When we last commented on the Alliance for Hippocratic Medicine v. FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.”
In continuing the stay, the Fifth Circuit recently clipped the district court’s decision (which purported to take mifepristone off the market altogether) still further, but in our opinion, still not enough. While we’re tempted to launch into another diatribe about: (1) the absurdity of what amounts to the issuance of a merits decision on drug regulation – not on the basis of the huge amount of science the FDA considered – but solely in the allegations of a complaint filed by an anti-choice political group, and (2) the bizarre concurrence by a judge some consider “the worst Trump Judge in America,” we’ve decided to stick (for now) to the implications of Alliance for Hippocratic Medicine v. FDA, ___ F.4th ___, 2023 WL 5266026 (5th Cir. Aug. 16, 2023) (Hippo III), which are significant enough.
In our line of work, much of what we do depends on the continuing validity of what the FDA does with respect to prescription medical products. That’s why Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), is so important. It prevents plaintiffs in prescription medical product liability litigation from making collateral attacks on in-force FDA decisions. It has generally been assumed that such plaintiffs, while free to seek an advisory opinion from the FDA, may not collaterally attack FDA decisions in other litigation. E.g., Estee Lauder, Inc. v. FDA, 727 F. Supp. 1, 6 (D.D.C. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. Collagen Corp., 870 F. Supp. 885, 891 (N.D. Ind. 1994) (“an advisory opinion, rather than being the catalyst for preemption, allows an ‘interested person’ to determine whether a state requirement can safely be ignored”), aff’d, 67 F.3d 1268 (7th Cir. 1995), vacated on other grounds, 518 U.S. 1030 (1996).
Thus, for what we do, the most disturbing aspect of Hippo III is the extraordinarily low bar it sets for “standing” to challenge the validity of FDA actions. If that bar is not re-raised, any medical crank in the country can try to overturn FDA product approvals. Just think about how antivax nuts could attempt to attack COVID-19 (or any other) vaccine if the “substantial risk” of “future injury,” Hippo III, 2023 WL 5266026, at *6, necessary for standing to file suit amounts to only a ”fairly likely” possibility that “one of them” might suffer one of four purported “injuries.”
- They “must participate in the medical treatment that facilitates” something they don’t like.
- “[T]reating [allegedly adversely affected] patients imposes mental and emotional strain above what is ordinarily experienced in an emergency-room setting.”
- “[P]roviding emergency treatment forces the Doctors to divert time and resources away from their ordinary patients, hampering their normal practice.”
- “[P]atients [allegedly injured by the FDA-approved product] involve more risk of complication than the average patient, and so expose the Doctors to heightened risk of liability and increased insurance costs.”
Id. at *7-8.
Remember, the product in Hippo III is an FDA-approved prescription medical product. There is a reason that a physician’s prescription is required for this kind of product – by definition, it comes with sufficient risks that medical supervision is necessary to approve its use. If mifepristone’s approval is subject to attacks on this flimsy sort of purported injury, then so is practically any other FDA-approved prescription product. The complaint is full of exaggerations of the purported risks of mifepristone that the procedural posture of Hippo III forces the court to accept as “true,” but those exaggerations are false. To take one of a myriad of publicly available examples:
Data analyzed by CNN shows mifepristone is even safer than some common, low-risk prescription drugs, including penicillin and Viagra. There were five deaths associated with mifepristone use for every 1 million people in the US who have used the drug since its approval in 2000, according to the US Food and Drug Administration as of last summer. That’s a death rate of 0.0005%.
Comparatively, the risk of death by penicillin − a common antibiotic used to treat bacterial infections like pneumonia − is four times greater than it is for mifepristone, according to a study on life-threatening allergic reactions. Risk of death by taking Viagra − used to treat erectile dysfunction − is nearly 10 times greater, according to a study cited in the amicus brief filed by the FDA.
CNN, “How safe is the abortion pill compared with other common drugs” (april 21, 2023)
Neither penicillin nor Viagra is subject to mass tort litigation (although plaintiffs tried with the latter). Plaintiffs – or purportedly “public interest” medical groups acting at their behest – are certainly capable of making the same sort of allegations found in against any targeted FDA-approved prescription medical product. If the laughably low standing standards permitted in Hippo III are, in fact, the law, then our side’s ability to assert preemption, compliance, and other defenses that presuppose the validity of FDA decisions will be threatened. Every mass tort could well be accompanied by a “second front” of belated collateral attacks on the FDA’s regulatory approvals, REMS, conditions of use, and who knows what other FDA actions.
On what level of risk? Well, the rate of “severe conditions” stated in Hippo III as the basis for allowing standing ranged between 0.02% (two in ten thousand) and 0.06% (six in ten thousand). 2023 WL 5266026, at *8. The majority of prescription drugs have significantly higher risks, indeed many come with boxed warnings. Moreover, the Hippo III plaintiffs also contend that “they are injured by treating women who experience less urgent medical side-effects.” Id. at *8 n.2. If the supine standing analysis in Hippo III is indeed the law – rather than “a ticket for one train only” invented by three Republican judges for anti-choice political reasons, then the barriers that have traditionally existed to collateral attack of FDA (and other administrative) decisions no longer exist. Linda Greenhouse, “Thinking About the Supreme Court After Bush v. Gore,” 35 Ind. L. Rev. 435, 436 (2002).
Yet bad as it is, the risk analysis in Hippo III is the most testable of the purported standing criteria. Even worse is standing based on the “considerable mental and emotional stress on emergency-room doctors,” purported injury from “divert[ing] time and resources away from their ordinary practice to treat [adverse reaction] patients, and even the possibility of increased malpractice insurance costs. 2023 WL 5266026, at *11. If this is the law, the law is an ass – and we can look forward to vastly increased litigation involving administrative agencies of all sorts.
Hippo III does the same damage to the concept of legally “cognizable injury.”
[T]hreatened injuries must also be legally cognizable. The injuries here are. To begin, economic harm − like damage to one’s business interest − is a quintessential Article III injury. The Doctors therefore sustain a concrete injury when they are forced to divert time and resources away from their regular patients. And by the same token, the Doctors sustain a concrete injury when mifepristone patients expose them to greater liability and increased insurance costs.
2023 WL 5266026, at *14 (citations omitted). The conclusion simply does not follow. Can plaintiffs sue over anything that might threaten to increase their insurance premiums? If that’s true then everybody can sue over increased flooding from climate change.
But it’s not true – the law is not an ass. Before Hippo III, the idea that increased insurance premiums as damage from use of prescription medical products has been considered nutty and well beyond the scope of private litigation. In fact, somebody actually tried and drew back a nub. See Enriquez v. Johnson & Johnson, 2021 WL 5272370, at *3 (N.J. Super. App. Div. Nov. 12, 2021) (no negligence claim because pharmaceutical company “owed no duty of care” not to increase plaintiffs’ insurance premiums; “The nature of the risk to consumers of health insurance is too far removed [from defendants’ conduct], and any risk too attenuated, to find as a matter of fairness that a duty should extend to such outer limits.”).
Thus, quite apart from any political views on the abortion issue itself, we strongly oppose the dumbed-down standing requirements that Hippo III appears to have authorized. This result threatens the integrity of the system of federal prescription medical product regulation that has served this country well for nearly a century. It also threatens our client’s ability to rely on the FDA’s expert decision-making in prescription medical product liability litigation. Hippo III is anti-law, anti-science, anti-government, and anti-common sense.