Higgins ex rel. McCall v. Texas Department of Health Services

801 F. Supp. 2d 541, 2011 U.S. Dist. LEXIS 72768, 2011 WL 2670178
CourtDistrict Court, W.D. Texas
DecidedJuly 7, 2011
DocketCivil Action No. SA-10-CV-990-XR
StatusPublished
Cited by1 cases

This text of 801 F. Supp. 2d 541 (Higgins ex rel. McCall v. Texas Department of Health Services) is published on Counsel Stack Legal Research, covering District Court, W.D. Texas primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Higgins ex rel. McCall v. Texas Department of Health Services, 801 F. Supp. 2d 541, 2011 U.S. Dist. LEXIS 72768, 2011 WL 2670178 (W.D. Tex. 2011).

Opinion

ORDER

XAVIER RODRIGUEZ, District Judge.

On this date, the Court considered Defendants’ Motion to Dismiss (docket no. 4) and the Response and Reply thereto. After careful consideration, the Court will grant the motion in part and dismiss it as moot in part.

I. Background

Plaintiffs bring suit against the Texas Department of Health Services (“the Department”) and David L. Lakey, in his Official Capacity as Commissioner of the Department. Plaintiffs are the parents of infants whose blood samples were taken in 2007 and 2008 as part of the State’s newborn screening program. Both at that time and thereafter, Section 33.011 of the Texas Health & Safety Code required physicians and others attending a newborn child to “subject the child to screening tests approved by the department for phenylketonuria, other heritable diseases, hypothyroidism, and other disorders for which screening is required by the department.” Tex. Health & Safety Code § 33.011. Until May 2009, Chapter 33 did not specify what would happen to the blood specimens obtained as part of the screening program after screening was completed. Apparently, the blood specimens were being kept and stored after the screening.

Parents concerned about this storage filed the Beleño lawsuit in March 2009. The Amended Complaint in Beleño complained that the Department collected the blood specimens and stored them indefinitely for the purpose of undisclosed research, and that the Department had not disclosed any transactions related to the specimens. During the pendency of the Beleno lawsuit, the Texas Legislature amended Chapter 33, effective May 27, 2009. See Act of May 27, 2009, 81st Leg., [545]*545R. S., ch. 179. The amendments included the addition of sections 33.0111 (“Disclosure”), 33. 0112 (“Statement Prohibiting Retention of Genetic Material”), and 33.017 (“Confidentiality”).

Section 33.0111 requires that the Department “develop a disclosure statement that discloses to the parent or guardian of a newborn child subjected to screening under § 33.011 that the department or a laboratory established or approved by the department under Section 33.016 may retain for use by the department or laboratory genetic material used to conduct the newborn screening tests and discloses how the material is managed and used; and (2) that the parent, managing conservator, or guardian may limit the use of the genetic material by providing to the department in accordance with Section 33.0112 a written statement prohibiting the department or laboratory from retaining the genetic material or using the genetic material for any purpose other than the conduct of newborn screening tests authorized under this chapter.” Tex. Health & Safety Code § 33.0111(a). This disclosure must be presented to a parent or guardian at the time the newborn is subjected to the screening tests. Id. § 33.0111(c).

Section 33.0112 also provides that a parent or guardian “of a newborn child may file with the department a signed written statement prohibiting the department or a laboratory established or approved by the department from retaining any genetic material related to the newborn screening tests conducted under this chapter or using the genetic material for any purpose other than the conduct of the newborn screening tests.” Id. § 33.0112(a). Within 60 days of receiving such a statement, “the department or laboratory shall destroy the genetic material used in the screening tests.” Id. § 33.0112(b). Further, an adult individual may file a written statement instructing the department or a laboratory to destroy any genetic material of the individual that is retained and used under the chapter. Id. § 33.0112(c).

Section 33.017, entitled “Confidentiality,” makes confidential all reports, records, and information obtained or developed by the Department under Chapter 33, allowing their disclosure only (1) for purposes of diagnosis or follow-up authorized under Section 33.014, with the consent of each identified individual or someone authorized to consent on behalf of an identified individual; (2) as authorized by court order; (3) to a medical examiner authorized to conduct an autopsy on a child or an inquest on the death of a child; or (4) to public health programs of the department for public health research purposes provided that the disclosure is approved by an institutional review board or privacy board of the department as authorized by the federal privacy requirements adopted under HIPAA. Id. § 33.017(a),(b). However, “reports, records, and information that do not identify a child or the family of a child may be released without consent” if the disclosure is for: (1) statistical purposes; (2) purposes related to obtaining or maintaining certification, approval, or quality assurance for the department’s laboratory or a public or private laboratory to perform newborn screening tests; (3) purposes relating to review, quality assurance, or improvement of the department’s newborn screening or newborn screening program services; (4) research purposes, provided that the disclosure is approved by an institutional review board or privacy board of the department; or (5) quality assurance.

The parties settled the Beleno case in November 2009. Pursuant to the settlement agreement, the Department agreed to destroy all blood specimens that were taken as part of the newborn screening program and received by the Department [546]*546before May 27, 2009 in its or Texas A & M Health Science Center’s possession (Texas A & M facilities were used to store the specimens) for which it did not have written consent for continued retention and use. The Department further agreed to post on the newborn screening program website a list of all research projects for which the defendants had provided blood specimens, and also agreed to post a comprehensive list of categories of quality assurance and quality control uses for which defendants provided the blood specimens. Last, the Department agreed to inform the named plaintiffs in writing of the uses to which their children’s blood specimens had been put, as well as any financial transactions regarding those specimens.

Plaintiffs Higgins and McCall filed this lawsuit in December 2010, asserting violations of their rights based on the distribution of the newborn screening blood samples to private research companies, government agencies, and other third parties without knowledge or consent. Citing the information posted on the Department’s website pursuant to the Beleño settlement, Plaintiffs note that “Defendants have distributed, sold, bartered, and traded at least 8,800 blood samples” and “[tjhere is no compelling state justification for such secretive, deceptive, and non-consensual activity.” Plaintiffs complain “that Defendants deceptively and unlawfully sold, traded, bartered, and distributed blood samples collected from their children ... for fees, various lab equipment, and various other purposes” and that the blood samples “were made available to private companies for undisclosed purposes and to the Armed Forces Institute of Pathology, without Plaintiffs’ knowledge or consent.” Plaintiffs complain that “Defendants knowingly and deceptively withheld this information during settlement negotiations in Beleño.” Plaintiffs allege that Defendants were asked during the settlement negotiation process whether they ever distributed or sold blood samples to third parties, and Defendants consistently denied that they had.

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Related

Higgins v. TEXAS DEPARTMENT OF HEALTH SERVICES
801 F. Supp. 2d 541 (W.D. Texas, 2011)

Cite This Page — Counsel Stack

Bluebook (online)
801 F. Supp. 2d 541, 2011 U.S. Dist. LEXIS 72768, 2011 WL 2670178, Counsel Stack Legal Research, https://law.counselstack.com/opinion/higgins-ex-rel-mccall-v-texas-department-of-health-services-txwd-2011.