Last month, the federal government lost a closely watched case in which a former GlaxoSmithKline lawyer had been indicted for obstructing an FDA investigation into whether the drugmaker illegally marketed its Wellbutrin SR antidepressant as a diet pill. The indictment initially signaled an effort by the feds to hold some pharma execs accountable for breaking the law. A federal trial judge, however, tossed the case, which turned, in part, on whether the lawyer, Lauren Stevens, should have been able to claim she relied on the advice of outside counsel during her interactions with the FDA, even though she is an experienced attorney herself (read here and here). There were also questions about the extent to which she was obligated to respond to FDA requests for information. We spoke with her attorneys - Colleen Conry and Brien O’Connor, co-practice leaders in the government enforcement practice group at the Ropes & Gray law firm – about some of the issues and the outcome…

Pharmalot: Ever since the indictment, I know some people have wondered whether your client was the ‘fall person.’ I’d like to know what you think.
O’Connor: I think there is a lot of talk in the government now about prosecuting individuals and getting results in those cases. I think that focus today was a contributing factor here with the decision to prosecute Lauren. Fall person? I don’t know exactly what that means, but one of the things we’ve been saying for a long, long time is that a full, competent team of lawyers had at their disposal the information that Lauren had when they made decisions when to write letters and make slide decks that were included in the evidence. A point we’ve been trying to make for a long time is that it would be difficult for the government to make a criminal case without making a case against all of them. But she was singled out and that was one of the difficult things the government had to overcome - and couldn’t overcome.

Conry: Every decision was made by consensus. Everybody read the letters and commented on them and no one raised their hands and said there was something wrong or not accurate. We’ve told the government this for years and their critical mistake was underestimating how that would sound.

Pharmalot: Would it have made more sense for the government to complete its probe and reach a settlement with Glaxo over off-label marketing before pursuing any individuals?
O’Connor: I think it’s unusual for the government to have gone ahead in a corporate investigation context and pursue a case against an individual before it’s made its peace with the company. I think that’s unusual. Whether it would have changed the decision making on Lauren Stevens if they’d gone ahead and resolve with the company, I don’t’ know. It was unusual for them to go out like this against an individual.

Pharmalot: So was it your view that she should have been exonerated if she simply relied on advice of outside lawyers, when she was an inside lawyer herself? And if so, why?
O’Connor: I think the focus whenever an individual is charged – inside business person or inside lawyer – with intentional crimes should be on their mental state and did they act intentionally? Did they intentionally disregard the law? Did they act in bad faith? That’s something the government needs to prove. When it’s an inside lawyer who is relying on good faith of outside counsel, absolutely that should be a defense, even if the person is a lawyer herself, and was also inside counsel and a former experienced FDA lawyer…She acted in good faith and was relying on experience (of the other counsel)… I don’t see any reason why inside lawyers shouldn’t be able to rely on outside counsel’s advice when charged with bad faith and specific intent to violate the law…

I think it is appropriate for a judge and jury to take account of her training and background. That said, it is also appropriate for a judge and jury to take account of what other input – the propriety of the rightfulness or wrongfulness of the course she was taking. I’m not saying anytime an in-house lawyer gets advice from an outside lawyer she can write a letter or put her name on the bottom of a letter and that will mean the lawyer can never be prosecuted. It may be reasonable for a reasonable juror to conclude a lawyer was acting with bad intent, acting with criminal intent. In these circumstances, it was entirely appropriate for the court to say (that relying on) outside counsel was relevant and we’ll weigh it along with facts and circumstances of Lauren’s background. I’m not saying there should be an automatic pass for lawyers who get advice from outside counsel. But in this case, there was evidence that a reasonable person could not conclude that Lauren acted criminally – with criminal intent in light of all the facts and circumstances.

Conry: In obstruction charges specifically, there’s the statutory safe harbor reference – as long as you’re part of a bona fide legal representation, you cannot be convicted of the two obstruction charges that were the first two counts in the indictment…Her actions were within the safe harbor…. Basically, it came down in our minds that, if it looks like you’re behaving in good faith and represent (the) client in good faith…then there was no reason to convict.

Pharmalot: Why should It matter whether the government sent a subpoena or a letter seeking info and documents? There is a difference, but to not do so invites trouble anyway, does it not?
Conry: In a voluntary request (from the government), you have every right to say no thank you. You can decline to give them anything… The FDA, for real purposes, doesn’t have subpoena power for all intents and purposes…. And every request started with ‘please’… With a subpoena, if you want relief, you get relief from the government by going to court…There’s a tremendous legal difference.

And they did respond. They interviewed 20 to 30 people. They deep-dived documents. They talked to 250 doctors about slide decks…They did a really thorough investigation and certain things they chose not to turn over and that was their right…But they did respond robustly to most requests and told them how they were expanding the scope (of their investigation) and not just what the indictment was focused on…

O’Connor: This does not excuse a knowing false statement to the government…but the court concluded here that no reasonable juror could convict on what happened…The only evidence the government focused on not being produced had to do with phone calls, where there was evidence about a discussion about producing slide decks and the team having gotten some slide decks from some doctors…There was a plan made by the team to continue to interact with the government…But the conversation never happened because the government stopped returning calls about what the government wanted…No, you can’t make a false statement whether it’s a voluntary investigation or not…The team expected some further discussions about slide decks, but that never occured because the government stopped responding and they didn’t’ know why…The decks were not thrown away and were ultimately produced…The DOJ turned it into a mandatory subpoena investigation and decks were turned over at one point…

Pharmalot: Are you concerned about disciplinary proceedings in North Carolina against Stevens?
Conry: I haven’t heard anything further about disciplinary proceedings being brought in North Caronlina.
O’Connor: Typically, you get concerned about such actions when there are adverse findings or admissions, but there were neither here…It should not happen and would be unlikely.

Pharmalot: By the way, would you have put Stevens on the stand?
Conry: We were ready to if needed. We worked diligently with Lauren and she would have been a great witness…It’s always a judgment call at the end of day…
O’Connor: We were talking about it every day and thinking about it. Fortuantely, it didn’t have to come to that decision, but she was ready.

scales pic thx to ericthefish on flickr