S.D. Texas Says Nay to Doctors’ Ivermectin Claim; Refuses to Rein in FDA Criticisms of Ivermectin Off-Label Use 

While the plaintiffs acknowledged the FDA’s authority to regulate drugs (they get no credit for that; it’s like Margaret Fuller’s announcement that she“accept[ed] the universe,” and Thomas Carlyle’s retort that“By Gad, she’d better!”), they argued that the FDA lacked authority to“prohibit, direct, or advise against off-label uses of drugs approved for human use.” The plaintiffs relied on 21 U.S.C. section 396, which provides that nothing in the federal Food, Drug and Cosmetic Act“shall be construed to limit or interfere with the full authority of a health practitioner to prescribe or administer any legally marketed device for any condition or disease within a legitimate health care practitioner-patient relationship.” Did you catch the word“device” in that quote? The plaintiffs did, but nevertheless contended that section 396 also applies to the prescription and administration of drugs. We have some sympathy with the overarching notion that the FDA does not regulate the practice of medicine, and we certainly have expressed some skepticism about some of the FDA’s efforts to limit off-label prescriptions (inasmuch as some of those off-label prescriptions are necessary and are within the standard of care), but we have little sympathy for the ivermectin pro-conspiracy and anti-vax crowd, and even less sympathy for the plaintiffs’ statutory construction inApter.

Be that as it may, the plaintiffs inApter asserted five claims for relief: (1) ultra vires acts by the FDA; (2) violation of the Administrative Procedure Act (the good old APA – taking us back to a third-year law school class we thought had been safely packed away in our life experience attic forever) by virtue of the FDA acting in an“arbitrary and capricious” fashion; (3) violation of the APA by virtue of the FDA acting“not in accordance with law,”which seems like a clumsy catch-all; (4) violation of the APA by virtue of the FDA acting in“excess of statutory authority” (and now we sigh at the monotony and redundancy); and (5) declaratory judgment in accordance with all the other claims. The defendant filed a motion to dismiss the complaint. Purely on aesthetic grounds, Judge DDL (woe betide the plaintiffs’ bar if Judge DDL should ever actually ascend to the bench – the first dispositive motion wins!) would grant the motion. Purely on legal grounds, the non-fictitious judge inApter did grant the motion.

The complaint inApterwas structured the way it was (ultra vires and APA) because the chief barrier facing the plaintiffs was sovereign immunity. The plaintiffs were suing the United States which, like the rest of us, does not enjoy being sued but, unlike the rest of us, cannot be sued absent the existence of consent. A waiver of sovereign immunity cannot be implied. It must be expressed unequivocally. One way for plaintiffs to overcome sovereign immunity is to claim that the governmental body acted ultra vires. If a governmental officer acted beyond statutory limitations, such action is considered that of an individual, not the sovereign. InApter, thecourt held that the FDA did not act in an ultra vires manner, because section 396 prevents the FDA from interfering with the practice of medicine only with respect to medical devices. Remarkably, theAptercourt’s analysis of this issue turned on another case’s employment of a“See” citation rather than a simple, straight-up citation to authority. That“See” meant that the other case (Fifth Circuit) had not quite cozied up the extension of section 396 to drugs. Don’t let anyone tell you that the Bluebook does not matter. Moreover, theAptercourt simply did not believe that the FDA, which is charged with protecting public health, lacks any authority to make public statements in furtherance of that mission. At the same time, theAptercourt allowed that the FDA“ should have been more prudent in their communications.” That, friends of the DDL blog, is dicta.

And now we get to the APA. Just seeing those three capital letters makes us wince in memory of Professor David Currie’s fiendishly difficult final exam. TheApter case reminded us that the APA provides another avenue for plaintiffs to overcome sovereign immunity. Section 702 of the APA waives sovereign immunity for actions against federal agencies, seeking nonmonetary relief, if the agency’s conduct is otherwise subject to judicial review. But the FDA’s anti-ivermectin statements in this case did not constitute final agency actions reviewable under the APA. The statements referenced“additional testing needed,” and“clinical trials ongoing.” Certainly“no case law establishes the proposition that fleeting content on social media can mark the consummation of an agency’s decisionmaking process.” (Thankfully, there was no social media back when we took Administrative Law. We’d hate to contemplate the diabolical hypotheticals that Currie would have inflicted on us.) In addition, the FDA’s statements did not“come close to determining the rights, obligations, and legal consequences” or future liabilities of noncomplying parties. That the FDA’s statements may have “incited” third parties, such as state medical boards, to take adverse actions (including investigating and firing the plaintiffs), did not create an action against the FDA. “A state-medical board investigation and losing one’s job – at the hands of non-agency third parties – are not the types of consequences that meet the finality requirement.”

In sum, theAptercomplaint“failed to allege a final agency action that would allow an exception to sovereign immunity under the APA.”

We’ve tried our best to resist the horse humor. We hope that does not cause any long faces.