Category: Blog

On June 5, 1981, the Centers for Disease Control (CDC) announced the presence of a rare form of pneumonia in five previously healthy gay men in its Morbidity and Mortality Weekly Report — it wouldn’t be until 1986 that the Reagan administration mentioned “AIDS” in public. Around this time, about 16,500 people had perished from AIDS. With the brave advocacy of groups such as ACT UP and medical advances, the landscape of HIV/AIDS prevention and treatment has changed dramatically; available daily or long-term (injectable) treatments not only dramatically improve the quality of life for those with HIV but will even suppress the amount of virus to undetectable levels and thus become untransmittable.

In addition to innovative HIV treatment, we now have better tools for prevention. PrEP, or pre-exposure prophylaxis, is a medicine that dramatically reduces a person’s chances of HIV infection by about 99%. Through a daily antiviral tablet or quarterly injection, the medicine helps stop the virus from spreading throughout the body when taken correctly. While the use of PrEP has increased since its first approval, only an estimated 36% of those eligible for the prevention tool have received a prescription. Additionally, the equity in PrEP usage by race and ethnicity has decreased. In 2019, the Trump administration enacted the Ending the HIV Epidemic (EHE), a multi-pillar initiative to dramatically reduce new HIV diagnoses and improve the quality of care for those living with HIV. However, the impact of EHE and other initiatives is under threat by the evolving case of Braidwood Management Inc. v. Becerra.  

One of the critical features of the Affordable Care Act, Section 2713, mandated the complete coverage of preventative services graded “A” or “B’ by the U.S. Preventative Services Task Force in private employer health plans. In 2019, the USPSTF issued an “A” grade for PrEP (expanding it to injectable PrEP in 2023), meaning that private plans were now required to cover PrEP without cost-sharing. While litigation surrounding the contraceptive coverage requirements of the ACA is nothing new (see Burwell v. Hobby Lobby), Braidwood targets the preventative care provisions mentioned above.

The plaintiffs in Braidwood brought forth significant challenges to the ACA preventative care mandate: they claimed that, among other things, the mandate violated RFRA because it substantially burdened the religious exercise of plaintiffs who objected to supplying PrEP on religious grounds and that recommendations violated Article II’s Appointments Clause. The District Court held that the USPSTF members were not adequately appointed under the Appointments Clause and rejected Braidwood’s nondelegation arguments. Thus, this challenge preliminarily struck down the preventative services mandate. While the Fifth Circuit stayed the District Court’s decision in May 2023, appellate oral arguments continued on March 4, 2024.

If the Fifth Circuit upholds the District Court’s decisions, not only would private employer plans have the discretion to choose whether to cover preventative services, but it would erase the progress the nation has made in HIV prevention and treatment. One report estimates that if PrEP coverage amongst men who have sex with men decreases from 28% to 10%, it will result in 2,083 new HIV diagnoses within the next year. However, all may not be lost entirely if the Fifth Circuit doesn’t decide in favor of HHS: one proposition suggests transferring authority to recommend PrEP from the USPSTF to the CDC’s Advisory Committee on Immunization Practice (ACIP). Although only time will tell, the Fifth Circuit may uphold the District Court’s ruling and such threatens the progress we have made in HIV-treatment and prevention.

In 2014, one American town prioritized cost-saving measures over the health of its people. The city of Flint, MI imprudently decided to trade its current drinking water system, which piped treated water from the nearby city of Detroit, to a new, familiar source: the Flint River. Inadequate treatment of this new water source prompted a deadly health crisis for the locals. The crisis persisted as government officials consistently neglected ongoing issues, despite escalating complaints about the putrid, off-tasting water supplied to Flint homes and reports of various severe health issues. Finally, two years after Flint had changed its water source,  then-President Obama spoke up about the federal government’s commitment to the residents of Flint, claiming he “will not rest until every drop of water. . . is safe to drink and cook with.” Today, many are still dealing with the lingering effects of the disaster. Fortunately, this crisis received attention, with settlements disbursed to residents and ongoing government commitment to the city’s water supply.   

The abundant government aid received by Flint during its crisis contrasts sharply with the current public health emergency unfolding in Gaza, where our government is contributing to the massacre through foreign assistance in both military and economic capacities. Specifically, since 2000, the majority of annual U.S. aid to Israel has funded military efforts, primarily in the form of maintaining and updating its missile defense system. Critically, the Palestinian people are not unfamiliar with violations against their human rights at the hands of the Israeli government. For decades, Israel has ignored obligations imposed by international and humanitarian law through the calculated denial of health resources, obstruction to healthcare access, and militant attacks on Palestinian health infrastructure. Now, in the aftermath of the initial outbreak of violence of October 7, 2023, the occupied Palestinian territory of Gaza has been the target of more relentless violence, including unlawful bombardment of healthcare facilities and obstruction of supplies for basic needs. Specifically, Israeli authorities were eager to cut innocent Gazan civilian’s access to water, medical supplies and electricity, while also maintaining full control over food deliveries into Gaza. Now, more than 96% of the water supply is unfit for consumption. The U.N. Children’s Fund expressed “the death toll will increase exponentially if incubators start to fail, if hospitals go dark, if children continue to drink unsafe water and have no access to medicine when they get sick.” The current humanitarian crisis evidently doubles as an extreme public health crisis, as Israel weaponizes basic necessities.

As those in Gaza fight to survive, one may question the absence of public outrage and intervention we witnessed from American leaders during the Flint disaster. Although the ongoing Israel-Palestine conflict is happening outside our American borders, the U.S. plays an extremely integral role here. Israel has been the largest cumulative recipient of U.S. foreign aid since its inception, currently valued at around $300 billion in assistance. Meanwhile, while the U.S. Government preaches its commitment to ensuring clean, safe water access as a basic human right, that same government is directly funding an Israeli military operation drastically limiting Gazans’ access to water. As of February 29, 2024, at least 100 Gazan civilians were killed or injured from Israeli bombardment while waiting desperately for food aid dispersal. The U.S. is funding this.

The catastrophe in Flint was devastating and preventable— with an estimated 140,000 individuals exposed to the bacteria-ridden water and at least 12 deaths. Thankfully, President Obama declared a national state of emergency, authorizing the government to provide necessary equipment and resources to the people affected using federal funding. Meanwhile, the death toll in Gaza currently exceeds 30,000, a number that even experts claim is more than likely an undercount, with around 70,000 civilians injured since October 7. The U.S. is not only complicit here, but is actively aiding the oppressors. In examining the stark disparity between the government aid and accountability seen with Flint’s public health emergency and the public health tragedy in Gaza, it serves as a reminder of the need for equitable and compassionate global responses to crises, irrespective of geographical boundaries or political affiliations, as well as the importance of government accountability.

 For years, the Food and Drug Administration (FDA) has considered revising how it defines the term “healthy.” This April, the FDA is due to publish its updated definition of the term, which would change which foods manufacturers could legally claim are healthy. The definition has not been updated since 1994. That said, what makes this change particularly relevant for manufacturers and consumers is not the change in definition, which is “unlikely to significantly change which foods would be eligible [under] the new [definition].” Rather, it is that FDA is also due to release a new logo that manufacturers could put on food to denote that their product is healthy – basically a healthy stamp, similar to the USDA Organic insignia. (Draft versions of FDA’s “Healthy” symbol can be seen here.).

The FDA has the authority under the Food, Drug and Cosmetic Act (FD&C Act) to promulgate regulations over the types of claims that can be made on food packaging. This includes the power to define terms, such as “healthy.” Several alternatives exist for food manufacturers who cannot meet FDA’s definition of “healthy”, however. FDA very loosely regulates several terms which manufacturers use to convey a sense of health to consumers, such as “natural”. No such logos exist for those terms, though, potentially incentivizing food manufacturers whose products are on the fringe of FDA-defined healthiness to adjust their products’ ingredients.

That said, why put resources into developing an official “healthy” logo? Although it may not be likely to change what every shopper puts in their cart, the initiative is motivated by research suggesting that front-of-pack (FOP) labels, particularly those with an endorsement from some institutional authority (like FDA or USDA), make it easier for consumers to evaluate what they are purchasing. Obviously, part of the reason for this is the time crunch – it is easier to recognize a logo than it is to search the packaging or research a product. However, the location of information on packaging is important as well, as the FDA is also considering FOP nutrition facts, since some consumers are unlikely to look at the back of food packaging. These mini-labels would highlight added sugars, saturated fat and sodium – things consumers might want to see.

What does it mean for a food to be “healthy,” though? When FDA was taking comments over their new proposed rules, many comments philosophically questioned how FDA planned to draw a single line between healthy and unhealthy nutritional contents. While the proposed update to the definition bases itself on the Dietary Guidelines for Americans, 2020-2025 and mainly creates limits based on the percentage of Daily Value for added sugars, saturated fat and sodium, there are reasonable objections to the existence of the definition. If some food product manufacturers are going to be winners under the new “healthy” logo scheme, then other manufacturers that sell food products that could reasonably be a part of a healthy diet may unfairly take a hit. At the same time, a more detailed system of labeling, such as a health rating system or logos identifying specific nutrients, would potentially undermine the simplicity of FOP logos.

In a landmark 1984 case before the Supreme Court, Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc. set forth a doctrine of judicial deference for administrative actions. The doctrine determined that a court should defer to an agency’s decision regarding an ambiguous statute whenever the agency’s action was reasonable, so long as it does not conflict with Congress. If the statute enabling the agency’s authority has a clear intent from Congress, that intent governs. If the intent of Congress is ambiguous, then the agency’s decision must be reasonable. If it is unreasonable, then the court may step in, but, otherwise, deference is given to the agency tasked with interpreting the ambiguous statute. The Chevron doctrine applies when agencies exert their discretionary authority in interpreting statutes. Chevron has had important implications across the legal field, being cited in nearly 1,000 judicial decisions yearly. The doctrine has also had a substantial impact on agency decisions in the healthcare field. The Food and Drug Administration (FDA) has used the doctrine for its decisions regarding new drug approvals. The Centers for Medicare and Medicaid Services (CMS) has relied on the doctrine in interpreting the Medicare Act daily, including reimbursement actions.

The Supreme Court is currently considering two cases that examine the Chevron doctrine: Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce. Both cases consider the overruling of the Chevron doctrine. It is anticipated that the Supreme Court will abolish or severely limit the doctrine as currently established, given the previous decisions weakening deference to federal bodies. The Court has already made a ruling in the healthcare field conspicuously rejecting the use of the Chevron doctrine despite its prevalence during oral arguments.

The abolition of the Chevron doctrine would make it easier for healthcare companies to bring litigation against an agency’s actions because the agency would no longer be afforded discretion. Abolishing Chevron would also bring large scale change to American healthcare, including the administration of Medicare and Medicaid, an insurance program for nearly half of Americans. Congress would be unable to practically draft and update statutes for Medicare and Medicaid administration post-Chevron, leaving a gap in the healthcare system’s ability to function.

The decision would also have a negative impact on science and technology. Courts lack the expert knowledge needed to understand some complex regulations, and pauses required to elaborate on statutes would represent a public health and environmental impracticality. Agencies that administer and regulate healthcare and health programs will need to change how they justify their proposed rules. However, all previous decisions on final rules for agencies like FDA and CMS will remain until challenged if Chevron is overruled.

In addition, a change from Chevron would result in a disruption of the financial stability these programs have afforded the healthcare system. With the overruling of Chevron, the first FDA new drug application approval may be overturned. Health agencies and industry are preparing for the possibility of Chevron upheaval and determining the impacts the change may bring.

Of note, Congress has the ability to alter or remove the Chevron doctrine by changing the Administrative Procedure Act (APA) to select a new standard of review in agency decision-making. A Congressional statute explicitly stating the standard of review for agency decision-making would establish a clear review regime and ensure that future judicial decisions were less likely to threaten well established agency decisions. The threat to all federal agencies of Chevron upheaval is looming, but it has farther reaching effects than federal agencies. The healthcare industry is trying to determine how to respond to the looming possibility of change, but it could result in an effect on patients, both financially and technically.

In vitro gametogenesis (“IVG”), a process through which scientists may induce any human cell to become either an egg or sperm cell, might eliminate the need for injections and painful egg retrieval procedures associated with in vitro fertilization (“IVF”). Though IVG has proven successful only in mice, hypothetical applications to human reproductive therapy may also extend to socially or situationally infertile non-heteronormative couples. This could enable gay and lesbian couples to have children genetically related to both partners.

Though some individuals feel unsettled by the implications of lab-created human life, a biotech start-up by the name of Conception opened research to human applications of IVG in 2023. As of this year, Conception scientists remain focused on their aim to create a ‘proof of concept human egg.’ Chief Scientific Officer Pablo Hurtado and Chief Executive Officer Matt Krisiloff both expressed hope that IVG would allow them to produce children genetically related to both parents in their respective partnerships.

Amid the flurry of research surrounding IVG in humans, bioethical literature entered a debate regarding the ethical hurdles should IVG become an approved Assisted Reproductive Therapy (“ART”). Such debates center around who might be precluded from IVG. If IVG, like IVF, emerges solely as an ART method, this could mean that IVG would only be accessible for those who would have the capacity to conceive but for egg and sperm count/quality challenges (heteronormative couples).

However, situational infertility also plays a role in IVG’s use as an ART. For example, should a man and a woman who knew prior to their union that neither had the ability to conceive with one another decide to marry in spite of this, their choice to pursue union would render them situationally infertile (i.e., but for their choice to be together, either party possess the potential to conceive). By the same parameters, non-heteronormative couples could be considered situationally infertile and, as such, eligible to use IVG as an ART. Despite this, questions of ART access stretch beyond the degree of infertility status.

Currently, IVF is the ideal predecessor to which one could compare IVG’s eligibility for insurance coverage (should human applications come to fruition). The National Infertility Association advertises that only eleven states and the District of Columbia have passed broadly accessible fertility preservation coverage. Of these, only the Colorado Revised Statutes and the Illinois Compiled Statutes define ‘infertility’ in a flexible manner such that it could include situationally infertile non-heteronormative couples. These definitions indicate that IVG, like IVF, will not be available through insurance for non-heteronormative couples except within Colorado and Illinois. Even within Colorado and Illinois, degree of insurance coverage will heavily depend on the policy and coverage qualifications, which will not be measured uniformly among candidates. Because of this, IVG will become the next headliner in boutique baby making, accessible to very few individuals.

This predictable inaccessibility of IVG strikes a chord among reproductive justice advocates. Those who experience infertility often feel grief, depression, anxiety, and loss of self-esteem. Those who experience situational infertility within both heteronormative and non-heteronormative couplings experience a sense of social dissonance and distress. Lack of access to IVG may also propagate the harmful societal notion that adoptive children are inferior alternatives to genetic children. As reproduction is an inherently human function, reproductive justice advocates argue that equal access to all available reproductive therapy, regardless of one’s choice in partner, is a human right.

Nevertheless, amidst the current tumultuous battleground in Alabama over the ethical implications of IVF, many wonder whether some states will begin to block ARTs such as IVF and IVG altogether. From a practical perspective, issues concerning legal accessibility and insurance coverage (espoused above) will likely block such a high percentage of otherwise eligible couples as to render the restrictive implications of the Alabama IVF ruling obsolete where IVG is concerned. Should Conception and/or similar laboratories successfully patent a reproducible methodology for IVG in humans, such a patent would likely be sold to consumers in other nations whose healthcare and legal systems better cater to cellular inducement ARTs.

In a ruling on February 16^th, 2024, the Alabama Supreme Court declared that frozen embryos outside of the womb are classified as children. There are a few steps to in vitro fertilization (IVF); hormones are taken for the egg retrieval process, and then mature eggs are collected from the ovaries and fertilized in a lab with sperm. One or more of the fertilized embryos are then inserted into the uterus. Many complications can arise from inserting multiple fertilized embryos into the uterus, and since an IVF retrieval process will typically produce additional embryos, it is standard procedure to freeze the embryos not used in the current IVF cycle and keep them preserved in the fertility clinic. By freezing the extra embryos, couples can have additional IVF cycles without the strains that come with egg retrieval, which can include surgeries and hormonal treatments.

In the current case, three couples went through a standard IVF treatment and kept their extra fertilized embryos cryo-preserved at the fertility clinic, which resided within a hospital. Unfortunately, those embryos were destroyed when a hospital patient entered the cryo-preservation area, opened a tank where the frozen embryos were stored, and dropped them to the ground.

The couples sued under the Wrongful Death of a Minor Act. For the court to rule on the matter and determine if there is proper standing under the Act, the court first had to look to whether the embryos were considered unborn children. In analyzing the statute, the Alabama Supreme Court determined that fertilized embryos qualify as children, as nothing in the Act specified unborn children must be in utero. So, the Act “applies on its face to all unborn children, without limitation.” The Court concluded the fertilized embryos fall within the definition of children because “all parties to these cases, like all members of this Court, agree that an unborn child is a genetically unique human being whose life begins at fertilization and ends at death.” Dobbs v. Jackson Women’s Health Organization is noted as a ruling factor in the case, with the court stressing that unborn fetuses were widely recognized as living persons with rights and interests dating as far back as the 18^th century.  

The ruling poses serious risks to not only those who rely on IVF treatments, but for general family planning, as the holding implies that life beings at fertilization. Holding embryos as children creates a slippery slope where individuals can be held civilly and possibly criminally liable for destroying embryos.

IVF clinics in Alabama are already closing with concerns the clinics will be penalized, or individual embryologists, for what they deem safe to freeze or in turn discard. With worry over IVF in the state, both the Alabama House and Senate rallied together and voted to approve legal protections for providers of IVF. The bill would extend civil and criminal immunity to providers of IVF services. While this creates legislature specifically for IVF providers, nothing has been discussed in relation to family planning measures. This poses a serious question: how far can this holding go in terms of family planning, birth control, and autonomy of one’s own body?

In relation to IVF, even individuals who choose to discard their frozen embryos could be liable for killing a child, in theory. What if a couple decides they no longer want to continue keeping the embryos viable? What if one parent wants to unfreeze the embryo and the other doesn’t? If the embryos are never destroyed, but additionally are never given the opportunity to be birthed, does this constitute as the embryos essentially dying? These questions just pose the beginning of larger disputes regarding parental rights of fertilized embryos.

Outside of IVF, emergency contraceptives like Plan B contain a hormone that can keep a fertilized egg from implanting in the uterus. With this ruling, emergency contraceptives can be deemed as killing a child, and those that take it may be at risk for civil or criminal penalties. Additionally, after Dobbs, Alabama reinstated a total abortion ban. However, if a mother miscarries, she could be liable for the death of her own child. While it may seem severe, the door is now open for courts to rule in this manner.