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Andrews v. U.S. Dep't of Health and Human Services

March 31, 2005

RAY ANDREWS, AND GAYLEE ANDREWS, PLAINTIFFS,
v.
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, ET AL., DEFENDANTS.



The opinion of the court was delivered by: James Robertson United States District Judge

MEMORANDUM

In this case, citizen plaintiffs bring a challenge to provisions of the Federal Food, Drug & Cosmetic Act (FDCA), 21 U.S.C. §§ 301-397, and the Medicare Prescription Drug, Improvement, and Modernization Act (MPDMA), 21 U.S.C. § 384, that prohibit the reimportation of prescription drugs from Canada by consumers. The complaint fails to state a claim upon which relief can be granted, and it will be dismissed.

Background

Plaintiffs Ray and Gaylee Andrews allege that they are a married couple residing in Chicago; that they are both 75 years old; that they take prescription drugs for arthritis, asthma, diabetes, emphysema, high blood pressure and replaced hips; that these drugs cost them about $1,100 per month; that they have almost depleted their life savings in order to pay for the prescription drugs they need; that they have both begun to work again to supplement their retirement and Social Security incomes and in order to qualify for health care benefits; that at some time in the future they will be forced to choose between purchasing medications and purchasing food or other essentials; that if they could buy their medications from Canada, they would save about $400 - $500 per month; that if it were lawful, they would purchase their medications from Canada; but that because it would be unlawful they have never done so.

The Andrews seek a declaratory judgment that the statutory prohibition on the reimportation of prescription drugs by consumers, 21 U.S.C. § 381(d)(1), violates their substantive due process rights under the Fifth Amendment. They also challenge, as arbitrary, capricious, and contrary to law, 5 U.S.C. § 706(2)(A), the refusal of the Secretary of Health and Human Services to issue the certifications to Congress under 21 U.S.C. § 384(l) that would be necessary to trigger certain waivers of the reimportation ban.

The government moves to dismiss pursuant to Rule 12(b)(1) for lack of subject matter jurisdiction and, alternatively, pursuant to Rule 12(b)(6) for failure to state a claim on which relief can be granted.

On a motion to dismiss, all facts, and all inferences drawn from those facts, are "liberally construe[d]... in the plaintiff's favor." Andrx Pharm. Inc. v. Biovail Corp. Int'l, 256 F.3d 799, 805 (D.C. Cir. 2001). "'However, the court need not accept inferences drawn by plaintiffs if such inferences are unsupported by the facts set out in the complaint. Nor must the court accept legal conclusions cast in the form of factual allegations.'" Id. (quoting Kowal v. MCI Communications Corp., 16 F.3d 1271, 1276 (D.C. Cir. 1994).

Article III Standing

When their standing to sue is challenged, as it has been here, the plaintiffs must demonstrate they have suffered an injury in fact, that the injury is traceable to the defendants' conduct, and that there is a likelihood that this court may redress the injury. Bhd. of Locomotive Eng'rs v. United States, 101 F.3d 718, 723 (D.C. Cir. 1996). The injury must be "'concrete and particularized and actual or imminent, not conjectural or hypothetical.'" Flynt v. Rumsfeld, 355 F.3d 697, 702 (D.C. Cir. 2004) (quoting Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992)). It may either be current and actual, or threatened to occur in the near future. Northwest Airlines v. FAA, 795 F.2d 195, 201 (D.C. Cir. 1986).

These plaintiffs plead present injury. They claim that they are currently deterred from purchasing more affordable medicines from Canada. They claim that, if they were to purchase their medications from Canada and if those medications were seized as other medications have been seized in the past, Second Am. Compl. ¶ 28; Mot. Dismiss 10 n. 3; Pl. Resp. Ex. A (in "blitz" seizures conducted by U.S. Customs at postal facilities), they could not afford to purchase substitute medicines. They allege -- and their allegation must be taken as true for purposes of the instant motion -- that the current statutory scheme prohibiting the reimportation of prescription medications deters them from purchasing drugs from Canada and thus injures them by requiring them to pay more than they otherwise would. Second Am. Compl. ¶ 28.

Economic injury may amount to injury-in-fact for standing purposes. National Rifle Ass'n of America v. Magaw, 132 F.3d 272, 282 (6th Cir. 1997) ("'economic injury which is traceable to the challenged action' satisfies the requirements of Article III standing") (citing Lipton v. Comm'r of Health and Env't, State of Tenn., 973 F.2d 1311, 1316 (6th Cir. 1992)). Citing Brotherhood of Locomotive Engineers, 101 F. 3d 718 (D.C. Cir. 1996), plaintiffs allege that the defendants' policies "impose substantial, unrecoverable financial losses on them." Id. at ¶¶ 17, 19. Union members in that case were held to have shown injury from the loss of job protections even without evidence that any union member would actually lose his job. Just so, the Andrews need not order medications, have them seized, and then forego either their prescription medications or other basic necessities in order to demonstrate injury sufficient for standing purposes. Their allegation of injury is sufficiently current, particularized, and actual to meet the requirements of Article III.*fn1

Substantive Due Process Claim

The scrutiny a court employs to test a statute or regulation's validity under the due process clause depends on whether or not that statute or regulation implicates a fundamental right. Fundamental rights recognized under Fifth Amendment jurisprudence receive the strictest scrutiny, requiring proof that the statute or regulation is narrowly tailored to further a compelling state interest. Troxel v. Granville, 530 U.S. 57, 65 (2000); Washington v. Glucksberg, 521 U.S. 702, 720-21 (1997). If a statute implicates no fundamental right, the court considers only whether the law is rationally related to furthering a legitimate government interest, and the government is granted much more deference. Glucksberg, 521 U.S. at 766 (Souter, J. concurring) (rational basis test presumes constitutionality).

The right to purchase drugs from a preferred source or at a preferred price--if there is such a right at all -- is not fundamental. Many courts have held that there is no fundamental right to choose a particular medical treatment. Eg. Rutherford v. United States, 616 F.2d 455, 456-57 (10th Cir. 1980) (no privacy right to access drugs not approved by the FDA); Carnohan v. United States, 616 F.2d 1120, 1122 (9th Cir. 1980) (same); Garlic v. FDA, 783 F. Supp. 4, 5 (D.D.C. 1992) (same). Certain rights pertaining to health-related and medical choices are protected by the Constitution, eg. Roe v. Wade, 410 U.S. 113 (1973), Carey v. Population Serv. Int'l, 431 U.S. 678 (1977), Cruzan v. Director, Mo. Dep't of Health, 497 U.S. 261 (1990), but the plaintiffs' argument for extending constitutional protection to the rights they assert is unsupported. See Glucksberg, 521 ...


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