A recent study by Economist Tatyana Avilova, coauthored with Adam Sacarny, Ian Williamson, Weston Merrick, and Mireille Jacobson, has been selected by the Editor of JAMA Health Forum as an Editor’s Choice: Clinical Trial of 2025.   

The study, focusing on Prescription Drug Monitoring Programs (PDMPs), examines whether low-cost interventions can increase the use of clinical tools and change treatment decisions by providers.  

In a randomized trial of 7,872 clinicians in Minnesota, the authors test the impact of emails emphasizing the legal PDMP mandate vs. clinical benefits.  The authors find that while prescribing behavior remained unaffected, PDMP use increased, including account creation/reactivation and searches for patients with indicators for high-risk prescribing. The effects were persistent, with stronger responses to legal messaging.   

For policymakers and health systems seeking to promote patient safety, the key takeaway is clear: targeted, low-cost interventions can be effective at preparing providers to treat patients at risk of adverse outcomes by prompting them to reengage with the PDMP.  

To learn more about the study’s data, methodology, and implications, connect with Tatyana Avilova. 

Secretariat is pleased to share that 10 of our experts have been recognized in the Lexology Index 2026 Investigations report, produced in partnership with Global Investigations Review. The guide highlights leading investigations lawyers, digital forensic specialists, and forensic accountants who are trusted to support the most demanding matters worldwide. 

Secretariat earned strong representation in the Investigations rankings, reflecting both the caliber of our professionals and the continued impact of Secretariat’s highly regarded Investigations & Disputes practice. 

Our continued presence in Lexology’s rankings speaks to the firm’s ongoing commitment to delivering rigorous, independent insight in complex and high‑stakes investigations. Clients rely on Secretariat for clarity, credibility, and experience when the outcome matters most, and this recognition reinforces the trust they place in our work. 

Explore the Lexology Index 2026 Investigations report to learn more and read what clients and peers have shared about our experts below.

Highly Recommended

Investigations Digital Forensic Experts

• Daniel Wang (Singapore) established himself as a leading digital forensics specialist across construction, financial services, shipping and government sectors. Daniel Wang manages intricate evidence collection and analysis processes, providing expert reporting in matters involving IP theft, information leakage bribery, corruption and employee misconduct.  

Investigations Forensic Accountants

• Arnold Castillo (USA) is distinguished by his ability to integrate data-driven methodologies with investigative expertise, he handles multi-jurisdictional fraud and compliance matters and is singled out for his “ability to quickly understand a matter” as well as his “deep knowledge for the industry”. 
• Peter Resnick (USA) established himself in a high-profile fraud and damages matters. He brings nearly three decades of forensic analysis and investigative experience, with sources celebrating “his phenomenal and measured approach” to handling complex corporate and government-initiated investigations.  
• Edward Westerman (USA) received high praise from peers for his “tremendous amount of experience working on high-profile investigations”. His extensive experience has equipped him with the skills necessary to expertly handle forensic accounting engagements in the United States and internationally.  

Recommended

Investigations Digital Forensic Experts

Sean Lim (Singapore) has over a decade of experience in digital investigations. He operates at the epicentre of matters involving regulatory scrutiny, employment disputes, intellectual-property concerns and post-breach analysis, offering sought-after guidance across multinational data environments.  

Investigations Forensic Accountants

• Howard Rosen (Canada) is widely regarded as “an extremely well-respected professional in the forensic accounting space”, bringing over four decades of expertise to complex multi-jurisdictional regulatory and corporate investigations.  
• Alexander Demuth (Germany) demonstrates impressive forensic accounting experience in investigations across a range of sectors, including automotive and biotechnology, garnering recognitions for “his dedicated and stellar approach”.  
• Eric Poer (USA) is lauded as “diligent, knowledgeable and creative”. He is sought after in high-profile investigations for his “tremendous amount of experience” as a forensic accountant handling sensitive forensic assignments.  
• Kiran P Sequeira (USA) is a seasoned financial and accounting expert with more than two decades of experience assisting with investigations and advising on global disputes across multiple industries and jurisdictions, including energy, mining and infrastructure. 

Investigations Future Leaders – Forensic Accountants

• Michael Garibaldi (USA) has deep expertise in forensic accounting and financial investigations enabling him to guide counsel and corporations through complex litigation and regulatory matters, including fraud and accounting irregularities.  

Secretariat, the leading global expert and advisory firm, is thrilled to announce the promotion of 57 individuals across 21 offices worldwide—highlighting the depth of experience and high caliber of talent cultivated throughout the organization.  

“These promotions reflect Secretariat’s ongoing momentum and growing impact across regions and service offerings,” said Managing Director Don Harvey. “We remain deeply committed to investing in our people, developing exceptional talent, and continuing to build a strong, globally connected firm.” 

Congratulations to our newest:

Managers

• Chase Bolling
• Nicolas Bouvier
• Ty Ehuan
• Isaiah Kline
• Mason Law
• Grace Martens
• Daniel Moreland
• Aaron O’Gara
• Rajat Pathak
• Kieran Raphael
• Adam Rowlands
• Stephanie Sharp

Senior Associates 

• Amr Adel Galal ElAttar
• Caleigh Cantalupo
• Andrew Costa
• Chirag Dodeja
• Joshua Irby
• Caleb Jensen
• Grant Kaus
• Charlotte Kershaw
• Colin Lacy
• Ryan Li
• Derek Li
• Elias Maaraoui
• Georgios Maragkos
• Berkeley Miesfeld
• Daniel Nazareth
• Adam Rawlands
• Mia Sharpe
• Patrick Sorensen
• Ari Tandan
• Arthi Thiruppathi
• Owen Woodard

Corporate Professionals 

• Sarah Morgan (Senior Marketing Manager)
• Anna Rose Novak (Communications Manager)
• Beth Stewart (Director of Talent and Development)

This move strengthens the firm’s capabilities in complex technology disputes, damages analysis, and AI-related investigations amid growing litigation and advisory demand.

Secretariat is pleased to announce that Carol Kaiser, a technology disputes expert with more than 20 years of experience, has joined the firm as a Managing Director. With the addition of Ms. Kaiser, Secretariat establishes a new Technology Disputes & Advisory Practice, deepening the firm’s capabilities in a growing area of litigation and advisory need as high-stakes technology failures and related disputes become increasingly common across industries.

Ms. Kaiser brings extensive experience advising clients on complex technology-related investigations and disputes around the world, including failed software implementations, technology trade secrets, outsourced IT services, and damages arising from complex technology breakdowns. She is trusted by clients for her practical approach, expansive knowledge of complex technology systems, and ability to translate highly technical information into clear, actionable insights.

A Certified Public Accountant and Certified Fraud Examiner, Ms. Kaiser brings a multidisciplinary background spanning finance, accounting, IT, and change management. She leverages her experience on both the client and provider sides of technology delivery to offer clients a uniquely holistic perspective on why major technology programs fail, and how those failures cascade into financial and operational impacts.

Managing Director Don Harvey notes. “Carol’s expertise and leadership at the intersection of technology, investigations, and damages strengthen our capabilities in a critical and growing area. As technology continues to reshape how organizations operate, our Technology Disputes & Advisory team will be industry leaders in providing the robust, data-driven guidance necessary during high-stakes business and legal challenges.”

Secretariat is pleased to announce the latest issue of Economists Ink. This publication includes insights from leading economists about recent developments in law and economics that may significantly impact the field.

This issue explores recent topics in the economics of AI-based discrimina­tion, antitrust remedies in Big Tech, market definition in the cannabis industry, and the evolving antitrust allegations in college athletics.

In the first article, Drs. Stuart Gurrea and Nicolas Suarez explore how economists may approach class-action litigation claims of discrimina­tion involving AI-driven hiring and selection tools. They evaluate the circumstances under which such algorithmic systems might not form a common policy sufficient to support class certification and consider the implications for future AI-related class-wide litigation.

In the second article, Dr. Stephanie Khoury examines the proposed settlement in Epic v. Google, which includes revisions to the court-ordered injunction intended to open the Android app ecosystem to meaningful competition. The article highlights judicial and third-party concerns that the proposed changes may fall short of providing an adequate remedy and underscores the importance of market-wide economic considerations in shaping effective relief.

In the third article, Dr. Jéssica Dutra analyzes the evolving competitive landscape of the U.S. cannabis industry as more states adopt cannabis laws. She discusses how federal prohibition under the Controlled Substances Act (CSA) alongside state-specific regulatory frameworks have produced fragment­ed markets with localized supply chains without interstate commerce. She also considers the implications for competition policy, including market concentration and geographic market definition in retail cannabis markets.

Finally, Dr. Kira Stearns examines how prior NIL and revenue sharing settlements in college athletics may have shaped economic incentives contributing to the recent increase in antitrust allegations against the NCAA.

Stay up to date on the latest from Secretariat’s economists by following us on LinkedIn.

Managing Director Tamika Tremaglio joined Emmy award-winning commentator Chris Hayes on his podcast “Why Is This Happening?,” for an in-depth conversation on the WNBA’s momentous CBA agreement and what it means for players, fans, investors, and the future of the league. The discussion explored the rapid rise of women’s sports, increased investment and visibility, and the growing gap between league expansion and player compensation structures.

During the episode, Tremaglio examined the role of collective bargaining, revenue sharing, and evolving economic models in better reflecting the WNBA’s accelerating value. She also addressed the long-term implications of emerging dynamics such as sports gambling, public scrutiny, and the mental health pressures that players must increasingly navigate.

Listen to Tamika on “Why Is This Happening? The Chris Hayes Podcast” here.

On February 24, 2026, the US Securities and Exchange Commission (SEC) released updates to its Enforcement Manual (“Enforcement Manual”).[1] In doing so, the SEC reaffirmed its commitment to “fairness, transparency, and efficiency” and highlighted key changes from the previous draft published in 2017.[2]

In particular, the SEC’s additions outline best practices and set out the SEC’s framework for evaluating certain decisions in enforcement actions, including cooperation and penalty recommendations. These updates also highlight several areas where the role and contribution of experts can provide significant value in enforcement matters.

Use of Experts to Address Key Investigative Issues

The SEC notes that the updates aim to improve the dialogue between the SEC and relevant parties with the goal of improving outcomes and enabling more timely investigation resolutions.[3] The Wells process is a key element of this important dialogue.

The recent updates explicitly encourage the incorporation of expert reports in Wells submissions to address “particularly complex or technical” charges during the pre-litigation phase.[4] This enables companies to use expert analysis to challenge the SEC staff’s preliminary findings, focusing on disputed technical, economic, or legal issues. Experts may also provide value by contributing to other written materials submitted to the SEC, such as white papers, addressing disputed matters.

Use of Experts to Improve Cooperation and Investigative Outcomes

The updates to the Enforcement Manual describe a revised framework for determining whether penalties should be reduced based on a company’s level of cooperation during SEC investigations.

Specifically, the Enforcement Manual explains that the SEC may “seek reduced civil penalties, against an entity in consideration of any self-policing, self-reporting, remediation, and cooperation by the entity.”

In evaluating whether companies will receive credit for self-policing or remediation actions, the Enforcement Manual now specifies that the SEC will consider the “independence, thoroughness, and effectiveness” of a company’s investigation as key criteria.[5]

The Enforcement Manual also identifies examples of effective remediation following an internal investigation, including strengthening internal controls and retaining independent compliance consultants to advise on remedial issues.[6]

In addition, the Enforcement Manual now provides expansive examples of cooperation, including “providing financial analyses conducted by external experts” to the SEC in a timely manner.[7]

Looking Forward

The updated Enforcement Manual introduces “Top 5” priority matters (replacing “National Priority Matters”), which SEC Unit Chiefs will determine and update quarterly. The Enforcement Manual identifies several criteria Unit Chiefs will consider when making their priority determinations, including, for example, whether the matter:[8]

• Involves potential wrongdoing as clearly prohibited under newly enacted legislation or regulatory rules;
• Presents an opportunity to send a strong and effective message of deterrence, including with respect to emergent issues in the market, or involves matters where wrongdoing is difficult to detect;
• Involves a substantial number of potentially harmed investors and/or particularly vulnerable investors.

These criteria reiterate the emphasis the SEC is now placing on a “back to basics” approach that prioritizes protecting vulnerable investors, even amidst new and emerging market developments.

Conclusion

The updates to the Enforcement Manual specifically highlight areas where experts can add significant value to the investigative process conducted by registrants prior to self-reporting to the SEC. Secretariat professionals are closely monitoring the priorities identified by the SEC for 2026,[9] and the resulting enforcement actions.

Our experts are well positioned to assist companies and their counsel in navigating SEC inquiries and investigations. They are actively involved in domestic and international securities regulation and litigation dialogue. [10]

Further, our experts are trusted in high stakes matters that are considered high enforcement priorities by the SEC, includingcrypto, blockchain, and digital-asset investigations, as well as investment adviser regulation and enforcement.[11]

Reach out to the team to discuss the value we can bring to your securities enforcement-related matters.

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[1] U.S. Securities and Exchange Commission – Division of Enforcement, Enforcement Manual, February 24, 2026 (https://www.sec.gov/divisions/enforce/enforcementmanual.pdf).
[2] Press Release, SEC’s Division of Enforcement Announces Updates to Enforcement Manual, February 24, 2026 (https://www.sec.gov/newsroom/press-releases/2026-20-secs-division-enforcement-announces-updates-enforcement-manual).
[3] Press Release, SEC’s Division of Enforcement Announces Updates to Enforcement Manual, February 24, 2026 (https://www.sec.gov/newsroom/press-releases/2026-20-secs-division-enforcement-announces-updates-enforcement-manual).
[4] Enforcement Manual, Section 6.1.2. Framework for Evaluating Cooperation and Related Efforts by Companies.
[5] Enforcement Manual, Section 3.1.4. Parallel Investigations and the State Actor Doctrine.
[6] Enforcement Manual, Section 6.1.2. Framework for Evaluating Cooperation and Related Efforts by Companies.
[7] Enforcement Manual, Section 6.1.2. Framework for Evaluating Cooperation and Related Efforts by Companies.
8] Enforcement Manual, Section 2.2.4 Ranking Investigations and Allocating Resources.
[9] U.S. Securities and Exchange Commission – Division of Examinations, Fiscal Year 2026 Examination Priorities, November 17, 2025 (https://www.sec.gov/files/2026-exam-priorities.pdf).
See also: https://secretariat-intl.com/insights/the-evolving-sec-enforcement-landscape-trends-for-2026/
See, also: https://secretariat-intl.com/insights/eric-poer-discusses-ai-and-enforcement-trends-shaping-securities-litigation-in-forbes/
[10]  See, for example: https://secretariat-intl.com/insights/secretariat-expert-quoted-by-thomson-reuters-regulatory-intelligence/.
See, also: https://secretariat-intl.com/insights/trends-in-ai-related-securities-class-actions-through-2025/.
[11] See, for example: https://secretariat-intl.com/engagements/robert-mis-provided-pivotal-expert-findings-in-a-doj-landmark-577m-crypto-fraud-prosecution/.

by Kira Stearns[1]

Antitrust scrutiny of the National Collegiate Athletic Association (NCAA) has a long history, rooted in tensions between the organization’s role as a regulator of college sports and the requirements of U.S. competition law. Until 2014, the NCAA relied on amateurism as its primary defense against antitrust challenges, particularly regarding limits on athlete compensation. This framework was directly challenged in O’Bannon v. NCAA (2014), which focused on the NCAA’s prohibition on compensating athletes for the use of their names, images, and likenesses (NIL), especially in video games and broadcasts. The Ninth Circuit ruled that while the NCAA could maintain some limits tied to amateurism, its complete ban on NIL-related compensation violated antitrust law. On July 1, 2021, a wave of state legislation and new NCAA policies allowed college athletes to begin signing endorsement deals and earn revenue on their NIL.

Another consequential recent ruling came in NCAA v. Alston (2021), where the Supreme Court unanimously affirmed that NCAA limits on education-related benefits—such as scholarships for graduate school, tutoring, or laptops—were unlawful restraints of trade. Notably, the court rejected the NCAA’s broad claims that amateurism justified deference under antitrust law and openly questioned the legality of nearly all NCAA compensation restrictions. While Alston technically addressed only education-related benefits, its reasoning signaled broad skepticism toward the NCAA’s business model.

The House v. NCAA settlement was the most recent antitrust resolution that significantly changed how college athletes at certain institutions may be compensated.[2] Approved in 2025, it resolved multiple lawsuits alleging that the NCAA had unlawfully restricted athlete pay in violation of federal antitrust law. As part of the settlement, schools are now permitted to share athletic revenue directly with athletes, subject to annual caps. While the settlement does not classify athletes as employees, it effectively dismantles the NCAA’s traditional amateurism model and marks a structural shift toward a revenue-sharing system in college sports.

Despite implementing these significant changes, the NCAA cannot reasonably expect the end of legal challenges on antitrust grounds. Recent cases suggest that the next battleground may revolve around the NCAA’s eligibility rules.[3] As it currently stands, the NCAA provides student athletes with four years of athletic eligibility within a five-year period. According to the NCAA, this five-year clock begins once the athlete enrolls at any collegiate institution, regardless of whether its athletic programs operate within the NCAA. The clock does not reset when the athlete transfers to a different school.

Under the prior regime—before revenue-sharing and NIL agreements—the NCAA’s eligibility requirements were relatively innocuous, from an economic perspective. Although many athletes received valuable in-kind benefits related to tuition and living expenses, participation in collegiate sports did not involve direct monetary compensation. As a result, for many athletes, the economic opportunities available outside of college were strictly superior to those available within it. This disparity was especially pronounced for elite athletes in highly lucrative professional sports, such as football and men’s basketball. For these athletes, the requirement that they compete without monetary pay in college—often due to age-based professional league restrictions—was widely understood as an economic sacrifice.[4]

However, under the current regime, and for a select group of individual athletes, the economic returns to remaining in college may now far exceed the income available outside of the NCAA. This dynamic is particularly pronounced for athletes in sports without highly paid professional leagues, such as gymnastics. As an extreme example, Louisiana State University (LSU) gymnast Olivia Dunne reportedly earned an estimated $4.1 million in endorsement deals during her fifth year of eligibility.[5] Whether that level of brand value can be sustained beyond the college sports ecosystem remains to be seen.

Moreover, women’s college basketball players may now earn substantially more through NIL arrangements than they would as professionals in the Women’s National Basketball Association (WNBA). As of June 2025, top NIL earners in women’s college basketball reportedly secured deals ranging from roughly $300,000 to $1.5 million, while the salary for a first-round WNBA draft pick begins at approximately $75,000.[6] The highest paid WNBA player in 2025 commanded an annual average salary of $252,450.[7] For players who fear that their marketability may diminish upon leaving a prominent college program, these disparities create a strong economic incentive to remain in college for an additional year.

Importantly, this incentive is not limited to athletes without lucrative professional alternatives. Even in sports such as football and men’s basketball, the opportunity cost of remaining in college for an additional year has fallen substantially. With the availability of NIL income and revenue-sharing arrangements, athletes now forgo less by staying in school an extra season to develop their skills and potentially improve their draft position.  Indeed, a recent study of player’s decisions to enter the NBA draft between 2019–2024 finds that, following the liberalization of NIL rules, more men’s colleges basketball players choose to use their remaining collegiate eligibility.[8]

This growing incentive to maximize one’s time in college athletics likely holds for all but the very top prospects of high-paying professional leagues. For example, a top-five college quarterback projected as a second-round pick may hope to improve to a top-three quarterback, and first-round selection, after an additional year playing college football. Moving from a second-round selection to a first-round selection has significant economic upsides. For example, a player chosen in the first round of the National Football League (NFL) can expect average total compensation of $21.7 million, versus $8.6 million for a player chosen in the second round. When combined with NIL income and revenue sharing from the university, the upside of staying in college an additional year is now significantly more economically appealing.

Taken together, these developments point to a new potential source of economic harm arising from the NCAA’s position as the sole governing body of major college athletics. If an alternative collegiate athletic association existed, it might compete to attract athletes by offering more generous revenue-sharing arrangements, improved NIL opportunities, or more favorable terms governing the duration over which athletes can receive such compensation. While previous changes to the NCAA compensation rules sought to address alleged harm related to the first two dimensions, it did not meaningfully confront, and has perhaps exacerbated, the third.

In conclusion, as the economic value of participating in college athletics continues to rise, the antitrust implications of NCAA eligibility rules are likely to become more pronounced. Restrictions that limit how long athletes may participate—and therefore earn—within the collegiate system may increasingly be viewed as anticompetitive restraints. Whether courts or the NCAA itself will adapt in response to these pressures remains an open question.

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[1] This article benefitted from excellent research assistance by Matthew Domke.
[2] The settlement only impacted athletes at Division I schools, though it is expected that Division II and Division III programs may need to adapt their business models in order to recruit talented athletes.
[3] For example, Jabarrek Hopkins, a football player at Prairie View A&M filed suit against the NCAA and its eligibility rules.  This follows a suit by Diego Pavia, a star quarterback at Vanderbilt filed in [year], also challenging the eligibility rules.  See:
Hopkins v. Nat’l Collegiate Athletic Ass’n, Case No. 4:26-cv-00014-RH-MJF (N.D. Fl.)
Diego Pavia v. National Collegiate Athletic Association, Case No. 3:24-cv-01336 (U.S. District Court for the Middle District of Tennessee).
[4] Some professional athletes have waited out the age requirement by playing professionally outside of the United States.
[5] https://www.si.com/college-basketball/highest-paid-college-athletes-via-nil-deals.
[6] https://www.foxsports.com/stories/womens-college-basketball/top-10-womens-college-basketball-players-highest-nil-valuations, https://www.spotrac.com/wnba/cba/minimum/, https://frontofficesports.com/how-much-will-2025-wnba-draft-picks-make/.
At the time of writing, the WNBA has put forth a collective bargaining agreement proposal that would considerably increase the salary cap.  See, for example:
https://www.espn.com/wnba/story/_/id/47862248/wnba-new-cba-proposal-includes-housing-provisions.
[7] https://www.si.com/wnba/highest-paid-wnba-players-now-and-all-time.
[8] McDaniel, Cole, Brian Meehan, and E. Frank Stephenson (2025), “Should I Stay or Should I Go? The Effect of NIL and Transfer Rule Changes on College Basketball Players Entering the NBA Draft,” Journal of Sports Economics 26(5): 543–561.

For the third consecutive year, Secretariat has been ranked No. 1 in the Global Arbitration Review (GAR) Expert Witness Firms’ Power Index 2026, unveiled March 26 at the GAR Awards during Paris Arbitration Week. 

The GAR Power Index is the definitive global benchmark of excellence for expert firms in arbitration. Rankings are determined through a rigorous evaluation that includes factors such as of the number of hearings, value of claims, and the collective strength of a firm’s expert rankings in Lexology Index. Together, these metrics offer a comprehensive view of a firm’s performance, impact, and market leadership. 

“Earning the top spots in GAR’s rankings for three consecutive years speaks to the unique consistency, depth, and quality that our experts bring to their work every day,” says Managing Director Don Harvey. “This accolade also affirms the trust our clients place in us to deliver elite-quality work across practices and geographies.” 

Secretariat’s dedication to developing talent, expanding our footprint in key markets, and deepening our expertise offerings continues to drive the firm’s growth and reinforce our position as a global leader in the arbitration community and beyond. 

See the full rankings here: https://globalarbitrationreview.com/survey/gar-100/2026  

by Farheen Khan

Human factors experts play a critical role in infant formula and nutrition‑product litigation because the central questions in these cases—what caregivers perceive, understand, retain, and ultimately do—are questions about human capabilities and limitations, not merely regulatory compliance. In the ongoing infant formula disputes, including the NEC multidistrict litigation and parallel state‑court proceedings, claims often hinge on whether manufacturers provided warnings and instructions that were sufficiently clear, prominent, and actionable for caregivers and clinicians who may be operating under time pressure, fatigue, and varying levels of health literacy.

An evidence‑based human factors analysis can help courts distinguish preventable, use‑related risk from the inherent residual risk associated with the product. This framework clarifies what hazards were reasonably foreseeable, what aspects of communication could have been controlled through better design, and where the appropriate boundaries of responsibility fall among manufacturers, healthcare providers, and caregivers. Such expert analysis provides essential context for evaluating the adequacy of warnings and the reasonableness of manufacturer conduct under the applicable legal standards.

A human factors analysis in product‑related litigation typically begins with a systematic review of the communication system at issue. This includes an examination of the design and content of labels, instructions for use, preparation charts, pictograms, and any supplemental print or digital materials, evaluated against established research on how individuals perceive and respond to warnings. A human factors expert assesses the adequacy of typography, contrast, signal words, pictograms, sequencing of steps, and the articulation of consequence and avoidance statements. This allows the expert to opine on whether the information provided was sufficiently conspicuous, comprehensible, and practical, and whether it could reasonably have supported safe behavior when read and followed.

Because directions for use must share limited labeling real estate with nutrition facts, preparation charts, and mandatory regulatory text, manufacturers frequently confront inherent constraints. A human factors expert can assist the trier of fact by explaining these constraints and how a manufacturer balanced completeness with the need for clarity and brevity. By relying on risk‑communication strategies supported by peer‑reviewed literature, a human factors expert can further demonstrate the reasonableness of a manufacturer’s approach to informing consumers, caregivers, and healthcare professionals. Such analysis provides critical context for evaluating whether a communication system met industry expectations and foreseeable‑use standards under the applicable legal framework.

Recognized frameworks can provide benchmarks. The Infant Formula Act and FDA’s infant formula labeling regulations at 21 C.F.R. §107 set specific expectations for directions for preparation and use. FDA labeling requirements include directions for storage, agitation, dilution or reconstitution, sterilization of water and bottle components when necessary, pictograms depicting the major steps for preparation, a warning about the need to follow directions, and a statement about consulting a health care provider for guidance. Human factors experts can map label elements to FDA requirements, demonstrating regulatory alignment of the label, and help courts determine whether alleged inadequacies reflect a true warning defect or a broader, multi‑actor systems issue.

In litigation involving microbial hazards, whether the on‑package and caregiver‑facing materials reasonably conveyed risk associated with the product, environmental factors (e.g., water source), and user behavior (e.g., refrigeration, disposal, cleaning) may be questioned. Public health guidance from the CDC and the FDA emphasizes hand hygiene, equipment sanitation, safe preparation, and, when appropriate, the use of ready‑to‑feed sterile liquid formulas for higher‑risk infants. In such litigation, human factors experts can identify the expected and proper channels to provide additional information, examine whether on‑package instructions and caregiver‑facing instructions obtained from various sources reasonably conveyed such information, whether caregivers carried out the steps provided or asked for, and whether the lack of such information on the package affected the behavior of caregivers and contributed to foreseeable misuse.

What caregivers can reasonably accomplish must be understood against documented literacy constraints. Research has found that a large proportion of U.S. caregivers have limited health literacy (Yin et al., 2009). A study evaluating powdered formula instructions found readability and comprehension difficulty for critical sections on a label (Wallace et al., 2016). A human factors expert can separate what was knowable in the relevant time periods, what constraints exist on label real estate, and whether additional information would reasonably improve comprehension, oversimplify technical requirements, or become a source of information overload for caregivers.

Because many infant formula and pediatric nutrition products are administered under clinician direction, particularly in NICU environments, a human factors analysis can help clarify the appropriate division of responsibility for risk communication. This includes distinguishing between information intended solely for healthcare professionals and the messages that must appear on consumer‑facing labeling. In practice, it is reasonable for caregiver‑directed materials to focus on tasks within the caregiver’s control, such as hygiene practices, mixing procedures, storage conditions, and discard intervals. Conversely, information directed at clinicians should support clinical judgment, product selection, and individualized patient care.

Publicly available resources, such as CDC guidance on bottle‑feeding and equipment cleaning, along with materials from state nutrition programs, illustrate the type of step‑wise, concrete behavioral instructions that can meaningfully reduce risk when aligned with on‑package directions. Harmonizing these evidence‑based practices with product labeling can improve compliance, mitigate microbial hazards, and help prevent dosing and preparation errors. A human factors framework provides the structure needed to evaluate whether the communication system reasonably supported each user group in carrying out their respective responsibilities.

• Given the state of knowledge and standards at the time, did the communication system make it reasonably likely that intended users would be able to notice, understand, and follow the steps that could reduce risk?
• Should risks about, for example, Enterobacter, Cronobacter or NEC be reasonably expected to be on consumer‑facing labels versus conveyed within clinician‑directed feeding protocols?
• Should products handed out by hospitals be expected to be accompanied by instructions from health care providers?
• Did marketing content undermine warnings?
• Did the company do enough to keep pace with external guidance and emerging knowledge?

Extensive research in warnings science demonstrates that even well‑crafted warnings may fail to elicit safe behavior if they are not noticed, read, understood, and followed. In the courtroom, systematic human factors testimony can clarify that warnings alone cannot eliminate all risk, nor can they replace the behavioral safeguards, environmental controls, and professional clinical judgment required in hospital and home settings, particularly when caring for medically fragile infants. Human factors experts can, however, evaluate whether a manufacturer took reasonable, evidence‑based steps to reduce use‑related risk. This includes assessing whether on‑package communications were consistent with prevailing standards and public health guidance at the time, and whether the manufacturer maintained an appropriate process to monitor real‑world use, incorporate feedback, and improve its communication system over time. Such analysis helps delineate the respective responsibilities of manufacturers, healthcare providers, and caregivers, providing the court with a clear framework for understanding how risk is distributed and managed across users and contexts.

How Can Secretariat Assist?

Secretariat’s Human Factors experts assist courts and litigants in infant formula and nutrition‑product litigation by evaluating whether warnings and instructions reasonably supported safe use under foreseeable conditions. We assess whether caregiver‑ and clinician‑facing communications could be noticed, understood, and followed in real‑world contexts. Our analyses examine the full communication system against applicable FDA requirements, prevailing public health guidance, and human factors science available at the relevant time and differentiates alleged warning or instruction defects from risks reasonably addressed through clinical judgment, hospital feeding protocols, and caregiver practices. This systems-based analysis provides technical context to assess the reasonableness of manufacturer conduct and understand the role relevant stakeholders play in managing risk.

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References

1. Yin, HS, Johnson, M, Mendelsohn, AL, Abrams, MA, Sanders, LM, & Dreyer, BP (2009). The Health Literacy of Parents in the United States: A Nationally Representative Study. Pediatrics, 124(Suppl 3), S289–S298.
2. Wallace, LS, Rosenstein, PF, and Gal, N (2016). Readability and Content Characteristics of Powdered Infant Formula Instructions in the United States. Maternal and Child Health Journal, 20, 889-894.

Managing Director Michael Koenig, Director Jéssica Dutra, and Director Pablo Varas contributed to the “2025 Annual Review of Antitrust Law Developments” from the ABA Antitrust Law Section.

Their chapter contributions include:

• Jéssica Dutra — Chapter IV — Joint Ventures
• Michael Koenig — Chapter VIII — Civil Government Enforcement
• Pablo Varas — Chapter II — Monopolization and Related Offenses

For over 40 years, this publication and its annual supplements have been recognized as among the most authoritative and comprehensive research tools for antitrust practitioners. The 2025 edition summarizes key developments in the courts, at the agencies, and in Congress.

Explore the latest developments and connect with our team to discuss what they may mean for your business.

In our latest white paper, Driving Transparency and Accountability: Saudi Arabia’s Expanding Reach in Enforcement and Disclosure, Managing Director Ralph Stobwasser and Director Tarek Bleik examine Saudi Arabia’s expanding enforcement activity and evolving transparency framework. The paper analyses the Kingdom’s approach to anti-corruption enforcement and financial transparency as part of its broader governance transformation under Vision 2030.

This publication forms part of our Saudi Arabia anti-corruption and transparency series, which tracks enforcement activity and regulatory developments across the Kingdom. Earlier papers in the series include Integrity and Accountability: Anti-Corruption Enforcement in Saudi Arabia (January 2025) and Mid-Year 2025 Update: Nazaha’s Progress in the Fight Against Corruption (September 2025). 

The latest report provides a data-led overview of the Oversight and Anti-Corruption Authority (Nazaha)’s reported activities in 2025, including trends in inspections, investigations and arrests across key government sectors. It also examines the wider economic-crime control framework developing in Saudi Arabia, including new counter-fraud expectations, beneficial ownership transparency, and evolving disclosure standards as capital markets open further to foreign investors.

If you would like to discuss any of the issues raised in this paper, please get in touch with our team.