Former Glaxo Lawyers Asks Judge To Dismiss Case

Former Glaxo Lawyers Asks Judge To Dismiss Case

May 10th, 2011 // 1:10 pm @

On the eve of presenting her defense, former GlaxoSmithKline lawyer Lauren Stevens has asked a federal judge to toss the indictment in which she is charged with obstructing an FDA probe into off-label marketing of the Wellbutrin SR antidepressant and making false statements to the agency. If US District Court Judge Roger Titus denies her request, the Stevens team will call its witnesses today.

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The case is being closely watched for several reasons: it offers the unusual spectacle in which the feds are attempting to make an example of a pharma employee, the proceedings peel back the curtain on the internal machinations that occur when the FDA undertakes a probe and, finally, the trial is pitting the former Glaxo lawyer against some of her former colleages, including lawyers at the King & Spalding law firm that has done a great deal of work for the drugmaker over the years (back story).

Over the past few months, the Stevens team has succeeded in having the first indictment tossed (see this), but whether the gambit to dismiss the case at this stage is unclear. In a 37-page motion, her lawyers argue, for instance, that Stevens did not attempt to conceal information, but rather did not produce info, such as slide decks, that was not sought by the FDA by way of subpoena.

“Where the company was under no legal compulsion (such as a subpoena) to produce the decks, and never purported to have produced them or not to have them, this does not amount to concealment under the statute,” her lawyers write. “Furthermore, the government has not proven that Ms. Stevens acted with specific, corrupt intent with regard to the decks; she acted at all times in accordance with the informed advice of reputable counsel.”

Elsewhere in her motion, her attorneys maintain that a decision about info that was included in spreadsheets, which detailed entertainment provided docs, was provided to the FDA as requested and that King & Spalding lawyers were involved in deciding the details conveyed to the agency. “They fully participated in conversations regarding the speaker event spreadsheets,” they argue. “And ultimately, they drafted the letter that accompanied and commented on the spreadsheets.”

In a similar vein, the Stevens lawyers argue she did not make false statements because these were open to interpretation. For instance, she maintained docs were not paid, reimbursed or compensated for attending certain events, except for parking fees in some cases. “At best,” her lawyers say, docs participated in entertainment activity as part of a speaking event or received a “medically relevant gift.” But no compensation was paid. And after reviewing the entertainment info, her lawyers note, King & Spalding sent Glaxo a draft letter that attendees were not paid, reimbursed or compensated.”

And to cover the rest of the bases, the Steven team maintains that even if some of her statements were incorrect, these were not “material, intentional falsehoods” and, consequently, the feds “failed to prove that Stevens acted with a specific intent to make a false or fraudulent statement.” As Perry Mason would say, your witness…


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