Friday, June 20, 2025

"abortion reversal" promoter engaged in inherently and potentially misleading commercial speech, court rules

Culture of Life Family Services, Inc. v. Bonta, 2025 WL 1677783, No. 3:24-cv-01338-GPC-KSC (S.D. Cal. Jun. 13, 2025)

In two opinions on the same day, the court didn’t give much comfort to an “abortion reversal” provider.

COLFS sought to enjoin AG Bonta’s pending state court false advertising proceeding against its “abortion reversal” claims. APR is touted for pregnant women who have started the chemical abortion process by ingesting mifepristone, the first pill out of two; it involves taking the hormone progesterone in order to counteract mifepristone’s blocking of the body’s natural supply of progesterone. The main proponent, COLFS’s medical director, has done small human case studies, claiming an overall fetal survival rate was 48%, higher for the subgroup that received progesterone intramuscularly (64%) and the subgroup that received a high dose of oral progesterone followed by daily oral progesterone until the end of the first trimester (68%).  

The state enforcement action under California’s UCL and FAL challenged as unsupported by credible scientific evidence: the use of the terms “reverse” and “reversal”; claims that APR “has been shown to increase the chances of allowing the pregnancy to continue”; claims that APR has a success rate of 64-68%; claims that the rate of birth defects following APR is “less or equal to the rate in the general population”; claims that “thousands of lives have been saved” through APR; claims that APR may be effective at longer time ranges and following administration of misoprostol and methotrexate; and claims that APR can cause only non-life-threatening side effects, even though it can cause severe bleeding.

The court found the UCL and FAL to be content-neutral, because they were laws of general applicability that prohibit false and misleading statements. (This is probably not consistent with Reed, but Reed doesn’t make a ton of sense, especially applied to commercial speech—the underlying conclusion that strict scrutiny doesn’t apply is correct.)

Bonta argued that COLFS’s APR statements were commercial speech, used to advertise the treatment, and that fundraising provided an economic motivation for the APR claims. The court noted that many of the disputed statements appeared on COLFS’s website, and appeared more informational and educational than client-soliciting. Statements about APR in fundraising weren’t as clear as in a previous case, where a “majority” of fundraising communications involved the advertising language at issue, nor did COLFS anywhere claim to compete with abortion providers. However, in exchange for its APR services, COLFS accepts insurance and/or payment from women who have insurance or the means to pay; it also provides free treatment. On a motion to dismiss, COLFS sufficiently pled that its statements weren’t commercial speech.

However, the Free Exercise claim failed. A Free Exercise claim requires that a government entity has “burdened [a plaintiff’s] sincere religious practice pursuant to a policy that is not ‘neutral’ or ‘generally applicable.’ ” But the UCL and FAL “protect consumers by prohibiting false and misleading advertisements – because of the stated interest in consumer protection, not because of any sort of motivations underlying those advertisements – and as such these laws are neutral.” There were no exceptions to the UCL and FAL that could discriminate against religious conduct, nor did they treat “any comparable secular activity more favorably than religious exercise.” The AG “regularly enforces” these laws against secular entities. Although the UCL and FAL don’t apply to public entities or political speech, that wasn’t required to make them “generally applicable” laws. Instead, laws of general application treat religious and secular speech comparably. “Whether secular and religious activity are ‘comparable’ is evaluated ‘against the asserted government interest that justifies the regulation at issue’ and requires looking at the risks posed, not the reasons for the conduct.” The risks posed by public entity and political speech were different. Public entities are exempted because the state is a “sovereign entity representing the people,” and can have sovereign immunity. Political speech is exempted because “false and misleading political speech is protected while inherently false and misleading commercial speech is not.”

Although COLFS claimed that allowing progesterone to be prescribed for everything except APR treatment was not neutral and generally applicable, “laws do not need to cure every problem or aspect of a problem.” Seems like the correct result for the wrong reason—it might not be false or misleading to proscribe progesterone for something else! Plus, the claim here isn’t against the prescription, it’s against the advertising. The court gets there: “AG Bonta is not banning APR treatment, but is enforcing consumer protection laws against specific advertisements of APR treatment.”

COLFS argued selective enforcement against COLFS, but not Planned Parenthood. But “COLFS’s statements refer to a medical treatment that has only undergone studies for efficacy and safety since 2012, while Planned Parenthood’s statements speak to an FDA-approved medical procedure…. COLFS’s statements about APR treatment and Planned Parenthood’s statements about the abortion pill are not comparable.” There was no indication that Planned Parenthood had violated the UCL or FAL.

COLFS also didn’t have a valid “right to receive information” claim, which is cognizable “only where the listener has a concrete, specific connection to the speaker.” That wasn’t pled here, for statements outside a doctor-patient relationship.

The substantive due process claims for “COLFS’s patients’ rights to procreation, reproductive privacy, and to reject unwanted medical treatment” also failed.

 

Culture of Life Family Services, Inc. v. Bonta, 2025 WL 1687929, No. 3:24-cv-01338-GPC-KSC (S.D. Cal. Jun. 13, 2025)

The court denied a preliminary injunction against AG Bonta.

Continuing the First Amendment analysis: Content-neutral regulations like the FAL and UCL “are generally subject to heightened scrutiny: the government may impose reasonable restrictions on the time, place, or manner of protected speech, provided the restrictions ‘are justified without reference to the content of the regulated speech, that they are narrowly tailored to serve a significant governmental interest, and that they leave open ample alternative channels for communication of the information.’” This is weird framing because false advertising does assess content; the court thus turns to the commercial speech inquiry, which is the dispositive issue.

The court credited the AG’s evidence that COLFS uses the APR statements in advertisements that are directed towards, and solicit, women to become potential clients. The statements were “placed in a commercial context and are directed at the providing of services rather than toward an exchange of ideas.” COLFS’s use of the APR statements in its yearly fundraising gala and use of patient stories about APR to solicit donations also provided a “powerful economic motivation.” Plus, even though COLFS argued that it provided “numerous free services,” including “free APR treatment,” it still accepts insurance and payment for APR treatments from women who do have the ability to pay. That was an obvious economic motivation, which COLFS didn’t address.

What about falsity/misleadingness? “Three district courts have struck down state laws that required abortion providers, under threat of criminal sanction, to inform patients about supplemental progesterone therapy in language providers objected to for being untruthful or misleading.” Plus, district courts have split on this situation: “a pro-life organization asking for a preliminary injunction that would disallow an attorney general from pursuing a hypothetical enforcement action against them based on APR-related speech.”

Use of the terms “reverse” and “reversal”: These statements are based on a theory that supplemental progesterone can “outcompete” mifepristone to counteract or “reverse” the effects of mifepristone. Typically, mifepristone acts as a “competitive binder of the progesterone receptor – it binds to progesterone receptors at twice the avidity of progesterone itself, thus blocking endogenous progesterone from acting to support a pregnancy.” But, given high amounts of progesterone in pregnancy, mifepristone is still able to work; adding more progesterone would be like “rain on a swimmer in a pool – the swimmer cannot get more wet.” Rat studies were unhelpful because “there are significant differences between rat and human pregnancies and progesterone’s actions in each” and “[p]rogesterone receptors also vary widely between species in their responsiveness to different molecules...”

A recent placebo-controlled study on nine people was designed to examine the effects of progesterone supplementation, after mifepristone administration, on the endometrium (the inner lining of the uterus where implantation occurs) on nonpregnant persons, but the endometrial lining, uterus, and hormonal milieu of a pregnant person are all “vastly different” from those of a nonpregnant person.

Given that the science was “unclear on how exactly supplemental progesterone reacts with mifepristone,” the court turned to the common understanding of the word “reverse” to determine whether it accurately captures what we do know about the effects of supplemental progesterone. According to dictionary definitions, “reverse” means “to change the direction, order, position, result, etc. of something to its opposite.” Or, “to turn completely about in position or direction” or “to undo or negate the effect of (something, such as a condition or surgical operation).” “Reversal” was the wrong way to describe the evidence here. It was also plausible that “failing to continue taking the second drug in the medication abortion regimen, misoprostol, may result in continued pregnancy in some percentage of women who take mifepristone[.]” (The court notes that there is no agreement on the baseline here. In studies, continuing pregnancy rates ranged from 8% to 46%, depending on the mifepristone regimen used, making it hard to conclude that supplemental progesterone did any better than simply not taking the second medication.) Without better evidence, “it would be at the very least potentially misleading to state that supplemental progesterone can ‘reverse’ an abortion.”

Effectiveness statements: COLFS’s principal’s study purportedly showed that progesterone increases the chances of a pregnancy continuing after taking mifepristone. But some patients were screened by ultrasound for viable pregnancies before joining the study, which biased the data towards pregnancies already likely to continue. It also did not record how far along in her pregnancy each patient was or how much progesterone each patient took – even though mifepristone is less effective at terminating pregnancies as they progress. And there were no controls in the study, despite treatment by 325 different medical providers. Thus, the study didn’t support the statement that APR is “effective” in continuing pregnancies. [Reminder: the AG can go after advertising for lack of substantiation.] “The Court finds that given the lack of robust scientific study on this issue, statements on the effectiveness of APR are potentially misleading.”

Likewise, there wasn’t enough evidence to conclude that the side effects were limited/that APR was safe. “No study offered or used by COLFS appears to track health or safety outcomes for the pregnant individual.” The first and only randomized clinical study to attempt to test the safety and efficacy of APR had to stop because of the serious “safety concerns” after 3 of the 12 participants experienced “severe bleeding” after taking mifepristone without misoprostol. Two of those three received a placebo; the third person had been given progesterone. The “dearth” of evidence made it potentially misleading to say that APR can only cause non-life-threatening side effects.

Birth defects: Again, the evidence was limited and tiny. “Given the lack of scientific evidence on this specific question, the Court finds the statements on birth defects following APR to be potentially false and misleading.”

That APR has a 64-68% success rate was also inherently false and misleading, given the defects in the supporting studies and the lack of clarity about what percentage of COLFS patients would use which methods of administration.

“Thousands of lives saved” statement: This claim was based on the number of pregnant people who used APR and were confirmed by Heartbeat International to remain pregnant at 13 weeks, plus the number of those who started APR (but Heartbeat cannot confirm remained pregnant) multiplied by a 64% success rate. But there was no reason to generalize this statistic to all women who started APR. These were potentially false and misleading.

Statements on non-standard situations (after 72 hours have passed from the ingestion of mifepristone and t after taking the second pill of medication abortion): “From the Court’s review, nothing from the expert declarations submitted by COLFS even purports to support either of these statements.” These statements were inherently misleading.  

Where the statements were inherently misleading, the court’s analysis was done. Where they were only potentially misleading, the court proceeded to apply Central Hudson. (In my view, this is the wrong approach. The potentially misleading standard goes to the scope of a prohibition—if a statement is potentially misleading, the question is whether it can be communicated in a nonmisleading way, in which case the properly presented claim can’t be prohibited entirely. But the particular way in which a defendant is communicating a claim may be actionable/enjoinable even if the state would be required to allow a properly qualified claim. Given the posture of the case, I would expect this to be an issue for the state court.)

Under Central Hudson, the regulation of misleading advertising by medical professionals directly advances a substantial government interest (protecting medical consumers). And it directly advances the asserted government interest and was not more extensive than necessary to serve that interest. “AG Bonta is not aiming to limit the actual practice of APR. And reproductive choices are not apart from consumer choices: women, in exercising their reproductive rights, are also consumers who must be given the correct information to make knowledgeable decisions for themselves.”

 

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