We’ve read recently about a court taking the unprecedented step of ordering the off-label administration of an animal drug, ivermectin, to a seriously ill COVID-19 patient over the objections of that patient’s treating physicians and of the hospital in which the patient was being treated.
Off-label use is something we know a little bit about. Bexis, in particular, has written three major law review articles on off-label use. Beck, “Off-Label Use in the Twenty-First Century: Most Myths and Misconceptions Mitigated,” 54 UIC J. Marshall L. Rev. 1 (2021) (available here, too recent for PubMed); Beck & Blackwell, “Drug Manufacturers’ First Amendment Right To Advertise & Promote Their Products for Off-Label Use: Avoiding a Pyrrhic Victory,” 58 Food & Drug L.J. 439 (2003) (PubMed ID 14626985); Beck & Azari, FDA, Off-Label Use, & Informed Consent: Debunking Myths & Misconceptions,” 53 Food & Drug L.J. 74 (1998) (PubMed ID 11795338).
We view ivermectin for COVID-19 treatment as an “off-label” use, because it is our understanding that, in different doses for different indications, there is an FDA-approved human use for ivermectin:
Ivermectin tablets are approved by the FDA to treat people with intestinal strongyloidiasis and onchocerciasis, two conditions caused by parasitic worms. In addition, some topical (on the skin) forms of ivermectin are approved to treat external parasites like head lice and for skin conditions such as rosacea.
FDA, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19,” available here. Likewise, ivermectin’s manufacturer (which would stand to make a lot of money if the Internet hype were true) has publicly stated that there is no scientific basis that this product provides any benefit at all in the COVID-19 context.
We are unaware of any legal basis for a court to order the off-label use of any medication over the objections of treating physicians and hospitals, whether or not some interloping non-staff physician might have prescribed it. It strikes us as an extreme example of what this Blog has called “judicial triumphalism” – the notion that courts know better than everyone else and can solve society’s problems through civil litigation.
As with the mandatory vaccination issue we discussed previously, precedent rejecting some sort of constitutional right to “medical” use of unproven treatments goes back a long time. During Prohibition, physicians were not allowed to prescribe large amounts of alcoholic “medicine.” “Congress must be regarded as having concluded − as it well might do in the absence of any consensus of opinion among physicians . . . − that malt liquor has no substantial medicinal qualities making its prescription necessary, and that this made it impossible to say the provision was an unreasonable and arbitrary exercise of power.” Lambert v. Yellowley, 272 U.S. 581, 594 (1926).
The Supreme Court also held, in rejecting a Commerce Clause-based demand for medical use of marijuana, “the dispensing of new drugs, even when doctors approve their use, must await federal approval.” Gonzales v. Raich, 545 U.S. 1, 28 (2005). In a more on-point decision, the Court also held that terminally-ill cancer patients could not go to the courts to enjoin an FDA prohibition on the importation of the quack “drug” Laetrile – rejecting precisely the sort of judicial triumphalism seen in the ivermectin lawsuit:
In the Court of Appeals’ view, an implied exemption from the Act was justified because the safety and effectiveness standards set forth in [the FDCA] could have “no reasonable application” to terminally ill patients. We disagree. Under our constitutional framework, federal courts do not sit as councils of revision, empowered to rewrite legislation in accord with their own conceptions of prudent public policy.
United States v. Rutherford, 442 U.S. 544, 555-56 (1979) (citations omitted).
To accept the proposition that the safety and efficacy standards of the Act have no relevance for terminal patients is to deny the [FDA’s] authority over all drugs, however toxic or ineffectual, for such individuals. If history is any guide, this new market would not be long overlooked. Since the turn of the century, resourceful entrepreneurs have advertised a wide variety of purportedly simple and painless cures [long list of quack cures omitted]. . . . [T]his historical experience does suggest why Congress could reasonably have determined to protect the terminally ill, no less than other patients, from the vast range of self-styled panaceas that inventive minds can devise.
Id. at 557-58 (footnote omitted).
Rutherford was not a constitutional case, but courts have likewise concluded that there is no constitutional right of access to scientifically unproven medical treatments. That was decided in Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007), which we discussed in detail here. After an exhaustive review of the history of “drug regulation in the United States, id. at 703 that court concluded that terminally ill patients had no constitutional to take drugs that the FDA had not found effective:
[T]o succeed on its claim of a fundamental right of access for the terminally ill to experimental drugs, [plaintiff] must show not only that there is a tradition of access to drugs that have not yet been proven effective, but also a tradition of access to drugs that have not yet been proven safe.
Examining, as we are required . . ., our Nation’s history, legal traditions, and practice with respect to the regulation of drugs for efficacy and safety, we conclude that our Nation has long expressed interest in drug regulation, calibrating its response in terms of the capabilities to determine the risks associated with both drug safety and efficacy.
Id. (citation omitted).
Nor could such a constitutional right be grounded in the “doctrine of necessity.” “Given the Supreme Court’s conclusion that the common law defense of necessity remains controversial and cannot override a value judgment already determined by the legislature, the common law doctrine of necessity provides little support to [plaintiff’s] proposed right.” Id. at 708. Tort law also did not support any new constitutional right. Id. at 708-09 (rejecting analogies to “traditional self-defense principles” and “intentional interference with lifesaving efforts.”
Thus, Abigail Alliance concluded:
[Plaintiff] has not provided evidence of a right to procure and use experimental drugs that is deeply rooted in our Nation’s history and traditions. To the contrary, our Nation’s history evidences increasing regulation of drugs as both the ability of government to address these risks has increased and the risks associated with drugs have become apparent. Similarly, our legal traditions of allowing a necessity defense, prohibiting intentional interference with rescue, and recognizing a right of self-defense cannot justify creating a constitutional right to assume any level of risk without regard to the scientific and medical judgment expressed through the clinical testing process.
Id. at 711 (footnote omitted).
Abigail Alliance cited a number of appellate decisions supporting its position: Sammon v. New. Jersey Board of Medical Examiners, 66 F.3d 639, 645 (3d Cir. 1995) (“state restrictions on a patient’s choice of particular health care providers are subjected only to rational basis review”); Mitchell v. Clayton, 995 F.2d 772, 775 (7th Cir. 1993) (“most federal courts have held that a patient does not have a constitutional right to obtain a particular type of treatment or to obtain treatment from a particular provider if the government has reasonably prohibited that type of treatment or provider”); New York State Ophthalmological Society v. Bowen, 854 F.2d 1379, 1389 (D.C. Cir. 1988) (“We disagree that the constitutional right to privacy comprehensively protects all choices made by patients and their physicians or subjects to ‘strict scrutiny’ all government interference with choice of medical treatment. There is no basis under current privacy case law for extending such stringent protection to every decision bearing, however indirectly, on a person’s health and physical well-being.”); United States v. Burzynski Cancer Research Institute, 819 F.2d 1301, 1313 (5th Cir. 1987) (“to the extent that the patients’ counterclaim can be construed as a challenge to the authority of the FDA to bar interstate distribution of unapproved drugs, the claim is frivolous”); Rutherford v. United States, 616 F.2d 455, 457 (10th Cir. 1980) (“the patient[’s] . . . selection of a particular treatment, or at least a medication, is within the area of governmental interest in protecting public health”); Carnohan v. United States, 616 F.2d 1120, 1122 (9th Cir. 1980) (constitutional rights to privacy and personal liberty “do not give individuals the right to obtain [unapproved drugs] free of the lawful exercise of government police power”).
Abigail Alliance has also been followed by subsequent decisions.
In pursuing one’s own health, an individual has a fundamental right to obtain and reject medical treatment. But, this right does not extend to give a patient a fundamental right to use any drug, regardless of its legality. . . . Thus, we conclude, in pursuing health, an individual does not have a fundamental affirmative right of access to a particular drug. A patient’s selection of a particular treatment, or at least a medication, is within the area of governmental interest in protecting public health, and regulation of that medication does not implicate a fundamental constitutional right.
Montana Cannabis Industry Ass’n v. State, 286 P.3d 1161, 1167 (Mont. 2012) (citations and quotation marks omitted).
No court has recognized a fundamental right to receive specific treatment from a specific provider at a specific facility. To the contrary, it appears that every court to consider the issue has rejected the argument that access to a specific treatment or specific provider − let alone at a specific facility − is a fundamental right protected by the Constitution.
Birchansky v. Clabaugh, 2018 WL 10110860, at *18 (S.D. Iowa Oct. 17, 2018), aff’d, 955 F.3d 751 (8th Cir. 2020). See Gomperts v. Azar, 2020 WL 3963864, at *8 (D. Idaho July 13, 2020) (“patients . . . do not have a fundamental right to non-FDA approved drugs”); Richards v. Holder, 2014 WL 2805280, at *4 (D. Mass. June 19, 2014) (plaintiff “does not have a fundamental constitutional right to buy a kidney”); Pickup v. Brown, 42 F. Supp.3d 1347, 1375 (E.D. Cal. 2012) (“plaintiffs in this case do not have a fundamental right to receive a therapy that [the government] has deemed harmful and ineffective”), aff’d, 740 F.3d 1208 (9th Cir. 2014); CareToLive v. von Eschenbach, 525 F. Supp.2d 952, 966 (S.D. Ohio 2007) (agreeing with Abigail Alliance that the constitution “d[oes] not establish a fundamental substantive due process right of access to experimental drugs for the terminally ill”).
Beyond the constitution, we know of no other enactment that could support a court injunction requiring health care providers to allow scientifically unproven off-label treatments over their objections. The federal “compassionate use” program is expressly voluntary, and requires submission of a request to the FDA. 21 U.S.C.A. §360bbb(b-c). We haven’t looked at every state “right to try” law (and we’re not going to), but every one we’ve seen was likewise voluntary, and also did not extend to off-label use situations. And unlike human drugs, the FDA has statutory power over “new animal drugs,” such as ivermectin, to preclude their sale altogether if “the conditions of use . . . in the proposed labeling are not reasonably certain to be followed in practice.” 21 U.S.C. §360b(c)(2)(A)(ii).
Nor, with respect to off-label use, is there any basis for a patient to demand off-label treatments from health care providers that are unwilling to provide them. If some other doctor wants to engage in off-label use, s/he should assume treatment responsibility. Judicial compulsion is not what off-label use is about. Unless a particular off-label use is sufficiently well-accepted to be considered the medical standard of care, a health care provider’s decision whether or not to provide off-label treatment is entirely discretionary. “Physicians may prescribe drugs and devices for off-label uses.” Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 351 (2001). “Physicians may, in their professional judgment, prescribe a drug for a purpose other than that for which it has been approved by the FDA.” T.H. v. Novartis Pharmaceuticals Corp., 407 P.3d 18, 24 n.1 (Cal. 2017). “The decision to prescribe such ‘off-label usage’ . . . is regarded as a professional judgment for the healthcare provider to make.” Nightingale Home Healthcare, Inc. v. Anodyne Therapy, LLC, 589 F.3d 881, 884 (7th Cir. 2009). “Doctors are free to exercise their professional judgment to prescribe FDA-approved drugs for any use they see fit.” Sommers v. UPMC, 185 A.3d 1065, 1072 n.6 (Pa. Super. 2018). Physicians are “allowed,” not compelled, to use prescription medical products off-label “for any purpose that he or she feels will improve the patient’s condition[.]” United States v. Algon Chemicals, Inc., 879 F.2d 1154, 1163 (3d Cir. 1989). See Bennett v. Teva Pharmaceuticals USA, Inc., 2021 WL 797834, at *2 (D. Del. March 2, 2021) (“doctors are free to prescribe a drug for off-label use if they deem it medically appropriate for a patient”); Gardner v. Vanda Pharmaceuticals, Inc., 2020 WL 2542121, at *6 (D.D.C. May 19, 2020) (“physicians are free to prescribe drugs for off-label uses as they see fit”) (citation omitted); Smith v. C.R. Bard, Inc., 730 F. Supp.2d 783, 803 (M.D. Tenn. 2010) (“[p]hysicians may prescribe drugs for off-label uses at their discretion”) (citation omitted). There is, in short, no basis for anyone to compel unwilling health care practitioners to allow or participate in off-label use.
That includes courts. The only cases involving court compelled initiation of off-label use that we know of are criminal in nature. See United States v. Garnos, 2017 WL 548215, at *5 (D.S.D. Feb. 10, 2017) (“involuntary administration” of off-label drugs to restore competency to stand trial); United States v. Ruark, 2014 WL 4966913, at *10 (N.D. Ga. Oct. 2, 2014) (same); State v. Richard Z., 49 N.Y.S.3d 278, 287 (N.Y. Sup. 2017) (off-label chemical castration ordered for sex offender). On a couple of other occasions, courts have intervened to require continuation of existing off-label regimens. In re Marriage of Harris, 877 N.W.2d 434, 443 (Iowa 2016) (affirming order to continue off-label treatment of child in custody dispute); Cruz v. Zucker, 218 F. Supp. d 246, 247 (S.D.N.Y. 2016) (§1983 action ordering insurance coverage of off-label “hormone therapies to treat individuals with gender dysphoria”). None of these cases involved an off-label use that was objected to by the relevant health care providers.
Finally, there is a good argument that ivermectin litigation should fail, given the immunity conferred by the PREP Act, which we’ve described at length here. That act provides the following immunity:
[A] covered person [which includes anyone treating COVID-19 patients] shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure [which is anything used to treat COVID-19].
During the effective period of a declaration under subsection (b) [these have been in effect since mid-2020], or at any time with respect to conduct undertaken in accordance with such declaration, no State or political subdivision of a State [which includes state courts] may establish, enforce, or continue in effect with respect to a covered countermeasure any provision of law or legal requirement that −
(A) is different from, or is in conflict with, any requirement applicable under this section; and
(B) relates to the design, development, clinical testing or investigation, formulation, manufacture, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing, dispensing, or administration by qualified persons of the covered countermeasure, or to any matter included in a requirement applicable to the covered countermeasure under this section or any other provision of this chapter, or under the Federal Food, Drug, and Cosmetic Act.
This blog has been among the strongest advocates of truthful, scientifically-based off-label use, but use of ivermectin to treat COVID-19 is anything but that. If a patient wants to self-medicate against COVID-19, whether by taking ivermectin, injecting bleach, or anything else, we’re not trying to stop them. Just leave a forwarding address for any Darwin Award. Nor would we object to a patient seeking off-label use of ivermectin as a COVID-19 treatment being transferred to a facility willing to provide it. But beyond that, patients have no legal basis to go to court to force unwilling health care providers either to participate in an off-label use they do not believe is therapeutic, or to force hospitals tolerate such a use in their facilities.