Category: Blog

“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.

Cell-Based Meat: Meet the Future

In recent years, plant-based meat products have gone from an option for a vegan diet to a popular dish, in fact one in every ten Americans say they do not eat meat. However, plant-based meat products are no longer the only alternative to traditional meat. Cell-based meat is a new alternative that is way “beyond” plant-based meat—it is real meat. Cell-based meat is grown in a laboratory from cells taken from living animals. This technique requires zero animal slaughter,  uses fewer natural resources,  potentially produces less air pollution, and yields less potential for environmental contamination.

The evolution of cell-based meat and sea food as a potential human food has resulted in significant disagreement about how and who should regulate the products. Since cell-based meat is produced by stem cells obtained from the species of livestock and parts of the animals, the meat may satisfy the U.S. Department of Agriculture’s (USDA) current definition of meat and trigger its jurisdiction. Still, the Food and Drug Administration (FDA) has jurisdiction over most food products according to the Federal Drug and Cosmetic Act, which authorizes, among many other things, the FDA’s jurisdiction over biologics. Appropriately, the FDA has taken the lead role involving the safety determination of new biotechnological approaches to foods. Under 7 U.S.C § 1639(1), bioengineered food refers to food made up of genetic material that is modified in vitro using certain laboratory techniques and which modification could not have been obtained through conventional breeding or found in nature. The FDA and USDA agreed in 2019 to ensure that, when it comes to the market, cell-based meat is “safe and properly labeled.” FDA will oversee the cell collection, banking, and growth, using existing rules such as facility registration, and Current Good Manufacturing practices while USDA will conduct inspections and develop labeling for cell-based meat.

When asked about consumers being worried about a product in the market that may have such recent FDA approval, Arye Elfenbein, co-founder at Wildtype Foods, one of the food biotechnology companies that is currently working on the field of cell-based salmon, answered “the imminent availability of cultivated meat and seafood options have resulted in an illuminating dialogue between us and our future customers… the process of FDA consultation has mirrored our discussion with future customers, resulting in a thoughtful and productive exchange from the beginning.” He also added that “the process with FDA is one that has transpired over the past 4 years; it’s been an extremely thorough review, one that we believe will further bolster customer confidence when these products hit the market,” giving us a bit of an insight of the rigorous FDA approval process every cell-based startup is currently going through.

In December 2020, Singapore became the first nation to approve the sale of cultivated meat—chicken nuggets from the company Eat Just. In comparison the U.S. seems to be making regulatory strides to get cell-based meat approved by administrative agencies. The agencies published a request for comment in November of last year, asking interested parties to suggest what the cell-based meat should be called. More excitedly, as of November 16, 2022, the FDA announced the pre-approval of Upside foods, a cell-based chicken startup, making it the first company in the U.S. cell-based space to receive pre-approval from FDA. Products are expected to appear as early as 2023, and it will be interesting to see how the American public will respond to this new innovative and refreshing idea to the market.

States Support Abortion in Midterm Elections

Abortion has long been a contentious issue in American politics, but the debate has been revived, perhaps more than ever, since the Supreme Court’s decision to overturn Roe v. Wade, altering the landscape of abortion access across the nation. One major impact of the Dobbs decision was a distinct shift in the scope of abortion policy to the state level. Elisabeth Smith, Director for State Policy and Advocacy for the Center for Reproductive Rights, says that in a post-Roe United States, “state constitutions are now the best vehicle to protect abortion rights and ensure access.”

The midterms held earlier this month were the first major elections held across the United States since Roe was overturned, providing many voters with an opportunity to contribute to abortion decisions in their states. Elected state officials such as governors, legislative representatives, and judges can play significant roles in shaping abortion policies and access in their states. In addition to the elected officials in the midterms, abortion was directly on the ballot in a record number of states with abortion-related legislative proposals.

With so much at stake for the right to abortion in midterm elections, many voters took advantage of the opportunity to make their voices heard. According to polling conducted by the Keiser Family Foundation, the Supreme Court decision to overturn Roe v. Wade had a major impact on voter turnout and choice for at least half of democratic voters, first time voters, and younger women voters.

The results of this voter turnout are clear: in each of the five states where abortion was directly on the ballot, proposed abortion protections were expanded, and proposed restrictions were rejected. Voters in California, Michigan, and Vermont approved amendments to their state constitutions to protect reproductive freedoms, and limit government intrusion into reproductive health care decisions. In Kentucky and Montana, voters rejected efforts to further restrict access to abortion. These results are following Kansas’ rejection of an anti-abortion state initiative in August. Although these states range from liberal, moderate, to conservative, where abortion was directly on the ballot, the people ultimately voted in support of abortion rights.

The election results are promising for abortion advocates. President and Chief Executive of the Center for Reproductive Rights, Nancy Northup called the midterms “a seismic win for abortion rights,” and emphasized that the outcomes show that “when people can vote directly on abortion in a non-partisan ballot initiative, abortion rights win.” The outcomes of the first major elections after the Dobbs decision may make the case for a glimmer of hope for the future of abortion rights and access in the United States.