Category: Blog

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.

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.