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Glaxo Lawyer Says Disclosing Illegal Activity Would Be "Misleading" to the FDA

A former lawyer for GlaxoSmithKline (GSK) has all but admitted she concealed from the FDA evidence that the company was illegally promoting antidepressants as a diet pills, according to court papers which argue that disclosing the transgressions would have been "misleading."

In the case, former GSK vp/associate general counsel Lauren Stevens is charged with making false statements to the FDA about the marketing of the antidepressant Wellbutrin. In her defense, Stevens has argued she relied in good faith on the advice of her lawyers, who were helping her respond to the FDA's requests for documents and information about how Wellbutrin was promoted. The investigation may have spiraled into a wide-ranging probe of the entire company, Stevens claims.

A federal judge recently unsealed several pretrial motions and exhibits in the case, and in one Stevens makes a version of the classic argument favored by adulterers who've been caught in flagrante delicto: "This isn't what it looks like!" Part of Stevens' defense revolves around whether lawyers have a general duty to be truthful in their business dealings. During the FDA investigation, Stevens' team interviewed more than a dozen GSK employees, wrote to 500 doctors, collected promotional slideshows from 40 of them, and discovered that three of those physicians had been touting Wellbutrin for weight loss, and had created slideshows or other documents to do so.

At that point, Stevens consulted with her lawyers at the firm King & Spalding and, fatefully, decided not to turn over the incriminating slideshows. Her lawyers argued:

Concerned that simply producing the presentations with no explanation could create a misleading impression, the GSK and King & Spalding team subsequently discussed at length whether to produce the presentations to the FDA absent the context necessary to fairly assess the presentations. The team reached a consensus decision not to produce the presentations immediately, but instead to seek a meeting with the FDA at which GSK would discuss the presentations.
This is lawyerly dissembling at its finest. Having discovered documents showing that GSK's people were promoting the drug illegally, Stevens and her attorneys concluded that these documents "could create a misleading impression ... absent the context necessary" to "fairly" assess them!

A meeting that never happened
Stevens' insistence that she would have turned over the documents if only the FDA had granted her a meeting to explain them is thin gruel, also. On May 21, 2003, Stevens wrote a "final" and "last" letter to the FDA on the Wellbutrin matter, the first paragraph of which states:

This letter represents our final supplemental response to your letter dated October 9,2002 ... this will be our last submission, ....
The letter goes on to admit that it did find some doctors talking about weight loss in promotional seminars, but suggests that they were bad apples in a barrel that has since been sterilized. In the final paragraph of the letter, Stevens asks the FDA for a meeting, but the invitation in no way suggests that she has more material to hand over. In fact, the invite begins by stating that GSK's production of documents is "complete":

A lawyer might conclude that a teleconference at which one can ask "any final questions" is a suggestion that you have a box full of smoking guns, but it is hard to imagine 12 laypersons seeing it that way.

The admissions are all legal arguments about what can and cannot be used at trial, so it is unlikely that a jury will get to read Stevens' semi-confession as presented here. Nonetheless, Stevens' team appears to be laying out a map of their weakest defenses for prosecutors to follow.

And who were legal geniuses at GSK who helped Stevens reach the conclusion that the least "misleading" way to give the FDA incriminating documents was to not tell the FDA they existed? Stevens was assisted by GSK lawyer Doug Snyder, a former associate general counsel at the FDA for five years, and King & Spalding's Mark Brown, a former FDA associate chief counsel who was one of the FDA's chief litigators and had handled both civil and criminal cases for the agency.


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