Bioterror and Pandemic Preparedness Protection Act

Bill: 109-hr-3970
Sponsor: Rep. Issa, Darrell E. [R-CA-49]
Introduced: 2005-10-06 in the House
Policy area: Health
Subjects: Administrative remedies
Antibiotics
Biological warfare
Chemical warfare
Civil actions and liability
Claims
Commerce
Crime and Law Enforcement
Department of Justice
Drug approvals
Drug industry
Drugs
Emergency Management
Emergency medicine
Epidemics
Evidence (Law)
Government liability
Governmental investigations
Judicial review
Law
Medical malpractice
Nuclear terrorism
Products liability
Terrorism
Vaccines

Summary:
action_date: 2005-10-06
text: 
Bioterror and Pandemic Preparedness Protection Act - Amends the federal judicial code to establish an exclusive federal cause of action for all claims relating to a qualified pandemic or epidemic product or a security countermeasure. 
 
Restricts all causes of action for such claims against a manufacturer, distributor, or health care provider and instead provides for sole and exclusive action against the United States. Gives jurisdiction over such an action to the U.S. District Court for the District of Columbia.
 
Establishes a rebuttable presumption of immunity for the federal government in any such action concerning: (1) a security countermeasure that has been procured for or donated to the National Strategic Stockpile; (2) a qualified pandemic or epidemic product that has been procured by or donated to the Secretary of Health and Human Services; or (3) a designated security countermeasure or qualified pandemic or epidemic product in an actual or potential public health emergency.
 
Allows a party to petition the Attorney General to investigate claims against a manufacturer, distributor, administrator, or heath care provider. Disallows judicial review of the Attorney General's decision as to whether to undertake such an investigation.
 
Declares that the immunity presumption shall be overcome by a determination by the Attorney General, by finding clear and convincing evidence, that the manufacturer, distributor, administrator, or health care provider intentionally or with willful disregard violated the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act and that such violation: (1) caused the product to present a significant or unreasonable human health risk; and (2) proximately caused the injury alleged by the party.


Legislative actions:
action_date: 2005-10-17
text: Referred to the Subcommittee on Health, for a period to be subsequently determined by the Chairman.
action_date: 2005-10-06
text: 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.
action_date: 2005-10-06
text: 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.
action_date: 2005-10-06
text: 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.
action_date: 2005-10-06
text: Introduced in House
action_date: 2005-10-06
text: Introduced in House