Category: Blog

Acetaminophen, Pregnancy, and Neurodevelopment: What the Science Really Says

Acetaminophen, more commonly recognized by the brand name Tylenol, has been recommended by physicians to pregnant women as a safe fever-reducer and effective pain-reliever for decades. However, in September of this year, President Donald Trump and U.S. Health and Human Services Secretary Robert F. Kennedy Jr. issued a warning regarding a supposed link between Tylenol use during pregnancy and an increased risk of autism in children. These warnings have received massive media attention and spread rapidly across social media platforms, but the scientific evidence behind these claims remains far from conclusive.

The warnings and statements presented by President Trump and Secretary Kennedy risk confusing the public by blurring the crucial distinction between correlation and causation. Correlation merely suggests that two variables are related in some way, while causation indicates that a change in one variable directly causes a change in the other. The difference may sound subtle, but in science and law it is fundamental. Correlation alone is insufficient to prove a cause-and-effect relationship, as other confounding variables may be present. The studies cited by President Trump and Secretary Kennedy merely demonstrate correlation; none provide credible evidence that Tylenol use during pregnancy causes autism in children.

A comprehensive review of 46 studies investigating the relationship between Tylenol use during pregnancy and neurodevelopmental disorders found that more than half showed only minimal associations, while the remainder showed no evidence of increased risk whatsoever. In another large-scale Swedish study involving 2,480,797 children born from 1995 to 2019,  researchers found no statistically significant link between prenatal Tylenol use and autism in children. Additionally, the U.S. Food and Drug Administration (FDA) has reiterated that no causal relationship has been established between Tylenol and neurodevelopmental disorders.

Despite this, President Trump has gone so far as to advise pregnant women to “tough it out” and avoid Tylenol entirely. Yet Tylenol is commonly taken for fever and pain, both of which can pose serious health risks if left untreated. In fact, research suggests that untreated fever during pregnancy may increase the risk for autism in the child as much as forty percent in the second trimester, and more than 300 percent for pregnant women who reported three or more fevers after the twelfth week of pregnancy.

Discouraging pregnant women from using Tylenol, the only over-the-counter pain-reliever approved to use while pregnant, could increase health risks for both mothers and their unborn children. Without access to safe fever and pain management, women may turn to unsafe alternatives or endure conditions that themselves elevate the risk of poor health and pregnancy outcomes.

From a legal perspective, the warnings presented by President Trump and Secretary Kennedy raise significant concerns. The FDA has initiated a process to update the labeling of products containing Tylenol in response to the claims of a potential association between pregnancy use and neurodevelopmental disorders, despite the lack of evidence establishing causation. Manufacturers of Tylenol could be exposed to product-liability litigation because the label change process shifts the standard of care and opens the door to claims of inadequate warnings or information. Additionally, when a highly influential public figure advises pregnant women to “tough it out” and avoid the only approved over-the-counter pain-reliever for use in pregnancy, healthcare providers could face increased exposure to malpractice claims if fever or pain in pregnancy is left untreated and injury results. The discourse created by the warnings from President Trump risks generating confusion among pregnant women about safe Tylenol use, which may lead to under-treatment of fever or pain or even to the substitution of Tylenol with less safe alternatives, increasing potential legal exposure across providers, insurers, and manufacturers.

As of now, both the FDA and the Centers for Disease Control (CDC) continue to advise that acetaminophen remains the safest and most effective over-the-counter pain relief option for pregnant women.

Florida Lawmakers Hope to Close Medical Malpractice Loophole with House Bill 6003

Earlier this month, Florida lawmakers introduced House Bill 6003 to close the “deadly legal loophole” for the current medical malpractice law. Under current Florida medical malpractice law, people who are 25 years old or older cannot collect “non-economic” damages for the wrongful death of a family member who is also 25 years or older. House Bill 6003 would “restore the rights  of certain adults and adult children to recover non-economic damages in wrongful death cases tied to medical negligence.” The Republican lawmaker who introduced House Bill 6003, Dana Trabulsy, asked, “How is it just for a family to be able to recover non-economic damages when their loved one died from a car accident, but not for a death related to medical malpractice?”      

     

As of 2024, Florida is currently ranked number two for having the most medical malpractice suits and payouts in the country. Despite this high number, there has been an uproar among families who have lost a loved one and were prevented from seeking justice for their family member’s wrongful death. Florida Governor Ron DeSantis, vetoed a previous version of House Bill 6003 in May 2025. DeSantis sided with opponents concerned that physicians would be reluctant to move to Florida, and practicing physicians would move away from Florida due to the fear of being sued for medical negligence. One orthopedic surgeon from Tallahassee was quoted saying, “if you actually want physicians who are well trained, well-experienced, to stay here in Florida and take care of you and your patients, you need to reconsider this.” However, doctors should not fear if they are “well-trained and well-experienced,” because the probability of committing medical negligence would be low.

Misdiagnosis, delay of diagnosis, and surgical errors are among the biggest causes of medical negligence. As of now, in Florida, patients who are 25 years and older may not be receiving the best possible care due to the lack of accountability placed on physicians if their actions result in medical negligence. If House Bill 6003 is passed and repeals the current Florida law, then the effect of House Bill 6003 would indirectly impose stricter health compliance and standards upon physicians to provide the best care and exercise the utmost caution to avoid committing medical negligence. Those physicians who may take shortcuts or minimize patients’ voices and concerns are more likely to be affected by House Bill 6003 because their actions are the ones that are more likely to result in medical negligence to the extent that it results in a wrongful death. So, would the implications of House Bill 6003 really be that detrimental to the healthcare field in Florida? 

As of October 15, 2025, House Bill 6003 is currently being reviewed by the judiciary committee in the House. House Bill 6003 bill has the potential to decrease medical negligence cases overall by holding physicians more accountable and elevating patients’ voices to ensure the best care and utmost caution are being provided and exercised. Florida’s lawmakers are commendably taking a step towards reshaping justice and restoring health rights for many of its residents.

Detaining Medical Information: The Growing Threat to Immigrants’ Health Care Access

Emboldened by President Trump, armed and masked immigration enforcement agents are increasingly threatening the public and conducting raids to detain people whom they suspect are undocumented immigrants. Attention, both in popular and social media, has primarily focused on immigration enforcement in areas once considered safe, including raids occurring in schools, public parks, and grocery stores. However, these highly publicized incidents overshadow an alarming immigration enforcement and detention strategy—confiscating immigrants’ medical information. 

This past June, the Trump Administration granted Immigration and Customs Enforcement (ICE) officials access to the personal information of millions of Medicaid enrollees. This information included home addresses, ethnicities, social security numbers, and even immigration status. Initially, U.S. Department of Health and Human Services (HHS) officials stated that the goal of the transfer was to disqualify those improperly enrolled in Medicaid. The Associated Press, however, obtained a copy of the agreement between the Centers for Medicare & Medicaid Services and the Department of Homeland Security, which indicates that the purpose of the data is to allow ICE to “find the location of aliens.” It seems that it is no coincidence that the states targeted in the data transfer—California, New York, Washington, Oregon, Illinois, Minnesota, and Colorado—all have programs that allow non-citizens to enroll in Medicaid. 

In response, 20 states sued the federal government, arguing that the data release violated federal health privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA). In August, a federal judge issued a partial preliminary injunction precluding ICE from using the accessed data. Citing key cases such as FCC v. Prometheus Radio Project and FCC v. Fox Television Stations, Inc., Judge Vince Chhabria found that the government’s decision was arbitrary and capricious. As the case continues to play out in the courts, it is imperative to discuss its implications for privacy concerns and, more importantly, the intense chilling effect it will create, both in the present day and potentially for decades to come.

Now that such medical information, which includes citizenship status, is in the possession of ICE, there is certainly a fear that this information will be used to track down and detain immigrants (or those who may appear as undocumented immigrants to authorities). But beyond the looming threat of ICE using the data to detain people, there is also a harmful chilling effect: immigrants are reporting that they are avoiding health care facilities entirely. 

The relationship between immigrants and the United States health care system was already precarious. Examples of systematic, repeated racism in the health care system have already strained migrants’ trust. Furthermore, there are several documented cases in which doctors have engaged in medical care without informed consent or conducted unethical research on immigrants. These stories and incidents have created enduring narratives that understandably engender distrust in the American health system. As a result of these deeply embedded fears, immigrant communities are more likely to attempt to avoid the health care system altogether until their health situation becomes dire. 

ICE’s entanglement in our health care system is a moral and economic injury. Managing an effective health care system needs more than just surgical kits, prescriptions, and check-ins. It requires fostering a safe environment where people, regardless of their citizenship status, can receive the care they need. Furthermore, it is commonly cited that immigrants invest more in American health care than they deduct. Several health policy scholars have demonstrated that ensuring communities have access to preventative health care is cost-saving for the country’s overall economy.

Freely handing sensitive Medicaid data to ICE is a betrayal of the core values of health care: autonomy, trust, and privacy. The fear of detention since Trump’s first presidency already loomed over immigrant communities. However, this distrust and fear are now magnitudes worse due to the cruel and novel tactics now being employed by ICE. Embedding immigration enforcement within health care is harmful; some may even argue that the goals of the two institutions are inherently at odds. As ICE raids increase in intensity across the country and immigrants become increasingly aware that their data is now in possession of ICE, this fear––and resulting harm––will grow. 

Mental Health Parity: A Question of Agency Authority

A recent legal challenge to a key mental health parity law sparks conversations about federal agencies’ power to interpret and enforce statutes. Earlier this year, the Employee Retirement Income Security Act Industry Committee (ERIC) filed a lawsuit against the Department of Health and Human Services (HHS), the Department of Labor (DOL), and the Treasury, regarding the enforcement of the updated 2024 Mental Health Parity and Addiction Equity Act (MHPAEA).

MHPAEA was enacted in 2008 to address disparities in benefits between mental health or substance use disorder (MH/SUD) treatment and medical/surgical (M/S) services. Under MHPAEA, MH/SUD treatment and financial limits must not be more restrictive than those for M/S services, and MH/SUD benefits cannot have separate limits that are not also applied to M/S benefits. In practice, the law required health plans and healthcare facilities to cover MH/SUD services in the same way as M/S services. 

A 2013 Rule updated MHPAEA, clarifying ambiguity about parity for non-quantitative treatment limits (NQTLs), such as prior authorizations, network adequacy, medical necessity standards, and step therapies. This Rule also confirms that parity applies across all care levels, including outpatient, inpatient, and “intermediate” behavioral health settings. 

Enforcing compliance with insurance plans under MHPAEA was difficult because the Act did not require strong proof of adherence. The 2021 Consolidated Appropriations Act (CAA) addressed this issue by requiring a comparative analysis of health plans to demonstrate parity between MH/SUD and M/S services, specifically NQTLs, and by allowing federal agency audits and on-demand submissions from health plans. 

The 2024 Final Rule aimed to improve enforceability further and reduce ambiguity across employer plans (ERISA), ACA marketplace plans, and Managed Care plans through several new standards: requirements to report NQTL comparative analysis data to federal agencies and beneficiaries with clear explanations, fiduciary certification for ERISA plans, a more detailed NQTL collection and reporting process, and a standard that ensures plans offering any MH/SUD benefits provide meaningful material benefits in every classification that the plan also offers M/S benefits. 

ERIC filed a lawsuit on January 17, 2025, with several allegations against the implementation of the 2024 Final Rule. First, ERIC argued that the Final Rule is too vague in guiding the collection and reporting of NQTL outcome measures and in addressing and fixing material differences in MH/SUD and M/S benefits. ERIC also claimed that many of these measures, now required for collection, could be affected by external factors that might hinder payers’ ability to remain compliant.

Additionally, ERIC questioned the scope of the Final Rule, arguing that the 1:1 requirement for MH/SUD and M/S benefits across all classifications exceeds the Act’s scope and intent. Finally, ERIC challenged the applicability date of January 1, 2025, claiming that it offers too little time for employers/agencies to make the necessary adjustments to comply. Throughout their complaint, ERIC argued that HHS, DOL, and the Treasury violated the Administrative Procedure Act by creating and enforcing what they describe as a vague and overbroad regulation. 

On May 12, 2025, the U.S. District Court for the District of Columbia agreed to stay ERIC’s lawsuit after the Tri-Agencies made a motion for abeyance to consider rescinding or modifying the 2024 Rule. The agencies also issued a non-enforcement policy for the components of the Rule that took effect in January 2025 or were set to take effect in 2026.

Several advocacy organizations and provider-focused trade associations have criticized the decision not to enforce, claiming that it harms agencies’ ability to implement and enforce aspects of the 2021 additions to MHPAEA, while also inhibiting critical steps to ensure more detailed analysis of parity and leaving room for health insurers to take advantage of potential loopholes.

Following the Supreme Court’s decision in Loper Bright v. Raimando, debates over federal agency authority and explicit statutory authorization requirements have become more common. ERIC’s complaint, in large part, focuses on concerns regarding agency overreach in interpreting and enforcing statutes. Lawsuits like this are likely to play a part in setting a precedent for what constitutes an acceptable scope for federal agency interpretation and enforcement of statutes governing their authority.

Lawsuits Continue to Spike for Ozempic: Express Warranty Claims for the Drug Manufacturer

Ozempic and other GLP-1 medications have taken center stage in popular culture, reshaping how Americans think about weight loss, but they are not encountering growing legal challenges. Ozempic and related GLP-1 medications have been dominating popular culture and reframing how the entire country approaches weight loss but are now facing increasing legal challenges. Ozempic and GLP-1s are a tool for weight loss, but if it sounds too good to be true, that might just be because it is. With the rapid consumption of these medications, consumers are mounting lawsuits against the drug manufacturers for extended warranty claims, failure to warn of potential side effects, and risk association.

Originally intended for Type 2 Diabetes, Ozempic’s notoriety lies with the off-label weight loss side effect. According to the CDC, 42% of Americans suffer from obesity. GLP-1 agonists are glucose-like peptide-1,  a class of medications that lowers your blood sugar (glucose) levels to help manage and treat diabetes, but also treats obesity. Approved by the Federal Drug Administration (FDA) as a medication for diabetes, its popularity on social media and advertising has been aligned with the off-label use for weight loss. These medications reduce hunger levels and trigger insulin responses in your body by inducing naturally occurring hormones. These “Ozempic Drugs” have different names and ingredients, but all the big-name brands of this class of medications are “Ozempic” and “Wegovy,” which share the same ingredient, alongside others such as “Zepbound” and “Mounjaro”. While originally intended for the demographic of diabetes impacted individuals and those with a high BMI, the drug has become readily accessible to celebrities and individuals looking for a weight-loss supplement due to its rapid weight loss effects without the traditional output effects like intense dieting or extensive exercise.

Despite the success of the drug in treatments beyond diabetes, the lawsuits demonstrate concern about the potential, and sometimes permanent, side effects of taking these weight-loss drugs. Ozempic is manufactured by Novo Nordisk and has already amassed over 1800 lawsuits consolidated into federal multidistrict litigation, with experts estimating over $2 billion in total liability, and growing. Affected patients are claiming to have developed symptoms like gastroparesis (stomach paralysis), intestinal blockages, gallbladder and kidney injuries, alongside vision loss. The suit’s main claim is the drug manufacturer’s failure to warn patients of the potential side effects.  Litigation is in its early stages for manufacturers, but it sheds important light on the safety concerns, informed consent, and what risks should be disclosed when participating in such a popular class of medications. These recent legal disputes imply that drug manufacturers have not been explicit with warnings and potential harm associated with a semiglutide compound, and consumers should take time to consider if this is the right choice for them before starting.

With Ozempic and other GLP-1s impacting the way society views weight loss, experts see a future where many more of us are taking them. The public should recognize that pharmaceutical medications should be a tool in approaching obesity regulation, not the only approach. Having a balanced approach to weight management strategies will reduce the reliance on these medications and offset the amount of adverse consequences patients are facing from taking these medications. The fast-growing market for these medications will have lasting effects on society, and the legal implications should caution people taking or planning on taking these medications to know the risks associated with them. Drug companies should implement more comprehensive policies that will adequately warn people of the adverse side effects of these medications. The legal landscape in the future will be influenced by the increasing complexity of mainstream medications and how these large drug companies structure their warning labels.

The Affordable Care Act’s Impact in Reducing the Uninsured Rate in America & the Upcoming Health Insurance Cliff

In March 2010, President Barack Obama signed the Patient Protection & Affordable Care Act, commonly known as the ACA or Obamacare, into law. One of the legislation’s main goals was to reduce the number of Americans lacking health insurance coverage. Between the law’s passage in 2010 and 2023, the number of uninsured Americans fell from 46.5 million to 25.3 million.

The ACA sought to increase health insurance coverage for Americans through two main mechanisms: Medicaid expansion and subsidies for Americans to buy insurance through the health insurance marketplaces administered by the federal government and many states. The ACA sought to expand the number of adults under the age of 65 eligible for Medicaid, a jointly funded federal and state program, which traditionally provided coverage to the lowest income Americans. Specifically, the maximum income eligibility threshold for most Medicaid members effectively increased from 100 to 138% of the federal poverty level. However, the Supreme Court, in National Federation of Independent Business v. Sebelius, ruled that states could choose whether to expand Medicaid in their states. As of 2025, 10 states, including populous states such as Texas and Florida, have still not expanded Medicaid.

For Americans ineligible for Medicaid and earning less than 400% of the federal poverty level annually, the Affordable Care Act provides subsidies in the form of a tax credit, the Advanced Premium Tax Credit (APTC), to help people afford their health insurance premiums. By 2019, the number of uninsured Americans had fallen to 28.9 million.

In 2021, President Joe Biden signed the American Rescue Plan Act (ARPA) into law. The legislation provided enhanced subsidies, known as the Enhanced Premium Tax Credit (EPTC), which expanded assistance to Americans seeking to purchase health insurance through the ACA marketplaces. Specifically, ARPA removed the cap on premium tax credits for those making more than 400% of the federal poverty level, providing subsidies for middle-income Americans for the first time. The EPTCs have been successful in increasing health insurance coverage through the ACA marketplaces, as a record 21 million Americans purchased insurance coverage through the marketplace in 2024. Bolstered by these subsidies, a low unemployment rate, and pandemic-era policies protecting Medicaid coverage, the nation’s uninsured rate reached a record low 7.9% in early 2023.

The EPTCs are currently set to expire at the end of 2025, as they were not extended in the One Big Beautiful Bill Act signed into law by President Donald Trump in July. In fact, the EPTCs have become more important in the health safety net because of the impact of the One Beautiful Bill Act’s cuts to Medicaid and other assistance for low- and middle-income Americans, which are estimated by the nonpartisan Congressional Budget Office (CBO) to increase the number of uninsured Americans by 10 million through 2034. The CBO also predicts that the expiration of the EPTCs would increase the number of uninsured Americans by an additional 3.8 million people by 2034, with 2 million Americans losing their insurance next year alone.

For Americans able to still afford their health insurance coverage, their premiums may skyrocket. According to a 2024 analysis, EPTCs saved the average subsidized health insurance plan enrollee more than $700 on their monthly premium. In anticipation of the expiration of these enhanced subsidies, insurers on the ACA marketplace are raising premiums by roughly 20% for 2026.

Health insurance coverage is important for two main reasons. First, it allows Americans to utilize health care services without paying exorbitant out of pocket costs. Secondly, the reimbursement hospitals and other health care facilities receive from insurance companies for services provided to insured patients provide needed financial support to help allow these facilities to stay open. In an time with rising economic headwinds for both Americans and for health care providers, a rise in the health uninsurance rate caused by the expiration of the Enhanced Premium Tax Credits would add to economic challenges faced by patients and health care providers alike.