Liability protections for pandemics, epidemics, and countermeasures

Part B of title III of the Public Health Service Act is amended by inserting after section 319F–2 (42 U.S.C. 247d–6b) the following:

319A–3.

Liability protections for pandemics, epidemics, and security countermeasures

(a)

Authority

The Secretary 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 arising out of, relating to, or resulting from the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, administration, and use of a qualified pandemic or epidemic product or a security countermeasure as provided for in clauses (i) and (ii) of paragraph (2)(B). (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)for products subject to designation by the Secretary as provided for in clause (ii) of paragraph (2)(B), 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). (2)

Affirmative defense

(A)

In general

There shall be a rebuttable presumption that the Federal Government is immune from liability 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, administration, or use of— (i)a security countermeasure that has been procured for the National Strategic Stockpile under section 319F–2 or a qualified pandemic or epidemic product that has been procured by the Secretary; or (ii)a security countermeasure or qualified pandemic or epidemic product in anticipation of and preparation for, in defense against, or in response or recovery to an actual or potential public health emergency, that is a security countermeasure or is designated as a qualified pandemic or epidemic product by the Secretary after the Secretary declared a public health emergency as described in paragraph (1) or (2) of section 319(a). (C)

Rebuttability

(i)

In general

The presumption described in subparagraph (A) shall be overcome by a determination by the Secretary as provided for in subparagraph (D). (ii)

Investigation by secretary

A party seeking a determination under subparagraph (D) may petition the Secretary to investigate claims against a manufacturer, distributor, dispenser, 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, 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 Secretary's discretion and shall not be subject to judicial review. (D)

Determination by Secretary

(i)

In general

In making a determination under this subparagraph, the Secretary must find clear and convincing evidence that the manufacturer, distributor, 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 this Act and such violation— (I)caused the product to present a significant risk to health; and (II)proximately caused the injury alleged by the petitioner. (ii)

Notice and hearing

Prior to the Secretary's making a determination under clause (i), the manufacturer, distributor, dispenser, 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)

Judicial review

At any time prior to the 90th day following a determination by the Secretary under clause (i) of this subparagraph, any manufacturer, distributor, or health care provider who will be adversely affected by 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 Secretary or other officer designated by the Secretary for that purpose. The Secretary thereupon shall file in the court the record of the findings on which the Secretary based his or her determination. The filing of a petition under this clause shall automatically stay the Secretary's determination for the duration of the judicial proceeding. The sole parties to the judicial proceeding shall be the Secretary 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 Secretary under this clause shall conform to the procedures for judicial review of administrative orders set forth in paragraphs (2) through (6) of section 371(f) of title 21, United States Code, to the extent consistent with this section. (E)

Scope

The presumption under subparagraph (A) 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, administration, or use by the Federal Government or by non-Federal Government customers. (F)

Designation

In any declaration of a public health emergency under section 319, the Secretary shall 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 National Strategic 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)

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). (2)

Loss

The term loss means death, bodily injury, or loss of or damage to property, including business interruption loss. (3)

Non-Federal Government customers

The term non-Federal Government customers means any customer of a manufacturer that is not an agency or instrumentality for the United States Government with authority under Public Law 85–804 to provide for indemnification under certain circumstances for third-party claims against its contractors, including a State, a local authority, a private entity, a health care provider, or an individual. (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 this 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); or (C)is authorized by the Secretary under this section, except that the Secretary may authorize under this 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 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, 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; and (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 may by regulation prescribe are satisfied. (5)

Security countermeasure

The term security countermeasure has the meaning given such term in section 319F–2(c)(1)(B).