United States District Court, W.D. Arkansas, Fort Smith Division
FOR
THE DEFENDANTS: FOR THED STATES J. DALTON PERSON, ESQ. JONES
JACKSON & MOLL, PLC, JAMES T. WHITE, LORI A. LAYNE
INDIVIDUALLY
FOR
THE UNITED STATES DUANE (OAK) KEES UNITED STATES ATTOREY,
MARK W. WEBB
OF
COUNSEL ROBERT CHARROW GENERAL COUNSEL, STACY CLINE AMIN
CHIEF COUNSEL, ANNAMARIE KEMPIC DEPUTY CHIEF COUNSEL.
LITIGATION, SETH I. HELLER ASSOCIATE CHIEF COUNSEL
CONSENT DECREE OF CONDEMNATION AND PERMANENT
INJUNCTION
P.K.
HOLMES, III UNITED STATES DISTRICT JUDGE
On
November 7, 2018, a Complaint for Forfeiture against the
above-captioned articles was filed in this Court on behalf of
the United States of America by its attorneys for the Western
District of Arkansas. The Complaint alleges that the articles
proceeded against are articles of food, drug, device, and
cosmetic within the meaning of the Federal Food, Drug, and
Cosmetic Act (the "Act"), 21 U.S.C. §§
301 -399i, that are adulterated while held for sale after
shipment of one or more of their components in interstate
commerce, within the meaning of 21 U.S.C. §§
342(a)(4), 351(a)(2)(A), and 361(c), in that they have been
prepared, packed, or held under insanitary conditions whereby
they may have become contaminated with filth or may have been
rendered injurious to health. The Complaint additionally
alleges that the defendant articles of drug are also
adulterated while held for sale after shipment of one or more
of their components in interstate commerce, within the
meaning of 21 U.S.C. § 351(a)(2)(B), in that the
facilities or controls used for their manufacture,
processing, packing, or holding do not conform to, or are not
operated or administered in conformity with, current good
manufacturing practice to assure that such drugs meet the
requirements of the Act as to safety, and have the identity
and strength, and meet the quality and purity
characteristics, which they purport or are represented to
possess.
Pursuant
to the Warrant for Arrest issued by this Court, the United
States Marshals Service (the "USMS") for this
District seized the articles on November 7 and 8. 2018.
Thereafter, notice of the complaint and seizure were
published in accordance with the applicable rules of this
Court.
On
November 9, 2018, J and L Grocery, LLC ("J&L"
or "Claimant") intervened and filed a claim to the
seized articles. On June 14, 2019, the United States amended
the Complaint to seek injunctive relief and add J&L,
J&L's owner, James T. White, and J&L's
manager, Lori A. Layne (collectively "Defendants")
as parties.
Defendants
now consent to the entry of this Decree without contest,
before any testimony has been taken.
Whereupon,
the Court being fully advised, it is on motion of the parties
hereto, ORDERED, ADJUDGED, AND DECREED as follows:
1. This
Court has subject matter jurisdiction over this action
pursuant to 28 U.S.C. § 1345 and 21 U.S.C. § 334.
Venue is proper in this district pursuant to 28 U.S.C.
§§ 1391(b) and 1395.
SEIZURE
PROVISIONS
2.
Claimant affirms that it is the sole owner of the seized
articles of food, drug, device, and cosmetic and that no
other person has an interest in the goods.
3. The
seized articles are adulterated while held for sale after
shipment of one or more of their components in interstate
commerce, within the meaning of 21 U.S.C. §§
342(a)(4), 351(a)(2)(A), or 361(c), in that they have been
prepared, packed, or held under insanitary conditions whereby
they may have become contaminated with filth or may have been
rendered injurious to health. The seized articles of drug are
also adulterated while held for sale after shipment of one or
more of their components in interstate commerce, within the
meaning of 21 U.S.C. § 351(a)(2)(B), in that the
facilities or controls used for their manufacture,
processing, packing, or holding do not conform to or are not
operated or administered in conformity with current good
manufacturing practice to assure that such drugs meet the
requirements of the Act as to safety, and have the identity
and strength, and meet the quality and purity
characteristics, which they purport or are represented to
possess.
4. The
seized articles are hereby condemned pursuant to 21 U.S.C.
§ 334(a) and forfeited to the United States.
5.
Pursuant to 21 U.S.C. § 334(e), the United States of
America shall recover from the Claimant all court costs and
fees, storage and other proper expenses already incurred with
respect to the condemned articles, and such additional
expenses as may hereafter be incurred and taxed pursuant to
the authority set forth in 21 U.S.C. § 334. Claimant
shall pay these costs within sixty (60) calendar days after
receiving notice of such costs from the United States Food
and Drug Administration ("FDA"), the USMS, and/or
the United States Department of Justice ("DOJ").
6.
Within twenty (20) calendar days after entry of this Decree,
Claimant shall execute and file with the Clerk of this Court
a good and sufficient penal bond with surety, in a form
acceptable to the Clerk of this Court and payable to the
United States of America, in the amount of forty thousand
dollars ($40, 000.00), conditioned on the Claimant's
abiding by and performing all of the terms and conditions of
this Decree with respect to the condemned articles and such
further Decrees or Orders as may be entered in this
proceeding with respect to the condemned articles. The bond
shall be applied to Lot 1 as defined in the Destruction Plan
to be submitted and approved under paragraph 8 of this Decree
and held for application to each successive lot as defined in
the Destruction Plan.
7.
Claimant shall provide all necessary documentation in its
possession, custody, or control to verify to FDA's
satisfaction the content and value of each lot of the
condemned articles of food (including dietary supplements),
drug, medical device, and cosmetic.
8.
After filing of the bond with this Court, the Claimant shall
give written notice to the FDA Dallas District Office
pursuant to paragraph 29, that Claimant, at its own expense,
is prepared to destroy the condemned articles under the
supervision of the USMS and a duly authorized representative
of FDA. Claimant shall not commence, permit any other person
to commence, or cause any other person to commence destroying
the condemned articles unless and until Claimant: (a) submits
a written statement to FDA detailing Claimant's proposed
plan to destroy the condemned articles (the
''Destruction Plan"), including a schedule for
the destruction; (b) receives written approval of the
Destruction Plan from FDA; (c) receives written authorization
from FDA to commence destroying the condemned articles under
the supervision of FDA; and (d) has fully paid the costs and
fees pursuant to paragraph 5. Claimant shall submit its
Destruction Plan to FDA within thirty (30) calendar days
after filing its bond with the Court.
9. The
Claimant shall at all times, until the condemned articles
have been destroyed pursuant to paragraphs 8 and 10, retain
intact each lot of condemned articles for examination or
inspection by FDA and the USMS, and shall maintain the
records or other proof necessary to establish the identity of
the articles comprising each lot to the satisfaction of FDA
and the USMS.
10. If
the Destruction Plan is approved by FDA pursuant to paragraph
8, the USMS for this District shall successively release each
specified lot of the condemned articles to the Claimant for
the sole purposes of destroying such articles pursuant to the
Destruction Plan. After release of the first lot, subsequent
lots shall be released by the USMS to the Claimant for the
sole purposes of destruction pursuant to the Destruction
Plan, if and only if Claimant complies with all of the terms
of this Decree with respect to each previously-released lot,
and each such lot has been successfully ...