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.”
from Blogger http://tushnet.blogspot.com/2025/06/abortion-reversal-promoter-engaged-in.html
Rebecca Tushnet 