Conferences / Symposia, In-House Counsel

House Rules: When S**t Gets Real

Last week, I wrote about the ACC Annual Meeting. A highlight of that meeting was an interview with Lauren Stevens, linked here. The clip is over an hour long, with the interview starting around eleven minutes in; I can see the tl;dw comments now. Let me give you a summary.

This is a case of an in-house counsel getting prosecuted, twice, for doing her job. We are tasked with protecting our companies zealously. Just like any outside lawyer. And you know what, sometimes we’re the windshield, but most times we’re the bug, to paraphrase Mark Knopfler. This isn’t a fluff piece, it’s a column about stuff getting real, and what can happen to a gatekeeper simply doing her job….

More and more in-house attorneys are becoming generalists. In fact, approximately 60 percent of ACC members are from smaller law departments. That’s a majority, for those of you following along, or who still think George W. beat Al Gore. I am fortunate in many ways to work in a large law department where I am not the end all and be all of legal decision and analysis. The pressure can be enormous for those who are in that role — some would say that such lawyers have targets on their backs. And they do. The buck stops with them.

But for me, in a 200+ person department, I am safe in my cubby, right? Wrong. Lauren Stevens was one of “us”, counsel in a large department in Big Pharma. She was Associate GC for GlaxoSmithKline. Yup, a large law department lawyer getting cherry picked and prosecuted by the government, for doing what? Allegedly misleading the FDA while cooperating with an FDA request for information. Yes, cooperating. She wasn’t fighting the request, she was complying. And she ended up with an indictment, and faced up to 60 years in prison. Nice.

Ms. Stevens was not the VP of legal affairs, she was one of many. Just like all those financial “VPs” on the prowl in Wall Street bars. She received a subpoena-like request from a department within the FDA that has no subpoena power. The request asked 15 broad questions, and GSK agreed to comply.

Now, in-house is a bit different than Biglaw in that we don’t immediately start to figure out how to fight or quash such requests. I receive subpoenas all the time, and it’s usually no big deal. We’ll do a risk analysis for the company, and most times the subpoena only tangentially involves us, and we’ll agree to comply. I will call up the AUSA, or other relevant contact, and ask how we can assist. Often, they want some documentation regarding a fraud investigation or illegal exportation practices by a third party. We have an interest in stopping such practices due to the implications for the company, so we readily agree to assist.

There’s also something to be said for relationships with U.S. Attorneys and other investigating arms of the government. I have friends at the local office, and I will go out of my way, if appropriate, to assist them if they need some help. We also have a raft of former government agents that work for us, and they are quite useful in advising how and when to cooperate, and what methodology to use when getting involved with a government investigation. So it went with Ms. Stevens.

The internal response team realized that some mistakes had been made with respect to the marketing of the product at issue in the FDA inquiry. They did the right thing and disclosed the information, and went the next logical step by rectifying the mistakes. All good moves on the part of the company. Sunshine is the best disinfectant, and if you can open the kimono before the government does it forcibly, you are more likely to avoid a crisis. GSK also kept the lines of communication open with the FDA. Again, a best practice in this type of situation.

So let’s review. She responded positively and diligently to the inquiry. She put together a crack team of attorneys and outside counsel to assist in responding. She maintained open lines of communication with the agency. And when mistakes were discovered, they were disclosed, rectified, and steps were taken to avoid the same mistakes occurring. What happened next is not only frightening, but wrong and unjust.

I’ve laid out the bare facts gleaned from the interview, and I’ll leave it to you to pick it up around the 22 minute mark. It ought to send chills down your back. It did mine.


After two federal clerkships and several years as a litigator in law firms, David Mowry is happily ensconced as an in-house lawyer at a major technology company. He specializes in commercial leasing transactions, only sometimes misses litigation, and never regrets leaving firm life. You can reach him by email at dmowry00@gmail.com.

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