Drug Shortage Plaintiffs Fail to Demonstrate Injury, Causation

December 10, 2013

By Jennifer M. Thomas

To the extent that Plaintiffs, or interested observers, hoped the District Court for the District of Columbia would seize an opportunity to take FDA to task for failing to prevent or stop drug shortages, they were disappointed by Judge Howell’s Thanksgiving ruling in Carik v. HHS, No. 12-00272 (D.D.C. Nov. 27, 2013). 

On the other hand, FDA may hug itself.  Judge Howell concurred completely with FDA’s argument that Plaintiffs lacked Article III standing because they failed to adequately allege any action by the government with a “causal connection” to their alleged injuries.  In doing so, he found expressly that two pharmaceutical manufacturers had caused the complained-of shortages, not FDA.  Nor did FDA have any ability, let alone a statutory or constitutional “duty to act,” to alleviate the drug shortages.  Finally, Judge Howell determined that the actions of the pharmaceutical companies in managing their drugs in shortage could not be fairly attributed to FDA, since the Agency was not alleged to have significantly encouraged those companies’ drug rationing schemes.

Judge Howell went further in favor of dismissal on Article III grounds even than FDA in its brief, finding that only one of the twenty-five Plaintiffs had adequately alleged injury in fact.  The “possibility that adverse effects may result from taking a diluted dose” of the drug in shortage could not constitute injury in fact where the Plaintiff’s had failed to quantify the increased risk of physical injury, and thus “demonstrate a ‘substantial probability’ that they will be injured.”

Coming on the heels of a major setback for FDA on the drug shortage front in the D.C. Circuit (Cook v. FDA, No. 12-5176 (Jul. 23, 2013)), as we discussed here, FDA may feel vindicated by Judge Howell’s recognition of the Agency’s serious limitations in managing drug shortages, and attribution of responsibility to pharmaceutical companies.