Beaty v. Food and Drug Administration

• Court: District Court, District of Columbia
• Decided: March 27, 2012
• Docket: Civil Action No. 2011-0289
• Status: Published

Opinion

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