West Virginia's Ban on Prescribing Mifepristone By Telemedicine Is Pre-Empted By FDA Rules

In GenBioPro, Inc. v. Sorsaia,, (D WV, Aug. 24, 2023), a West Virginia federal district court dismissed a challenge to West Virginia abortion restrictions that are no longer in effect. The restrictions will go back into effect only if provisions of the more recent Unborn Child Protection Act (UCPA) are held unconstitutional. The court held that neither federal statutes nor FDA rules pre-empt state restrictions on when abortions may be performed. However, the court refused to rule further on the UCPA provisions, saying in part:

[T]he Court has not found that the UCPA is unconstitutional. As none of these prior restrictions are currently in effect, this Court may not issue an advisory opinion as to the constitutionality of a law not presently operative.

The court also rejected arguments that state restrictions on the sale of mifepristone violate the Commerce Clause, saying in part:

[T]he Supreme Court and Courts of Appeals have repeatedly affirmed that morality-based product bans do not intrinsically offend the dormant Commerce Clause. 

However the court did find that West Virginia's ban on prescribing mifepristone by telemedicine, which is still in effect, is pre-empted by FDA rules allowing telemedicine prescriptions for the drug. The Hill reports on the decision.

Court Preliminarily Enjoins Georgia's Ban on Hormone Therapy for Transgender Minors

In Koe v. Noggle, (ND GA, Aug. 20, 2023), a Georgia federal district court issued a preliminary injunction against enforcement of Georgia's ban on hormone replacement therapy for treatment of gender dysphoria in minors. The court said in part:

... SB 140 is subject to intermediate scrutiny both because it classifies on the basis of natal sex ... Adams, and because it places a special burden on nonconformity with sex stereotypes....

First, the preliminary record evidence of the medical risks and benefits of hormone therapy shows that a broad ban on the treatment is not substantially likely to serve the state’s interest in protecting children.... 

... [I]t should be recalled that the question put to the Court is not what the correct course of treatment is for an adolescent with gender dysphoria. The question is whether Georgia has shown an “exceedingly persuasive justification” for the challenged legislative scheme—a scheme that prohibits clinicians and parents from determining the correct course of treatment on an individualized basis, and which does so in a sex-based manner in that it imposes this prohibition only when it comes to “hormone replacement therapy” as a treatment for gender dysphoric youth....

... Defendants’ position that the quality of the existing evidence supporting hormone therapy justifies a ban of that therapy is not persuasive.

The court's decision was handed down one day before the 11th Circuit Court of Appeals (which includes Georgia) issued an opinion vacating a preliminary injunction against Alabama's ban on hormone treatment for minors with gender dysphoria. (See prior posting.)  The Hill reports on the decision.

11th Circuit: No Constitutional Right to Treat Minors with Gender Transition Medications

 In Eknes-Tucker v. Governor of Alabama, (11th Cir., Aug. 21, 2023), the U.S. 11th Circuit Court of Appeals vacated a district court's preliminary injunction against Alabama's ban on hormone blockers and cross-sex hormones to treat minors with gender dysphoria. The court said in part:

On review, we hold that the district court abused its discretion in issuing this preliminary injunction because it applied the wrong standard of scrutiny. The plaintiffs have not presented any authority that supports the existence of a constitutional right to “treat [one’s] children with transitioning medications subject to medically accepted standards.” Nor have they shown that section 4(a)(1)–(3) classifies on the basis of sex or any other protected characteristic. Accordingly, section 4(a)(1)–(3) is subject only to rational basis review. Because the district court erred by reviewing the statute under a heightened standard of scrutiny, its determination that the plaintiffs have established a substantial likelihood of success on the merits cannot stand.

Judge Brasher filed a concurring opinion, saying in part:

[E]ven if the statute did discriminate based on sex, I think it is likely to satisfy intermediate scrutiny. If Alabama’s statute involves a sex-based classification that triggers heightened scrutiny, it does so because it is otherwise impossible to regulate these drugs differently when they are prescribed as a treatment for gender dysphoria than when they are prescribed for other purposes. As long as the state has a substantial justification for regulating differently the use of puberty blockers and hormones for different purposes, then I think this law satisfies intermediate scrutiny.

AL.com reports on the decision.

5th Circuit Says FDA Improperly Reduced Abortion Pill Restrictions, But Prior Supreme Court Order Keeps FDA Rules In Effect During Appeals

In Alliance for Hippocratic Medicine v. U.S. Food & Drug Administration, (5th Cir., Aug. 16, 2023), the U.S. 5th circuit Court of Appeals upheld the portions of a Texas federal district court's orders that stayed actions taken by the FDA in 2016 and 2021 regarding the administration and distribution of the abortion pill mifepristone. The 2016 action increased the gestational age when the drug can be used from 49 to 70 days. It also lightened certain other dosage and prescribing restrictions. In 2021, in connection with the Covid epidemic, the FDA removed the in-person prescribing requirement for mifepristone, allowing it to be sent by mail. The court found that doctors have standing to challenge these actions, among other things citing conscience injuries to objecting doctors.  Challenges to two other FDA actions on mifepristone were rejected on standing and statute of limitations grounds.

The court concluded that plaintiffs are likely to succeed on their Administrative Procedure Act challenges that the FDA's actions were arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law. This was the case as to the 2016 action because the FDA did not consider the cumulative effect of the changes it was proposing. They were likely to succeed on their challenge to the 2021 action because the FDA did not adequately study adverse event data.

However, as the court recognized, the U.S. Supreme Court has already ordered a stay of all the district court's orders until federal appeals are completed. Thus the 5th Circuit's action does not reinstate the district court's bans. 

Judge Ho concurred in part and dissented in part, saying tht he would also hold that the initial approval of mifepristone in 2000 should be set aside.

NPR reports on the decision.

Louisiana Legislature Overrides Veto of Gender Transition Ban for Minors

Yesterday the Louisiana legislature overrode Governor John Bel Edwards' veto of HB648, the Stop Harming Our Kids Act (full text). The law prohibits medical professionals from providing puberty blockers, hormonal treatments or surgery to treat gender dysphoria in minors. AP reports on the legislative override.

Michigan Legislature Bans Conversion Therapy-- 22nd State To Do So

The Michigan legislature yesterday gave final passage to HB 4616 (full text) and HB 4617 (full text), bills which together prohibit mental health professionals from engaging in conversion therapy with a minor. HB4617 contains an elaborate definition of "conversion therapy" which explicitly excludes, among other things, "counseling that provides acceptance, support, or understanding of an individual or facilitates an individual's coping, social support, or identity exploration and development ...  as long as the counseling does not seek to change an individual's sexual orientation or gender identity."  When signed by the Governor, Michigan will become the 22nd state (plus the District of Columbia) to ban conversion therapy for those under 18. M Live reports on the new legislation.

Nevada Governor Vetoes Medical-Aid-In-Dying Bill

On Monday, Nevada Governor Joe Lombardo vetoed (full text of veto message) S.B. 239 (full text) which would have authorized physicians and advanced practice registered nurses to prescribe medications which a patient certified to be terminally ill could self-administer to end his or her own life. The Governor said in part:

Fortunately, expansions in palliative care services and continued improvements in advanced pain management make the end-of-life provisions in SB 239 unnecessary.

KLAS News reports on the governor's action.

Texas Legislature Passes Law Banning Gender-Affirming Health Care for Individuals Under 18

Yesterday the Texas legislature gave final approval to SB 14 (full text) which prohibits the provision of gender transitioning or gender reassignment procedures to individuals under 18 years of age. The bill bars both surgeries and puberty suppression or blockers. The state medical board is required to revoke the license of any physician who violates the treatment ban. Texas Governor Greg Abbott is expected to sign the bill.  AP reports on the bill's passage.

Montana Supreme Court: State Constitution Protects Abortion Care by Advance Practice Registered Nurses

In Weems v. State of Montana, (MT Sup. Ct., May 12, 2023), the Montana Supreme Court held that a 2005 Montana statute that bars Advance Practice Registered Nurses from delivering abortion care violates the Montana Constitution.  The court summarized its decision:

Article II, Section 10, of the Montana Constitution guarantees a woman a fundamental right of privacy to seek abortion care from a qualified health care provider of her choosing, absent a clear demonstration of a medically acknowledged, bona fide health risk. The State has failed to meet its burden of demonstrating that APRN-FNPs and APRN-CNMs providing abortion care present a medically acknowledged, bona fide health risk. The State has failed to present any evidence that demonstrates abortions performed by APRNs include more risk than those provided by physicians or PAs. The State has failed to identify any reason why APRNs should be restricted from providing abortions, and thus failed to articulate a medically acknowledged, bona fide health risk. The District Court correctly determined that no genuine dispute of material fact exists regarding the safety and efficacy of APRNs providing early abortion care. Accordingly, § 50-20-109(1)(a), MCA, is an unconstitutional interference with a woman’s right of privacy to seek medical care from a qualified provider of her choice.

Law & Crime reports on the decision.

Suit Challenges California's Protection of Out-of-State Minors Seeking Gender-Affirming Health Care

Suit was filed yesterday in a California federal district court challenging the constitutionality of California Senate Bill 107 which protects out-of-staters obtaining gender transition services for a minor in California from the reach of laws in their home states that create civil or criminal liability for allowing a minor to receive such services. The complaint (full text) in Our Watch With Tim Thompson v. Bonta, (CD CA, filed 3/7/2023), claims that:

SB 107 will allow California doctors, via telehealth appointments, to prescribe cross-sex hormones to children in South Dakota or Utah, where gender-reassignment treatment is banned. 

... SB 107 also denies parents the right to access their child’s medical information. Section 1 of the bill mandates that doctors conceal a child's medical information from parents if it is related to "gender identity" drugs and procedures. S.B. 107 § 1. 

SB 107 amended California law to directly conflict with federal law by taking away other states’ rightful jurisdiction of children visiting California who seek – or claims to be seeking – puberty blockers, cross-sex hormones, irreversible gender reassignment surgery, etc. Section 4 of SB 107 updates the California Family Code to read: “[t]he presence of a child in this state for the purpose of obtaining gender-affirming health care or gender-affirming mental health care…is sufficient to meet the requirements” for California courts to exercise jurisdiction over a custody decision. S.B. 107 § 4. This ignores the proper and rightful jurisdiction of the child’s home state....

The suit alleges that the law violates constitutional rights of familial association as well as Article IV's full faith and credit clause. Advocates for Faith & Freedom issued a press release announcing the filing of the lawsuit.

South Dakota Passes Law Banning All Gender-Affirming Treatments For Minors

The South Dakota legislature last week gave final passage to House Bill 1080 (full text) which prohibits healthcare professionals from providing either drug, hormonal or surgical treatments to minors for the purpose of altering the appearance of the minor's sex or validating a minor's perception of their sex that is inconsistent with the biological indication of their gender. The bill specifically includes a ban on administering drugs that delay puberty for minors. Minors currently receiving drug or hormonal treatments for gender dysphoria must be weaned off their medication by Dec. 31, 2023.  According to CNN, Gov. Noem will sign the bill into law.

HHS Issues Notice of Proposed Rulemaking on Conscience Protections For Healthcare Providers

The U.S. Department of Health and Human Services released yesterday a Notice of Proposed Rulemaking (full text) titled Safeguarding the Rights of Conscience as Protected by Federal Statutes. In 2019, the Trump Administration HHS adopted final rules on protecting the conscience rights of health care providers. The rules were criticized as possibly imperiling care for persons seeking reproductive health care, weakening childhood vaccination efforts and potentially leading to discrimination against gay and transgender patients. (See prior posting.) Several courts enjoined enforcement of the 2019 rules. (See prior posting.) Yesterday's Notice of Proposed Rulemaking says in part:

The Department also proposes to retain, with some modifications, certain provisions of the 2019 Final Rule regarding federal conscience protections but eliminate others because they are redundant or confusing, because they undermine the balance Congress struck between safeguarding conscience rights and protecting access to health care access, or because significant questions have been raised as to their legal authorization. Further, the Department seeks to determine what additional regulations, if any, are necessary to implement certain conscience protection laws. The Department is seeking public comment on the proposal to retain certain provisions of the 2019 Final Rule, including on any alternative approaches for ensuring compliance with the conscience protection laws....

The ACLU issued a press release calling the HHS Notice "an important first step toward repealing the most harmful aspects of this dangerous rule."

Massachusetts Supreme Judicial Court Says No State Constitutional Right to Physician Assisted Suicide

In Kligler v. Attorney General, (MA Sup. Jud. Ct., Dec. 19, 2022), the Massachusetts Supreme Judicial Court held that the Massachusetts state constitution does not protect a right to physician-assisted suicide.  The court said in part:

[G]iven our long-standing opposition to suicide in all its forms, and the absence of modern precedent supporting an affirmative right to medical intervention that causes death, we cannot conclude that physician-assisted suicide ranks among those fundamental rights protected by the Massachusetts Declaration of Rights. Thus, application of the law of manslaughter to physician-assisted suicide would not impinge on an individual's right to substantive due process....

Application of the law of manslaughter to physician-assisted suicide passes constitutional muster because the law is reasonably related to the State's legitimate interests in preserving life; preventing suicide; protecting the integrity of the medical profession; ensuring that all end-of-life decisions are informed, voluntary, and rational; and "protecting vulnerable people from indifference, prejudice, and psychological and financial pressure to end their lives."

Justice Cypher filed a concurring opinion, saying in part:

I concur with the court that the plaintiffs' proposed physician-assisted suicide schema is, as a matter of right, too procedurally complex for us to adopt whole cloth..... In addition, I fully support the court's thoughtful and timely primer on substantive due process, which preserves the comprehensive approach as the proper test for identifying fundamental rights under our State Constitution.... I therefore concur in the judgment. 

However, based on the strength of our existing case law concerning end-of-life patient autonomy, in conjunction with current palliative treatments that are commensurate with physician-assisted suicide, I do "not foreclose the possibility that some applications" of our criminal statutes "may impose an intolerable intrusion on" patient freedom.... When that appropriate challenge (or challenger) does come forward, we must be ready to extend our State constitutional protections to terminally ill patients seeking to exercise what remains of their bodily autonomy.

Justice Wendlandt, joined in part by Chief Justice Budd, filed an opinion concurring in part and dissenting in part.  He said in part:

Because I agree with the court that there is no fundamental right to prescribe, or to receive a prescription for, medication to assist a terminally ill, mentally competent patient's suicide (physician-assisted suicide), I concur in the judgment as it concerns Steinbach. I also agree with the court that application of the criminal laws to physician-assisted suicide generally survives rational basis review. I write separately because, when a terminally ill, mentally competent patient approaches the final stage of the dying process, the Commonwealth's interest in criminalizing physician-assisted suicide reduces to a nullity, such that even under rational basis review, the State Constitution protects the nonfundamental right to physician-assisted suicide from application of the State's criminal laws.

WBUR News reports on the decision.

Court Upholds Conversion Therapy Ban

In Chiles v. Salazar, (D CO, Dec. 19, 2022), a Colorado federal district court rejected constitutional challenges to Colorado's ban on mental health professionals engaging in conversion therapy for minors who identify as gay, lesbian, bisexual, transgender, or gender non-conforming. In a suit brought by a licensed counselor, the court found no violation of plaintiff's free speech rights because the Minor Therapy Conversion Law regulates professional conduct rather than speech. Any speech that is affected is incidental to the professional conduct. The court also found no violation of plaintiff's free exercise rights, saying in part:

According to Ms. Chiles, the Minor Therapy Conversion Law is not neutral because it was “well-known” at the time the Colorado General Assembly enacted the Minor Therapy Conversion Law that conversion therapy was primarily sought for religious reasons.... Therefore, Ms. Chiles’ argument goes, the Minor Therapy Conversion Law impermissibly burdens practitioners who hold particular religious beliefs.... The Court disagrees. The Minor Therapy Conversion Law does not “restrict [therapeutic] practices because of their religious nature.”... [T]he Minor Therapy Conversion Law targets specific “modes of therapy” due to their harmful nature— regardless of the practitioner’s personal religious beliefs or affiliations.... [T]he Minor Therapy Conversion law targets these therapeutic modalities because conversion therapy is ineffective and has the potential to “increase [minors’] isolation, self-hatred, internalized stigma, depression, anxiety, and suicidality”....

EEOC Sues Over Refusal to Accommodate First Responders' Need to Wear Beards

The EEOC announced yesterday that it has filed a Title VII and ADA suit against Global Medical Response, Inc. and American Medical Response, Inc. which operate one of the largest medical transport companies in the country. The suit alleges that the companies have refused to accommodate employees in EMT and paramedic positions who wish to wear facial hair for religious reasons or because of medical conditions. The companies contend that facial hair prevents respirators from fitting properly, but the EEOC says that the companies should have accommodated the religious and medical needs of employees by allowing them to wear the type of respirators that would have allowed them to maintain beards.

Court Enjoins Enforcement In Texas Of HHS Emergency Abortion Guidance

In State of Texas v. Becerra, (ND TX, Aug. 23, 2022), a Texas federal district court issued a preliminary injunction prohibiting enforcement in Texas of the Department of Health and Human Services' guidance to hospitals (and accompanying letter) which, relying on the federal Emergency Medical Treatment & Labor Act, requires hospital emergency rooms to perform certain abortions even when they violate Texas law. According to the Guidance, when an abortion is the stabilizing treatment necessary to resolve an emergency medical condition, EMTALA requires emergency rooms to perform it. The court's 67-page opinion said in part:

Texas law already overlaps with EMTALA to a significant degree, allowing abortions in life-threatening conditions and for the removal of an ectopic or miscarried pregnancy. But in Dobbs’s wake and in an attempt to resolve any potential conflict with state law, the Department of Health and Human Services issued Guidance purporting to remind providers of their existing EMTALA obligations to provide abortions regardless of state law. That Guidance goes well beyond EMTALA’s text, which protects both mothers and unborn children, is silent as to abortion, and preempts state law only when the two directly conflict. Since the statute is silent on the question, the Guidance cannot answer how doctors should weigh risks to both a mother and her unborn child. Nor can it, in doing so, create a conflict with state law where one does not exist. The Guidance was thus unauthorized. In any event, HHS issued it without the required opportunity for public comment.

Reuters reports on the decision.

Biden Issues Executive Order On Access To Reproductive Health Care Services

Yesterday, President Biden issued an Executive Order on Securing Access to Reproductive and Other Healthcare Services (full text). The White House also issued a Fact Sheet explaining the Executive Order.  The Executive Order reads in part:

There have been numerous reports of women denied health- and life-saving emergency care, as providers fearful of legal reprisal delay necessary treatment for patients until their conditions worsen to dangerous levels.  There are also reports of women of reproductive age being denied prescription medication at pharmacies — including medication that is used to treat stomach ulcers, lupus, arthritis, and cancer — due to concerns that these medications, some of which can be used in medication abortions, could be used to terminate a pregnancy.  Reportedly, a healthcare provider, citing a State law restricting abortion, even temporarily stopped providing emergency contraception.

As it remains the policy of my Administration to support women’s access to reproductive healthcare services, including their ability to travel to seek abortion care in States where it is legal, I am directing my Administration to take further action to protect access to reproductive healthcare services and to address the crisis facing women’s health and public health more broadly.

The Executive Order among other things directs the HHS Secretary to advance access to Medicaid coverage for patients traveling across state lines for medical care. It also directs the Secretary to promote compliance with non-discrimination laws in obtaining medical care. 

Texas Sues Feds Over Abortion Guidance Given To Hospital Emergency Rooms

On Thursday, the state of Texas filed suit against the Biden administration challenging HHS's guidance to hospitals that the Emergency Medical Treatment & Labor Act requires hospital emergency rooms to perform an abortions when an abortion is the stabilizing treatment necessary to resolve an emergency medical condition. The complaint (full text) in State of Texas v. Becerra, (ND TX, filed 7/14/2022) alleges in part:

The Biden Administration’s response to Dobbs v. Jackson Women’s Health Org.... which ended the terrible regime of Roe v. Wade, is to attempt to use federal law to transform every emergency room in the country into a walk-in abortion clinic.

The suit contends that the guidance exceeds statutory authority and violates various constitutional provisions. The Texas attorney general issued a press release announcing the filing of the lawsuit.

Ohio Enacts Conscience Protections For Medical Personnel and Institutions

On July 1, Ohio Governor Mike DeWine signed Am. Sub. House Bill 110, Ohio's Budget bill. (Signing ceremony.) Included in the 2438-page bill is a provision providing conscience protections for health care practitioners, institutions and insurers (at pg. 1453- 1455, enacting ORC Sec. 4743.10). The new section reads in part:

Notwithstanding any conflicting provision of the Revised Code, a medical practitioner, health care institution, or health care payer has the freedom to decline to perform, participate in, or pay for any health care service which violates the practitioner's, institution's, or payer's conscience as informed by the moral, ethical, or religious beliefs or principles held by the practitioner, institution, or payer. Exercise of the right of conscience is limited to conscience-based objections to a particular health care service.

... When possible and when the medical practitioner is willing, the medical practitioner shall seek to transfer the patient to a colleague who will provide the requested health care service. If participation in a transfer of care for a particular health care service violates the medical practitioner's beliefs or convictions or no willing colleague is identified, the patient shall be notified and provided the opportunity to seek an alternate medical practitioner. Upon patient request, the patient's medical records shall be promptly released to the patient.

The law provides for treble damage actions and injunctive relief for medical personnel where the new conscience provisions have been violated.

Metro Weekly reports on the enactment of this provision. [Thanks to Scott Mange for the lead.]