Category: Blog

EMTALA in the Age of Rising Abortion Bans

Following the decision in Dobbs v. Jackson Women’s Health Organization in 2022, abortion bans have been popping up in states across the country. Many states have qualified their bans with exceptions based on the gestational age of the pregnancy, assault, or medical necessity. However, for 12 states, the exceptions, if present at all, are narrow, creating near-total abortion bans. This has widespread implications not just for patients, but for medical providers who traditionally provide abortions or greater obstetrics care.

One specific class of providers has found itself in the middle of a clash between state and federal law due to these bans. Emergency medical providers are not just bound by state law, but by the Emergency Medical Treatment and Active Labor Act (EMTALA). EMTALA is a federal act passed in 1986 as a response to a problematic practice of “patient dumping,” where hospitals refuse to treat low-income patients or patients from marginalized communities and transfer them to other hospitals. The primary requirement of the act is that any patient who arrives at an emergency room in a hospital that receives Medicare funding must be screened and stabilized before being transferred or released. The majority of guidance on EMTALA has left the medical decision-making aspect of stabilization and treatment up to the discretion of medical providers within the scope of their capabilities and the current standards of care.

The issue arises in cases where an abortion is determined to be medically necessary for the stabilization of a patient by a provider in an emergency setting. Pregnancy complications are the fifth most common reason that women between 18 and 65 visit the emergency room, with 84% of women visiting the emergency room at some point during their pregnancy. Due to the breadth of procedures that fall under the clinical term “abortion,” many medical procedures required for emergency obstetrics care fall under the abortion umbrella. Often, these procedures are life-saving and needed for even the most basic stabilization of a pregnant patient, such as in the case of ectopic pregnancy.

A few cases reflecting this conflict have made their way to the Supreme Court, hoping to receive a concrete answer as to whether emergency abortion procedures would remain protected. The most recent of these is Idaho v. United States, where the DOJ contended that Idaho’s near-total abortion ban would have to yield to federal law in terms of the provision of necessary stabilizing treatment. However, SCOTUS dismissed the complaint in 2024 without a specific ruling on the interaction between EMTALA and abortion bans, finding that the writ of certiorari was improvidently granted.

Despite this dismissal, the Supreme Court has another chance to hear arguments concerning the interaction between EMTALA and abortion bans due to a recent lawsuit where Texas sued the DOJ in an attempt to force ER compliance with the state’s strict abortion ban. The Fifth Circuit Court of Appeals sided with the state, allowing for the abortion ban to prevail over EMTALA obligations. The DOJ, under President Biden, filed for a review of the decision in 2024, but after the change in administration, it remains to be seen whether the DOJ will continue to pursue the complaint or whether SCOTUS will hear the case.

Without a clear ruling from federal courts, the conflict between the duties of providers under EMTALA and state-based bans leaves providers wary of legal repercussions, no matter which actions they take. Guidance from the Center for Medicare & Medicaid Services, as given in 2022, stated that providers would be protected under EMTALA for the provision of medically necessary abortions for the stabilization of emergent patients. However, that guidance was rescinded under President Trump as of June 3rd, 2025, and subsequent communication from the HHS on June 13th, 2025, was unclear. The lack of clear information and rising legal consequences of providing abortions in certain states have thrust providers and patients alike back into a state of uncertainty and fear.

M&A Momentum in the Medical Device Industry

From EpiPen smartphone cases to portable kidney dialysis, the MedTech industry revolutionizes access to life saving care for patients. Robust market innovation has improved personalized treatments, reduced time in hospitals, and lowered healthcare costs. In the past year, high value investments and acquisitions have gained significant traction as businesses seek to leverage their portfolios to generate new solutions for healthcare providers. Over 305 acquisitions were announced in 2024, exceeding $63 billion, according to JPMorgan figures. In light of regulatory challenges and complex mega-deals, M&A legal teams have taken a leading role in facilitating these high stakes transactions, counseling clients across borders and fostering vital alliances. The strategic consolidation of smaller innovators with well-established MedTech companies catalyzes a swifter deployment and integration of new devices into health systems around the world. This article investigates driving forces behind the industry’s M&A surge and future implications across the health law landscape.

External innovation has long played a crucial role in market capitalization for leading MedTech companies, such as Johnson & Johnson, Medtronic, Stryker, Abbott Laboratories, and Boston Scientific. Although multi-billion dollar deals draw more public attention, smaller strategic opportunities have become an attractive avenue for garnering strong returns by harnessing the novel creativity of breakthrough start-ups. Specialized technologies that impact essential clinical areas, such as cardiovascular health, stroke prevention, and advanced screening and diagnostics, have grown through recent advancements in AI. In an industry hungry for innovation, competitive designs specifically related to preventative medicine and remote monitoring have become high-demand targets of M&A activity. These deals tend to offer a more cost effective method for portfolio growth and maintaining a competitive advantage, rather than developing products in-house. Law firms across the globe diligently guide corporations in navigating intricate regulatory, commercial, and ethical challenges to help bring cutting-edge products to the market.

Along with recent scientific progress, economic and political factors contribute to the rise in MedTech transactions and venture investments, such as declining interest rates and industry deregulation. From advising on intellectual property protections to litigating industry-wide resolutions, M&A lawyers assume a significant role in the oversight of successful MedTech deals. In response to modern technology, legislators continuously adjust regulations on both national and state-specific levels, requiring practitioners to adapt to ongoing changes across the industry. For example, many digital products in medicine present future challenges for safeguarding patient privacy and ensuring consumer transparency, placing a greater emphasis on compliance for market expansion in the field. In order to make products accessible in the global market, corporations must secure various approvals, often requiring the regulatory expertise and risk-averse strategies of legal counsel. Specialized knowledge about data privacy, structured finance, and market dynamics are a key backdrop of MedTech dealmaking, with the goal of delivering and implementing life changing health care devices.

With a variety of unique ideas and actors populating across the medical device industry, new and exciting products are on the horizon. Many have already accumulated data and evidence reflecting success but await FDA approval for public distribution. Because of extensive relations between physicians and medical device companies, incremental modifications are made in the research and development process to maximize potential. The emergence of “wearable” health technologies, such as electrocardiograms, glucose monitors, and AI-powered robotic prostheses, offer numerous benefits to patients by adapting to the body using real-time data and trends. Smartwatches that detect irregular heart rhythms offer a vital form of self-monitoring, as heart disease remains the leading cause of death worldwide. Certain types of paralysis and blindness, previously incurable diagnoses, are now targeted with neural implants, altering the future of regenerative medicine and stimulating cell growth. By facilitating deals between promising tech firms and far-reaching device companies, M&A has expedited patient access to remarkable tools and encouraged a competitive edge in pushing innovative boundaries.

DTC Advertising Under Fire: A Turning Point for Drug Promotion?

The Trump Administration has taken assertive steps to rectify the overmedicalization of American citizens by increasing oversight of Direct-to-Consumer (“DTC”) prescription drug advertising. Specifically, President Trump delegated authority to the Food and Drug Administration (“FDA”) to implement stringent regulations to ensure patients receive balanced information. The Administration has emphasized that DTC advertisements have become increasingly misleading by omitting critical risk information, glamorizing the use of prescription medication, and deterring patients from cheaper or healthier alternatives.

On September 9, 2025, President Trump released an Executive Memorandum that underscored the prominence of deceptive DTC advertisements and the necessity for stricter regulation. The memorandum authorized the FDA and the Department of Health and Human Services to “regulate prescription drug advertising” by ensuring compliance with the principles of transparency and accuracy. President Trump additionally commanded the Commissioner of Food and Drugs to enforce the Federal Food, Drugs, and Cosmetics Act (“FDCA”) in connection with DTC advertising in the pharmaceutical space.

The Administration has pursued three key strategies to regulate DTC advertisements. Their approach includes (1) issuing warning letters to pharmaceutical companies, (2) reforming the adequate provision rule, and (3) restricting social media advertisements. Experts anticipate an increase in agency activity in the coming months.

Following President Trump’s memorandum, the FDA has released over 100 warning or untitled letters to various pharmaceutical companies, telehealth providers, and online pharmacies to target deceptive advertising practices. On September 16, 2025, the agency issued over 60 warning letters citing alleged violations of the FDCA. The violations primarily involved minimizing risks or side effects and publishing misleading content about medications. In light of this action, Alnylam Pharmaceuticals Inc. removed a DTC advertisement for its new heart medication, Amvuttra. The FDA alleged that the advertisement, which broadcast patients being active, was misleading because it indicated that patients with heart disease “can be carefree.” While President Trump’s initiative may reduce faulty advertisements, it may also limit patients’ access to information on transformative medications. However, these are merely pre-enforcement measures, and actual enforcement will possibly require the Department of Justice to intervene on behalf of the FDA.

The FDA is additionally establishing a regulatory framework to “close the ‘adequate provision’ loophole created in 1997,” which allows pharmaceutical companies to “conceal critical safety risks” in their DTC advertisements. Before the adoption of the adequate provision rule, DTC advertisements were obligated to include full boxed warnings and clearly state all risks. Further, in the 1990s, over 130 enforcement letters were issued annually to ensure compliance. After 1997, pharmaceutical companies circumvented these rigorous requirements due to the ease of restrictions, which permitted them to only include the most prevalent risks. This led to a profound increase in DTC advertisements, and in 2024, pharmaceutical companies spent $10.8 billion on advertising. From 1997 to 2016, there was a 460% increase in DTC advertisement spending.

Pharmaceutical companies have used the rise of social media to expand DTC advertising. However, according to the FDA, 88% of top-selling drug advertisements on social media allegedly failed to comply with the agency’s requirements of balanced information. Phase three of the Administration’s reform targets influencer partnerships, sponsored advertisements, and AI-generated content.

While the Trump Administration has illuminated the negative effects of DTC advertising, it is vital also to consider positive factors. The increase in patient exposure to drug advertisements provides crucial information about possible treatments or relief, and allows patients to make inquiries with their doctors. Additionally, DTC advertisements permit individuals to stay informed about pioneering developments in the pharmaceutical industry. With heightened awareness, the word-of-mouth spread of positive experiences can help inform others about possible treatment avenues.

President Trump’s DTC advertisement restriction is likely to be met with legal ramifications. Legal action to challenge the paradigm shift would plausibly be focused on First Amendment and commercial free speech rights. A 1980 Supreme Court case, Central Hudson Gas & Electric Corporation v. Public Service Commission of New York, established a four-part test to evaluate the constitutionality of regulation. Essentially, Trump’s administration would have to affirm that their regulations would strictly benefit public health—yet pharmaceutical companies could adequately counter-argue using the aforementioned positive factors. To efficiently navigate this evolving climate, pharmaceutical companies and the government should collaborate on policies going forward.

The Future of Abortion Pill Mifepristone Now Uncertain as it Faces a New Missouri District Judge

The US District Court for the Eastern District of Missouri is the new battleground for the legal fight over access to the abortion pill Mifepristone. This development comes after the Supreme Court remanded Judge Matthew Kacsmaryk’s injunction against the FDA’s current regulations on the drug last summer, ruling the case had no legal standing in Texas. Given the options to dismiss the case or transfer it to another venue, Judge Kacsmaryk announced his decision to transfer the case to the Eastern District of Missouri.

The Attorney Generals for Missouri, Idaho, and Kansas joined the plaintiff, the Alliance for Hippocratic Medicine, last October to challenge the FDA’s restrictions on Mifepristone.

Their arguments challenging the FDA’s 2000 approval of Mifepristone center around claims that the drug is unsafe, citing statistics that 3-5% of women who take Mifepristone end up hospitalized due to complications from the medication. The plaintiffs are advocating for the reinstatement of previous regulations surrounding the drug, including rolling back the Mifepristone REMS program, which allows the medication to be dispensed by mail. Additionally, they’re requesting that the FDA implement new regulations requiring three in-person doctor visits before access to Mifepristone is granted. Given that medical abortions made up 63% of all abortions in 2023, restricting access to this abortion medication would have a significant impact nationwide.

This latest development leads to new apprehensions for reproductive health advocates. One such concern is how the new Missouri venue may grant the plaintiff, specifically the Attorney General of Missouri, an advantage in the forthcoming litigation.  The pool of judges is also a worry in reproductive rights groups. Among Missouri district judges who could hear this case are Zachary Blueston and Christian Stevens, who were both nominated to the court by the Trump Administration. Other potential judges include Joshua Divine and Maria Lanahan, two more Trump nominations who both represented Missouri in prior Mifepristone litigation earlier this year. The Trump Administration has been public about its pro-life views and has already taken steps to cut access to abortion. More recently, the Administration expressed skepticism about Mifepristone. These findings suggest that the judges who may potentially preside over the Mifepristone case already have anti-abortion biases that reproductive health advocates are worried will reflect in the court’s ultimate decision.

The Eastern District of Missouri has not publicly announced whether it will accept the case, nor given any statement about who the presiding judge might be. Now that this case has gone up and back down from the Supreme Court, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration is up for a second round of litigation. It is to be seen if the battle will reach its climax in Eastern Missouri’s District Court.

The Trump Administration Issues Inconsistent Guidance Regarding Acetaminophen and Autism

The current presidential administration has placed significant focus on addressing a cited increase in the rate of autism diagnoses. Late last month, President Trump, alongside the Health Secretary, Robert F. Kennedy Jr., issued new health guidance and announced in a press conference that there is evidence of a link between the use of acetaminophen during pregnancy and neurological effects, specifically autism and attention-deficit/hyperactivity disorder (ADHD), in children post-birth. The announcement was coupled with a notice from the U.S. Food and Drug Administration (FDA) that it plans to initiate a process for a label change on acetaminophen products to inform consumers of the link, as well as a letter issued by the FDA to physicians about the potential link. The FDA’s letter specifies that “a causal relationship has not been established” between use of the medication and autism, while also asserting that clinicians may want to suggest pregnant people reduce their use of the medication. The issuance of sweeping advice from the Trump Administration in light of these inconsistencies is unsettling from a public health perspective because acetaminophen remains the recommended drug for fever reduction in pregnant people. The guidance to minimize acetaminophen use could be harmful for pregnant people because it may lead them to endure unnecessary pain and fever, which are dangerous for the pregnant person and the fetus.

In addition, mixed messages have created confusion in the legal context because of the announcement’s reliance on a study that was previously found inadmissible by a judge. In 2022, a group of families sued the maker of Tylenol, an acetaminophen product, for failure to warn consumers of the risk that prenatal exposure to the medication may create a heightened risk of autism. One of the experts used to support the families’ proposition was Andrea Baccarelli, MD, PhD, who was also cited in the Trump Administration’s recent announcement. The judge rejected this expert, as well as all of the families’ other experts, in an order in 2023, stating that the experts had “cherry-picked” data in their analyses. The case was subsequently dismissed in 2024, and the dismissal is currently on appeal.

In light of the executive branch’s reliance on one of the same experts as the families, the plaintiffs’ attorney has filed a letter with the court in support of their appeal, noting that the expert had been relied upon in the conclusions of a recent White House briefing. The lawyer notes the separation of power concerns that would arise if the ruling that this expert’s opinions are inadmissible in court is affirmed, while the opinions are simultaneously cited as valid by the executive branch. On the other hand, the attorney for Tylenol in the same lawsuit has also filed his own letter referencing the advice put out by the Trump administration as support of the defendant’s position that they have not failed to include any warning of a link to autism on their products. The defendant’s lawyer cites the language in the FDA’s letter to doctors stating that there is no causal relationship between the drug and autism. In light of each of letters, the judge has pushed back oral argument on this appeal that was set to occur on October 6, 2025 to November 17, 2025.

The use of the Trump administration’s guidance in this litigation to both support and disprove a link between Tylenol and autism emphasizes the confusion the new health guidance has created. What does this mean going forward? In the immediate future, the guidance may create fear among pregnant people about treating their pain and fever during pregnancy. If moving forward, the guidance does successfully ignite litigation aimed at a requirement to label acetaminophen products as not recommended during pregnancy, it could lead to an increase in pregnant people leaving pain and fever untreated during pregnancy, potentially putting them in danger of other complications.

Tribal Youth vs TikTok: The Fight to Protect Native American Mental Health

As technology becomes more salient in everyday life, American youth now collectively spend more time on screens than any other leisure activity. In fact, around half of American teenagers ages 12-17 self-reported four or more hours of screen time per day. Of those teenagers with four plus hours of screen time, about 25% of them showed symptoms of anxiety or depression in the past two weeks. 

The negative effects of adolescents’ high exposure to screen time are well researched, particularly its negative effects on mental health. Studies have shown that excessive screen time exposure increases the risk of depression, sleep disorders, social isolation, and other mental health issues among children and adolescents. Between 2017 and 2019, social media, one of the main sources of screen time, was associated with 30% of adolescent suicides, the leading cause of adolescent death.

A particularly vulnerable group to struggles with mental health is Native American communities. Out of all ethnoracial groups, Native Americans have the highest rates of mortality from deaths of despair (e.g., suicide, overdose, alcohol-associated liver failure). A long and dark history of oppression, forced assimilation, and violence has left thousands of Native Americans suffering from multi-generational trauma, manifesting itself in mental illness, substance use disorders, and suicide. Despite the increased need for mental health services in Native American communities, many barriers continue to limit access. Lack of funding, poverty, rural and isolated locations, mistrust in government services, and mental healthcare providers’ lack of cultural competency are only a few of the many ways access to mental health care is restricted. The historic and continuous discrimination of Native American peoples, coupled with the barriers to mental health care services, leaves these communities in a unique position of vulnerability.   

The epidemic of social media has been felt acutely amongst many Native American tribes. On September 15, 2025, the Chickasaw Nation became the latest of about half a dozen Native American Tribes to lodge claims against social media platforms. These claims allege the companies’ products (Facebook, TikTok, Instagram, etc.) are harming their youth, who are already at disproportionate risk of mental health problems and suicidal ideation. The suit claims that social media platforms design their product to addict young users and profit from their addiction. Approximately 65% of tribal youth spend three to seven hours a day on social media, reporting difficulties with time management and impulse control related to social media use. On January 8, 2025, an Apache tribe filed an extremely similar suit, alleging that these platforms have put profit above all else at the expense of the cognitive development of the tribe’s children and their vulnerability to mental health problems. 

The uptick of cases filed by Native American tribes is a small part of a larger trend in the legal community aiming to hold social media companies accountable for designing their platforms to be addictive to children and adolescents without warning of the mental and physical harm that follows. While companies like Meta, the owner of Instagram and Facebook, have made efforts to improve the safety of young users, such as Parental controls, many claims have introduced evidence suggesting their safety initiatives are little more than PR stunts. It will be crucial for regulators and lawmakers to consider the evidence produced from these lawsuits when making important decisions about the future of social media regulations.

Years of published research have time and again shown that increased social media use can lead to concerning mental health issues among children and adolescents, especially among populations who are already at an increased risk. Yet social media companies are failing to protect their most vulnerable users, children. The trend in Native American tribe suits against social media tycoons is not only crucial in repairing, restoring, and preventing the mental health crisis among young Native Americans but also a crucial step in protecting vulnerable children and adolescents across the country.