[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3970 Introduced in House (IH)]







109th CONGRESS
  1st Session
                                H. R. 3970

To amend title 28, United States Code, to provide liability protections 
               for certain pandemics and countermeasures.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 6, 2005

   Mr. Issa introduced the following bill; which was referred to the 
Committee on the Judiciary, and in addition to the Committee on Energy 
    and Commerce, for a period to be subsequently determined by the 
  Speaker, in each case for consideration of such provisions as fall 
           within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
To amend title 28, United States Code, to provide liability protections 
               for certain pandemics and countermeasures.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Bioterror and Pandemic Preparedness 
Protection Act''.

SEC. 2. LIABILITY PROTECTIONS FOR PANDEMICS, EPIDEMICS, AND 
              COUNTERMEASURES.

    (a) In General.--Part VI of title 28, United States Code, is 
amended by adding at the end the following new chapter:

     ``CHAPTER 181--LIABILITY PROTECTION FOR CERTAIN PANDEMICS AND 
                            COUNTERMEASURES

``Sec.
``4101. Liability protections for pandemics, epidemics, and security 
                            countermeasures.
``Sec. 4101. Liability protections for pandemics, epidemics, and 
              security countermeasures
    ``(a) Authority.--The Attorney General shall be solely and 
exclusively responsible for the administration of this section. This 
section shall apply with respect to the design, development, clinical 
testing and investigation, manufacture, labeling, distribution, sale, 
purchase, donation, dispensing, administration, or use of a security 
countermeasure or a qualified pandemic or epidemic product.
    ``(b) Litigation Management.--
            ``(1) Federal cause of action.--
                    ``(A) In general.--There shall exist an exclusive 
                Federal cause of action for all claims for loss of 
                property, personal injury, bodily injury, including 
                mental anguish, or death arising out of, relating to, 
                or resulting from the design, development, clinical 
                testing and investigation, manufacture, labeling, 
                distribution, sale, purchase, donation, dispensing, 
                administration, or use of a qualified pandemic or 
                epidemic product or a security countermeasure as 
                provided for in clauses (i) and (ii) of paragraph 
                (2)(B). Section 1346(b) and Chapter 17 of title 28, 
                United States Code, shall not apply to the cause of 
                action provided for in this paragraph. Such cause of 
                action shall be exclusive of any other civil action or 
                proceeding relating to the same subject matter.
                    ``(B) Action.--With respect to the Federal cause of 
                action provided in subparagraph (A)--
                            ``(i) an action may be commenced solely and 
                        exclusively against the United States for 
                        claims identified in subparagraph (A) that are 
                        against a manufacturer, distributor, or health 
                        care provider;
                            ``(ii) no cause of action shall be 
                        maintained against a manufacturer, distributor, 
                        or health care provider for claims identified 
                        in subparagraph (A); and
                            ``(iii) if the product is described in 
                        paragraph (2)(B)(ii) and is not described in 
                        clause (i) of such paragraph, the protections 
                        set forth in clauses (i) and (ii) shall apply 
                        to all claims identified in subparagraph (A) 
                        that involve products sold, purchased, donated, 
                        dispensed, or administered during the effective 
                        period set forth in the designation provided 
                        for in paragraph (2)(F), regardless of the date 
                        of alleged injury.
                    ``(C) Jurisdiction.--The United States District 
                Court for the District of Columbia shall have sole and 
                exclusive jurisdiction over any claim for loss of 
                property, personal injury, or death arising out of, 
                relating to, or resulting from the design, development, 
                clinical testing and investigation, manufacture, 
                labeling, distribution, sale, purchase, donation, 
                dispensing, administration, or use of a qualified 
                pandemic or epidemic product or security countermeasure 
                as provided for in clauses (i) and (ii) of paragraph 
                (2)(B). The substantive law with respect to a decision 
                in any such action shall be derived from the law, 
                including choice of law principles, of the State in 
                which such action arose, unless such law is 
                inconsistent with or preempted by Federal law.
            ``(2) Affirmative defense.--
                    ``(A) In general.--Except as provided in 
                subparagraph (C), neither the Federal Government nor a 
                manufacturer, distributor, administrator, or health 
                care provider shall be liable in an action described in 
                subparagraph (B).
                    ``(B) Action described.--An action described in 
                this subparagraph is an action that is commenced 
                against the United States for claims arising out of, 
                relating to, or resulting from the design, development, 
                clinical testing and investigation, manufacture, 
                labeling, distribution, sale, purchase, donation, 
                dispensing, prescribing, administration, or use of--
                            ``(i) a security countermeasure that has 
                        been procured for or donated to the Strategic 
                        National Stockpile under section 319F-2 of the 
                        Public Health Service Act or a qualified 
                        pandemic or epidemic product that has been 
                        procured or donated to the Secretary of Health 
                        and Human Services; or
                            ``(ii) a security countermeasure or 
                        qualified pandemic or epidemic product 
                        distributed, sold, purchased, donated, 
                        dispensed, administered, prescribed, or used in 
                        anticipation of and preparation for, in defense 
                        against, or in response to or recovery from an 
                        actual or potential public health emergency, 
                        that is a designated security countermeasure or 
                        a qualified pandemic or epidemic product by the 
                        Secretary of Health and Human Services in a 
                        public health emergency as described in 
                        paragraph (1) or (2) of section 319(a) of the 
                        Public Health Service Act.
                    ``(C) Potential liability upon determination.--
                            ``(i) In general.--A manufacturer, 
                        distributor, administrator, or health care 
                        provider may be liable in any action described 
                        in subparagraph (B) only if the Attorney 
                        General makes a determination as provided for 
                        in subparagraph (D).
                            ``(ii) Investigation by attorney general.--
                        A party seeking a determination under 
                        subparagraph (D) may petition the Attorney 
                        General to investigate allegations against a 
                        manufacturer, distributor, administrator, or 
                        health care provider arising out of, relating 
                        to, or resulting from the design, development, 
                        clinical testing and investigation, 
                        manufacture, labeling, distribution, sale, 
                        purchase, donation, prescribing, dispensing, 
                        administration, or use of products as provided 
                        for in clauses (i) and (ii) of subparagraph 
                        (B). The decision to undertake such 
                        investigation shall be within the Attorney 
                        General's discretion and shall not be subject 
                        to judicial review.
                    ``(D) Determination by attorney general.--
                            ``(i) In general.--In making a 
                        determination under this subparagraph, the 
                        Attorney General must find clear and convincing 
                        evidence that the manufacturer, distributor, 
                        administrator, or health care provider 
                        intentionally or with willful disregard 
                        violated a provision of the Federal Food, Drug, 
                        and Cosmetic Act (21 U.S.C. 301 et seq.) or the 
                        Public Health Service Act and such violation--
                                    ``(I) caused the product to present 
                                a significant or unreasonable risk to 
                                human health; and
                                    ``(II) proximately caused the 
                                injury alleged by the party.
                            ``(ii) Notice and hearing.--Prior to the 
                        Attorney General's making a determination under 
                        clause (i), the manufacturer, distributor, 
                        administrator, or health care provider shall 
                        have notice and a right to a formal hearing in 
                        accordance with section 556 of title 5, United 
                        States Code.
                            ``(iii) Effect of determination.--If the 
                        Attorney General makes an affirmative 
                        determination under clause (i), a case may 
                        proceed against a manufacturer, distributor, 
                        administrator, or health care provider 
                        involved.
                            ``(iv) Judicial review.--At any time prior 
                        to the 90th day following a determination by 
                        the Attorney General under clause (i) of this 
                        subparagraph, any manufacturer, distributor, 
                        administrator, or health care provider named in 
                        such determination may file a petition with the 
                        United States Court of Appeals for the circuit 
                        wherein such person resides or has his 
                        principal place of business, for a judicial 
                        review of such determination. A copy of the 
                        petition shall be forthwith transmitted by the 
                        clerk of the court to the Attorney General or 
                        other officer designated by the Attorney 
                        General for that purpose. The Attorney General 
                        thereupon shall file in the court the record of 
                        the findings on which the Attorney General 
                        based his or her determination. The filing of a 
                        petition under this clause shall automatically 
                        stay the Attorney General's determination for 
                        the duration of the judicial proceeding. The 
                        sole parties to the judicial proceeding shall 
                        be the Attorney General and the petitioner. 
                        Intervention by third parties in the judicial 
                        proceeding shall not be permitted. No subpoenas 
                        shall be issued nor shall other compulsory 
                        process apply. The court's review of a 
                        determination by the Attorney General under 
                        this clause shall conform to the procedures for 
                        judicial review of administrative orders set 
                        forth in paragraphs (2) through (6) of section 
                        701(f) of the Federal Food, Drug, and Cosmetic 
                        Act (21 U.S.C. 371(f)), to the extent 
                        consistent with this section.
                            ``(v) Tolling of statute of limitations.--
                        The computation of the statute of limitations 
                        for any action against a manufacturer, 
                        distributor, administrator, or health care 
                        provider described under this subparagraph 
                        shall not include any time occurring before the 
                        determination by the Attorney General under 
                        this subparagraph.
                    ``(E) Scope.--Subparagraph (C) shall apply 
                regardless of whether the claim against the United 
                States arises from the design, development, clinical 
                testing and investigation, manufacture, labeling, 
                distribution, sale, purchase, donation, dispensing, 
                prescribing, administration, or use by the Federal 
                Government or by any person.
                    ``(F) Designation.--In any declaration of a public 
                health emergency under section 319 of the Public Health 
                Service Act, or in a separate declaration under such 
                section, the Secretary of Health and Human Services 
                may, if necessary, identify the pandemic, epidemic, or 
                biological, chemical, nuclear agent, or toxin that 
                presents, or may present, a public health emergency and 
                shall designate the security countermeasure(s) or 
                qualified pandemic or epidemic product(s) to be sold 
                by, purchased from, or donated by a manufacturer or 
                drawn from the Strategic National Stockpile and shall 
                specify in such designation the beginning and ending 
                dates of such sale, purchase, donation, or use from the 
                stockpile. The period so defined shall be the effective 
                period of such qualification for any products specified 
                in the designation. The declaration shall subsequently 
                be amended to reflect any additional sale, purchase, or 
                donation of products specified in the designation.
    ``(c) Definitions.--In this section:
            ``(1) Administrator.--The term `administrator' means--
                    ``(A) a person who administers, dispenses, 
                distributes, or otherwise provides a security 
                countermeasure or a qualified pandemic or epidemic 
                product to a person to diagnose, mitigate, treat, 
                identify, cure, or prevent harm from--
                            ``(i) a pandemic or epidemic or any 
                        biological, chemical, radiological, or nuclear 
                        agent; or
                            ``(ii) a serious or life-threatening 
                        disease or condition caused by such 
                        countermeasure or product; or
                    ``(B) a person that has established requirements, 
                provided policy guidance, supplied technical or 
                scientific advice or assistance, or otherwise 
                supervised or administered a program with respect to 
                the administration, dispensing, distribution, or 
                provision of a security countermeasure or a qualified 
                pandemic or epidemic product.
            ``(2) Health care provider.--The term `health care 
        provider' means a person, including a volunteer, who lawfully 
        prescribes, administers, dispenses, or provides a facility to 
        administer a security countermeasure or a qualified pandemic or 
        epidemic product, including persons who prescribe, administer, 
        or provide a facility to administer in accordance with a 
        designation under subsection (b)(2)(F).
            ``(3) Loss.--The term `loss' means death, bodily injury, or 
        damage to property, including business interruption loss.
            ``(4) Qualified pandemic or epidemic product.--The term 
        `qualified pandemic or epidemic product' means a drug (as such 
        term is defined in section 201(g)(1) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as 
        such term is defined by section 351(i) of this Act) or device 
        (as such term is defined by section 201(h) of the Federal Food, 
        Drug and Cosmetic Act (21 U.S.C. 321(h))) designed, developed, 
        modified, or procured to diagnose, mitigate, prevent, treat, or 
        cure a pandemic or epidemic or limit the harm such pandemic or 
        epidemic might otherwise cause or a serious or life-threatening 
        disease or condition caused by such a product, that--
                    ``(A) is approved or cleared under chapter V of the 
                Federal Food, Drug, and Cosmetic Act or licensed under 
                section 351 of the Public Health Service Act;
                    ``(B) is a product for which the Secretary 
                determines that sufficient and satisfactory clinical 
                experience or research data (including data, if 
                available, from pre-clinical and clinical trials) 
                support a reasonable conclusion that the countermeasure 
                will qualify for approval or licensing within 8 years 
                after the date the Secretary declares a public health 
                emergency as described in paragraph (1) or (2) of 
                section 319(a) of the Public Health Service Act; or
                    ``(C) is authorized by the Secretary of Health and 
                Human Services under this section, except that the 
                Secretary of Health and Human Services may authorize 
                under thus section the emergency use of a product only 
                if, after consultation with the Director of the 
                National Institutes of Health and the Director of the 
                Centers for Disease Control and Prevention (to the 
                extent feasible and appropriate given the circumstances 
                of the emergency involved), the Secretary of Health and 
                Human Services concludes--
                                    ``(i) that an agent or toxin 
                                identified in a declaration described 
                                under subsection (b) can cause a 
                                serious or life-threatening disease or 
                                condition;
                                    ``(ii) that, based on the totality 
                                of the scientific evidence available to 
                                the Secretary of Health and Human 
                                Services, including data from adequate 
                                and well-controlled clinical trials, if 
                                available, it is reasonable to believe 
                                that--
                                            ``(I) the product may be 
                                        effective in diagnosing, 
                                        mitigating, preventing, 
                                        treating or curing--

                                                    ``(aa) a pandemic 
                                                or epidemic; or

                                                    ``(bb) a serious or 
                                                life threatening 
                                                disease or condition 
                                                caused by a product;

                                            ``(II) the known and 
                                        potential benefits of the 
                                        product, when used to diagnose, 
                                        mitigate, prevent, treat or 
                                        cure such disease or condition, 
                                        outweigh the known and 
                                        potential risks of the product;
                            ``(iii) that there is no adequate, 
                        approved, and available alternative to the 
                        product for diagnosing, mitigating, preventing, 
                        treating, or curing such disease or condition; 
                        and
                            ``(iv) that such other criteria as the 
                        Secretary of Health and Human Services may by 
                        regulation prescribe are satisfied.
            ``(5) Party.--The term `party' means an individual who can 
        reasonably demonstrate to the Secretary that such individual 
        has suffered a loss (as defined above) as a direct result of 
        the alleged misconduct or illegal activities of a manufacturer, 
        distributor, administrator, or health care provider.
            ``(6) Person.--The term `person' includes an individual, 
        partnership, corporation, association, entity, or public or 
        private corporation, including a Federal, State, or local 
        agency or department.
            ``(7) Security countermeasure.--The term `security 
        countermeasure' has the meaning given such term in section 
        319F-2(c)(1)(B) of the Public Health Service Act.''.
    (b) Conforming Amendment.--The table of chapters for part VI of 
title 28, United States Code, is amended by adding after the item 
relating to chapter 180 the following new item:

``181. Liability protection for certain pandemics and           4101''.
                            countermeasures.
                                 <all>