schedules/downloads/child/0-18yrs-child-combined-schedule.pdf). 19. Robert F. Kennedy, Jr. and Plaintiff’s founder, Del Bigtree, along with a few other.
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1 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK INFORMED CONSENT ACT ION NETWORK , Plaintiff, – against – UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES Defendant. COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF Plaintiff as for its Complaint against the above – captioned Defendant alleges as follows: INTRODUCTION 1. The Nation al Childhood Vaccine Injury Act of 1986, codified at 42 U.S.C. § § 300aa – 1 through 300aa – 34, g ranted economic i m m u n i t y t o pharmaceutical companies for the injurie s caused by their vaccines . The responsibility for vaccine safety was therefore placed in the hands of the United States Department of Health and Human Services HHS pursuant to 42 U.S.C. § 300aa – 27(a) which provided, inter alia , adverse reaction reporting, and research on vaccines, in order to reduce the risk s of adverse reactions to vaccines. 2. , 42 U.S.C. Section 300aa – 27(c) provided that , Within 2 years after December 22, 1987, and periodically thereafter, the Secretary [of HHS] shall prepare an d transmit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report describing the actions taken pursuant to subsection (a) of this section during the preceding 2 – year per io Case 1:18-cv-03215 Document 1 Filed 04/12/18 Page 1 of 10
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2 3. On May 31, 2017, Robert F. Kennedy, Jr. and , Del Bigtree, along with a handful of other individuals, had a two – hour meeting regarding vaccine safety with the Counselor to the Secretary of HHS, the Director of the National Institu NIH , Principal Deputy Director of the NIH, and the Directors from various institutes at the NIH. During that meeting , Plaintiff and Robert F. Kennedy, Jr. became concerned that HHS was not faithfully fulfilling its obligations under 42 U.S.C. § 300aa – 27(a ). Plaintiff theref ore decided to submit a request , pursuant to the Freedom of Information Act (5 U.S.C. § 55 2 FOIA , to obtain copies of the reports the Secretary of HHS submit ted to Congress pursuant to 42 U.S.C. § 300aa – 27(c) which should detail the actions taken by HHS pursuant to 42 U.S.C. § 300aa – 27(a ) to improve vaccine safety . 4. On August 25, 2017, Plaintiff submitted a FOIA request to the HHS for : all reports transmitted to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate by the Secretary of HHS pursuant to 42 U.S.C. §300aa – FOIA Request HHS failed to timely respond to the FOIA Request. s failure to respond and provide copies of its reports to Congress pursuant to this section, copies of which HHS should have readily accessible. Case 1:18-cv-03215 Document 1 Filed 04/12/18 Page 2 of 10
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3 PARTIES 5. Plaintiff ICAN is a not – for – profit organization with an office located at 140 Broadway, 46th Floor , N ew Y ork, N ew Y ork 10005 . 6. Defendant the United States Department of Health and Human Services ( Defendant HHS is a department within the Executive Branch of the United States Government and is an a gency within the meaning of 5 U.S.C. §552(f). JURI S DICTION AND VENUE 7. This Court has jurisdiction over this action pursuant to 5 U.S.C. § 552(a)(4)(B) and 28 U.S.C. § 1331. Venue is proper within this District pursuant to 5 U.S.C. § 552(a)(4)(B) and 28 U.S.C. § 1391(a). FACTS I. Background 8. litigation costs associated with claims of damage from vaccines had forced several companies to end their vaccine research and development programs as well as to stop producing already licensed vaccines. ( Institute of Medicine, Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality , at 2 (1994). ) The remaining pharmaceutical companies producing vaccin es threatened to withdraw from the vaccine market. 9. In response, Congress passed the National Childhood Vaccine Injury Act, i n 1986, codified at 42 U.S.C. §§ 300aa – 1 through 300aa – 34 1986 Act , which virtually eliminated economic liability for phar maceutical companies for injuries caused by their vaccines . 42 U.S.C. § 300aa – or in an unspecified amount against a vaccine administrator or manufacturer in a State or F ederal Case 1:18-cv-03215 Document 1 Filed 04/12/18 Page 3 of 10
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4 court for damages arising from a vaccine – ; Bruesewitz v. Wyeth LLC , 562 – empts all design – defect claims against vaccine manufacturers brought by plaintiffs who seek compensation 10. By granting immunity from actual or potential liability from injuries caused by vaccines, Congress eliminated the market forces that are generally relied upon to assu re the safety of all other products. Recognizing that the 1986 Act eliminated the incentive for vaccine makers to assure the safety of their vaccine products, th e 1986 Act explicitly places the responsibility for vaccine safety in the hands of the Unit ed States Department of Health and Human Services HHS 42 U.S.C. §§ 300aa – 1 through 300aa – 34 . 11. To that end, Section 300aa – The Secretary shall establish in the Department of Health and Human Services a National V accine Program to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against 12. Section 300aa – that the National Vaccin e Program , inter alia : (1) Vaccine research . The Directo coordinate and provide direction for research carried out in or through the Na tional Institutes of Health, the Centers for Disease Control an d Prevention, the Office of Biologics Research and Review of the Food and Drug Administration, the Department of Defense, and the Agency for International Development on means to prevent adverse reactions to vaccines. (2) Vaccine development . The Direct or of the Program shall coordinate and provide direction for activities carried out in or through the Nat ional Institutes of Health, the Office of Biologics Research and Review of the Food and Drug Administration, the Department of Defense, and the Agenc y for Case 1:18-cv-03215 Document 1 Filed 04/12/18 Page 4 of 10
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5 International Development to develop the techniques needed to produce safe and effective vaccines. (3) Safety and efficacy testing of vaccines . The Director of the Program shall coordinate and provide direction for safety and efficacy testing of vaccines carried out in or through the National Institutes of Health, the Centers for Disease Control and Prevention, the Office of Biologics Research and Review of the Food and Drug Administration, the Department of Defense, and the Agency for International Development. * * * (7) Evaluating the adverse effects of vaccines and immunization activities . The coordinate and provide direction to th e National Institutes o f Health , the Centers for Disease Control and Prevention, the Office of Biologics Research and Review of the Food and Drug Administration, the National Center for Health Statistics, the National Center for Health Services Research and Health Care Technolog y Assessment, and the Centers for Medicare & Medicaid Services in monitoring adverse effects of vaccines and immunization activities. 13. Section 300aa – puts t h e f o l l o w i n g responsibility directly in the hands of the Secretary of HHS : (a) In the administration of this part and other pertinent laws under the jurisdiction of the Secretary, the Secretary shall (1) promote the development of childho od vaccines that result in fewer and less serious adverse reactions than those vaccines on the market on December 22, 1987, and promote the refinement of such vaccines, and (2) make or assure improvements in, and otherwise use the authorities of the Secretary with respect to, the licensing, manufacturing, processing, testing, labeling, warning, use instructions, distribution, storage, administration, field surveillance, adverse reaction reporting, and recall of reactogenic lots or batches, of vaccines, and res earch on vaccines, in order to reduce the risks of adverse reactions to vaccines. Case 1:18-cv-03215 Document 1 Filed 04/12/18 Page 5 of 10
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6 14. To assist the Secretary of HHS in performing these duties, Section 300aa – 27 (b) directs the Secretary to establish a task force responsible for making recommendations to the S ecretary concerning implementation of the requirements of Section 300aa – 27(a). This task force is entitled Task Force Task Force on Safer Childhood Vaccines 42 U.S.C. § 300aa – 27(b). The Directo r of the NIH is the chair of t he Task Force , which by statute also includes the Commissioner of the FDA and the Director of the CDC. Id. 15. As provided in Section 300aa – 27(b) (3) : In consultation with the Advisory Commission on Childhood Vaccines, the task force shall prepare recommendations to the Secretary concerning implementation of the requirements of subsection (a). 16. The Task Force, chaired by the Director of NIH, is therefore statutorily responsible, pursuant to Section 300aa – 27(b), to provide the Secretary of HHS with recommendations concerning implementation of the requirements of Section 300aa – 27(a). 17. T o assure the Secretary of HHS takes action based on the recommendations made by the Task Force and is otherwise fulfilling its important obliga tions pursuant to Section 300aa – 27(a) to assure the safety of the vaccines administered to children in the United States , Secti on 300aa – 27(c) provides that : Within 2 years after December 22, 1987, and periodically thereafter, the Secretary shall prepare an d transmit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report describing the actions taken pursuant to subsection (a) of this section during the preceding 2 – year per iod. 18. The rapid growth in the number of pediatric vaccines s ince passage of the 1986 Act has only increased the need for HHS to faithfully fulfill its obligations under 42 U.S.C. § 300aa – 1 Case 1:18-cv-03215 Document 1 Filed 04/12/18 Page 6 of 10
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8 by the Secretary of HHS pursuant to 42 U.S.C. $300aa – 27(c) [sic] . We received your request on August 28, 2017 . We have initiated a search to locate records falling within the scope of your request. If our searching units advise us that you have requested a voluminous amount of records that require extensive search and examination, my staff will contact you shortly to discuss your willingness to modify your request. The FOIA requires that we respond to your request within 20 working days of its receipt in this office. Please note the following unusual and exceptional circumstances that will impact our response time : (1) we will need to search for and collect records from components and/or field offices external to this office; and (2) because we receive a very heavy volume of FOIA requests, we will n, our office from responding within the 20 working day timeframe, we will utilize a 10 working day extension to process your request, as permitted pursuant to the FOIA. (Emphasis in or iginal.) 22. H HS never request ed that Plaintiff modify the FOIA Request . HHS also failed to respond within 20 days n or did it seek a 10 day extension thereafter for re sponding to the FOIA Request. HHS also did not respond to the numerous follow – up inquiries for a status update regarding the FOIA Request, including inquiries sent on January 23, 2018, January 30 , 2018, and February 6, 2018. 23. On March 13, 2018, Plaintiff appealed the FOIA Request to Deputy Agency Chief FOIA Officer at HHS and received an acknowledgment of this appeal from HHS which provided, March 13, 2018 , concerning the constructive denial of your initial reques t, which is assigned case number 2017 – 01119 – FOIA – OS. We received your appeal on March 13, 2018 Case 1:18-cv-03215 Document 1 Filed 04/12/18 Page 8 of 10
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9 original). HHS, however, failed to respond within 20 days nor did it seek an extension of the statutory processing time for this administrative appeal . Requested Relief WHEREFORE , P laintiff prays that this Court: a. P rovide for expeditious proceedings in this action; b. Enter an Order declaring that it was unlawful for to fail to timely either (1) disclose the reports transmitted by HHS to Congress pursuant to 42 U.S.C. § 300aa – 27(c) , (2) assert an exemption for such reports , or (3) state that no such reports exist; c. Enter an Order directing HHS to , within 20 days of issuance of the order, either (1) make available to Plaintiff any and all reports responsive to the FOIA Request; (2) assert a valid exemption listed in 45 CFR §§ 5.31, 5.32 for withholding any such reports ; or (3) state that no such reports exist ; d. A ward Plaintiff its costs and reasonable attorneys fees incurred in this ac tion as prov ided by 5 U.S.C. § 552(a)(4)(E) ; and e. G rant such other and further relief as the Court may deem just and proper. Case 1:18-cv-03215 Document 1 Filed 04/12/18 Page 9 of 10
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10 Dated: April 1 2 , 2018 SIRI & GLIMSTAD LLP ______________________________ Aaron Siri 200 Park Avenue, 17th Floor New York, New York 10166 Tel: (212) 532 – 1091 Co – Counsel for Plaintiff KENNEDY & MODONNA LLP ______________________________ Robert F. Kennedy, Jr. 48 Dewitt Mills Road Hurley, NY 12443 Tel: ( 845 ) 481 – 2622 Co – Counsel for Plaintiff Case 1:18-cv-03215 Document 1 Filed 04/12/18 Page 10 of 10
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