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Carik v. United States Department of Health & Human Services

United States District Court, D. Columbia.

November 27, 2013

JOSEPH M. CARIK, et al., Plaintiffs,

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[Copyrighted Material Omitted]

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For ALL PLAINTIFFS, Plaintiff: Charles Allen Black, Jr., LEAD ATTORNEY, THE LAW OFFICE OF C. ALLEN BLACK, JR., Allison Park, PA; Thomas Mansfield Dunlap, LEAD ATTORNEY, David Ludwig, DUNLAP WEAVER PLLC, Leesburg, VA.

For UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, KATHLEEN SEBELIUS, In her Official Capacity as Secretary, U.S. Department of Health and Human Services, UNITED STATES FOOD AND DRUG ADMINISTRATION, MARGARET A. HAMBURG, Dr., In her Official Capacity as the Commisioner of the United States Food and Drug Administration, UNITED STATES NATIONAL INSTITUTES OF HEALTH, FRANCIS S. COLLINS, Dr., In his official capacity as the Director, National Institutes of Health, Defendants: Andrew E. Clark, LEAD ATTORNEY, U.S. DEPARTMENT OF JUSTICE, Consumer Protection Branch, Washington, DC; Lauren Hash Bell, LEAD ATTORNEY, U.S. DEPARTMENT OF JUSTICE, Consumer Protection Branch, Civil Division, Washington, DC.

For MOUNT SINAI SCHOOL OF MEDICINE, Defendant: Douglas Hallward-Driemeier, LEAD ATTORNEY, ROPES & GRAY LLP, Washington, DC.


BERYL A. HOWELL, United States District Judge.

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The twelve named and thirteen unnamed plaintiffs (collectively, " the plaintiffs" ) in this action suffer from certain rare diseases and seek declaratory, injunctive, and monetary relief from the defendants, the United States Department of Health and Human Services and its Secretary, the United States Food and Drug Administration and its Commissioner, the United States National Institutes of Health and its Director, (collectively, " the defendants" ) to ensure an adequate supply of the medications they need.[1] See Compl., ECF No. 1, generally. The defendants have moved to dismiss this action under Federal Rules of Civil Procedure 12(b)(1) and (b)(6), claiming this Court lacks subject matter jurisdiction over the action and that the plaintiffs have failed to state a claim upon which relief can be granted. See Defs.' Mot. to Dismiss (" Defs.' Mot." ) at 1, ECF No. 20. For the reasons set forth below, the defendants' motion is granted.


The plaintiffs' 470-paragraph, 89-page complaint tends to obfuscate the relevant facts of this matter, as it mixes facts, legal arguments, and political and social theory, often in the same paragraph. See Compl. generally. As the defendants point out " [t]he precise nature of the claims in plaintiffs' . . . complaint is often difficult to

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discern." Defs.' Mem. Supp. Mot. Dismiss (" Defs.' Mem." ) at 27 n.19, ECF No. 20. At base, this suit is about the defendants' response to two drug shortages, which all parties agree were caused by two manufacturers, Genzyme and Hospira. See Defs.' Mem. at 20 (" [M]anufacturers, not the government, produce and distribute prescription drugs, [thus] they are the ones who are responsible for the drug shortages" ); Compl. ¶ 72 (" Genzyme created a shortage of Fabrazyme" ); Compl. ¶ 87 (" Hospira . . . created a drug shortage by switching manufacturing facilities." ).

All but one of the plaintiffs suffer from a rare disease known as Fabry disease and hold " state-issued, lawfully obtained prescription[s] for treatment" with a drug known as " Fabrazyme." See Compl. ¶ ¶ 1-24.[2] Plaintiff Jennifer Lacognata suffers from vitamin A deficiency disease and has a " state-issued, lawfully obtained prescription for treatment" with a drug called " Aquasol A." Id. ¶ 25. The plaintiffs allege that they were harmed and continue to be harmed by " interstate drug shortages . . . currently caused by FDA licensees and allowed to continue by the willful inaction of the government agencies tasked with protecting the public health and regulating interstate commerce." Id. ¶ 69.

Fabrazyme is the only drug available in the United States to treat Fabry disease, a potentially life threatening ailment. Id. ¶ 71. A shortage of the drug began in 2009 after the company that makes the drug, Genzyme, which is not a party to this suit, " introduc[ed] adulterated injectable vials [of] Fabrazyme into interstate commerce." Id. ¶ 72. This adulteration, caused by a virus entering the production apparatus in the facility where Genzyme manufactured Fabrazyme, eventually led to a consent decree between the United States Department of Justice and Genzyme, pursuant to which the company paid a substantial fine and pledged to fix the problems at its facility. See Consent Decree of Permanent Injunction, United States v. Genzyme Corp. et al., No. 10-cv-10865 (D. Mass.), ECF No. 12 (" Consent Decree" ) generally. The Consent Decree also gave the United States some limited oversight over manufacturing at the facility, see Consent Decree ¶ ¶ 4-5, and specifically authorized Genzyme to " manufacture, process, test, pack, label, hold, and distribute (including for export) or cause any of the foregoing at and from the Allston Facility the drugs Cerezyme, Fabrazyme, Myozyme, and Thyrogen," id. ¶ 5A. While the Consent Decree contains strict requirements for the production of some drugs, including Thyrogen, Elaprase, and Aldurazyme, see id. ¶ ¶ 5A--B, only a few provisions apply to Fabrazyme, see id.

Aquasol A is manufactured by the pharmaceutical company Hospira, which is not a party to this suit, and is the only drug available for the type of vitamin A deficiency with which Plaintiff Lacognata is afflicted. See id. ¶ ¶ 86-87. The plaintiffs allege that Hospira closed the only facility creating Aquasol A, thus creating a shortage of the drug worldwide. Id. ¶ 88. The plaintiffs further allege that the defendants continue to issue licenses to Hospira " despite the fact that over thirty-three discrete shortages in the availability of Hospira [manufactured drugs] on the U.S. marketplace have occurred since the FDA first licensed Hospira." Id. ¶ 91.

A description of the regulatory scheme administered by the defendants and within which Genzyme and Hospira operate is

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helpful to understand the context for the plaintiffs' claims.

A. The Regulatory Framework For Pharmaceuticals

1. " Drug" and " Biological Product" Licensing

Under the Federal Food, Drug, and Cosmetics Act, 21 U.S.C. § § 301 et seq. (" FDCA" ), a " drug," is, inter alia, an " article[] intended for use in the . . . mitigation, treatment, or prevention of disease" or " intended to affect the structure of any function of the body of man." 21 U.S.C. § § 321(g)(1)(B-C). All drugs are " new drugs" until their safety and effectiveness is certified under prescribed conditions. See 21 U.S.C. § 321(p)(1). Pharmaceutical companies may not market and distribute new drugs in the United States until the FDA approves the company's " new drug application" (" NDA" ), demonstrating the safety and effectiveness of the drug. See 21 U.S.C. § 355(a).

Under the Public Health Service Act (" PHSA" ), ch. 373, 58 Stat. 682 (1944) (codified as amended in scattered sections of 42 U.S.C.), a " biological product" is a " virus, therapeutic serum, toxin, antitoxin, vaccine . . . or analogous product . . . applicable to the prevention, treatment, or cure of a disease or condition of human beings." 42 U.S.C. § 262(i). A biological product is subject to all the provisions of the FDCA, except that a company need not apply for a drug license under the FDCA if the FDA has already approved a " biologics license application" (" BLA" ) and granted the company a license for the biological product under the PHSA. See 42 U.S.C. § 262(j). The FDA may issue licenses for biological products if, inter alia, the product is " safe, pure, and potent," and the manufacturing facility for the product meets certain standards. See id. § § 262(a)(2)(C)(i)(I-II).

2. Enforcement Authority

The federal government has certain enforcement powers to stop and punish violations of the FDCA: it may, inter alia, (1) seek an injunction against the violation, see 21 U.S.C. § 332; (2) criminally prosecute the offender, see 21 U.S.C. § 333; and/or (3) seize any materials made in violation of the FDCA, see 21 U.S.C. § 334. Notably, there is no statutory enforcement authority to force a drug maker to make more of its product or to mandate particular distribution patterns. See 21 U.S.C. § § 301 et seq. generally ; Defs.' Mem. at 6 (" FDA does not have the authority to force a private entity to manufacture or distribute its products at all, much less distribute them to particular patients." ).

In certain circumstances, the FDA is statutorily authorized to revoke approval of a drug manufacturer's NDA or BLA, but such authorization is limited and may only be exercised after certain actions are taken. The FDA " shall" revoke an approved NDA, for example, only after due notice and an opportunity for a hearing, if the drug is not safe, does not have the claimed effects, or the manufacturer fails to file required paperwork. See 21 U.S.C. § 355(e). The FDA " may," after notice and an opportunity for a hearing, revoke an approved NDA if the drug manufacturer fails to comply with certain requirements, including for recordkeeping, processing, and labeling. Specifically, an NDA may be revoked when " the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to assure and preserve its identity, strength, quality, and purity," or the drug's labeling is false or misleading. See id. The circumstances under which the FDA shall or may revoke an approved application do not mention or relate in any way to drug

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shortages or distribution patterns of the manufacturers. See id.

The PHSA requires the FDA to promulgate regulations governing the revocation of an approved BLA, 42 U.S.C. § 262(a)(2)(A), and the associated regulations provide for such a revocation if: (1) FDA staff cannot inspect a manufacturing facility because they cannot access the facility or because the manufacturer has discontinued production " to an extent that a meaningful inspection or evaluation cannot be made" ; (2) the manufacturer does not report a change to its application under 21 C.F.R. § 601.12; (3) the manufacturer's facility fails to meet the applicable standards provided for in the license; (4) the manufacturing center or methods have changed to such a degree that a new " showing that the establishment or product meets the requirements established" in the PHSA regulations is required; (5) " [t]he licensed product is not safe and effective" ; or (6) the licensed product " is misbranded with respect to any [intended] use." See 21 C.F.R. § § 601.5(b)(1)(i--vi). Similarly to the NDA requirements, due notice and a hearing must be held before a BLA may be revoked. 21 C.F.R. § 601.5(b)(1). Also similarly to the NDA requirements, no federal regulations authorize the FDA to revoke or suspend an approved BLA because the drug manufacturer causes a shortage, exports its drugs, or institutes a rationing program. See id.

3. The Bayh-Dole Act

Drugs developed, at least in part, with federal funding are subject to what is commonly referred to as the Bayh-Dole Act (" the Act" ), 35 U.S.C. § § 200 et seq. The Act is designed " to ensure that the Government obtains sufficient rights in federally supported inventions to meet the needs of the Government and protect the public against nonuse or unreasonable use of inventions." 35 U.S.C. § 200. To effectuate this goal, the Act provides the federal government with " march-in rights," which consist of the right to require a " contractor, an assignee or exclusive licensee of a subject invention to grant a nonexclusive, partially exclusive, or exclusive license in any field of use to a responsible applicant or applicants" in certain situations. See 35 U.S.C. § 203(a). Among those situations is when a " Federal agency determines that such . . . action is necessary to alleviate health or safety needs which are not reasonably satisfied by the contractor, assignee, or their licensees." 35 U.S.C. § 203(a)(2). " To date, the government has never exercised its march-in authority." Defs.' Mem. at 11.

B. The Drug Shortages

The plaintiffs' complaint centers on shortages of the two drugs at issue, Fabrazyme and Aquasol A. The circumstances of each shortage are outlined below.

1. Fabrazyme Shortage

In June 2009, " in response to a viral contamination at the plant where Fabrazyme is manufactured," Genzyme " shut down and sanitized" the facility, " causing an interruption in production and a temporary Fabrazyme shortage." Compl. Ex. H (" Revised Guidance to the U.S. Fabry Community: Management of Fabrazyme (agalsidase beta for injection) Supply" ) at 4, ECF No. 1-8. In response to the shortage, Genzyme convened a " Fabrazyme Stakeholders Working Group" (" FSWG" ), consisting of representatives from Genzyme as well as the Fabry Support and Information Group, the National Fabry Disease Foundation, and the Fabry Registry North American Board of Advisors, to recommend action to effectively manage the remaining supply. See id. at 1, 4. The FSWG recommended that prescribing physicians provide Fabrazyme doses at " approximately 80% of normal levels,

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which would be achieved by asking all patients to miss the equivalent of two doses, either by skipping two full infusions or receiving a half-dose for four infusions." Id. at 4. When resumption of normal production was delayed, the FSWG recommended reducing dosage levels to thirty percent of normal " to avoid a complete depletion of the medication." Id. at 4-5. These reduced dosage levels persisted until early 2012. See ...

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