Fabio
76b8ec33a7
Ingested titles 12–51 and 54 from OLRC USLM XML @119-100 (the whole Code now, uniform edition; Title 53 is reserved/empty). LegalText 11,221 -> 59,740; repo total 105,704 records. Deterministic (byte-identical rerun, verified on Title 42's 8,356 sections); make check green. make legal-us-code default now covers every title. Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
60 lines
4.4 KiB
Markdown
60 lines
4.4 KiB
Markdown
---
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type: "LegalText"
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title: "42 U.S.C. § 300aa–22"
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description: "Standards of responsibility"
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jurisdiction: "us"
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corpus: "united_states_code"
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kind: "code_section"
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title_number: 42
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title_name: "THE PUBLIC HEALTH AND WELFARE"
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chapter_number: "6A"
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chapter_name: "PUBLIC HEALTH SERVICE"
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section: "300aa–22"
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citation: "42 U.S.C. § 300aa–22"
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status: "current"
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release_point: "119-100"
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release_date: "2026-06-26"
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source: "official"
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source_url: "https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc42@119-100.zip"
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source_identifier: "/us/usc/t42/s300aa–22"
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source_file: "data/legal/raw/us/code/title-42/usc42.xml"
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source_hash: "668e67d8ec6c830b34615f5162a309ef7c164f55cc99ebcded9cbe793aa8c710"
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raw_snapshot_hash: "644321055a08eb1f260a6a3e31ac157fa024756abf612a9fd6857e7e400cf24e"
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text_hash: "69e87068f12266dd003ab5b8769d7a50d4731ebe5b813d2710f042666250a895"
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retrieved_at: "2026-07-04"
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confidence: "official"
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tags: ["legal", "us-code"]
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---
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# 42 U.S.C. § 300aa–22 - Standards of responsibility
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## Text
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(a) General rule Except as provided in subsections (b), (c), and (e) State law shall apply to a civil action brought for damages for a vaccine-related injury or death.
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(b) Unavoidable adverse side effects; warnings (1) No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.
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(2) For purposes of paragraph (1), a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and section 262 of this title (including regulations issued under such provisions) applicable to the vaccine and related to vaccine-related injury or death for which the civil action was brought unless the plaintiff shows—
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(A) that the manufacturer engaged in the conduct set forth in subparagraph (A) or (B) of section 300aa–23(d)(2) of this title, or
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(B) by clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compliance with such Act and section (and regulations issued under such provisions).
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(c) Direct warnings No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, solely due to the manufacturer’s failure to provide direct warnings to the injured party (or the injured party’s legal representative) of the potential dangers resulting from the administration of the vaccine manufactured by the manufacturer.
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(d) Construction The standards of responsibility prescribed by this section are not to be construed as authorizing a person who brought a civil action for damages against a vaccine manufacturer for a vaccine-related injury or death in which damages were denied or which was dismissed with prejudice to bring a new civil action against such manufacturer for such injury or death.
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(e) Preemption No State may establish or enforce a law which prohibits an individual from bringing a civil action against a vaccine manufacturer for damages for a vaccine-related injury or death if such civil action is not barred by this part.
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(July 1, 1944, ch. 373, title XXI, § 2122, as added Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100 Stat. 3773; amended Pub. L. 100–203, title IV, § 4302(b)(1), Dec. 22, 1987, 101 Stat. 1330–221.)
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## Notes
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Editorial Notes
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References in TextThe Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b)(2), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see Tables.
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Codification In subsecs. (b)(1), (c), “October 1, 1988” was substituted for “the effective date of this subpart” on authority of section 323 of Pub. L. 99–660, as amended, set out as an Effective Date note under section 300aa–1 of this title.
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Amendments1987—Subsecs. (b)(1), (c). Pub. L. 100–203 substituted “effective date of this subpart” for “effective date of this part”.
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