Physicians' group and others file suit claiming laws force physicians to mislead patients.
This article was first published on Tuesday, July 9, 2019 in MedPage Today.
By Shannon Firth, Washington Correspondent, MedPage Today.
The American Medical Association last month filed suit against two North Dakota laws that they say violate physicians' First Amendment rights by requiring them to "mislead and misinform" patients seeking abortions.
In the late-June filing, the AMA and its co-plaintiffs argue that the laws could "inflict irreparable harm on patients" and undermine physicians' responsibility to deliver "honest and informed advice," according to an AMA press release.
"North Dakota's law undermines [the patient-physician] relationship by requiring physicians to mislead and misinform their patients with messages that contradict reality and science," said AMA President Patrice Harris, MD, in the release.
In particular, the laws infringe on physicians' and other care team members' freedom of speech by inserting "government scripted information" of an "ideological" nature into the patient-physician relationship under the guise of informed consent, notes the complaint filed by the AMA and its co-plaintiffs, the Center for Reproductive Rights, Red River Women's Clinic in Fargo, and Kathryn Eggleston, MD, the clinic's medical director.
"The AMA will always defend science and open conversations about all health care options available to patients," Harris said.
'Indoctrinate, Shame and Stigmatize'How SPOT works
The first law, which has already been enacted, requires physicians to tell patients that an abortion terminates "the life of a whole, separate, unique, living human being." The plaintiffs call this law the "Compelled Personhood Mandate."
"Effectively through the Compelled Personhood Mandate, the State attempts to use Physicians to indoctrinate, shame and stigmatize patients seeking abortion," the complaint notes.
The second law, which the AMA and co-plaintiffs dubbed the "Compelled Reversal Mandate," requires physicians to provide what they describe as "a controversial, ideological, and non-medical message" regarding abortion reversals. The lawsuit was filed in the U.S. District Court for the District of North Dakota, and the law is slated to take effect on Aug. 1, 2019.
The law requires that "the physician or the physicians' agent" verbally tell a patient "[t]hat it may be possible [to] reverse the effects of an abortion-inducing drug if she changes her mind, but time is of the essence, and information and assistance with reversing the effects of an abortion-inducing drug are available in the printed materials given to her," according to the complaint.
This information must be delivered within 24 hours before either surgical or medical abortions, the AMA complaint states.
Seven other states -- Arkansas, Idaho, Kentucky, Oklahoma, Nebraska, South Dakota, and Utah -- have passed similar legislation requiring doctors to inform patients about medication-abortion "reversal" methods, according to the AMA press release.
The aim of the lawsuit is to block enforcement of the state's "compelled speech laws," as the AMA and co-plaintiffs refer to them.
'I Cringe Because I Don't Believe It'
Red River is the state's only clinic that provides abortion services. Clinic Director Tammi Kromenaker said she's currently required to state the "whole, separate, unique, living human being" language to patients, but each time she says it, "I cringe because I don't believe it."
While patients, especially in red states like North Dakota, are used to having to overcome multiple hurdles before receiving an abortion -- including hearing such statements -- that does not mean such policies are inevitable, Kromenaker said.
"I don't want to lie to our patients without putting up a fight," she told MedPage Today.
North Dakota has made it clear that it doesn't support abortion and does not want anyone to make the decision to have an abortion, Kromenaker added. She stressed that "by giving [patients] this false information, it's almost like the state is ... encouraging women to make the decision without being confident ... 'Oh go ahead and take the first pill because you can always just reverse it.'"
She said she is also concerned that if she's forced to share information about abortion reversals, problems and confusion are likely to ensue.
"What happens when a patient says, 'Wait, hold on ... what does [abortion reversal] mean?' Then, what do I say? I'm not going to quote the New England Journal of Medicine," Kromenaker said, referring to a 2018 article refuting claims about abortion reversals by Daniel Grossman, MD, and Kari White, PhD, MPH.
A 2015 systemic review by Grossman and colleagues concluded that the "evidence is insufficient" to show that receiving progesterone after mifepristone (Korlym and Mifeprex) leads to a higher proportion of continued pregnancies than "expectant management."
"We believe very strongly that women should be confident in their decision before they take the pill or undergo the abortion procedure," Kromenaker said.
Donna Harrison, MD, executive director for the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), argued that both North Dakota laws are sound.
"It's ridiculous to argue that it's government scripted" information, Harrison said.
Regarding the law that the AMA calls Compelled Personhood Mandate, "It isn't an issue of assigning legal personhood; it's an issue of stating scientific fact," she said. "Full informed consent is the medical standard of care prior to a procedure, and all this law is doing is requiring that abortionists comply with full informed consent."
"If they want to admit that what they're doing is not medical, [that] it's in fact an elective procedure ... abortion treats no disease ... Then they can't hide behind an argument that what they're doing is actually providing any kind of medical care," she added.
As for the evidence for abortion reversal, Harrison said it's "well-established" that the effects of mifepristone can be reversed with progesterone.
She highlighted a 1989 study on the effects of mifepristone and progesterone in pregnant rats, a 2017 systematic review of embryo survival after mifepristone, and a 2018 observational case series of 754 patients who tried abortion reversal using progesterone, which concluded that the "reversal of the effects of mifepristone using progesterone is safe and effective."
"It's the same principal that we use when someone comes in with an opioid overdose, and you give them naloxone," she told MedPage Today.
Progesterone has been used in the fertility industry for decades and has already been proven safe, Harrison added.
Harrison also said it was "bizarre" that the AMA decided "without consulting its membership, to become a pro-abortion activist organization. I don't think that they represent the AMA membership in this."
The AMA indicated to MedPage Today that the North Dakota lawsuit does not represent a change in policy, and is grounded in an opposition to government interference in the practice of medicine, including "the use of government-mandated physician recitations."
The AMA has filed numerous lawsuits supporting access to comprehensive healthcare, including numerous cases supporting women's reproductive health.
Molly Duane, JD, the lead attorney on the case for the Center for Reproductive Rights, countered that the main studies used to bolster anti-abortion arguments have questionable methodology, small sample sizes, or data from self-selected patients for "continued survival." She also said that some of these studies lacked control groups or did not have the approval of institutional review boards.
Medication abortion is a two-drug regimen in which patients take one pill orally and then a second 24 to 48 hours later, Duane said.
"What we know from the real literature is that mifepristone, on its own, will cause termination of pregnancy in around half of cases, and so there's no evidence that taking progesterone after mifepristone, instead of misoprostol [synthetic prostaglandin E1 analogue], is any better or worse for survival of the pregnancy than doing nothing at all," Duane said.
"Every major mainstream medical organization in the country rejects the idea that abortion reversal is possible," she added.
Also, the medical abortion regimen is FDA-approved, whereas the FDA has never approved any form of abortion reversal, Duane said.
"Just because one physician has a theory about something doesn't mean that it works in practice," she said.
Harrison countered that the studies submitted to the FDA for approval of mifepristone were not randomized, blinded, or controlled. Moreover, randomizing a study for patients who want progesterone wouldn't be ethical, she said.
'All Physicians Should Be Worried'
Duane stressed that the reason for the current lawsuit is the "imminent danger to physicians' free speech right," noting the August 1 planned enactment of the abortion-reversal law. (A press representative was present during the phone interview.)
A handful of other states have either amended or enacted laws requiring physicians to tell patients that abortion can be reversed, and most of those laws were passed just in the last year.
Duane emphasized that "this is something that all physicians should be worried about, because if the state can force physicians to act as a mouthpiece for a controversial and patently false statement in the abortion context, what's to stop them from doing that in other contexts as well?" Duane asked.
One ruling that seems to have encouraged the plaintiffs to pursue the case against North Dakota is the recent Supreme Court decision in the National Institute of Family and Life Advocates v. Becerra.
That decision "highlights that physicians have First Amendment rights just like everybody else, and they don't lose those constitutional rights just because they're speaking in a physician's office or because they're providing abortion care," Duane said.
Such rights are "paramount" when it comes to the patient-provider relationship, she continued.
"Physicians need to be able to develop a relationship of trust with their patients, which they can't do if the state is forcing them to lie to their patients and effectively to violate their own medical ethics as a condition of providing abortion care, which is exactly what this law does," Duane said.
Violators of North Dakota's laws would be subject to criminal penalties, including imprisonment, a fine, or both, Duane said.
She said she expects to have more information from the courts regarding the implementation of the abortion-reversal law "in the weeks to come."
“North Dakota's law undermines [the patient-physician] relationship by requiring physicians to mislead and misinform their patients with messages that contradict reality and science.”
AMA President Patrice Harris, MD,
A handful of states have either amended or enacted laws requiring physicians to tell patients that abortion can be reversed.
The AMA says such laws infringe on physicians' freedom of speech by inserting 'government scripted information' of an 'ideological' nature into the patient-physician relationship under the guise of informed consent.