Introduced Version
HOUSE BILL No. 1426
_____
DIGEST OF INTRODUCED BILL
Citations Affected: IC 16-18-2; IC 16-42-29.
Synopsis: 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.
Effective: Upon passage.
Borders
January 13, 2025, read first time and referred to Committee on Public Health.
2025 IN 1426—LS 7594/DI 149 Introduced
First Regular Session of the 124th General Assembly (2025)
PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana
Constitution) is being amended, the text of the existing provision will appear in this style type,
additions will appear in this style type, and deletions will appear in this style type.
Additions: Whenever a new statutory provision is being enacted (or a new constitutional
provision adopted), the text of the new provision will appear in this style type. Also, the
word NEW will appear in that style type in the introductory clause of each SECTION that adds
a new provision to the Indiana Code or the Indiana Constitution.
Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts
between statutes enacted by the 2024 Regular Session of the General Assembly.
HOUSE BILL No. 1426
A BILL FOR AN ACT to amend the Indiana Code concerning
health.
Be it enacted by the General Assembly of the State of Indiana:
1 SECTION 1. IC 16-18-2-12.5 IS ADDED TO THE INDIANA
2 CODE AS A NEW SECTION TO READ AS FOLLOWS
3 [EFFECTIVE UPON PASSAGE]: Sec. 12.5. "Allergenicity", for
4 purposes of IC 16-42-29, has the meaning set forth in
5 IC 16-42-29-1.
6 SECTION 2. IC 16-18-2-48.4 IS ADDED TO THE INDIANA
7 CODE AS A NEW SECTION TO READ AS FOLLOWS
8 [EFFECTIVE UPON PASSAGE]: Sec. 48.4. "Carcinogenicity", for
9 purposes of IC 16-42-29, has the meaning set forth in
10 IC 16-42-29-2.
11 SECTION 3. IC 16-18-2-128.2 IS ADDED TO THE INDIANA
12 CODE AS A NEW SECTION TO READ AS FOLLOWS
13 [EFFECTIVE UPON PASSAGE]: Sec. 128.2. "Fertility impact", for
14 purposes of IC 16-42-29, has the meaning set forth in
15 IC 16-42-29-3.
16 SECTION 4. IC 16-18-2-186.6 IS ADDED TO THE INDIANA
17 CODE AS A NEW SECTION TO READ AS FOLLOWS
2025 IN 1426—LS 7594/DI 149 2
1 [EFFECTIVE UPON PASSAGE]: Sec. 186.6. "Immunogenicity", for
2 purposes of IC 16-42-29, has the meaning set forth in
3 IC 16-42-29-4.
4 SECTION 5. IC 16-18-2-201.7 IS ADDED TO THE INDIANA
5 CODE AS A NEW SECTION TO READ AS FOLLOWS
6 [EFFECTIVE UPON PASSAGE]: Sec. 201.7. "Liability shield
7 product", for purposes of IC 16-42-29, has the meaning set forth in
8 IC 16-42-29-5.
9 SECTION 6. IC 16-18-2-243.5 IS ADDED TO THE INDIANA
10 CODE AS A NEW SECTION TO READ AS FOLLOWS
11 [EFFECTIVE UPON PASSAGE]: Sec. 243.5. "Mutagenicity", for
12 purposes of IC 16-42-29, has the meaning set forth in
13 IC 16-42-29-6.
14 SECTION 7. IC 16-18-2-284.5 IS ADDED TO THE INDIANA
15 CODE AS A NEW SECTION TO READ AS FOLLOWS
16 [EFFECTIVE UPON PASSAGE]: Sec. 284.5. "Placebo", for
17 purposes of IC 16-42-29, has the meaning set forth in
18 IC 16-42-29-7.
19 SECTION 8. IC 16-18-2-284.6 IS ADDED TO THE INDIANA
20 CODE AS A NEW SECTION TO READ AS FOLLOWS
21 [EFFECTIVE UPON PASSAGE]: Sec. 284.6. "Placebo controlled
22 study", for purposes of IC 16-42-29, has the meaning set forth in
23 IC 16-42-29-8.
24 SECTION 9. IC 16-18-2-307.7 IS ADDED TO THE INDIANA
25 CODE AS A NEW SECTION TO READ AS FOLLOWS
26 [EFFECTIVE UPON PASSAGE]: Sec. 307.7. "Reactogenicity", for
27 purposes of IC 16-42-29, has the meaning set forth in
28 IC 16-42-29-9.
29 SECTION 10. IC 16-18-2-320.8 IS ADDED TO THE INDIANA
30 CODE AS A NEW SECTION TO READ AS FOLLOWS
31 [EFFECTIVE UPON PASSAGE]: Sec. 320.8. "Safety outcome
32 metrics", for purposes of IC 16-42-29, has the meaning set forth in
33 IC 16-42-29-10.
34 SECTION 11. IC 16-42-29 IS ADDED TO THE INDIANA CODE
35 AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE
36 UPON PASSAGE]:
37 Chapter 29. Liability Shield Products
38 Sec. 1. As used in this chapter, "allergenicity" means the ability
39 to provoke an allergic reaction in an individual.
40 Sec. 2. As used in this chapter, "carcinogenicity" means the
41 ability to cause cancer in an individual.
42 Sec. 3. As used in this chapter, "fertility impact" means the
2025 IN 1426—LS 7594/DI 149 3
1 ability to adversely affect the reproductive health or fertility of an
2 individual.
3 Sec. 4. As used in this chapter, "immunogenicity" means the
4 ability to cause an immune response in an individual.
5 Sec. 5. As used in this chapter, "liability shield product"
6 includes a:
7 (1) medical;
8 (2) pharmaceutical;
9 (3) biological; or
10 (4) technological;
11 product that has been designated as immune from liability under
12 federal law.
13 Sec. 6. As used in this chapter, "mutagenicity" means the ability
14 to cause a genetic mutation in an individual.
15 Sec. 7. As used in this chapter, "placebo" means a substance
16 used as a control in a placebo controlled study that:
17 (1) is administered to a participant; and
18 (2) should not have a pharmacological effect on the
19 participant.
20 Sec. 8. As used in this chapter, "placebo controlled study"
21 means a scientific study that randomly assigns a participant to
22 receive either a product that is being studied or a placebo to
23 measure:
24 (1) health effects; and
25 (2) the safety outcome metrics;
26 of the product being studied over a period of time.
27 Sec. 9. As used in this chapter, "reactogenicity" means the
28 symptoms or the outcome of a vaccine that is administered to an
29 individual.
30 Sec. 10. As used in this chapter, "safety outcome metrics" means
31 data that is collected and analyzed on a product concerning the
32 following aspects of the product:
33 (1) Allergenicity.
34 (2) Carcinogenicity.
35 (3) Fertility impact.
36 (4) Immunogenicity.
37 (5) Mutagenicity.
38 (6) Reactogenicity.
39 Sec. 11. (a) A manufacturer of a liability shield product must
40 ensure that the liability shield product is subject to a placebo
41 controlled study before it is:
42 (1) distributed;
2025 IN 1426—LS 7594/DI 149 4
1 (2) manufactured;
2 (3) marketed; or
3 (4) administered;
4 within Indiana.
5 (b) A placebo controlled study described in subsection (a) must
6 continue for at least five (5) years and continuously collect safety
7 outcome metrics during this period of time.
8 (c) The results of a placebo controlled study and the safety
9 outcome metrics collected under this section must be made publicly
10 available and accessible to:
11 (1) patients;
12 (2) health care providers (as described in IC 16-18-2-163(a));
13 and
14 (3) state agencies.
15 Sec. 12. (a) The state department shall do the following:
16 (1) Monitor and track adverse outcomes of liability shield
17 products using the:
18 (A) Indiana health information exchange; and
19 (B) electronic support for public health - Vaccine Adverse
20 Event Reporting System.
21 (2) Publish any post-market surveillance data that reports an
22 adverse consequence of a liability shield product.
23 (b) The state department shall issue an alert and bulletin with
24 information about any adverse consequences of a liability shield
25 product identified through the required activities described in
26 subsection (a).
27 (c) Not later than January 1, 2026, the state department shall
28 establish a policy to monitor and publish data collection required
29 under this section. The policy must be made publicly available.
30 Sec. 13. (a) All manufacturers of liability shield products that
31 are distributed, manufactured, marketed, or administered within
32 Indiana must, not later than July 1, 2028, submit documentation to
33 the state department confirming that a placebo controlled study
34 has been initiated on the liability shield product.
35 (b) Not later than December 31, 2030, all manufacturers of
36 liability shield products that are distributed, manufactured,
37 marketed, or administered within Indiana must submit a
38 compliance report to the state department confirming that a
39 placebo controlled study has been completed as required under
40 section 11 of this chapter.
41 (c) The documentation required under subsection (a) and the
42 compliance reports required under subsection (b) must describe
2025 IN 1426—LS 7594/DI 149 5
1 the safety outcome metrics collected and the compliance report
2 must describe all final results of the placebo controlled study.
3 Sec. 14. An individual has the right to refuse a liability shield
4 product and may not be subject to coercion or threat to use a
5 liability shield product.
6 Sec. 15. (a) If an entity violates section 13 or 14 of this chapter,
7 the attorney general may bring an action to obtain any of the
8 following:
9 (1) Injunctive relief.
10 (2) A civil penalty of not more than one hundred thousand
11 dollars ($100,000) for each violation of the chapter.
12 (3) Reasonable attorney's fees and costs.
13 (b) This subsection is effective January 1, 2031. If a
14 manufacturer of a liability shield product violates section 11 of this
15 chapter, the attorney general may bring an action to obtain the
16 relief described in subsection (a).
17 Sec. 16. (a) An individual who suffers an injury due to a
18 violation of this chapter may bring an action to obtain the
19 following:
20 (1) Injunctive relief.
21 (2) Compensatory damages.
22 (3) Reasonable attorney's fees and costs.
23 (b) A suit brought under this section may be filed by the
24 individual or a personal representative on behalf of the individual.
25 SECTION 12. An emergency is declared for this act.
2025 IN 1426—LS 7594/DI 149