Five Cases Health Care and Life Sciences GCs Should Keep Watching in 2026

This material was presented as part of Epstein Becker Green’s Counsel to Counsel Roundtable on Monday, May 4, 2026. Co-presenters were Professor Kathleen M. Boozang and Professor David Obderbeck of Seton Hall School of Law.

In 2026, several federal cases are poised to shape regulatory risk, reimbursement, and False Claims Act exposure, as well as innovation pathways across the health care and life sciences sectors.

These include cases decided in 2024 and 2025 that continue to have ongoing impacts, as well as more recent cases involving cutting-edge technology. This article highlights five cases to monitor (or their progeny), why these cases matter to in-house legal teams, and practical steps for health care and life sciences general counsel (GC) to consider.

Past Tense: Already Decided Cases Having Ongoing Impacts

Loper Bright Enterprises v. Raimondo (2024)—Scope of Agency Authority Affecting Health Programs and Payments

By now, everyone has heard of the 2024 case of Loper Bright Enterprises v. Raimondo, 144 S.Ct. 2244, which overruled the 40-year Chevron doctrine and eliminated judicial deference to federal agencies’ interpretations of ambiguous statutes. Courts now exercise independent judgment on what Congress intended, regardless of agency expertise (See EBG blog post here).

Loper itself dealt with a challenge to the Magnuson-Stevens Fishery Conservation and Management Act (MSA). Yet post-Loper, every rule issued by the Centers for Medicare and Medicaid Services (CMS), every guidance document from the Food and Drug Administration (FDA), and every interpretation from the Health Resources and Services Administration (HRSA) is now a litigation target, no longer insulated by Chevron deference.

Impact is already materializing in 340B and drug pricing litigation. One example we envision relates to GLP-1 / IRA drug pricing, as semaglutide negotiation and Part B drugs raise new theories and other GLP-1 bundling disputes open new litigation fronts. Post-Loper, courts will independently interpret “maximum fair price” and drug grouping—giving the pharmaceutical industry new arguments that prior rounds could not make.

Why CGs Should Care:

• Judicial Scrutiny: Every agency rule in health care is now subject to independent judicial scrutiny.
• Audits: Audit CMS, FDA, and HRSA rules that your organization relies on for compliance.
• 340B: 340B program and drug pricing rules face particular vulnerability.
• Monitor Agency Guidance: What was previously settled law may now be litigated.
• Legal Action: Consider challenging longstanding agency interpretations that negatively impact your organization.

Wisconsin Bell v. United States ex rel. Heath (2025)

The U.S. Supreme Court in the 2025 case of Wisconsin Bell v. United States ex rel. Heath, 604 U.S. ___ (2025), held that a whistleblower can bring a lawsuit under the False Claims Act (FCA) over reimbursements from a private, industry-funded program where the government provides any portion of the money, thus expanding what constitutes a “claim” under the FCA. The civil FCA, 31 U.S.C. §§ 3729-3733, provides that any person who knowingly submits, or causes to submit, false claims to the government is liable for three times the government’s damages plus a penalty that is linked to inflation.

The FCA has long served as a tool for the U.S. Department of Justice to sue perpetrators of fraud in government programs including Medicare and Medicaid, either on the Department’s own initiative or by intervening in a case originally filed by a relator. Wisconsin Bell potentially expands opportunity for both the Department and relators to pursue more claims. Key questions will go beyond the definition of “claim,” as we see how other aspects of the FCA will play out in cases involving private, industry-funded programs.

Why GCs Should Care:

• Government Funding: Companies receiving even minimal government funding in a mixed program face FCA exposure.
• Audit Funding Structures: Medicare Advantage, Center for Medicare & Medicaid Innovation (CMMI) models, research grants, hybrid programs.
• Review qui tam Exposure: Whistleblowers now have a broader avenue for FCA claims.
• Engage FCA Counsel: Counsel can map every government-sourced funding stream and assess litigation risk.

Chiles v. Salazar (2026)

Colorado’s 2019 Minor Conversion Therapy Law (MCTL) banned licensed mental health professionals from engaging in talk therapy intended to change a minor’s sexual orientation or gender identity. Kaley Chiles, a Christian counselor, challenged the law as viewpoint discrimination violating the First Amendment. Colorado argued it was regulating professional conduct, not speech.

In an 8-1 decision decided March 31, 2026, Justice Neil Gorsuch held in Chiles v. Salazar, 607 U.S. __ (2026), that laws regulating the content or viewpoint of a licensed therapist’s speech must survive strict scrutiny, not rational basis. A state may not simply label clinical speech as “conduct” to avoid First Amendment review. The decision effectively invalidates Colorado’s law and the 23 similar state laws on similar grounds.

“The First Amendment stands as a shield against any effort to enforce orthodoxy in thought or speech in this country,” Gorsuch wrote for the majority.

Why GCs Should Care:

• The Double-edged Sword: The same First Amendment shield that protects conversion therapy practitioners can be raised against federal funding cutoffs for institutions providing gender-affirming care.
  • Justice Elena Kagan’s concurrence explicitly acknowledged a “mirror image” law banning therapy affirming gender identity would be equally unconstitutional.
  • CMS is already moving: Proposed rules would cut off Medicare and Medicaid funding for any hospital providing gender-affirming care to minors. Chiles gives those hospitals a First Amendment argument.
• Standard-of-Care Regulation is Now in Play: If the government cannot restrict a therapist’s speech to enforce a clinical consensus, it may not be able to enforce the opposite consensus either. Justice Ketanji Brown Jackson’s dissent warned this logic “opens a dangerous can of worms” for all medical regulation.
• Post-Loper Amplifier: Courts no longer defer to HHS on what constitutes the “standard of care” for reimbursement purposes. Chiles compounds this—neither may they accept a government speech restriction as merely incidental to a permissible clinical regulation.
• Audit Now: Any organization providing, restricting, or planning to restrict clinical speech-based care should assess its exposure under Informed consent, prior authorization scripts, clinical protocols, and credentialing standards that restrict what clinicians may say are all potentially implicated.

The Present Tense: Cases Winding Through the Courts That Demand Your Attention

Estate of Lokken v. UnitedHealth Group (D. Minn.)

Estate of Lokken v. UnitedHealth Group, No. 0:23-cv-03514, is a proposed class action alleging UnitedHealthcare used an AI algorithm (“nH Predict”) to automatically deny Medicare Advantage claims for post-acute care. The court found that use of AI in lieu of clinical review could breach contractual promises to members that coverage decisions would be made by “clinical staff and physicians.”

The defining question is, “Does using AI for coverage decisions create independent liability to patients?” That is a separate question from whether the underlying denial was clinically correct. And some ancillary questions: If AI coverage decisions are ratified by a human reviewer, is the contract breached? And must human beings review coverage decisions on reimbursing pathology determinations made using AI?

Why GCs Should Care:

• Review: Review what your contracts actually promise about who makes clinical decisions.
• Audit: Audit whether AI tools are accurately described in member-facing materials.
• Assess: whether human clinical oversight is substantive or cosmetic.
• Application:Applies to all plans using algorithmic tools in prior auth or utilization management.

In Re Meta Pixel Healthcare Litigation (N.D. Cal.)

This consolidated class action, No. 3:22-cv-03580, alleged that Meta Platforms received protected health information from hospital websites through Meta Pixel (a JavaScript snippet transmitting patient portal logins, appointment scheduling, and medical condition searches to Facebook’s ad infrastructure) without Health Insurance Portability and Accountability Act (HIPAA)-compliant business associate agreements (BAAs) or patient authorization. OCR Guidance issued in 2022 and updated in 2024 indicates that using pixel tracking tools on hospital websites violates HIPAA unless a BAA exists with the vendor or patients have provided valid authorization.

Why GCs Should Care:

• Audit: 1 in 3 health care websites still use Meta Pixel or equivalent. Audit yours now.
• HIPAA: Meta is not a HIPAA business associate, thus no BAA can be established.
• Triple Exposure:S. Office for Civil Rights enforcement, Federal Trade Commission action, and private class action simultaneously.
• Review: Review all third-party tracking tools across patient-facing digital properties.

Takeaways: The Future Tense

These cases are the “known unknowns,” but what are the “unknown unknowns”? How do we define them and their characteristics? Plan for them and contain them?

Though we have mentioned artificial intelligence, we have not focused on use of AI for diagnostic purposes. As FDA-cleared AI diagnostic tools proliferate in radiology, pathology, and cardiology, the first malpractice/products liability cases naming the AI vendor, the hospital, and the treating physician jointly are overdue. Who is liable when an AI-assisted diagnosis is wrong? Post-Loper, FDA clearance may no longer provide the liability shield manufacturers assumed.

Another area to watch is Medicaid work requirement challenges, as the work requirements under the One Big Beautiful Bill Act take effect on January 1, 2027. State attorneys general and beneficiary groups will challenge these federal Medicaid work requirements under the APA and the Medicaid Act’s purpose clause. Hospitals and health systems serving disenrolled patients face uncompensated care surges and potentially have standing to challenge such requirements.

A third area to watch is rescinded grants. Research institutions, health systems, and state health departments whose congressionally appropriated grants were unilaterally rescinded will bring Impoundment Control Act, APA, and constitutional spending clause challenges. Finally, as state initiatives conflict with federal directives to challenge “onerous” state AI laws, a commerce clause/preemption test case is imminent.

For now, the practical takeaways for health care and life sciences GCs:

Post-Loper Bright:

• Audit all agency rules your organization relies on for regulatory compliance.
• Identify interpretations vulnerable to legal challenge.
• Consider affirmative litigation where agency overreach has harmed your organization.

FCA Exposure:

• Map all government-sourced funding streams, even if indirect or partial.
• Brief leadership on qui tam risk, given record FCA recoveries.

AI and Coverage Decisions:

• Review all member contracts. What do they promise about who decides?
• Ensure AI tools are accurately described in member-facing materials.
• Document that human clinical oversight is substantive, not cosmetic.

Digital Privacy

• Audit all tracking tools on patient-facing websites immediately.
• Simultaneous OCR, FTC, and class action exposure is real.

Looking Ahead

Finally, anticipate litigation intersecting AI, data privacy, and new regulatory interpretations; and proactively advise leadership on emerging risk areas—before cases are filed. Build cross-functional legal-operations compliance teams for rapid response. Remember: the GC who anticipates is far better positioned than the one who has to merely react.

Epstein Becker Green Staff Attorney Ann W. Parks contributed to the preparation of this post.