Category: Blog

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.

On February 3^rd, 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.

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.

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.

While research and education regarding domestic violence and abuse continues to grow, domestic violence remains a prevalent issue accounting for roughly ten million victims per year in the United States. National statistics show that on average, twenty people per minute are victimized by domestic violence, with roughly one in four women and one in nine men suffering either physical or mental abuse by their partner. Additionally, one in four women and one in seven men are abused through severe physical violence such as beating, burning, or strangulation throughout their lifetime by an intimate partner. While abused individuals are at risk for various physical, mental, sexual, reproductive, and substance abuse issues, only thirty four percent of victims receive medical care for their injuries. 

There are social stigmas surrounding disclosure of abuse from victims for fear of additional harm by their abuser and judgment by society, making domestic violence hard to measure. Previous studies have found that forty four percent of victims have talked to someone about their abuse, with only thirty seven percent of those individuals disclosing their abuse to a healthcare provider. 

Many state and federal laws have required individuals working in a professional capacity to report signs of possible abuse regardless of the patient’s disclosure. Majority of these statutes specify health professionals such as therapists, nurses, and doctors as mandated reporters for domestic violence. State legislation typically falls into four categories: requiring reporting of injuries caused by weapons; reporting injuries that are caused as a result of violence, through non-accidental means, or in violation of criminal law; specifically addressing domestic violence reporting; or there is no general requirement related to mandatory reporting. However, with difficulty around accurately measuring rates of domestic abuse, it is hard to discern if areas with mandated reporting laws truly assist victims, or if they create an additional risk and barrier to those that have not personally disclosed their abuse. 

Two large discussions on mandatory reporting for health professionals include the effectiveness of reporting in maintaining victim’s safety and the victim’s rights to medical privacy. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) addresses privacy protection issues between health care professionals and their patients. However, when health professionals observe clear signs of abuse, especially when they feel the patient is in danger, abuse must be reported. Regardless of a victim’s request to remain confidential, HIPAA does not cover protected health information if a crime has occurred. HIPPA does not prohibit law enforcement officers from gaining access to patients who were victims of a crime and allows officers to obtain information directly from a patient if it relates to a crime.

Many patient visits of domestic abuse victims do not meet the standards for mandatory reporting. For instance, visits related to extreme harm like stab wounds or gun shots would require a report. However, visits associated with abuse, like chronic health conditions of memory loss or depression, would not constitute a report. During these appointments, patients may describe and disclose forms of domestic abuse, but depending on local laws, health providers may not be required to disclose the abuse that is reported to them.

Despite these mandates, one study notes that most primary care physicians do not routinely screen for signs of abuse. Though screening is separate from reporting, two thirds of women who have been abused said they would have wanted their health professional to ask about domestic abuse . Contrastingly, with various state laws, there is a misconception as to what health professionals must report. Particularly with minority or undocumented victims, individuals avoid seeking medical care because they fear the abuser will find out or that deportation agencies will be contacted. Nevertheless, health professionals remain cautious in their reports, hoping that patients will continue to seek care without fear of a privacy breach.

Ultimately, applying mandatory reporting laws creates a fine line between help and harm. Professionals continue to try and decrease domestic violence, but with the understanding that some patients may experience increased harm; alternative measures and a harsh analysis of local laws must be used to provide patient safety. Possible solutions include amending law to refer patients to professionally trained domestic and sexual violence services instead of to the police.   

The Final Rule for the No Surprises Act was released in August 2022, containing changes to the materials an independent dispute resolution (IDR) entity must consider in the IDR process. The No Surprises Act, a part of the 2021 Consolidated Appropriations Act, restricted healthcare providers from balance billing patients enrolled in job-based and individual health plans when receiving out-of-network emergency care, non-emergency care from out-of-network providers within in-network facilities, and air-ambulance services from out-of-network providers. The July 2021 Interim Rules for the No Surprises Act established an IDR process to place the burden of negotiating a fair price for any out-of-network services on providers and health plans.

Before the No Surprises Act, insured patients who received services from an out-of-network provider could receive a bill for the difference between the provider’s charge and their health plan’s allowed amount, a practice referred to as balance billing. Patients receiving emergency care from out-of-network facilities and non-emergency care from out-of-network doctors within in-network facilities could be subjected to balance billing. As a result of a provider being out-of-network and non-contracting with a patient’s health plan, the provider could bill the patient over the plan’s allowed amount. Typically, the allowed amount is a pre-negotiated rate a contracted provider will receive from the health plan and the patient based on the services rendered. Contracted providers cannot balance bill a patient to exceed the patient’s health plan’s allowed amount. However, if a patient received a balance bill from an out-of-network provider, they were responsible for the bill on their own. The No Surprises Act intends to prevent these unfair balance billing practices from plaguing patients.

Throughout this past year, the Act created to safeguard patients’ rights was met with resistance from the American Hospital Association (AHA) and the American Medical Association (AMA). The AHA and AMA criticized the Act’s IDR process, which established a negotiating forum for health plans and out-of-network providers unable to determine appropriate payment. The Act’s July 2021 Interim Rules required government-certified IDR entities to select the settlement offer closest to the health plan’s qualifying payment amount (QPA). The QPA is the health plan’s median contracted rate for the same or similar services in the geographic area relevant to the dispute.  Healthcare providers were quick to point out that the IDR process heavily favored health plans, as a health plan’s QPA swayed the IDR process’ possible outcome.

Medical providers pursued litigation in early 2022 regarding the legality of the IDR process. In February 2022, Texas Medical Associates sued the U.S. Department of Health & Human Services, claiming the IDR process skewed arbitration results in favor of health plans. The District Court found that the October 2021 Interim Rules created unbalanced arbitration processes and caused a procedural injury to providers. Thus, the court vacated the Act’s Interim Rules relating to the IDR process.

In response to the lawsuit, the Act’s Interim Rules were revised in August 2022, removing the regulations the District Court vacated. The Final Rules of August 2022 specify that an IDR entity should select the offer that best represents the value of the service after considering the QPA and all permissible information submitted by the parties to reflect the appropriate out-of-network rate. While the QPA will continue to be a factor in the IDR process, the settlement offer is not predetermined by the QPA alone.  To facilitate health plan transparency, the updated Final Rules also require health plans to disclose “downcode” information, which is the health plan’s reasoning for changing or removing the coding of a disputed claim.

Between April 2022 and August 2022, over 46,000 IDR claims were initiated, a substantially higher amount than the Department for Health & Human Services anticipated for the whole year. Further litigation can be expected regarding the IDR process. While the August 2022 Final Rules substantially adjusted the IDR bargaining field, the AMA and AHA have stated they intend to “make their voices heard in court” soon about ongoing issues with the Act’s IDR process still favoring health plans through the use of the QPA.