Whitehead v. Edmondson, NO. 1:97CV29-S-D (N.D. Miss. 3/24/1998), 1:97CV29-S-D.

• Decision Date: 24 March 1998
• Docket Number: NO. 1:97CV29-S-D.,1:97CV29-S-D.
• Parties: CHARLES D. WHITEHEAD, et al., Plaintiff, v. HENRY L. EDMONDSON, M.D., et al., Defendants.
• Court: U.S. District Court — Northern District of Mississippi

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CHARLES D. WHITEHEAD, et al., Plaintiff, v. HENRY L. EDMONDSON, M.D., et al., Defendants.

NO. 1:97CV29-S-D.

United States District Court, N.D. Mississippi, Eastern Division.

March 24, 1998.

OPINION

In this case, plaintiffs, the alleged wrongful death beneficiaries of Michael S. Whitehead, claim that defendants violated the Clinical Laboratory Improvement Act (CLIA), 28 U.S.C. § 263a, and are liable for negligence per se and for failure to diagnosis and treat decedent's medical condition. In making these allegations, plaintiffs invoked only this court's federal question jurisdiction under 28 U.S.C. § 1331. Presently before the court is defendants' motion to dismiss based on lack of subject matter jurisdiction and failure to state a claim for relief. Specifically, defendants maintain that CLIA does not provide a private cause of action for alleged violations of its provisions and, alternatively, that if CLIA does provide such a right, four of the five instant plaintiffs are not properly before the court as wrongful death beneficiaries.

After carefully considering the matter, the court is of the opinion that a plain reading of the statute clearly indicates that CLIA does not provide a private cause of action to individuals seeking relief for its alleged violation and that no such implicit right of action exists. Indeed, nearly every provision of that act directly delegates oversight of clinical laboratories to the Secretary of Health and Human Services and to no one else. See, e.g., 28 U.S.C. § 263a(b) (Secretary must issue certificate allowing laboratory to conduct certain tests); 28 U.S.C. § 263a(d)(1)(D) (Secretary has authority to inspect laboratory records); 28 U.S.C. § 263a(d)(2)(B) (Secretary must be notified of changes in laboratory examinations and procedures); 28 U.S.C. § 263a(e) (Secretary approves and disapproves laboratory accreditation body); 28 U.S.C. § 263a(f)(1) (Secretary issues standards "to assure consistent performance by laboratories issued a certificate under this section of valid and reliable laboratory examinations and other procedures"); 28 U.S.C. § 263a(g)(1) (Secretary may conduct planned or surprise inspections); 28 U.S.C. § 263a(n) (Secretary "shall compile and make available to physicians and the general public information...which the Secretary determines is useful in evaluating the performance of a laboratory....").

Furthermore, and of particular importance in this court's mind, are the provisions dealing with laboratories which are in noncompliance with the Secretary's standards. In that instance, only the Secretary may impose intermediate sanctions, including monetary civil penalties, 28 U.S.C. § 263a(h)(1) and (2); suspend, revoke, or limit certification of the laboratory, 28 U.S.C. § 263a(i)(1) and (2); or seek to enjoin the laboratory from continuing activity which creates a significant hazard to the public health, 28 U.S.C. § 263a(j). The United States Attorney General may also prosecute anyone intentionally violating the provisions of CLIA or its regulations. 28...