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Teva Parenteral Medicines, Inc., et al v. U.S. Department of Health and Human Services

October 9, 2012

TEVA PARENTERAL MEDICINES, INC., ET AL., PLAINTIFFS,
v.
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, ET AL., DEFENDANTS.



The opinion of the court was delivered by: Robert L. Wilkins United States District Judge

MEMORANDUM OPINION*fn1

Plaintiffs Teva Peranteral Medicines, Inc. ("Teva") and McKesson Medical-Surgical Inc. ("McKesson") filed suit against Defendants U.S. Department of Health and Human Services ("HHS") and Kathleen Sebelius in her official capacity as Secretary of Health and Human Services. Plaintiffs are seeking declaratory and injunctive relief under the Administrative Procedure Act, 5 U.S.C. §§ 701(a) ("APA"), alleging that the Centers for Disease Control ("CDC"), a division within HHS, improperly denied Plaintiffs' request that certain CDC employees be permitted to give testimony in underlying lawsuits currently pending in Nevada state court.

Before the Court are the parties' cross-motions for summary judgment. For the reasons set forth below, the Court concludes that the CDC was not arbitrary or capricious in its denial of Plaintiffs' request for testimony. Accordingly, the Court shall grant Defendants' motion for summary judgment and deny Plaintiffs' motion for summary judgment.

I. BACKGROUND

Teva and McKeeson are defendants in product liability tort actions filed by hundreds of litigants in Nevada state court related to a Hepatitis C outbreak that occurred in Clark County, Nevada between December 2007 and January 2008. In these state court actions, the plaintiffs claim that they have either contracted Hepatitis C, or have been unnecessarily exposed to the risk of contracting Hepatitis C, while being anesthetized during endoscopic procedures at clinics in Clark County, Nevada. Teva and McKesson are the manufacturer and distributor of Propofol, a short-acting hypnotic agent used in the induction and maintenance of anesthesia employed during these endoscopic procedures. The plaintiffs in the state court actions have sued Teva and McKesson under a theory of strict liability, claiming that they were exposed to Hepatitis C when they were anesthetized using contaminated Propofol vials, and that these vials were unsuitable for use at endoscopy clinics.

Both the Southern Nevada Health District ("SNHD") and the CDC investigated the Hepatitis C outbreak in December 2007 and January 2008. Among the CDC employees involved in the investigation were Scott Holmberg, Gayle Fischer Langley, Joseph Perz, and Melissa Scheafer. During these investigations, CDC employees conducted interviews with patients and medical personnel, collected specimens from patients, reviewed medical records, and observed medical personnel. In addition, "phylogenetic testing" was conducted in order to identify source patients.

On May 15, 2008, the CDC released its findings in the Epi-Aid Trip Report ("CDC Trip Report"). Dkt. No. 18, Ex. 3. The CDC Trip Report disclosed the investigation team's methodology, the information gathered, and suggested courses of action. Id. The CDC Trip Report concluded that some staff routinely reused syringes during individual procedures to withdraw anesthesia from single-use Propofol vials, and inappropriately used these vials to provide medication for multiple patients; "[t]his was considered the most likely mode of [Hepatitis C] transmission." Id. at 9. In December 2009, SNHD released a separate report ("SNHD Final Report") that contained the final results of the SNHD's two-year investigation. Dkt. No. 18, Ex. 4. The SNHD Final Report incorporated information from the CDC Trip Report and concluded that unsafe injection practices and reuse of contaminated Propofol vials were deemed to be the likely causes of the Hepatitis C infections. Id. at 50.

Because of the allegations lodged against them, Teva and McKesson have sought the deposition testimony of the CDC employees who investigated the Hepatitis C outbreak. In a letter dated August 20, 2010, Plaintiffs requested permission from the CDC to depose Scott Holmberg, Gayle Fischer Langley, Joseph Perz, and Melissa Schaefer in connection with the pending state court cases. On September 24, 2010, the CDC Director declined Plaintiffs' request and determined that the CDC employees would not be made available for deposition. Seeking review of the CDC's decision in this Court, Plaintiffs ask the Court to set aside the Defendants' decision and issue an injunction compelling the Defendants to permit the depositions sought by plaintiffs.

III. LEGAL STANDARD

Summary judgment is appropriate "if the movant shows [through facts supported in the record] that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). "The rule governing cross-motions for summary judgment . . . is that neither party waives the right to a full trial on the merits by filing its own motion; each side concedes that no material facts are at issue only for the purposes of its own motion." Sherwood v. Washington Post, 871 F.2d 1144, 1148 n.4 (D.C. Cir. 1989) (quoting McKenzie v. Sawyer, 684 F.2d 62, 68 n.3 (D.C. Cir. 1982)).

II. REGULATORY FRAMEWORK

Under the federal "housekeeping statute," 5 U.S.C. § 301, a federal agency is authorized to promulgate regulations regarding the disclosure of agency information, including procedures for responding to requests for documents and testimony by agency employees. See 5 U.S.C. § 301; see also Touhy v. Ragen, 340 U.S. 462, 469-70 (1951). Regulations promulgated under Section 301 are commonly known as an agency's Touhy regulations. Truex v. Allstate Ins. Co., 233 F.R.D. 188, 190 (D.D.C. 2006).

The HHS's pertinent Touhy regulations are found in 45 C.F.R. §§ 2.1-2.6. The conditions under which a party may request the testimony of a HHS employee are set forth in Section 2.4(a), which provides that:

All requests for testimony by an employee or former employee of the DHHS in his or her official capacity and not subject to the exceptions set forth in ยง 2.1(d) of this part must be addressed to the Agency head in writing and must state the nature of the requested testimony, why the information sought is unavailable by any other means, and the ...


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