charged, the junior attorneys could argue that they relied on the partner as well as in-house GSK attorneys, including Stevens (who may have significantly more pharmaceutical legal experience than the junior outside lawyers)? And the partner could argue that he relied on the legal research performed by junior lawyers and factual information and legal input provided by GSK attorneys (including Stevens), in response to their draft responses to the FDA?
So, if understand Stevens' argument and facts, all the lawyers (who should know that they should not lie to the government), can argue that no one should be guilty, because they all relied on each others' advice? In other words, no one is guilty because everyone is guilty. Sorry, this doesn't seem right.
Pfizer did a big internal investigation on Bextra. THe documents that COvington and Burling showed us were incredible off-label documents. Pfizer's legal officers had all those documents. After the case is over how did Pfizer's senior compliance officer get away with his statements on CNBC. ANd then they even said that no false statements were made to physicians which was absolutely absurd. How does Pfizer get away with all they did when it is obvious their legal team is totally corrupt?