How Long Until A New Grand Jury Indicts Ex-GSK Lawyer, In FDA Obstruction Case?


Yesterday, an ex-Glaxo internal lawyer won a (nominal) dismissal, without prejudice, of a grand jury indictment charging her with false statements to the FDA, and obstruction of justice. Ed Silverman, writing over at Pharmalot, has been covering this case very closely — do go read all of his background. Are you up to speed, now? Good. Now. . .

While most headlines portray yesterday’s opinion and order as a vindication of Ms. Stevens, I think this view is premature. In the longer run, I think it likely that the government will empanel a new grand jury, and simply correct its inadvertent mistake, in describing the doctrine of negating intent by good-faith reliance on advice of independent counsel, to the new grand jury. [What the government should have said appears below, in blue. When said as in blue below, the outcome will likely be the same: an indictment of Ms. Stevens, in my opinion.]

In any event, it is hard to see how a decision to exclude slides plainly covered by an FDA demand, by an officer, and high-ranking corporate attorney, to boot (thus an expert in what is required when one signs a document submitted to the FDA) — from the response to the FDA (simply because another lawyer purportedly said it would be okay to do so) will pass muster.

Lawyers accept special obligations when they undertake to practice before the FDA, or the SEC. Knowingly omitting GSK promotional slides, when the request is for “all GSK promotional slides,” is simply not cricket — and thus, in my estimation, the government will be able to win a new indictment here. So, stay tuned — as this case is still very-likely to send a chill through C-Suites — up and down the PhRMA member roster.

Here’s what should have been said, from Judge Roger W. Titus’ opinion:

“. . . .the defendant received advice from a lawyer and you may consider that evidence in deciding whether the defendant acted willfully and with knowledge. The mere fact that the defendant may have received legal advice does not, in itself, necessarily constitute a complete defense. Instead, you must ask yourselves whether the defendant honestly and in good faith sought the advice of a lawyer as to what she may lawfully do; whether she fully and honestly laid all the facts before her lawyer; and whether in good faith she honestly followed such advice, relying upon it and believing it to be correct. In short you should consider whether, in seeking and obtaining advice from a lawyer, the defendant intended that her acts shall be lawful. If she did so, it is the law that a defendant cannot be convicted of a crime which involves willful and unlawful intent, even if such advice were an inaccurate construction of the law. On the other hand, no woman can willfully and knowingly violate the law and excuse herself from the consequences of her conduct by pleading that she followed the advice of her lawyer. Whether the defendant acted in good faith for the purpose of seeking guidance as to the specific acts in this case, and whether she acted substantially in accordance with the advice received, are questions for you to determine. . . .”

1 Sand et al., ¶ 8.04 Instr. 8-4 (emphasis supplied). . . .

Do stay tuned, especially over at Pharmalot. I know I will.

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