Ass'n of Am. Physicians & Surgeons v. Food & Drug Admin.

• Decision Date: 14 August 2020
• Docket Number: CASE No. 1:20-CV-493
• Citation: 479 F.Supp.3d 570
• Parties: ASSOCIATION OF AMERICAN PHYSICIANS & SURGEONS, Plaintiff, v. FOOD & DRUG ADMINISTRATION, et al., Defendants.
• Court: U.S. District Court — Western District of Michigan

479 F.Supp.3d 570

ASSOCIATION OF AMERICAN PHYSICIANS & SURGEONS, Plaintiff,

v.FOOD & DRUG ADMINISTRATION, et al., Defendants.

CASE No. 1:20-CV-493

United States District Court, W.D. Michigan, Southern Division.

Signed August 14, 2020

Andrew Schlafly, Far Hills, NJ, Lawrence J. Joseph, Law Office of Lawrence J. Joseph, Washington, DC, for Plaintiff.

James W. Harlow, U.S. Department of Justice, Washington, DC, Ryan D. Cobb, U.S. Attorney, Grand Rapids, MI, for Defendants.

OPINION AND ORDER

ROBERT J. JONKER, CHIEF UNITED STATES DISTRICT JUDGE

INTRODUCTION

In March 2020, as part of the federal government's response to the ongoing COVID-19 pandemic, the United States Food and Drug Administration ("FDA") approved an Emergency Use Authorization ("EUA") for hydroxychloroquine, a drug that has commonly been used in treating diseases like malaria and lupus. The EUA permitted healthcare providers to prescribe hydroxychloroquine that was distributed from the federal government's Strategic National Stockpile for use in combating COVID-19. The scope of the emergency authorization was limited. Distribution of the drug from the stockpile for purposes of treating COVID-19 was authorized only to treat adults and adolescents who had already been hospitalized with COVID-19 and for whom clinical trials were unavailable. Approximately three months later the FDA revoked this authorization, meaning that distribution of hydroxychloroquine from the stockpile to treat COVID-19 was restricted further to use only in clinical trials.

Plaintiff Association of American Physicians & Surgeons ("AAPS") is a nonprofit organization comprised of physician members. Its mission includes protecting its members from arbitrary and unlawful government action.¹ AAPS argues in this lawsuit that its members, including an unidentified physician practicing in the Western District of Michigan, wish to prescribe the drug hydroxychloroquine to their patients as a prophylactic against COVID-19. The drug has been touted by some physicians, commentators and government leaders, including President Trump, as an effective treatment or preventative measure against the disease. Indeed, AAPS contends that the actions of Defendants have "impeded the ability of President Trump to make [hydroxychloroquine] available to the public." (ECF No. 8-2, PageID.80).

The matter before the Court is on the motion for preliminary injunction filed by Plaintiff AAPS, and the Defendants’ motion to dismiss under Rules 12(b)(1) and 12(b)(6) for lack of standing and failure to state a claim. After review of the motions, and the respective briefing, the Court finds that oral argument on the motions is unnecessary. Hydroxychloroquine is commercially available, and physicians are free to prescribe the drug for off-label uses absent any direction to the contrary by state medical authorities. Nothing in the EUA, or its revocation, had any direct impact on the availability of hydroxychloroquine in the commercial market. AAPS does not really dispute this. Rather they aver the actions of Defendants have led state medical regulatory entities to restrict physician access to the drug that is available on the commercial market causing harm to the organization itself, its physician members, and those members’ patients.

The causal connections between the alleged injuries and the complained of actions by the Defendants are attenuated and general, and for the reasons set out below, the Court agrees with Defendants that AAPS lacks standing in this matter under any of the possible theories articulated by AAPS. Accordingly, the Court grants the defense motion, denies AAPS's motion for a preliminary injunction and dismisses this case.

BACKGROUND

1. Statutory Background -- The Emergency Use Authorization in General

This lawsuit involves the issuance, and eventual revocation, of an EUA by the FDA and the Secretary of the Department of Health & Human Services. The authority to issue an EUA is granted by statute that permits the Secretary of Health & Human Services to "authorize the introduction into interstate commerce ... of a drug, device, or biological product intended for use in an actual or potential emergency," in a public health crisis. 21 U.S.C. § 360bbb-3(a)(1). This includes an emergency use of a product that the FDA has approved as safe and effective in other circumstances. Id. at § 360bbb-3(a)(2).

Under the statutory framework, the Secretary must first "make a declaration that the circumstances exist justifying the authorization." Id. at 360bbb-3(b)(1). One such circumstance is a determination "that there is a public health emergency ... that affects, or has a significant potential to affect, national security ... and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents[.]" Id. at § 360bbb-3(b)(1)(C). An EUA relating to a drug may then issue if the Secretary concludes that "based on the totality of scientific evidence available," which includes "data from adequate and well-controlled clinical trials, if available, it is reasonable to believe" that (1) the drug "may be effective in diagnosis, treating, or preventing ... a serious or life-threatening disease or condition"; (2) "the known and potential benefits of the product ... outweigh the known and potential risks" of the drug; and (3) a determination that "there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition[.]" Id. at § 360bbb-3(c).

The Secretary may also "establish such conditions on an authorization .... as the Secretary finds necessary or appropriate to protect the public health." Id. at § 360bbb-3(e)(1)(B). The Secretary is required to "periodically review" the EUA and may revise or revoke the EUA if the justification for the emergency is no longer met, if the criteria for the EUA are no longer met, or "other circumstances make such revision or revocation appropriate to protect the public health or safety." Id. at § 360bbb-3(g)(1)-(2). All these determinations are expressly "committed to agency discretion." Id. at § 360bbb-3(i).

2. The March 2020 EUA with Respect to HCQ

As the COVID-19 virus spread the Department of Health & Human Services responded by, among other things, issuing an EUA regarding hydroxychloroquine to treat the disease. On February 4, 2020, the Secretary of the department issued a "Determination of Public Health Emergency" that stated COVID-19 "has a significant potential to affect national security or the health and security of United States citizens living abroad." 85 Fed. Reg. 7316, 7317 (Feb. 7, 2020). On March 27, 2020, the Secretary then declared that "circumstances exists justifying the emergency use of drugs and biological products during the COVID-19 pandemic[.]" 85 Fed. Reg. 18250-51 (Mar. 27, 2020).

An EUA for hydroxychloroquine to respond to COVID-19 was issued by the FDA the following day. It concluded the criteria for the issuance of the authorization was met. The authorization specifically noted:

1. The [COVID-19 virus] can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans invested by this virus;

2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that [hydroxychloroquine and a similar drug] may be effective in treating COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of [the drugs] when used to treat COVID-19 outweigh the known and potential risks of such products; and

3. There is no adequate, approved, and available alternative to the emergency use of [the two drugs] for the treatment of COVID-19.

(ECF No. 9-6, PageID.475-476). The scope of the authorization was limited in several respects. The drug, for example, had to be prescribed by a healthcare provider under a valid prescription. It also was limited for treatment of adult and adolescent patients who were hospitalized with COVID-19 and "for whom a clinical trial is not available, or participation is not feasible." ( Id. at PageID.477).

The scope was also limited to those supplies of the drug from the federal government's Strategic National Stockpile. Id. The Secretary of the Department of Health & Human Services, along with other officials, maintains a Strategic National Stockpile of drugs, vaccines, and other biological products, medical devices, and supplies in order "to provide for and optimize the emergency health security of the United States .... in the event of a bioterrorist attack or other public health emergency[.]" 42 U.S.C. § 247d-6b. The EUA did not bear on the supplies of hydroxychloroquine available in the commercial market. AAPS does not dispute this, nor does it aver there is any shortage of the drug in the commercial marketplace.

3. The Revocation of the EUA

The March 28th authorization expressly noted that that clinical trial data results, and other information, would continue to inform the agency's review and the risk benefit assessment of the hydroxychloroquine EUA. The authorization noted that the EUA would be effective until the circumstances justifying the authorization for the emergency use was terminated, or the EUA had been revoked. (ECF No. 9-6, PageID.480). On June 15, 2020, the "ongoing assessment" of the hydroxychloroquine EUA resulted in the revocation of the authorization because "the criteria ... for the issuance of the EUA ... are no longer met." (ECF No. 8-6, PageID.153). In a June 16, 2020 document further explaining the rationale for the revocation, the FDA stated that it had "determined that [HCQ is] unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of [the drugs] no longer outweigh the known and potential risks for the...