Court Opinion

ID: 9516863
Source: CourtListenerOpinion
Date Created: 2023-08-06 23:54:40.596292+00
Date Added: 2024-06-11T09:39:43.308471
License: Public Domain

CHEZEM, Judge,
concurring in result.
I concur in result. While I agree that summary judgment should not have been granted against JKB, I arrive at this conclusion for reasons different than the majority's.
The pharmaceutical companies argue that they are protected by the Blood Shield Statute, Ind.Code § 1641-12-11, because they fall within the definition of a "storage facility." "As used in the Blood Shield Statute, 'storage facility' has the meaning set forth in IC 29-2-16-1." Ind.Code § 16-41-12-9. According to Ind.Code § 29-2-16-1(a), storage facility means "a facility licensed, accredited or approved under the laws of any state for storage of human bodies or parts thereof." The pharmaceutical companies assert that their FDA licenses qualify them as being licensed for storage "under the laws of any state." I do not believe that the legislature was referring to an FDA license when it drafted that language..
Indiana Code Section 16-41-12-16 outlines what it means to be licensed in Indiana, and, I believe, provides guidance for the resolution of the. present issue. That section states:
It is unlawful to operate a blood center in Indiana without a license issued by the state department under this chapter. A blood center that applies for a license in Indiana must also be Hicensed or appropriately registered by the federal Food and Drug Administration and remain in compliance with all applicable federal regulations.
16-41-12-16(a) (emphasis added). Therefore, merely having an FDA license or registration is not enough to operate a blood center in Indiana; a blood center must have a registration or license from the FDA and a license issued by the State of Indiana. As used in Ind.Code § 16-41-12, the term "blood center" expressly includes a "blood storage facility." Ind.Code § 16-41-12-8. Accordingly, it seems reasonable that an out of state blood storage facility which distributes blood products in Indiana would need to be licensed for storage by a state as well as be licensed or registered by the FDA in order to fall within the parameters of a "storage facility" as used in the Blood Shield Statute..
The appellees have not designated any evidence which would indicate that they are licensed to store blood, blood products, etc., in Indiana, or in any other state. They have only produced the licenses from the FDA. These are not enough to bring them within the protection of the Blood Shield Statute.