Miami-Luken, Inc. v. United States Drug Enforcement Administration

DEA ordered Miami-Luken, a registered controlled substances pharmaceutical wholesaler, to show cause why its registration should not be revoked, for failing to maintain effective controls against the diversion of oxycodone and hydrocodone and failing to disclose suspicious orders. At the company’s request, an ALJ issued a subpoena requiring DEA to produce various investigative records. DEA filed a notice declaring that it would not comply. Miami-Luken filed an emergency motion and the district court adopted a magistrate’s recommendation to enforce the subpoena in part, eliminating one category of subpoenaed documents, narrowing another, and permitting DEA to provide “reasonably redacted versions.” DEA's Acting Administrator determined that the enforcement order, permitting the DEA to make reasonable redactions, also permitted DEA to review the validity of the subpoena itself, and found that the requested categories of documents were not “necessary to conduct” the hearing as would be required for disclosure under 21 C.F.R. 1316.52(d) and ordered the subpoena quashed. DEA obtained a stay of the order enforcing the subpoena pending further judicial review and moved for relief from judgment. Miami-Luken then petitioned the Sixth Circuit to review directly DEA’s order quashing the subpoena. Meanwhile, the district court denied DEA’s motion for relief from judgment, stating: Nothing in this Court’s Order permitted the DEA Administrator to set aside the subpoena. The Sixth Circuit denied Miami-Luken’s petition for lack of jurisdiction. The Administrator’s order was not a “final decision” under 21 U.S.C. 877. View "Miami-Luken, Inc. v. United States Drug Enforcement Administration" on Justia Law