Category: Blog

In 2022, JUUL, an e-cigarette company originally founded to help cigarette smokers quit, settled a lawsuit that alleged that Plaintiffs paid more for JUUL products than they would have if accurate information regarding the product’s addictiveness and safety had been provided. The lawsuit further alleged that JUUL products were unlawfully marketed to minors. The complaint, filed in the Northern District of California, noted that JUUL’s advertising techniques were specifically employed to garner interest from a younger consumer population and used long-banned cigarette advertising techniques. The $300 million settlement was paid out to consumers in the middle of October 2024, with some purchasers receiving thousands of dollars in return. 

In avoiding the risk of going to trial, JUUL’s settlement sets the stage for future claims against substance producers potentially marketing to children or concealing the risks associated with consuming their product. As research emerges regarding alcohol consumption’s link to increased cancer risk, companies that produce sweet liquors with fun colors could be at risk for marketing to children. Per the National Institute of Health, nearly 5.8% of cancer deaths worldwide are attributable to alcohol consumption. As of October 22, 2024, the United States does not require that alcohol bottles bolster a warning of cancer risk. Ireland recently became the first country to require cancer warning labels on alcohol bottles. Many liquors also appear to be marketed towards children in many of the same ways that JUUL products were; they are colorful, with sleek designs, and often fruity or exotic flavors. At what point do the same legal principles apply to alcohol litigation?

Arguably, JUUL’s massive settlement set the stage for future substance complaints and litigation, particularly as it concerns public health and concern for minors. The alcohol industry finds itself at a crossroads: how can it continue to innovate its product and increase its revenue while treading carefully to avoid bankruptcy-inducing settlement payouts? The question might actually be one of abandoning some long-held, capitalistic business practices, pivoting from seemingly marketing to a younger audience, and bolstering the existing market. Instead of creating fun designs with exotic flavors, perhaps leaning into a “sophisticated” type of marketing that emphasizes the exclusivity of being of age to consume alcohol. By moving away from the youth-targeted marketing, companies can instead generate excitement for a new consumer base by advertising anticipation of reaching the drinking age. Perhaps they can also shift marketing to reflect a slower, less volume-induced type of consumption. By elevating the experience and shifting marketing strategy to reflect a sophisticated, adult activity, alcohol companies can avoid potential marketing litigation as it pertains to childish advertising. In looking towards the future, alcohol companies should be prepared to comply with all warning regulations and potentially shift marketing materials to target an older audience. 

Chaos ensued in the nursing home industry after the federal Centers for Medicare and Medicaid Services (CMS) issued its final rule mandating minimum nurse staffing in every nursing home that accepts Medicaid and/or Medicare funds. This means virtually all U.S. nursing homes will be subject to the new rules as of April 22, 2024. The reaction has been swift, with 20 states joining together to sue the U.S. federal government over the requirements, representing a significant pushback against the Biden administration’s attempt to upgrade the quality of care in long-term care facilities (“LTCs”). The new rules require that nursing facilities have a registered nurse on campus twenty-four hours a day, seven days a week as well as additional specified staffing levels for all other nursing staff (e.g., licensed practical nurses and certified nursing assistants).

Staffing minimums in nursing homes are not new by any means; since 1987, with the passing of the Nursing Home Reform Law, facilities have been required to ensure sufficient staffing at all times so that residents can “attain and maintain her highest practicable physical, mental, and psycho-social well-being.” However, the law was rarely enforced, leading to a less-than-optimal standard of care. This new law adds a quantitative requirement to improve enforcement of the purely qualitative 1987 Nursing Home Reform Law. 

The real question is, how will this new law impact nursing homes now? The benefits of increased staffing are clear: more staff means more efficient care. But why would 20 states be suing over it? The slow implementation of the new rule puts current residents at risk; CMS is allowing years for facilities to comply with the rule, and facilities that have trouble staffing to the new minimum will likely have to stop admitting new residents. Additionally, the new rule gives so-called “hardship exemptions,” giving any facility that meets the requirement for hardship to skirt the rules, allowing for less than stellar care for residents. 

Furthermore, paying for the increase in staff is likely a non-issue for the majority of facilities as most nursing homes are run as for-profit businesses, with regular investments by Private Equity, Real Estate Investment Trusts, and other highly polished investors. In fact, nursing homes had total net revenues of $126 billion and a profit of $730 million in 2019. Additionally, spending for residents’ direct care comprised only 66% of net revenues, including 27% on nursing, in contrast to 34% spent on administration, capital, and others. 

Despite most nursing homes seeing large net profits, attorneys general from the twenty states participating in that lawsuit contend that the new requirements are not feasible in rural communities that don’t have the same venture capital presence. Moreover, traditionally, nursing home care has been regulated at the state level, arguing that this mandate “represents an overreach of federal power and fails to account for the diverse needs and resources of different states and communities.” States further assert that the new rule represents a one-size-fits-all model that fails to account for the unique needs of different patient populations. 

As the lawsuit proceeds through the legal system, it will likely have notable implications for nursing home care policy throughout the United States. The outcome of the case will likely set important precedents regarding state and federal authority over healthcare regulation.

On June 16, 2021, Erica Russell died while undergoing cosmetic surgery for a “Brazilian Butt Lift (BBL),” a procedure that has grown in popularity in recent years. Last March, her family filed suit in Miami-Dade County Court for wrongful death against Seduction Cosmetic Center, the facility where the operation was performed, and Dr. John Sampson, the operating surgeon. The complaint’s allegations echo findings by the Florida Department of Health in disciplinary action against Sampson regarding Russell’s death. There, the Department of Health found that, by puncturing several of Russell’s organs and injecting fat below her gluteal muscles, which caused the pulmonary fat embolism that led to her death, Sampson had violated the standard of care for a cosmetic surgeon.

Although butt augmentation as a cosmetic procedure has been around for decades, in recent years, its popularity has spread like wildfire across the United States, likely due to shifting beauty standards which now favor a shapely posterior compared to the turn of the century, in part due to celebrity endorsements. Only around five hundred procedures were performed nationwide in 2005, whereas in 2020, that number jumped to over twenty thousand.

The standard procedure for a BBL is comprised of two parts: an initial liposuction procedure, which removes fat from elsewhere in the patient’s body, followed by the fat’s insertion and grafting into the fatty tissue on the patient’s buttocks. The American Society of Plastic Surgeons (ASPS) recognizes that while outcomes have improved over the past few years, the procedure inherently involves the risk of death. Complications are rare but usually manifest immediately; fat embolism, the cause of Russell’s death, was found to be the most severe identified complication, prompting the ASPS to recommend that surgeons modify their technique to avoid placing fat near the patient’s gluteal muscles. In response to these recommendations, the Florida Board of Medicine passed a regulation banning fat grafting techniques that inject fat below the gluteal muscles in 2019, two years before Russell’s demise.

Russell’s unfortunate case is an example of how the standard of care and its breach are defined during the two stages of the BBL procedure. Because the initial perforation of her organs occurred during the liposuction while the introduction of fat—which caused the embolism that ultimately killed her—happened during the grafting portion, Sampson is alleged to have breached the standard of care in at least two instances. Russell’s case is also an example of how medical regulatory bodies revise how the standard of care is defined to adapt to current events. In response to Russell’s case and other similar deaths, the Board of Medicine passed an emergency rule in 2022 limiting surgeons to three BBL procedures a day. Sampson and other doctors were found to have performed around double that amount at the time of their patients’ deaths.

Florida’s approach to the regulation of BBL surgeries should serve as a lesson to cosmetic surgeons who wish to avoid patient deaths and malpractice liability while providing an increasingly popular service. While there are no federal regulations on the practice, Florida’s regulatory law represents the sentiments held by the ASPS and other national cosmetic surgeon organizations. Florida is one of the most popular destinations in the country for these procedures; it was estimated in 2019 that practitioners in Miami-Dade County alone accounted for fifteen to eighteen thousand procedures. Should this trend in popular ideals of beauty and self-image continue to grow and other states seek to further their regulations on the practice, their measures will likely be in accord with Florida’s for the reasons held by the Board of Medicine. As a result, these actions will help clearly define the “national” standard of care for BBL surgeries and ultimately help hold malpractitioners accountable wherever they may be.

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At the height of the pandemic, the public became increasingly aware of the socioeconomic disparities in health care. The prevalent news coverage of the pandemic and Black Lives Matter (“BLM”) movement shone a spotlight on the inequality suffered by people of color and its effects. Studies revealed that racial and ethnic minorities were infected and killed by COVID-19 at higher rates in comparison to their White counterparts due to inadequate access to testing and vaccines. Essential workers, whose numbers predominantly consisted of racial and ethnic minorities, had a higher likelihood of exposure to infectious diseases and often faced workplace mistreatment to the detriment of their health. In other instances, Black Americans seeking treatment for a range of symptoms were turned away by medical professionals who refused to believe their symptoms were genuine.

In a post-pandemic world, an essential aspect of improving such disparities is to acknowledge and address the role of institutional racism in the healthcare sector. Various institutions have created educational opportunities specifically on this topic to encourage inclusive and effective conversations on how to combat such issues. The Morehouse School of Medicine designed the Community Health Course (CHC) to train first-year medical students to identify deep-seated biases, understand disadvantaged communities’ struggles to access quality care, and recognize ways to advocate for said communities through future work. Similarly, other institutions, such as Vanderbilt University and Rutgers New Jersey Medical School, crafted curricula that explore the relationship between social factors, health, and healthcare. Such educational programs among healthcare professionals signal an upcoming generation of health professionals determined to address these issues.

Workforces have taken a similar approach, using policies and training to encourage diversity, equity, and inclusion. The American Medical Association (“AMA”) adopted guidelines and anti-discrimination policies to promote awareness and safety among workers. The AMA’s new policies promote education on systemic racism and its effects in healthcare settings. Additionally, these policies detail the protocol for handling complaints with urgency and seriousness. Many hospitals have followed suit by implementing diversity initiatives, creating training programs, and refining recruitment practices. More specifically, several residency training programs have improved their screening process to ensure underrepresented minorities (“URM”) have mentorship opportunities, minority faculty representation, and implicit bias training. For places lacking programming, “Safe Space” was founded by Dr. Deanna Stewart to provide a free diversity training program for healthcare employees and hospitals. Dr. Stewart’s program focuses on concepts such as systemic racism, privilege, unconscious bias, and discriminatory beliefs.  

Educational and workplace efforts to combat disparities in health care have laid the groundwork for future advancements in diversity, equity, and inclusion. While disparities will not be solved through these methods alone, such efforts encourage further policy improvements in various settings to tackle issues the pandemic brought forth. 

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In the United States, there are approximately 22 maternal deaths for every 100,000 live births. The rate of maternal deaths in the United States is more than double, almost nearly triple the rate for any other first-world/high-income nation. Many of these pregnancy-related deaths occur during the postpartum period. The postpartum period is days 1- 42 after the baby’s birth and ends around the time a mother’s body nearly returns to pre-pregnancy state. The postpartum time is critical because it lays the foundation for long-term health for the mother and baby. 

The American College of Obstetricians and Gynecologists (ACOG) explains that postpartum care for both the mother and the baby must become an ongoing process, not just a single encounter the mother gets before she leaves the hospital and one more visit at her six-week check-in. ACOG further implements that postpartum care should evolve over six weeks. Starting within the first three weeks postpartum, a mother should have a visit to address acute postpartum issues. After the 3-week check-in, postpartum care should include ongoing care as needed, which includes a comprehensive women’s exam and a transition into women’s care after pregnancy. 

Although many doctors and health agencies acknowledge the correlation between high maternal deaths and lack of postpartum care, the US still has the highest maternal death rate. In June 2022, the Biden-Harris Administration addressed the Maternal Health Crisis in our country. In their address, Vice President Kamala Harris explains that the systematic barriers and failure to recognize, respect, and listen to patients of color have meant that Black and American Indian/Alaska Native (AI/AN) women experience a greater share in maternal mortality than their counterparts. VP Harris goes on to extend that the Biden-Harris administration is committed to cutting the rates of maternal mortality and morbidity, reducing disparities in maternal health outcomes, and improving the overall experience of pregnancy, birth, and postpartum across the country. 

In July 2024, nearly two years after implementation, VP Harris announced that there had been key accomplishments from the administration’s effort to combat maternal mortality and morbidity. Starting off, their administration has created the first-ever baseline federal health and safety requirements for maternal emergency and obstetric services in hospitals. These new standards ensure that hospitals have the protocols and supplies for obstetrical emergencies, and if hospitals are unable to perform during the emergencies, they have procedures to transfer patients to other facilities. Second, the administration has expanded postpartum Medicaid coverage from two to twelve months, which ultimately provides lifesaving coverage to thousands of new moms. Extending has given postpartum moms the ability to seek doula care, and some states can cover the services. In addition to having designated hospitals, VP Harris launched the Newborn Supply Kit Pilot Project, which distributes kits with essential supplies to families. Supplies include diapers, baby lotion, baby socks, blankets, and wipes. The goal of this program is to reduce time, stress, and the burden on new parents to obtain supplies immediately needed. 

Specifically looking at the United States hospital system, the administration has also created “Birthing Friendly” Hospitals. These hospitals are designated to describe high-quality maternity care. To earn the designation of “birthing friendly,” hospitals have to participate in statewide or national perinatal quality improvement programs and implement evidence-based quality interventions in their hospital to improve maternal health. 

On August 27^th, 2024, it was released that the U.S. Department of Health and Human Services (HHS) announced more than $558 million in additional funding to improve maternal health. $440 million of their projected funding is to expand evidence-based maternal, infant, and early childhood home visiting services across the country. $118.5 million of their funding comes from the CDC to aid in building the public health infrastructure to better identify and prevent pregnancy-related deaths. 

As we pass the two-year mark on the Biden-Harris administration’s maternal mortality and morbidity project, it is safe to say the U.S. has made great strides in moving towards lowering its maternal death rate. There are still many areas that need work and change, but it is safe to say necessary changes to alter and protect the mothers of the U.S. are being made. 

The 21^st century has ushered in an era of incredible advancements in medicine. From the first uses of online patient portals to nanomedicine, how people are treated for their health has changed drastically. It then follows that as medicine itself develops, the regulations and protocols surrounding medicine change with it. In the United States, the Food and Drug Administration (FDA) is the gatekeeper of all new medicines. Each year, the FDA approves only dozens of novel drugs, approving fifty-five in 2023 and thirty-seven in 2022. At the end of 2023, the FDA approved the first CRISPR/Cas9-based gene therapy for treatment, implicating new questions surrounding regulations of the powerful yet controversial technology and its other applications. 

CRISPR/Cas9 is the nickname for “Clustered Regularly Interspaced Short Palindromic Repeats” and “CRISPR Associated Protein 9.” It is the leading technology for editing the human genome. The applications of CRISPR are virtually limitless, from treating genetic diseases to organ transplantation to altering the genetic code of future generations. The FDA approved clinical trials of CRISPR for treating genetic diseases in 2021, effectively treating patients with sickle cell disease. In just a few short years, these treatments were greenlit for treatment in the United States. However, as CRISPR technology advances, regulations have limited its other uses. Currently, there is a ban in the United States on using federal funds for editing the genes of future generations while embryos (i.e., “germline editing”), prohibiting the FDA from approving any clinical trials for such modification and the National Institute of Health (NIH) from funding research. However, germline editing is not technically illegal in the United States—any research must use only private funding, though it is globally discouraged. The question is: are the existing regulations on germline gene editing proper? 

There are clear ethical concerns about editing human embryos that make it widely acceptable amongst researchers that the brakes have been pumped on developing the technology, which isn’t quite ready for human trials. The lack of a specific ban on embryonic research has led some to push for stricter regulations to eliminate it altogether. There are concerns about genetic diversity becoming limited over time, which would not be seen within the first generation of genetically modified persons but later on. While a parent may undoubtedly want to edit a genetic disease out of their child, it becomes a public policy concern about generations down the line that may be adversely affected by dwindling genetic material. Further, unborn children cannot consent to alterations—and those alterations aren’t always accurate, and could lead to additional health issues. 

Conversely, some have argued for looser regulations on germline gene editing, specifically in favor of research forthree-parent embryos. This involves using DNA from the father and the mother as well as mitochondrial DNA from a donor mother to prevent mitochondrial diseases from being passed onto the child. Properly done, it would help couples conceive while mitigating or eliminating the risk of passing on genetic diseases. This is a less controversial use of the technology already approved for clinical trials in the United Kingdom, but research has been dampened in the United States by the above regulations. 

While CRISPR has recently received FDA approval for some applications, its use has been hindered in others. As the technology produces more treatments, it will gain efficiency and accuracy with increased research on the new type of medicine. With this increased accuracy, it may come time to reevaluate the current regulations regarding germline editing. Some may argue that Congress, the FDA, and the NIH have not done enough to restrict it and need to ban research on germline editing immediately. Others may argue to allow federal funds to be used for research and increase reproductive freedoms. Regardless, there is a growing conversation surrounding the use of CRISPR gene editing in medicine that has only become louder following FDA approval for one application.