Amends the Public Health Service Act to grant immunity from suit and liability to any covered person for any claims for loss relating to the administration or use of a covered countermeasure, provided:
(1) the claim has a causal relationship with the administration or use of such countermeasure;
(2) the countermeasure was administered or used during the effective period of the declaration by the Secretary of Health and Human that a public health emergency existed;
(3) the countermeasure was administered or used for the diseases, health conditions, or health threats specified in the declaration; and
(4) the countermeasure was administered to or used by an individual who was in a population and geographic area specified by the declaration.
Defines "covered person" as:
(1) the United States;
(2) a manufacturer or distributor of a covered countermeasure;
(3) a supervisor or administrator of a program to administer, dispense, provide, or use a covered countermeasure; or
(4) an authorized person who prescribes, administers, or dispenses such a countermeasure.
Defines "covered countermeasure" as:
(1) a qualified pandemic or epidemic product;
(2) a security countermeasure; or
(3) a drug, biological product, or device that is authorized for emergency use.
Allows the Secretary to:
(2) issue a declaration in the event of a threat to health that constitutes a public health emergency or credible risk of such an emergency in the future; and
(2) recommend the manufacture, testing, development, distribution, administration, or use of one or more covered countermeasures.
Sets forth the contents of such a declaration, including the period, population, and area for which such declaration is in effect.
(1) judicial review of the Secretary's actions related to such a declaration; and
(2) any state or political subdivision from establishing, enforcing, or continuing in effect any provision of law or legal requirement related to a covered countermeasure.
Sets forth reporting requirements.
Establishes an exception to such immunity for an exclusive federal cause of action against a covered person for death or injury proximately caused by willful misconduct.
Defines "willful misconduct" as an act or omission that is taken:
(1) intentionally to achieve a wrongful purpose;
(2) knowingly without legal or factual justification; and
(3) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.
Gives the plaintiff the burden of proving, by clear and convincing evidence, willful misconduct by each covered person sued and that such willful misconduct caused death or serious physical injury.
Excludes from the scope of willful misconduct:
(1) actions consistent with the declaration if the Secretary or a state or local health authority is notified within seven days of the discovery of material information regarding serious physical injury or death from the covered countermeasure; and
(2) actions or omissions by a manufacturer or distributor that are subject to certain regulations if neither the Secretary nor the Attorney General has initiated an action against such manufacturer or distributor or such an action has been finally resolved without a remedy.
Requires that such an action:
(1) be filed and maintained only in the United States District Court for the District of Columbia;
(2) be initiated by a complaint that has been verified by the plaintiff and that pleads with particularity each element of the claim;
(3) include an affidavit by a non-treating physician explaining the physician's basis for believing that the serious physical injury or death alleged in the complaint was proximately caused by a covered countermeasure;
(4) include certified medical records documenting such injury or death and such proximate causal connection; and
(5) be initially assigned to a panel of three judges.
Stays discovery in such an action until the resolution of any motions to dismiss filed by a covered person.
Allows the court to:
(1) permit discovery only on matters directly related to material issues; and
(2) compel a discovery response only if the court finds that the information is necessary to prove or defend a material, contested issue and that the likely benefits of a response equals or exceeds the burden of providing it.
Requires the amount of an award of damages under such an action to be reduced by the amount of collateral source benefits such plaintiff received.
Prohibits a provider of such benefits from having a lien or credit against the plaintiff's recovery or to be legally subrogated to the right of the plaintiff.
Allows the award of noneconomic damages only in an amount directly proportional to the percentage of responsibility of a defendant for the harm of the plaintiff.
Requires the court to impose sanctions on an attorney who files a complaint that is frivolous or without merit.