Category: Blog

Gender-Inclusive Health Care Means Access to Gender-Affirming Care

Gender-affirming care is a form of healthcare that includes medical, surgical, mental health, and non-medical services for transgender and nonbinary people. Early-gender affirming care is crucial to the well-being of transgender and nonbinary children (TGNB) and adolescents because it helps with social transitions and can provide resources while navigating the complicated American healthcare system. Overall, the gender-affirming care model affirms diversity in gender identity and highly focuses on the needs of each individual

Gender-affirming care is important. In the United States alone, an estimated 1.4 million people identify as transgender, and 1.2 million adults identify as nonbinary. Studies have shown that receiving gender-affirming care has been associated with lowering nearly 73% of the odds of suicidal thoughts among TGNB. Many prestigious medical organizations such, as the American Academy of Pediatrics, the American Medical Association, and the Endocrine Society, support gender-affirming care

Unfortunately, a number of bills have been introduced in the last two years attempting to limit, ban, or criminalize access to gender-affirming treatment for minors. Republican state senators have taken several measures to limit access to gender-affirming care by banning critical components of this care such as puberty blockers, hormone therapy, and surgeries for minors. For example, the “Arkansas Senate passed a bill prohibiting doctors from treating transgender, and nonbinary minors (TGNB) with puberty blockers and gender-affirming surgery…” To that end, Arkansas is not the only state to propose these types of bills. Just last month, Tennessee’s Senator Jack Johnson opened a discussion on a bill he is co-sponsoring to limit gender-affirming care such as hormone therapy and other medical services for TGNB. Moreover, there is recent news that Georgia Congresswoman Marjorie Taylor Green will introduce a bill calling gender-affirming care for minors a felony. Congresswoman Green called gender-affirming care “a new-disturbing ideology” that is making billions from “confused children who believe they are transgender.” Several states across the country have acted to restrict such care for minors

Although the ideology behind restricting gender-affirming care for minors was due to minors not having the “mental capacity to make such decisions,” republican senators are now also reaching out to take away access to affirming care from low-income people, including adults. Senator Jackson is also backing the HB1215 bill which prohibits Tennessee’s Medicaid program from working with healthcare insurance companies from covering gender-affirming care. Until this year, most proposed legislation targeted people under 18, but now some block Medicaid from covering it for all ages

While the opposition against gender-affirming care started to “protect” youth, now it is targeting all the transgender and nonbinary communities. Transgender rights advocates view bans on gender-affirming care as part of a broader attack on transgender rights. To have gender-inclusive health care means to have gender-affirming care as an option for transgender and nonbinary people.  

Threatening Affordable Access to Abortion: Mifepristone, The “Abortion Pill”

On January 3, 2023, the U.S. Food and Drug Administration (FDA) updated its risk evaluation and mitigation strategy (REMS) for reproductive health relating to “the abortion pill,” mifepristone. Mifepristone is a pill, used in combination with misoprostol, to terminate intrauterine pregnancies no later than 10 weeks past the individual’s last menstrual period. Additionally, it may be used for early-stage miscarriage management, and management of 2nd and 3rd trimester pregnancies where the fetus is no longer viable and has died before birth.

In 2011, the FDA implemented the Mifepristone REMS Program to place restrictions on the drug’s distribution and use. Specifically, it implemented an in-person dispensing requirement where the drug may only be dispensed in a clinic, medical office, or hospital through direct supervision of a certified clinician. This prohibited mifepristone from being sold in retail pharmacies or through the mail. The drug’s restrictions were criticized for creating barriers to patient access for medicated early-stage abortions and management of pregnancy loss. Additionally, those that opposed the restrictions claimed its implementation disproportionately harmed minority groups and communities that faced structural barriers to reproductive care. This accelerated throughout the COVID-19 pandemic, and advocacy efforts spearheaded by the American College of Obstetricians and Gynecologists pushed the FDA to reform the REMS program.

In 2021, the FDA completed a review of the REMS Program and set to modify the restrictions to help improve patient access and create efficiencies in health care delivery. Implementations of the Program’s modifications were halted until the FDA approved mifepristone’s updated prescription information by their manufacturer, resulting in the implementations officially going into effect on January 3, 2023. The FDA’s update removed the in-person dispensing requirement and a new pharmacy certification process was added that allows certain retail pharmacies to dispense mifepristone directly to patients who have a prescription. Additionally, given the impact of the Dobbs decision, this update will affect clinic practices based on the abortion laws and regulations of the state that the practices reside in.

Following the FDA’s updated policy, stores like Walgreen and CVS planned to offer mifepristone through their pharmacies in the states that legally allow abortions. However, on March 3, 2023, Walgreens publicly stated it would not be dispensing mifepristone in 20 states after being threatened by public officials. Headed by Missouri Attorney General Andrew Bailey with other attorney generals from Republican run states, a warning letter was issued to CVS and Walgreens on February 1, 2023. The letter alleged abortion pills sold through the mail would be federally illegal based on the Comstock Act, claiming the Act includes language that prohibits the mailing of articles designed to prevent conception or induce an abortion.

In early January of 2023, the Department of Justice (DOJ) noted that the Comstock Act does not prohibit abortion pills being mailed when those sending the pills lack intent that the drugs will be used for illegal purposes; however, Bailey argued against the DOJ and claimed the text of the Act is what governs, not “the Biden administration’s view.” Bailey further threatened CVS and Walgreens with civil litigation through either state attorneys or private citizens.

Walgreen’s announcement affects states where medication for abortions is legal, such as Alaska, Iowa, Kansas, and Montana. In a statement, Walgreens specified that once it was certified by the FDA to sell the abortion pill, the company will dispense the drug complaint to state and federal laws. The threat to selling mifepristone has opened a larger question about state authority in regulating FDA approved drugs and medicated abortion access. Since Walgreen’s announcement, activists have pushed to boycott Walgreens. Currently, there are 2 lawsuits arguing that states do not have the authority to regulate FDA approved drugs; one targeting a state’s restriction on abortion pills, and the other challenging West Virginia’s state abortion ban. If the court rules in favor of the plaintiffs in these cases there may be grounds to claim that FDA policy trumps state law on abortions, but more time is needed to determine the outcome of bans on the abortion pill through state and federal action.

“Ending” the Public Health Emergency Will Further the Suffering of Elderly Individuals

The elderly population (those 65 and older) in the U.S. continue to face a disproportionately negative impact from the COVID-19 epidemic. While elderly individuals account for only 16% of the total U.S. population, they represent close to 90% of recent COVID-19 deaths in just the last few months. Throughout 2022, deaths among elderly individuals routinely spiked as the year progressed. The number of deaths among elderly individuals increased by 125% between April and July; a disturbing trend continuing to October, which experienced over 2,000 more deaths than in April. Even with these spikes in COVID-19 deaths among elderly individuals, the Biden Administration announced that the COVID-19 Public Health Emergency will end on May 11, 2023. The proposed end of this incredibly important federal program will be devasting to elderly populations as it will likely limit access to crucial COVID-19 prevention and treatment.

The end of the COVID-19 Public Health Emergency will create cost barriers for both testing and vaccines. Elderly individuals under traditional Medicare will no longer have access to at-home tests free of charge and even those with Medicare Advantage plans are not guaranteed to receive them for free. When it comes to PCR and rapid tests administered by physicians, elderly individuals under both traditional and Medicare Advantage plans may now experience cost-sharing fees from their testing visits. While access to free COVID-19 vaccines will still be available after May 11th, the supply of federally purchased vaccines will eventually disappear and many pharmaceutical companies will commodify the vaccine, creating cost barriers that will decrease population-wide immunization rates.

The commodification of the vaccine and the new cost barriers in testing will likely lead to a surge in COVID-19 cases in the U.S., increasing the need for treatment. Unfortunately, elderly individuals receiving Medicare will now face cost-sharing fees for COVID-19 treatment due to the end of the Public Health Emergency. This cost barrier will lead to many elderly individuals not being able to access treatment, including the drug Paxlovid. Studies have demonstrated that Paxlovid can reduce COVID-19 hospitalizations in vaccinated elderly patients by 73%, along with reducing deaths by 81% in other studies.

Clearly the public health threat of COVID-19 has not ended, as the death rates among elderly individuals remain high. It is crucial that the Biden Administration revoke this proposal and extend the Public Health Emergency well beyond May 11, 2023. This proposal displays the federal government’s unjust intent to shift the financial responsibility of controlling the COVID-19 epidemic in the U.S. onto patients, many of whom lack the means to financially take on this tremendous unresolved burden. This will undoubtedly cause further harm to elderly individuals, who may include our parents, our grandparents, and our neighbors.

The Dangers of E-Cigarette Marketing: The Fight to Protect Our Youth

It comes as no surprise that children are heavily influenced by the social makeup of their environment, especially as they enter adolescence. Today, parents face a particularly unique fear with peer pressure: the fear that their children will develop an addiction to nicotine. Peer pressure is a contributing factor influencing children to pick up an e-cigarette, or vape, for the first time. Additionally, there is a plethora of marketing tactics purposefully utilized by e-cigarette manufacturers that influence America’s youth to buy these products. Some of these tactics include emotional appeal, targeted advertisements, social media, and even “fun” flavors and colors. In fact, the original tactics used by the tobacco industry (“Big Tobacco”) are so effective that many e-cigarette manufacturers have taken over the exact same trade secrets to advertise their products. For example, e-cigarette companies have been known to implement emotional appeal to attract teens to their products, including portraying friendship, happiness, sex, and success.

Perhaps even more alarming is the success the vaping industry has seen in using colorful, eye-catching packaging full of cartoon characters and sweet flavors. These advertisements directly target adolescents and appeal to children’s affinity to candy. Further, e-cigarette companies have found massive success in marketing to teens through social media platforms. The use of fun flavors, prestigious celebrities, and persistent marketing on youth dominated apps all exert influence on viewers’ decision to vape. Notably, this past September of 2022, Juul Labs Inc. reached a settlement agreement to pay $438.5 million to thirty-three states to resolve claims that it marketed addictive products to children. The agreement now prohibits Juul from marketing to youth and even bans advertisements featuring cartoons or anyone under thirty-five years old—but what about the rest of the manufacturers?

In 2020, likely in response to the growing fear by concerned parents, the Food and Drug Administration (“FDA”) began requiring all e-cigarette products to apply for and receive regulatory approval. This announcement led to nearly 8 million applications by distributors and manufacturers. Given the length of the approval process, regulatory delays by FDA have allowed for the e-cigarette products to stay on the market for years while waiting for review and authorization, further paving the way for the youth vape epidemic America faces today. Over two years after the established FDA requirement, the review process is ongoing and flavored vapes are still widely available on the market.

While FDA sorts out its administrative delays, families are filing personal injury suits against e-cigarette manufacturers. Juul currently has a number of pending lawsuits filed against it in relation to severe lung conditions, stroke, seizures, and nicotine addiction. These claims are made possible through product liability, which holds a manufacturer, distributor, or seller of a dangerous product financially liable for injuries caused by their defective product. Although legal success is possible, this litigation can be a time-consuming and expensive way to reach justice for those injured without addressing the initial problem of vape accessibility among the youth.

Perhaps the best solution here lies in implementing stringent regulations at the federal level, which would preempt any loose state laws. Policymakers should aim to halt children and teens’ access to vapes while maintaining other effective ways for adults to quit smoking. The youth of America deserve to be protected from this kind of harmful marketing that can detrimentally impact their health and their future as a whole. In the modern age of technology, marketing influence is practically inescapable. Thus, legislators and policymakers alike should step in and assist FDA to protect American youth now before it is too late.

Medications-The Next Battleground on Abortion in the United States

Anti-abortion supporters won a significant legal battle this summer in the Supreme Court’s Dobbs decision, overturning the constitutional right to abortion in the United States. But they aren’t stopping there. Another approach to limiting abortions is gaining traction in the form of several current lawsuits that are utilizing various methods to target mediation abortion in the United States.

Although in-clinic procedures may be the more commonly known option for abortion, in recent years, more than half of abortions in the United States are medication abortions. This approach most often includes a combination of two pharmaceutical drugs: mifepristone and misoprostol. One ongoing lawsuit, Alliance for Hippocratic Medicine v. FDA, seeks to bar the Food and Drug Administration (FDA) from permitting the sale of mifepristone in the United States. The FDA approved the use of mifepristone for abortion in 2000, and the drug has remained safe and effective in the 20 years since. The plaintiffs in this case are calling for an unprecedented overturning of the FDA’s approval of a pharmaceutical drug that has been utilized for more than two decades.

Although the plaintiff’s arguments are considered by many to be meritless, there is potential for the case to be upheld due to the strategic forum shopping by the plaintiffs. The plaintiffs brought suit in the Northern District of Texas, where the case was all-but-guaranteed to be heard by Judge Matthew Kacsmaryk, a federal judge appointed by former President Trump. Kacsmaryk was likely selected for his conservative political views and his work for far-right religious groups. In his short time as a federal judge, Kacsmaryk has established a reputation for conservative and poorly reasoned rulings limiting the rights of immigrants, of the LGBTQ+ community, and reproductive rights. 

Based on this track record, Judge Kaccsmaryk may rule for the plaintiffs and might grant an injunction that would ban the distribution of mifepristone throughout the nation, even in states with legal protections for abortion. Banning mifepristone would further restrict abortion access throughout the United States. With limited access to the option of a medication abortion, the demand for in-clinic abortion procedures is almost certainly increase, compounding the burden faced by abortion clinics and providers following the Dobbs decision, and likely increasing wait times for pregnant people seeking an abortion, issues that the FDA has stated will harm the public.

In addition to the detrimental impacts this decision may have on remaining abortion access in the United States, it could also place the FDA’s drug approval process in question, creating opportunities to question other drugs that have been used safely and effectively for decades.

If the judge sides with the plaintiffs, the decision will undoubtedly be appealed. However, the route would take the appeal to the Fifth Circuit Court of Appeals, with a conservative reputation. If appealed further, the case could be taken up by the Supreme Court, which just months ago overturned the constitutional right to abortion. The continued evolution of this case, and others like it, demonstrate the implications of the Supreme Court’s decision to overturn Roe v. Wade and the threat to abortion access in the United States for years to come.

Can East Palestine, OH Seek Derailment Relief Through a Medical Monitoring Program?

On February 3rd, 2023, a Norfolk Southern train derailed in East Palestine, Ohio. The village rests on the Ohio-Pennsylvania border. Investigators believe that a broken axle caused approximately fifty of the 100 car train to derail. Five derailed cars carried vinyl chloride. Over the following days, the vinyl chloride was released from the cars in a controlled burn, unleashing hydrogen chloride and phosgene gases into the air. Although residents were originally evacuated, they were soon permitted to return only a few days later.

The Environmental Protection Agency classifies vinyl chloride (VC), a chemical commonly used to manufacture PVC piping, as a Known Human Carcinogen. The chemical’s Category A classification is based on human occupational studies and animal testing. The tests and studies show that VC is hazardous if inhaled or absorbed orally or dermally. Nearly all cases of liver angiosarcomas have been linked to occupational exposure to VC. Furthermore, VC has been linked to liver, brain, lung, and lymphopoietic system cancers. Highly concentrated exposures can also cause headaches, drowsiness, and dizziness.

As of February 15th, the Ohio Environmental Protection Agency was testing the wells that supply drinking water to the area and maintained that they were not contaminated. However, residents of the area have reported headaches, sudden death of domesticated pets, and lifeless fish in nearby streams.

Undoubtedly, this disaster has major health and environmental implications, but developments in American tort law may burden Ohioans who seek relief. As of February 10th, four lawsuits had been filed, three in the United States District Court for the Northern District of Ohio and one in the Court of Common Pleas Columbiana County, Ohio. Two of the federal suits include a count of strict liability, alleging that transporting a known carcinogen is an ultrahazardous activity. The state suit partially relies on res ipsa loquitur. Res ipsa loquitur is a torts doctrine that allows plaintiffs to argue for liability based on the assumption that without the defendant’s negligence the event that occurred would not have ordinarily happened. 

All four suits have two things in common: they are petitioning for class action status and seek for Norfolk Southern to fund a medical monitoring program (MMP) for individuals within a certain radius of the detrainment and controlled burn. MMPs provide ongoing medical screening and care to populations who are not currently injured but will likely develop health issues caused by a negligent act. American tort law’s view of MMPs is being cautiously evaluated. MMPs would provide relief to those exposed to hazards that may take years to medically manifest but would impose liability without presence of a current physical injury, violating a tenant of tort law. The Supreme Court has previously rejected a MMP to relieve railroad workers exposed to asbestos because it was concerned about overextending liability. The American Legal Institute (ALI) is considering the topic while drafting its Restatement (Third) of Torts: Concluding Provisions.

As of October 2020, eleven states legally recognized MMPs. Pennsylvania and West Virginia not only allow MMPs but recognize them as a cause of action. These two states border Ohio and also sit within the Appalachian Mountains. Although MMPs present relatively novel considerations in American tort law, such a program may be the most just course of action when a railroad company experienced in derailments exposes an entire town to a known carcinogen due to a broken train axle.