Montgomery County, Maryland v. Mike Leavitt

445 F. Supp. 2d 505, 2006 U.S. Dist. LEXIS 62437
CourtDistrict Court, D. Maryland
DecidedAugust 22, 2006
DocketCivil Action AW-06-477
StatusPublished
Cited by4 cases

This text of 445 F. Supp. 2d 505 (Montgomery County, Maryland v. Mike Leavitt) is published on Counsel Stack Legal Research, covering District Court, D. Maryland primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Montgomery County, Maryland v. Mike Leavitt, 445 F. Supp. 2d 505, 2006 U.S. Dist. LEXIS 62437 (D. Md. 2006).

Opinion

MEMORANDUM OPINION

WILLIAMS, District Judge.

This action involves a suit by Montgomery County, Maryland (“County” or “Plaintiff’) against Mike Leavitt (“Leavitt”), Secretary of Health and Human Resources, and Andrew C. von Eschenbach (“Esehen-bach”), Acting Commissioner of the United States Food and Drug Administration (collectively, “Defendants”). The Complaint alleges that Defendants acted arbitrarily, capriciously, and abused their discretion, and otherwise acted in violation of 5 U.S.C. § 706, by failing to provide the County with a limited certification for a waiver under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”) to implement a Canadian prescription drug reimportation program. The County also requests mandamus relief pursuant to 28 U.S.C. § 136, demanding that Leavitt discharge his “non-discretionary duty” to certify importation of Canadian prescription drugs under the MMA. Now pending before the court is Defendants’ Motion to Dismiss [5]. The Court has reviewed the entire record, as well as the pleadings with respect to the instant motion. No hearing is deemed necessary. See Local Rule 105.6 (D.Md.2004). For the reasons set forth below, the Court will grant Defendants’ Motion to Dismiss.

I. FACTUAL AND PROCEDURAL BACKGROUND

In a letter dated October 10, 2005, County Executive Douglas M. Duncan, on behalf of Montgomery County, requested that Secretary Leavitt issue a waiver pursuant to the MMA to allow the residents of the County and its government to import prescription medications from Canada. (County Letter at 1.) The letter spoke of residents of Montgomery County who are forced to “choose between their health and putting food on the table” and stated that, while drug safety is a “first priority,” the County believed it to be “fundamentally unfair that people living in Canada pay a fraction of what Americans pay for the same prescription.” (County Letter at 1.)

Randall Lutter, the FDA’s Acting Associate Commissioner for Policy and Planning, responded to the waiver request in a letter to Mr. Duncan, dated November 8, 2005. The FDA’s response expressed concerns about the safety risks associated with the importation of prescription drugs from foreign countries, claiming that “many drugs that U.S. Consumers purchase from Canada and believe were made in Canada in fact originate from other countries such as India and Costa Rica.” (FDA Letter at 1.) The letter also described the relevant provisions set forth in the Federal Food, Drug and Cosmetic Act *508 (“FDCA”) and asserted that “it is virtually certain that a foreign wholesaler or pharmacy would fail to comply with these applicable requirements, and therefore virtually every importation of such drugs would violate federal law.” (FDA Letter at 1-2.) The letter mentioned prior communications between the Montgomery County Council and the FDA regarding the County’s program, including the FDA’s prior warning that the proposed program would not comply with the FDCA. (FDA Letter at 4.) Finally, the FDA letter pointed out that section 384 of the MMA “retains the requirement ... that FDA may make effective a program for the importation of drugs by pharmacists and wholesalers only if the Secretary of Health and Human Services (“HHS”) first certifies that implementing the program would (1) pose no additional risk to the public health and safety and (2) result in a significant reduction in the cost of drugs to the American consumer.” (FDA Letter at 5) (citing 21 U.S.C. § 884). The FDA letter concluded that this certification requirement applies to the entirety of section 384, including the individual waiver provision, that it, therefore, “does not authorize a specific waiver for a discrete state pilot program,” and, as a result, granting such a waiver would violate federal law. (FDA Letter at 5.)

On February 23, 2006, Montgomery County filed its Complaint with the United States District Court for the District of Maryland, alleging a violation of 5 U.S.C. § 706 and requesting mandamus relief pursuant to 28 U.S.C. § 136. Defendants filed a Motion to Dismiss Plaintiffs Complaint on April 26, 2006, and Plaintiff filed its Opposition to the Defendant’s Motion on May 19, 2006. On June 2, 2006 Defendants filed their Reply.

II STANDARD OF REVIEW FOR A MOTION TO DISMISS

A court may grant a 12(b)(6) motion to dismiss for failure to state a claim upon which relief can be granted if “it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief.” Conley v. Gibson, 355 U.S. 41, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957). When reviewing a motion to dismiss, a court assumes “the truth of all facts alleged in the complaint and the existence of any fact that can be proved, consistent with the complaint’s allegations” and examines only the legal sufficiency of the complaint. Conley v. Gibson, 355 U.S. 41, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957). While the court must view the facts in a light most favorable to the plaintiff, the court “need not accept the legal conclusions drawn from the facts,” nor should it “accept as ti-ue unwarranted inferences, unreasonable conclusions, or arguments.” Eastern Shore Markets, Inc. v. J.D. Associates Ltd. Partnership, 213 F.3d 175 (4th Cir.2000).

III. ANALYSIS

Montgomery County alleges that the FDA’s decision to deny their waiver request for a Canadian drug importation program violated 5 U.S.C. § 706(2)(a), that the Secretary’s failure to issue certification under 384(i) violated 5 U.S.C. § 706(2)(a), and that Mandamus relief is warranted because Defendants have failed to discharge their official duties. The Court will address these arguments in turn.

A. FDA’S DENIAL OF THE COUNTY’S WAIVER REQUEST WAS IN COMPLIANCE WITH APPLICABLE LAW AND, THEREFOR, NO RELIEF CAN BE GRANTED WITH REGARD TO THIS CLAIM.

a. Standard of Review For Administrative Agency Action

Section 701(a) of the Administrative Procedure Act (“APA”) provides that *509 each agency or “authority of the government of the United States” is subject to judicial review except where “(1) statutes preclude judicial review; or (2) agency action is committed to agency discretion by law.” 5 U.S.C. § 701(a).

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445 F. Supp. 2d 505, 2006 U.S. Dist. LEXIS 62437, Counsel Stack Legal Research, https://law.counselstack.com/opinion/montgomery-county-maryland-v-mike-leavitt-mdd-2006.