Tuesday, October 16, 2012

Franck’s Compounding Case: Parties File Joint Motion To Vacate and Dismiss Appeal As Moot


In September 2011, the U.S. District Court for the Middle District of Florida decided that the FDA lacked authority to enjoin the “long-standing, widespread, state-regulated practice of pharmacists filling a veterinarian’s prescription for a non-food producing animal by compounding from bulk substances.”  In November 2011, the government appealed that decision to the United State Court of Appeals for the Eleventh Circuit. Parties had filed their briefs. Amici had filed their briefs. Oral argument was scheduled for November 1, 2012.

Today, October 16, 2012, the Government and Fanck’s have filed a Joint Motion to Vacate and Dismiss as Moot that the Court will most likely grant very soon since the parties are in agreement.

The FDA Law blog summarizes the motion as follows:

According to the motion, Franck’s was acquired by Wells Pharmacy Network, LLC (“Wells”) through an asset sale and “no longer engages in compounding and no longer owns or operates the facilities at issue.” “Nor is there any reasonable probability that [Franck’s] will resume the challenged conduct,” and the company “has turned in the permits required by Florida law to operate as a compounding pharmacy, sold all its assets, and terminated all its employees.” Moreover, Paul Franck, the owner of Franck’s and the individual defendant in the case, “is no longer engaged in veterinary compounding of any kind,” “has no intention of reentering that profession in the anticipated future,” and has “executed a seven-year non-competition agreement with Wells,” according to the motion.
Given these circumstances and controlling law (i.e., Laidlaw Envtl. Servs., 528 U.S. 167 (2000)), the parties agreed that the case has become moot and jointly moved the Eleventh Circuit not only to dismiss the appeal, but to vacate the Florida district court’s judgment, and remand the case with instructions to dismiss the complaint.

Source found here


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