Are Attorneys the FDA’s New Enforcement Target?

By Jamie K. Wolszon –  

Hyman, Phelps & McNamara, P.C. Directors Douglas B. Farquhar and John R. Fleder presented a webinar on Monday December 20, 2010 for Thompson Interactive entitled: “Are Attorneys the FDA’s New Enforcement Target?”  The webinar slides can be found here.  The webinar discussed the November 9, 2010 six-count indictment of Lauren Stevens, former Vice President and Associate General Counsel for GlaxoSmithKline, for her alleged role in responding to FDA’s investigations into the company’s promotion of its anti-depressant drug Wellbutrin.  The charges, which include obstruction of justice and false statement offenses, could result in jail time.  We previously reported on the indictment.  

The webinar included discussion of two recent developments in the case that have yet to capture widespread attention.  The government filed a motion for a protective order that indicated that the investigation is ongoing.  “These charges are part of a broader, ongoing investigation.  The discovery relevant to the instant case thus contains information not only about this case, but also relates to the ongoing, underlying health care fraud investigation, including potential criminal activity by others,” the government revealed in the motion.  

In another recent development in the case, the government filed a motion on December 17, 2010 to preclude Ms. Stevens and her legal team from invoking the “advice of counsel” defense.  This defense can negate the wrongful intent element of crimes that require wrongful intent.  It generally applies if a lawyer provides legal advice that the defendant’s conduct was legal and the defendant relied in good faith on that advice, even if the legal advice was wrong, assuming that the defendant meets other criteria.    

The government claimed that the advice of counsel defense is not available for one of the obstruction of justice charges against Ms. Stevens.  With regard to the other two types of charges, the government claimed that Ms. Stevens cannot invoke the defense because (1) it claimed there is evidence that Ms. Stevens did not share all pertinent facts with the attorneys from the law firm that provided legal counsel; (2) Ms. Stevens knew that her representations to FDA were not true and it was not reasonable for her to rely on an attorney to knowingly make false statements; and (3) Ms. Stevens did not hire counsel to advise her personally, as the lawyers represented only the corporation.