Case Dismissed

Sue Reisinger

Corporate Counsel

12-01-2012

Lauren Stevens is convinced that she was unfairly charged with a crime, and should never have had to face charges for her work as an in-house lawyer. She and her family suffered through the ordeal of a seven-year investigation, she says, followed by two years of pretrial activity, and then a two-week trial. But she was relieved when the case was finally dismissed, and believes that ultimately justice was done.

"The justice system is not always perfect, but in my case it worked as it should," she says. "Unfortunately, that is not always the case."

Stevens is the former associate general counsel at GlaxoSmithKline who was accused of obstruction of justice during a Food and Drug Administration inquiry into the off-label marketing of a drug. Prosecutors alleged that she made false statements and withheld information that was requested but not subpoenaed. Her lawyers argued—and in May 2011 a federal judge agreed—that she was simply being a zealous advocate for her company and had committed no crime.

Stevens spoke to Corporate Counsel in October, after returning from a speech in London where she recounted her ordeal at a meeting of the International Association of Defense Counsel. When she speaks, Stevens says, the audience is generally sympathetic. "Some people have told me they are concerned it could happen to them, but I tell them what happened to me should not deter them from doing their job—zealously representing their clients. I don't share the story to scare people. I share it so that people hopefully can learn from my experience."

Stevens first told her story in early October at the Association of Corporate Counsel's annual meeting in Orlando. Amar Sarwal, chief legal strategist at ACC, introduced Stevens by warning the 1,600 in-house bar members that "the government and prosecutors have a target on your back."

But Stevens has a gentler take—thanks to the happy ending. She retired and was spending her time gardening and relaxing with her family. But GSK then asked her to return to work part-time. "I do the same kind of work as before, and I get to work with people I used to work with, and that is very special to me," she says.

During her ACC speech, Stevens walked the audience through her case. It began in 2002, when she was "working in the trenches" in the legal department at the drug giant in Raleigh-Durham. Her boss asked her to handle a letter the company had received from the FDA that asked about possible off-label marketing of the drug Wellbutrin. In time, the FDA sent six more, she said.

The first letter was unusual. It read like a subpoena, Stevens said, even though it wasn't. The FDA was seeking voluntary compliance, and GSK agreed to cooperate. Stevens put together a legal team that included in-house lawyers plus outside counsel. After 13 months of employee interviews and document research, "we discovered the company had no intent to market this drug off-label," Stevens said. "But of course mistakes were made, and we disclosed them quickly and rectified them."

Outside counsel drafted the responses, Stevens said, but she signed them because GSK was afraid that if "we fronted the law firm to the FDA, it would raise a red flag." Today, she noted, nearly every company hires outside counsel when it's dealing with an inquiry from a government regulator. She drew laughs when she said that that was the first lesson she learned: "If you're going to write letters to agencies, have your outside counsel sign them."

In 2009 the U.S. Department of Justice finally issued a target letter against her. A year later she was indicted, fingerprinted, and photographed for a mug shot. "And this nice jailer asks, in all seriousness, 'This isn't going to ruin your legal career, is it?' "

During the trial, her defense team painted her as a strong but honest advocate for her company. After the prosecution had rested its case but before the defense began, one of her lawyers asked for a dismissal because the government hadn't proved that a crime had been committed.

"My attorney said, 'Don't get your hopes up; this never happens," she recalled. But this time it did.