Texas 2015 - 84th Regular

Texas House Bill HB4027 Compare Versions

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

Old	New	Differences
1	1	By: Blanco H.B. No. 4027
2	2
3	3
4	4	A BILL TO BE ENTITLED
5	5	AN ACT
6	6	rel
7	7	ating to products liability action related to a pharmaceutical
8	8	product.
9	9	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
10	10	SECTION 1. Section 82.007, Civil Practice and Remedies
11	11	Code, is amended to read as follows:
12	12	Sec. 82.007. MEDICINES. (a) In a products liability action
13	13	alleging that an injury was caused by a failure to provide adequate
14	14	warnings or information with regard to a pharmaceutical product,
15	15	such as a failure of the manufacturer to place notice to the United
16	16	States Food and Drug Administration of a potential safety signal,
17	17	there is a rebuttable presumption that the defendant or defendants,
18	18	including a health care provider, manufacturer, distributor, and
19	19	prescriber, are not liable with respect to the allegations
20	20	involving failure to provide adequate warnings or information if:
21	21	(1) the warnings or information that accompanied the
22	22	product in its distribution were those approved by the United
23	23	States Food and Drug Administration for a product approved under
24	24	the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et
25	25	seq.), as amended, or Section 351, Public Health Service Act (42
26	26	U.S.C. Section 262), as amended; or
27	27	(2) the warnings provided were those stated in
28	28	monographs developed by the United States Food and Drug
29	29	Administration for pharmaceutical products that may be distributed
30	30	without an approved new drug application.
31	31	(b) The claimant may rebut the presumption in Subsection (a)
32	32	as to each defendant by establishing that:
33	33	(1) the defendant, before or after pre-market approval
34	34	or licensing of the product, withheld from or misrepresented to the
35	35	United States Food and Drug Administration relevant [required]
36	36	information that was material [and relevant] to the performance of
37	37	the product and was causally related to the claimant's injury;
38	38	(2) the pharmaceutical product was sold or prescribed
39	39	in the United States by the defendant after the effective date of an
40	40	order of the United States Food and Drug Administration to remove
41	41	the product from the market or to withdraw its approval of the
42	42	product;
43	43	(3)(A) the defendant recommended, promoted, or
44	44	advertised the pharmaceutical product for an indication not
45	45	approved by the United States Food and Drug Administration;
46	46	(B) the product was used as recommended,
47	47	promoted, or advertised; and
48	48	(C) the claimant's injury was causally related to
49	49	the recommended, promoted, or advertised use of the product;
50	50	(4)(A) the defendant prescribed the pharmaceutical
51	51	product for an indication not approved by the United States Food and
52	52	Drug Administration;
53	53	(B) the product was used as prescribed; and
54	54	(C) the claimant's injury was causally related to
55	55	the prescribed use of the product; or
56	56	(5) the defendant, before or after pre-market approval
57	57	or licensing of the product, engaged in conduct that would
58	58	constitute a violation of 18 U.S.C. Section 201 and that conduct
59	59	caused the warnings or instructions approved for the product by the
60	60	United States Food and Drug Administration to be inadequate.
61	61	(6) the defendant, before or after pre-market approval
62	62	or licensing of the product, failed to report any adverse event (or
63	63	adverse experience), adverse drug reaction or unexpected adverse
64	64	drug reaction for the product as defined by the United States Food
65	65	and Drug Administration.
66	66	(7) the United States Food and Drug Administration
67	67	adds or amends a boxed warning as defined by USC §201.57(c)(1).
68	68	(c) The claimant is entitled to reasonable discovery on any
69	69	rebuttable presumption before a dispositive motion under (a).
70	70	SECTION 2. This Act takes effect September 1, 2015.