Tag: health law

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.

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 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.

The Disproportionate Impacts of Obstetric Violence on Minority Women

Serena Williams is a superstar tennis player and a force to be reckoned with, especially after sharing her harrowing postnatal experience. Williams has a history of pulmonary embolisms, and the day after giving birth to her daughter via C-section, she had trouble breathing and believed she was experiencing a blood clot. After Williams alerted a nurse, the nurse suggested Williams’s pain medication left her confused and instead insisted a doctor perform an ultrasound on her legs. Doctors ignored Williams, who knew she needed a CT scan and heparin drip. This dismissal of Williams’ concerns delayed the discovery of several blood clots in her lungs and a large hematoma in Williams’ abdomen, near her C-section wound; she was placed on six-week’s bedrest following this event. Williams’ deeply upsetting interaction with her doctors is not uncommon for new mothers in the days following childbirth, especially among minority women.

Between 700 and 900 women die yearly from complications stemming from pregnancy and childbirth. For every death, there are a handful of women who suffer life-threatening birth injuries. There is a notable racial disparity in the figures, and black women are seventy-five percent more likely to experience a traumatic birth compared to white women. Traumatic birth experiences often result from obstetric violence, a notion that encompasses disrespectful attitudes from doctors, discrimination from care providers, and lack of consent for treatment. In 2016, the American College of Gynecologists published a committee opinion outlining that a “decisionally capable” woman has the right to refuse certain treatments while she is in labor. Furthermore, the College strongly discouraged “manipulation [and] coercion” to influence a woman’s treatment decision. Although this opinion offers guidance to practitioners, it is not binding, and many women nonetheless face varying forms of obstetric violence.

Obstetric violence is especially severe for women of
color due to the widespread discrimination within the maternity care field. The CDC notes that
Black women in the US are three times more likely to die from childbirth-related issues than white
women. Across the country, the maternal mortality rate has risen to 17.3 maternal deaths per 100,000 births.
The United States is one of only a select handful of
countries where the maternal
mortality rate is worse now than it was 25 years ago.

Anecdotal evidence
from doulas in Milwaukee and Washington, D.C., both cities that support a large
low-income and Black population, reveals how doctors often justify acts of
obstetric violence by feigning paternalistic worry and falsely claiming either
the mother or infant were in danger. Additionally, it is well-established that black women fare worse in pregnancy, and growing evidence points to a low quality of care
in hospitals where black women seek maternal care, which are often found in
highly segregated areas. Research has also indicated that women who deliver in
these hospitals are more
likely to have complications
from birth-related embolisms and hysterectomies. Black women believe their concerns
are not addressed by their healthcare teams; for many women of color, the news of a baby
evokes fear rather than joy because these women know of the alarming trends and
how treatment teams may disregard their wishes and concerns.

In the wake of the CDC and WHO data on obstetric
violence and maternal mortality rates, legislators have signed H.R. 1318/S. 1112,
which supports states to put an end to preventable maternal deaths.
Additionally, Senator Kamala Harris introduced the Maternal Care Access Reducing Emergencies Act meant to promote training programs for healthcare
professionals that would address implicit biased based on stereotypes. Until the
legislation takes effect, organizations like Improving Birth and Birth Monopoly
will continue advocating for women who have faced obstetric violence.

Blockchain’s Promise for the Future of Healthcare

In the winter of 2017, the world was captivated by the rise
and fall of Bitcoin. Every night during its historic rise, local
news ran rags-to-riches
stories of basement investors who had cashed out at the right time.
Every day, bloggers, tech journalists, and finance journalists tried to diagnose
the market and divine what portents this fluctuation may hold for
the future. Even before Bitcoin hit its fever pitch in December of 2017, the
national conversation focused on the technology powering it – Blockchain. Intrigued
by the success of Bitcoin, industry leaders sought to understand Blockchain’s structure,
potential, and capabilities. Although the Bitcoin craze eventually came to an
end, the conversation over Blockchain continues and it is now positioned to
make inroads into the healthcare industry.

Blockchain, in its modern form, was
created in the fallout of the 2008 financial crises. It is “[a] digital
record or ledger [mini database] that is structured as a series of blocks that
are strung together in a chain. Each block—a digital expression of a
transaction or an event—is validated by multiple computers on the internet.”
Blockchain is also highly secure by distributing “blockchains” to millions
of computers, creating a decentralized
database.

This combined ability to both secure and share files
simultaneously makes Blockchain an attractive new frontier for the healthcare industry.
Large
healthcare providers such as Cigna, Aetna, and Sentara Health have
signed onto Blockchain pilot programs; even Apple
signaled interest in Blockchain applications. In
2018, 45% of the healthcare industry experimented with Blockchain
applications and 11% of the industry deployed Blockchain applications for use
in business. By 2025, it is projected that 55%
“of healthcare applications will have adopted Blockchain for commercial
deployment.”

This growing trend of Blockchain’s presence in healthcare is
due to the enormous benefits the system presents. Cognizant’s
2017 report, “Healthcare: Blockchain’s Curative Potential for
Healthcare Efficiency and Quality,” identifies top benefits that healthcare
organizations could gain through its implementation, such as strengthened data
security and improved interoperability. As Cognizant’s
report states, “Blockchain technology enhances privacy through
modern public key encryption techniques, reinforces data integrity with its
properties of immutability, and improves security with its decentralized data
model” allowing for improved patient care through data interoperability between
different care providers. Deloitte’s 2018 global Blockchain
survey also identifies areas where Blockchain will provide
significant value, such as disintermediation, transparency and auditability,
and industry collaboration.

These advantages present
solutions to long-standing problems that have plagued the industry’s
ability to modernize, specifically the ability to digitize
patient records into Electronic Health Records. Blockchain’s decentralized
data also provides a single authoritative source for patient records resulting
in lower cost for patients, better collaboration between professionals, and
increased efficiency for providers. Full realization of these benefits has the
potential to revolutionize and modernize the healthcare industry and drastically
increase the quality of care that patients receive.

Yet Blockchain’s real world implementation highlighted some operational hurdles. The Mayor’s office of Austin, Texas undertook a project called the “MyPass Initiative” to utilize Blockchain technology to improve the city’s homeless services by replacing paper records with “electronic encrypted records that would be more reliable and secure.” The initiative aims to “consolidate the identity and vital records of each homeless person in a safe and confidential way while providing a means for service providers to access that information.” Yet the program faces difficulties such as social buy-in and a reliable way to connect a person with an identity, which can hamper full implementation and in turn preclude the complete realization of the initiative’s benefits. These challenges are not insurmountable and overcoming them will pave the way for larger implementation of Blockchain technology in fields such as healthcare.

Blockchain’s utilization in healthcare is nowhere near complete, but its capabilities and potential operational effectiveness are becoming clear to industry leaders. Its promise to improve patient care through better interoperability, heightened data security, and lower cost is a benefit that the healthcare industry has long been looking to provide to patients. With growing industry engagement with Blockchain technologies and continued innovative pilot programs, such as Austin’s MyPass Initiative, we move ever closer to realizing Blockchain’s promise for the future of healthcare.

The ACA Twilight Zone

Death by a thousand cuts has been the Trump Administration’s approach to the Affordable Care Act (ACA).  To be sure, President Trump  tweeted on April 23, 2017 that “ObamaCare is in serious trouble.”  On October 13, 2017, he tweeted, “ObamaCare is a broken mess. Piece by piece we will now begin the process of giving America the great HealthCare it deserves!”  On May 30, 2018, he stated: “For the most part, we will have gotten rid of a majority of Obamacare.”  And on June 4, 2018, he tweeted, “We had Repeal & Replace done (and the saving to our country of one trillion dollars) except for one person, but it is getting done anyway. Individual Mandate is gone and great, less expensive plans will be announced this month.”

In the courts, the ACA has certainly been no stranger to the artful attack.  But two lawsuits, one filed in Texas and the other in Maryland, have gained nationwide traction and hold nationwide consequences.  The first suit, Texas v. US, made its way to U.S. District Court Judge Reed O’Connor’s bench in the Northern District of Texas.  The 20-state GOP led suit was filed on February 26, 2018 by Texas Attorney General Ken Paxton.  It argues that since the ACA was only upheld by the Supreme Court in NFIB v. Sebelius because the individual mandate was a tax, and now that the Tax Cut and Jobs Act of 2017 (TCJA) zeroed-out the individual mandate penalty, the entire ACA is unconstitutional.  The Plaintiff-states also argue that since the ACA does not have a severability clause – a clause that would allow the rest of the statute to live if one part is stricken – the ACA as a whole must fall.

Under Attorney General Jeff Sessions direction, the government will not defend the ACA’s constitutionality.  Defending the ACA, and its patient protections like the prohibition on insurers from discriminating against patients with pre-existing conditions, are 17 Democratic attorneys general representing their respective states as Intervenor-Defendants.  A slew of patient groups and scholars filed amicus briefs in support of the Intervenor-Defendants, but only Citizens United filed as amicus in favor of the Plaintiff-States.  The American Cancer Society Cancer Action Network filed as amicus, urging the court to uphold the ACA and to “recognize Congress’s clear intent to improve access to lifesaving health care for millions of Americans.”  A bipartisan group of law professors filed as amicus, arguing that “[t]he arguments of both the plaintiff States and the United States on the severability of the insurance mandate from the other provisions of the ACA are inconsistent with settled law.”  On July 19, 2018, Senate Democrats introduced a Senate resolution that would authorize Senate Legal Counsel to intervene in Texas v. US to defend the ACA’s patient protections for people with pre-existing conditions.

The second suit, City of Columbus v. Trump, filed on August 2, 2018 by the Cities of Baltimore, Chicago, Columbus, and Cincinnati in the U.S. District Court for the District of Maryland alleges that the Trump Administration’s actions over the last several years amount to an unconstitutional sabotage of the law the President is required to faithfully execute.  The suit makes two claims: the first claim that the Administration is acting arbitrarily and capriciously, and the second that President Trump is violating the “Take Care” Clause of the Constitution.  Under the Take Care Clause of the U.S. Constitution, the President and his or her Administration must “take care that the laws be faithfully executed.” U.S. Const. art. II, § 3.  The suit cites a range of administrative actions taken to sabotage the ACA and have the aim and effect of weakening ACA exchanges, driving up premiums, and driving out issuers, ultimately increasing the rate of the uninsured and underinsured.

Judge O’Connor, after first announcing that oral arguments in Texas v. US would take place on Monday, September 10, moved up oral arguments to Wednesday, September 5, at 9:30 a.m.  At the same time in Washington, D.C., Supreme Court nominee Brett Kavanaugh will be testifying before the Senate Judiciary Committee for potential confirmation.  As some have noted, the fate of the ACA could turn on Kavanaugh’s appointment to the Supreme Court.  Kavanaugh’s preeminent views on separation of powers and his textualist-meets-originalist approach to statutory interpretation is consistent and can be expected to appear in his opinions, but is alarming to health care advocates and patients.  Kavanaugh’s jurisprudence shows that he cares deeply about administrative law and is unlikely to “deconstruct the administrative state,” but he is likely to “put a tighter leash on the regulatory state.”  In all, the fate of the ACA remains to be seen.