summary
Introduced
01/13/2025
01/13/2025
In Committee
01/13/2025
01/13/2025
Crossed Over
Passed
Dead
04/24/2025
04/24/2025
Introduced Session
2025 Regular Session
Bill Summary
Liability shield products. Defines a "liability shield product" as a certain type of product that has been designated as immune from liability under federal law. Requires a liability shield product to undergo a placebo controlled study before it is distributed, manufactured, marketed, or administered. Requires: (1) the Indiana department of health to monitor and publish certain information; and (2) certain entities to submit documentation and compliance reports; concerning liability shield products. Allows the attorney general or a private individual to bring an action if the requirements concerning liability shield products are not met.
AI Summary
This bill establishes a comprehensive regulatory framework for "liability shield products" in Indiana, which are defined as medical, pharmaceutical, biological, or technological products that have been designated as immune from liability under federal law. The legislation requires manufacturers to conduct a placebo-controlled study lasting at least five years on these products before they can be distributed, manufactured, marketed, or administered within the state. The study must collect and publicly disclose safety outcome metrics, including potential impacts on allergenicity, carcinogenicity, fertility, immunogenicity, mutagenicity, and reactogenicity. The Indiana Department of Health is mandated to monitor adverse outcomes through health information exchanges and vaccine event reporting systems, and must publish post-market surveillance data. Manufacturers must submit documentation proving the initiation of a placebo-controlled study by July 1, 2028, and a compliance report with final results by December 31, 2030. The bill also provides legal protections for individuals, allowing them to refuse these products without coercion and granting them the right to seek injunctive relief, compensatory damages, and attorney's fees if harmed. Additionally, the attorney general can bring actions against entities that violate the chapter's requirements, with potential civil penalties of up to $100,000 per violation.
Committee Categories
Health and Social Services
Sponsors (1)
Last Action
First reading: referred to Committee on Public Health (on 01/13/2025)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://iga.in.gov/legislative/2025/bills/house/1426/details |
| Fiscal Note #2: Introduced | https://iga.in.gov/pdf-documents/124/2025/house/bills/HB1426/fiscal-notes/HB1426.01.INTR.FN002.pdf |
| BillText | https://iga.in.gov/pdf-documents/124/2025/house/bills/HB1426/HB1426.01.INTR.pdf |
| Fiscal Note #1: Introduced | https://iga.in.gov/pdf-documents/124/2025/house/bills/HB1426/fiscal-notes/HB1426.01.INTR.FN001.pdf |
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