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SUPPLEMENTAL COMPLAINT REQUESTING JUDICIAL REVIEW UNDER THE ADMINISTRATIVE PROCEDURE ACT AND FOR DECLARATORY AND INJUNCTIVE RELIEF

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA

INTERNATIONAL ACADEMY OF )
ORAL MEDICINE & TOXICOLOGY, )
INC., an Oklahoma non-profit corporation; )
MOMS AGAINST MERCURY, INC., )
a North Carolina non-profit corporation; )
COMED, INC., a Delaware non-profit )
Corporation; DAMS, INC., a New Mexico )
non-profit corporation; AMY M. CARSON, )
guardian ad litem for KIT D. CARSON; )
REV. LISA SYKES, guardian ad litem )
for WESLEY SYKES; LINDA BROCATO; )
KRISTIN HOMME, PE, MPP, MPH; )
MICHAEL G. BURKE; )
HOLLIS HUGHES )
ROGER WALLER; KENNARD W. )
WELLONS; DAVID BARNES, DDS; )
PAULA KAVANAGH; ROBERTA VOSS; )
JOY CHMIELENSKI, RN; DORICE )
A. MADRONERO; ERIC EDNEY; )
KAREN PALMER; and KAREN BURNS, )
)
Plaintiffs, )
)
v. ) CASE NO.: 1:14-cv-00356
)
THE U.S. FOOD AND DRUG )
ADMINISTRATION )
10903 New Hampshire Avenue )
Silver Spring, MD 20993; )
)
)
DR. STEPHEN OSTROFF, M.D., )
Acting Commissioner of the U.S. )
Food and Drug Administration )
10903 New Hampshire Avenue )
Silver Spring, MD 20993 )
)
THE U.S. DEPARTMENT OF HEALTH )
AND HUMAN SERVICES, )
200 Independence Avenue, S.W. )
Washington, D.C. 20201 )
)

SYLVIA MATHEWS BURWELL )
Secretary of Health and Human Services )
U.S. Department of Health and Human )
Services )
200 Independence Avenue, S.W. )
Washington, D.C. 20201 )
)
Defendants. )

SUPPLEMENTAL COMPLAINT REQUESTING JUDICIAL REVIEW UNDER
THE ADMINISTRATIVE PROCEDURE ACT AND FOR
DECLARATORY AND INJUNCTIVE RELIEF

Plaintiffs, the International Academy of Oral Medicine & Toxicology, Inc., an Oklahoma non-profit corporation and others, allege and state as follows:
NATURE OF THE ACTION
1. This is an action to review and set aside a final action of the United States Food and Drug Administration (“FDA”) pursuant to the Administrative Procedure Act (“APA”), 5 U.S.C. § 702 et seq., and for related declaratory relief under 28 U.S.C. § 2201-02, and an injunction.
2. This Complaint supplements Plaintiffs’ action for declaratory and injunctive relief filed on March 5, 2014. The action arose out of the failure of the FDA to respond within a reasonable time to the Petitions concerning mercury fillings challenging the FDA’s July 28, 2009, Final Order classifying mercury amalgam dental filling material as a Class II device.
3. The Plaintiffs’ Petitions requested that FDA provide the following relief: (1) formally ban the use of mercury fillings as a dental restorative material pursuant to section 516 of the Medical Device Amendments of 1976 (21 U.S.C. § 360f) and 21 C.F.R. § 895, or in the alternative; (2) place encapsulated mercury fillings into Class III pursuant to section 513(3) of the Medical Device Amendments; (3) demonstrate proof of safety and effectiveness; (4) promulgate restrictions for the use of dental amalgam in certain individuals; (5) require that an Environmental Impact Statement (“EIS”) or at least an Environmental Assessment (“EA”) be prepared pursuant to 21 C.F.R. § 25.40; and, (6) provide meaningful informed consent to dental patients, or their parents, of the amalgam mercury content and potential risks associated with mercury exposure from amalgam fillings. (The citizens’ petitions and supplemental petition at issue are referred to below as the “Petitions.”)

 

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