Apter v. United States, HHS, 2022 U.S. Dist. LEXIS 225612 (S.D. Texas Dec. 6, 2022), is yet another ivermectin case, but with a twist.  Most of the ivermectin cases we have seen involve Covid-19 patients or their representatives complaining that they were denied ivermectin treatment by hospitals or doctors who insisted on following standard medical practice, which deems ivermectin to be ineffective against Covid.  But in Apter, the plaintiffs were three doctors who sued the FDA and some of its officials, claiming the doctors’ ability to practice medicine was impaired by the FDA’s statements criticizing off-label use of ivermectin for Covid-19. The plaintiffs pointed to several statements issued by the FDA counseling against the use of ivermectin to treat or prevent Covid.  They also pointed to republications of such FDA anti-ivermectin statements.  For example, they cited a tweet/LinkedIn post/Facebook post that reads, “You are not a horse. You are not a cow. Seriously, y’all. Stop it,” which links to an FDA article.  It is nice to see that the FDA enjoys equine jokes as much as we do.

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 in Apter.

Be that as it may, the plaintiffs in Apter 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 in Apter did grant the motion.

The complaint in Apter was 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.  In Apter, the court 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, the Apter court’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, the Apter court 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, the Apter court allowed that the FDA “ should have been more prudent in their communications.”  That, friends of the DDL blog, is dicta.  

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

With apologies, this time, to Sir Paul − “The circuit judge, who held a grudge, has put the FDA’s banned on the run. . . .”

That’s just about what happened in Judge Rotenberg Educational Center, Inc. v. United States FDA, ___ F.4th ___, 2021 WL 2799891 (D.C. Cir. July 6, 2021) (note the

The United States Supreme Court in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), determined that “off-label usage” is “accepted and necessary” by both the FDA and the medical community.  Id. at 350.  Thus, “[p]hysicians may prescribe drugs and devices for off-label uses.”  Id. at 351 n.5 (citation and quotation marks omitted). 

The recent appellate False Claims Act (“FCA”) decision in Dan Abrams Co. LLC v. Medtronic Inc., ___ F. Appx. ___, 2021 WL 1235845 (9th Cir. April 2, 2021), has us scratching our heads.  It’s like riding a legal roller coaster.  Some parts are really high, and others are really low.

Bexis first ran across

A great woman once said “When they go low, we go high.”  Apropos of nothing in particular these days, we have been thinking about the issue of tone recently.  For instance, what is the exact line between a negative political advertisement and a positive one?  Are there circumstances where a candidate might suspend negative ads

This guest post is from Liz Minerd, an associate at Reed Smith.  She previously wrote the post on the FDA’s off-label promotion meeting last November, so when she indicated that she’d like to write about the FDA’s “Midnight Memo” on the same topic, we were only too happy to say “yes.”  So here is some in-depth analysis of the FDA’s rather unusual decision to, in effect, comment on its own meeting.  As always, our guest posters deserve all the credit, and any blame, for their efforts.


As this blog reported here, last week—two days before the change in administrations—the FDA released a memorandum entitled “Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products” available here. The Agency characterizes this 12th hour memorandum as a follow up to the two-day public meeting it held on November 9-10 regarding off-label promotion (or what the Agency refers to as “communications regarding unapproved uses of approved/cleared medical products”).  In particular, the Agency claims that it is issuing this memorandum to provide “additional background” in response to frustrations expressed by certain speakers during the November meeting regarding the Agency’s failure to adequately address the First Amendment in the public hearing notice.

However, the real purpose of the memorandum appears to be to set forth the Agency’s justification for their current restrictions on off-label promotion before a new administration and a new FDA commissioner could have a chance to revisit them. Indeed, after briefly noting the First Amendment concerns raised at the November meeting, the Agency spends the first twenty pages of the memorandum detailing its oft-repeated policy justifications for its current restrictions before addressing any of the First Amendment jurisprudence that has called those restrictions into question.  Its attitude is reflected in the memorandum’s first case citation—to the dissent in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012).  [Memorandum, at p. 2. fn. 3]  The Agency’s lengthy policy discussion demonstrates that the outgoing policymakers at the FDA find very little benefit in communications from manufacturers regarding off-label uses even, though it recites that off-label uses can be the standard of care in some circumstances.  This attitude, that only the Agency can keep the public sufficiently safe, is classic governmental paternalism of the sort that the United States Supreme Court has repeatedly condemned in its First Amendment decisions over the past several decades.

For example, the Agency asserts that it seeks to “motivate” the creation of “robust scientific data” about the safety and effectiveness of drugs. [Memorandum at 4-5]  However, the current prohibitions only do so prior to approval of a product.  After approval—a time period usually much longer than the approval process itself—the current prohibitions prevent the same manufacturers from providing the same sorts of scientific data to the same audience.  Thus, the Agency’s current prohibitions actually interfere with the continued creation of robust scientific data after approval.  For example, a manufacturer can be required to post clinical trial results concerning an off-label use [Memorandum at 17-18], but is prohibited from informing doctors that they can view the results on ClinicalTrials.gov and decide whether their patients might benefit from the studied use.

Continue Reading Guest Post – Midnight Madness − The FDA Continues To Discount First Amendment Implications Of Restrictions On Off-Label Promotion