Indiana 2025 Regular Session

Indiana House Bill HB1426 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1
2	2	Introduced Version
3	3	HOUSE BILL No. 1426
4	4	_____
5	5	DIGEST OF INTRODUCED BILL
6	6	Citations Affected: IC 16-18-2; IC 16-42-29.
7	7	Synopsis: Liability shield products. Defines a "liability shield product"
8	8	as a certain type of product that has been designated as immune from
9	9	liability under federal law. Requires a liability shield product to
10	10	undergo a placebo controlled study before it is distributed,
11	11	manufactured, marketed, or administered. Requires: (1) the Indiana
12	12	department of health to monitor and publish certain information; and
13	13	(2) certain entities to submit documentation and compliance reports;
14	14	concerning liability shield products. Allows the attorney general or a
15	15	private individual to bring an action if the requirements concerning
16	16	liability shield products are not met.
17	17	Effective: Upon passage.
18	18	Borders
19	19	January 13, 2025, read first time and referred to Committee on Public Health.
20	20	2025 IN 1426—LS 7594/DI 149 Introduced
21	21	First Regular Session of the 124th General Assembly (2025)
22	22	PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana
23	23	Constitution) is being amended, the text of the existing provision will appear in this style type,
24	24	additions will appear in this style type, and deletions will appear in this style type.
25	25	Additions: Whenever a new statutory provision is being enacted (or a new constitutional
26	26	provision adopted), the text of the new provision will appear in this style type. Also, the
27	27	word NEW will appear in that style type in the introductory clause of each SECTION that adds
28	28	a new provision to the Indiana Code or the Indiana Constitution.
29	29	Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts
30	30	between statutes enacted by the 2024 Regular Session of the General Assembly.
31	31	HOUSE BILL No. 1426
32	32	A BILL FOR AN ACT to amend the Indiana Code concerning
33	33	health.
34	34	Be it enacted by the General Assembly of the State of Indiana:
35	35	1 SECTION 1. IC 16-18-2-12.5 IS ADDED TO THE INDIANA
36	36	2 CODE AS A NEW SECTION TO READ AS FOLLOWS
37	37	3 [EFFECTIVE UPON PASSAGE]: Sec. 12.5. "Allergenicity", for
38	38	4 purposes of IC 16-42-29, has the meaning set forth in
39	39	5 IC 16-42-29-1.
40	40	6 SECTION 2. IC 16-18-2-48.4 IS ADDED TO THE INDIANA
41	41	7 CODE AS A NEW SECTION TO READ AS FOLLOWS
42	42	8 [EFFECTIVE UPON PASSAGE]: Sec. 48.4. "Carcinogenicity", for
43	43	9 purposes of IC 16-42-29, has the meaning set forth in
44	44	10 IC 16-42-29-2.
45	45	11 SECTION 3. IC 16-18-2-128.2 IS ADDED TO THE INDIANA
46	46	12 CODE AS A NEW SECTION TO READ AS FOLLOWS
47	47	13 [EFFECTIVE UPON PASSAGE]: Sec. 128.2. "Fertility impact", for
48	48	14 purposes of IC 16-42-29, has the meaning set forth in
49	49	15 IC 16-42-29-3.
50	50	16 SECTION 4. IC 16-18-2-186.6 IS ADDED TO THE INDIANA
51	51	17 CODE AS A NEW SECTION TO READ AS FOLLOWS
52	52	2025 IN 1426—LS 7594/DI 149 2
53	53	1 [EFFECTIVE UPON PASSAGE]: Sec. 186.6. "Immunogenicity", for
54	54	2 purposes of IC 16-42-29, has the meaning set forth in
55	55	3 IC 16-42-29-4.
56	56	4 SECTION 5. IC 16-18-2-201.7 IS ADDED TO THE INDIANA
57	57	5 CODE AS A NEW SECTION TO READ AS FOLLOWS
58	58	6 [EFFECTIVE UPON PASSAGE]: Sec. 201.7. "Liability shield
59	59	7 product", for purposes of IC 16-42-29, has the meaning set forth in
60	60	8 IC 16-42-29-5.
61	61	9 SECTION 6. IC 16-18-2-243.5 IS ADDED TO THE INDIANA
62	62	10 CODE AS A NEW SECTION TO READ AS FOLLOWS
63	63	11 [EFFECTIVE UPON PASSAGE]: Sec. 243.5. "Mutagenicity", for
64	64	12 purposes of IC 16-42-29, has the meaning set forth in
65	65	13 IC 16-42-29-6.
66	66	14 SECTION 7. IC 16-18-2-284.5 IS ADDED TO THE INDIANA
67	67	15 CODE AS A NEW SECTION TO READ AS FOLLOWS
68	68	16 [EFFECTIVE UPON PASSAGE]: Sec. 284.5. "Placebo", for
69	69	17 purposes of IC 16-42-29, has the meaning set forth in
70	70	18 IC 16-42-29-7.
71	71	19 SECTION 8. IC 16-18-2-284.6 IS ADDED TO THE INDIANA
72	72	20 CODE AS A NEW SECTION TO READ AS FOLLOWS
73	73	21 [EFFECTIVE UPON PASSAGE]: Sec. 284.6. "Placebo controlled
74	74	22 study", for purposes of IC 16-42-29, has the meaning set forth in
75	75	23 IC 16-42-29-8.
76	76	24 SECTION 9. IC 16-18-2-307.7 IS ADDED TO THE INDIANA
77	77	25 CODE AS A NEW SECTION TO READ AS FOLLOWS
78	78	26 [EFFECTIVE UPON PASSAGE]: Sec. 307.7. "Reactogenicity", for
79	79	27 purposes of IC 16-42-29, has the meaning set forth in
80	80	28 IC 16-42-29-9.
81	81	29 SECTION 10. IC 16-18-2-320.8 IS ADDED TO THE INDIANA
82	82	30 CODE AS A NEW SECTION TO READ AS FOLLOWS
83	83	31 [EFFECTIVE UPON PASSAGE]: Sec. 320.8. "Safety outcome
84	84	32 metrics", for purposes of IC 16-42-29, has the meaning set forth in
85	85	33 IC 16-42-29-10.
86	86	34 SECTION 11. IC 16-42-29 IS ADDED TO THE INDIANA CODE
87	87	35 AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE
88	88	36 UPON PASSAGE]:
89	89	37 Chapter 29. Liability Shield Products
90	90	38 Sec. 1. As used in this chapter, "allergenicity" means the ability
91	91	39 to provoke an allergic reaction in an individual.
92	92	40 Sec. 2. As used in this chapter, "carcinogenicity" means the
93	93	41 ability to cause cancer in an individual.
94	94	42 Sec. 3. As used in this chapter, "fertility impact" means the
95	95	2025 IN 1426—LS 7594/DI 149 3
96	96	1 ability to adversely affect the reproductive health or fertility of an
97	97	2 individual.
98	98	3 Sec. 4. As used in this chapter, "immunogenicity" means the
99	99	4 ability to cause an immune response in an individual.
100	100	5 Sec. 5. As used in this chapter, "liability shield product"
101	101	6 includes a:
102	102	7 (1) medical;
103	103	8 (2) pharmaceutical;
104	104	9 (3) biological; or
105	105	10 (4) technological;
106	106	11 product that has been designated as immune from liability under
107	107	12 federal law.
108	108	13 Sec. 6. As used in this chapter, "mutagenicity" means the ability
109	109	14 to cause a genetic mutation in an individual.
110	110	15 Sec. 7. As used in this chapter, "placebo" means a substance
111	111	16 used as a control in a placebo controlled study that:
112	112	17 (1) is administered to a participant; and
113	113	18 (2) should not have a pharmacological effect on the
114	114	19 participant.
115	115	20 Sec. 8. As used in this chapter, "placebo controlled study"
116	116	21 means a scientific study that randomly assigns a participant to
117	117	22 receive either a product that is being studied or a placebo to
118	118	23 measure:
119	119	24 (1) health effects; and
120	120	25 (2) the safety outcome metrics;
121	121	26 of the product being studied over a period of time.
122	122	27 Sec. 9. As used in this chapter, "reactogenicity" means the
123	123	28 symptoms or the outcome of a vaccine that is administered to an
124	124	29 individual.
125	125	30 Sec. 10. As used in this chapter, "safety outcome metrics" means
126	126	31 data that is collected and analyzed on a product concerning the
127	127	32 following aspects of the product:
128	128	33 (1) Allergenicity.
129	129	34 (2) Carcinogenicity.
130	130	35 (3) Fertility impact.
131	131	36 (4) Immunogenicity.
132	132	37 (5) Mutagenicity.
133	133	38 (6) Reactogenicity.
134	134	39 Sec. 11. (a) A manufacturer of a liability shield product must
135	135	40 ensure that the liability shield product is subject to a placebo
136	136	41 controlled study before it is:
137	137	42 (1) distributed;
138	138	2025 IN 1426—LS 7594/DI 149 4
139	139	1 (2) manufactured;
140	140	2 (3) marketed; or
141	141	3 (4) administered;
142	142	4 within Indiana.
143	143	5 (b) A placebo controlled study described in subsection (a) must
144	144	6 continue for at least five (5) years and continuously collect safety
145	145	7 outcome metrics during this period of time.
146	146	8 (c) The results of a placebo controlled study and the safety
147	147	9 outcome metrics collected under this section must be made publicly
148	148	10 available and accessible to:
149	149	11 (1) patients;
150	150	12 (2) health care providers (as described in IC 16-18-2-163(a));
151	151	13 and
152	152	14 (3) state agencies.
153	153	15 Sec. 12. (a) The state department shall do the following:
154	154	16 (1) Monitor and track adverse outcomes of liability shield
155	155	17 products using the:
156	156	18 (A) Indiana health information exchange; and
157	157	19 (B) electronic support for public health - Vaccine Adverse
158	158	20 Event Reporting System.
159	159	21 (2) Publish any post-market surveillance data that reports an
160	160	22 adverse consequence of a liability shield product.
161	161	23 (b) The state department shall issue an alert and bulletin with
162	162	24 information about any adverse consequences of a liability shield
163	163	25 product identified through the required activities described in
164	164	26 subsection (a).
165	165	27 (c) Not later than January 1, 2026, the state department shall
166	166	28 establish a policy to monitor and publish data collection required
167	167	29 under this section. The policy must be made publicly available.
168	168	30 Sec. 13. (a) All manufacturers of liability shield products that
169	169	31 are distributed, manufactured, marketed, or administered within
170	170	32 Indiana must, not later than July 1, 2028, submit documentation to
171	171	33 the state department confirming that a placebo controlled study
172	172	34 has been initiated on the liability shield product.
173	173	35 (b) Not later than December 31, 2030, all manufacturers of
174	174	36 liability shield products that are distributed, manufactured,
175	175	37 marketed, or administered within Indiana must submit a
176	176	38 compliance report to the state department confirming that a
177	177	39 placebo controlled study has been completed as required under
178	178	40 section 11 of this chapter.
179	179	41 (c) The documentation required under subsection (a) and the
180	180	42 compliance reports required under subsection (b) must describe
181	181	2025 IN 1426—LS 7594/DI 149 5
182	182	1 the safety outcome metrics collected and the compliance report
183	183	2 must describe all final results of the placebo controlled study.
184	184	3 Sec. 14. An individual has the right to refuse a liability shield
185	185	4 product and may not be subject to coercion or threat to use a
186	186	5 liability shield product.
187	187	6 Sec. 15. (a) If an entity violates section 13 or 14 of this chapter,
188	188	7 the attorney general may bring an action to obtain any of the
189	189	8 following:
190	190	9 (1) Injunctive relief.
191	191	10 (2) A civil penalty of not more than one hundred thousand
192	192	11 dollars ($100,000) for each violation of the chapter.
193	193	12 (3) Reasonable attorney's fees and costs.
194	194	13 (b) This subsection is effective January 1, 2031. If a
195	195	14 manufacturer of a liability shield product violates section 11 of this
196	196	15 chapter, the attorney general may bring an action to obtain the
197	197	16 relief described in subsection (a).
198	198	17 Sec. 16. (a) An individual who suffers an injury due to a
199	199	18 violation of this chapter may bring an action to obtain the
200	200	19 following:
201	201	20 (1) Injunctive relief.
202	202	21 (2) Compensatory damages.
203	203	22 (3) Reasonable attorney's fees and costs.
204	204	23 (b) A suit brought under this section may be filed by the
205	205	24 individual or a personal representative on behalf of the individual.
206	206	25 SECTION 12. An emergency is declared for this act.
207	207	2025 IN 1426—LS 7594/DI 149