Court Opinion

ID: 2662686
Source: CourtListenerOpinion
Date Created: 2014-04-03 12:39:56.672366+00
Date Added: 2024-06-11T13:04:54.449807
License: Public Domain

UNITED STATES DISTRICT COURT
                      FOR THE DISTRICT OF COLUMBIA

 DONALD EDWARD BEATY, et ai.,                   )
                                                )
                    Plaintiffs,                 )
                                                )
             v.                                 )   Civil Case No. 11-289 (RJL)
                                                )
 FOOD AND DRUG                                  )
 ADMINISTRA TION,                               )
                                                )
 and                                            )
                                                )
 U.S. DEPARTMENT OF HEALTH                      )
 AND HUMAN SERVICES,                            )
                                                )
 and                                            )
                                                )
 KATHLEEN SEBELIUS, in her official             )
 capacity as Secretary of the U.S.              )
 Department of Health and Human                 )
 Services,                                      )
                                                )
 and                                            )
                                                )
 MARGARET A. HAMBURG, M.D., in                  )
 her official capacity as Commissioner of       )
 Food and Drugs,                                )

                    Defendants.
                                     ORDER
                                                ~+L
                                  (MarchZ},2012)
                                                                           ft-
      For the reasons set forth in the Memorandum Opinion entered thil.7 day of
March, 2012, it is hereby

      ORDERED that plaintiffs' Motion for Summary Judgment and Declaratory Relief
on Counts I and III [#12] is GRANTED; and it is further

     ORDERED that the defendants' Motion to Dismiss and/or for Summary
Judgment [#13] is DENIED; and it is further

                                            1
       DECLARED, pursuant to 28 U.S.C. § 2201(a), that

       1. the foreign manufactured thiopental (or "thiopental") imported by the
importing States (e.g. Arizona, California, South Carolina, Georgia, and Tennessee) is a
misbranded drug and an unapproved new drug within the meaning of the FDCA; and

       2. as such, this thiopental cannot lawfully be introduced or delivered for
introduction into interstate commerce or lawfully be imported into the United States; and

       3. defendants' recent actions allowing such thiopental to enter the United States
were each contrary to law, arbitrary, capricious, and an abuse of discretion under the
AP A; and, in particular,

       4. defendants' January 4, 2011 announcement that they will allow future
shipments of such thiopental to enter the United States is contrary to law, arbitrary,
capricious, and an abuse of discretion under the AP A; accordingly

       IT IS HEREBY ORDERED that the FDA:

       1. immediately notify any and all state correctional departments which it has
reason to believe are still in possession of any foreign manufactured thiopental that the
use of such drug is prohibited by law and that, that thiopental must be returned
immediately to the FDA; and

      2. be permanently enjoined from permitting the entry of, or releasing any future
shipments of, foreign manufactured thiopental into interstate commerce; and

       IT IS FURTHER ORDERED that the parties are hereby directed to meet and
confer to determine whether further litigation is necessary, or proper, with respect to the
remaining count in this Complaint.

       SO ORDERED.
                                                         ~

                                                 !I~
                                                  United States District Judge

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