FDA Law Blog - DC Circuit Vacates District Court Regarding TPSAC, Is the Menthol Report Back or in Limbo?

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DC Circuit Vacates District Court Regarding TPSAC, Is the Menthol Report Back or in Limbo? Posted: 18 Jan 2016 07:52 PM PST By Jay W. Cormier & David B. Clissold – As we reported 18 months ago here, in July of 2014 the District Court for the District of Columbia granted summary judgment for what is now R.J. Reynolds Tobacco Holdings, Inc. in a lawsuit that alleged that the FDA Tobacco Product Scientific Advisory Committee (“TPSAC”) was tainted by the inclusion of three members who had financial conflicts of interest.  In addition to finding that the appointments were improper, the District Court found that the committee’s 2011 Menthol Report was “at a minimum, suspect, and, at worst, untrustworthy.”  FDA was instructed to appoint an entirely new TPSAC.  Not surprisingly, FDA appealed on several grounds, the most relevant of which was that the plaintiffs lacked standing. Last Friday, the DC Circuit agreed with FDA and overruled the District Court’s summary judgment. The Circuit Court concluded that “all three [alleged plaintiff injuries] are too remote and uncertain” for the plaintiffs to have standing to bring the case.  The impact of vacating the District Court ruling is significant. As the Circuit Court stated in its last sentence of the ruling, “[w]e therefore vacate the judgment of the district court for lack of jurisdiction and dissolve its injunction barring the use of the menthol report and ordering the reconstitution of the Committee.” Although the direction from the Circuit Court is painfully clear, given the significance of this ruling, we expect that this is not the end of this fight.