¹ Restatements First and Second of Torts contained only minimal references to medical malpractice issues. However, since 1965, when Restatement Second was published, there has been a large volume of medical malpractice cases and case law. As Restatement Third of Torts was winding down, to finish tort treatment, the ALI Council in January 2019 approved work on what was then termed “Concluding Provisions” (since renamed “Miscellaneous Provisions”). See Torts: Medical Malpractice Is Approved, A.L.I. (May 21, 2024), https://www.ali.org/news/articles/alis-torts-medical-malpractice-approved/. Medical malpractice began as a part of that project but in 2022 the Institute decided to present the medical malpractice provisions as a free-standing Restatement. Id.

² See, e.g., Philip G. Peters, Jr., Modernizing the Medical Malpractice Standard of Care, 52 Sw. L. Rev. 465, 465-73 (2024) (explaining that the change from a problematic custom-based standard to one based on competency among similar medical providers in the same or similar circumstances in the Restatement is an improvement that reflects the shift in state law).

³ “§ 6. Establishing Breach of, or Compliance with, the Standard of Care …

(b) Evidence that the provider complied with a relevant and authoritative practice guideline may be:

(1) used to rebut the plaintiff’s claim that the provider breached the standard of care as provided in § 5; or

(2) sufficient to find that the provider met an acceptable alternative standard of care, as provided in § 5, Comment k.”

Restatement of the Law Third Torts: Medical Malpractice § 6(b) (Am. L. Inst., Draft Practice Guidelines, 2024) [hereinafter Medical Malpractice Practice Guidelines].

⁴ For example, Fed. R. Evid. § 802 and its state counterparts do not permit the admission of hearsay evidence except under severely constricted circumstances. See Fed. R. Evid. 802; See also, e.g., Commonwealth v. Markvart, 771 N.E.2d 778, 782 (Mass. 2002) (“[H]earsay not otherwise admissible under the rules of evidence is inadmissible at the trial … unless specifically made admissible by statute.”); Cal. Evid. Code § 1200(b) (West 2024) (“Except as provided by law, hearsay evidence is inadmissible.”). Fed. R. Evid. § 801 adopts the classic elements of hearsay: a statement, oral, written, or nonverbal, not made in the hearing or trial offered to prove the truth of the matter asserted. See Robert P. Mosteller et al., McCormick On Evidence § 246 (8th ed. 2020).

⁵ See, e.g., Fed. R. Evid. 803(18):

“The following are not excluded by the rule against hearsay, regardless of whether the declarant is available as a witness: …

(18) Statements in Learned Treatises, Periodicals, or Pamphlets. A statement contained in a treatise, periodical, or pamphlet if:

(A) the statement is called to the attention of an expert witness on cross-examination or relied on by the expert on direct examination; and

(B) the publication is established as a reliable authority by the expert’s admission or testimony, by another expert’s testimony, or by judicial notice.

If admitted, the statement may be read into evidence but not received as an exhibit.”

There are similar provisions in all state rules of evidence. See Mosteller et al ., supra note 4, § 321.

⁶ The reporters for the new Restatement explain, in a comment, that this provision concerns only the “substantive legal principles rather than rules of evidence.” Medical Malpractice Practice Guidelines, supra note 3, § 6, Reporters’ Note, cmt. f. The authors still should explain how admission of the guidelines comports with the rules of evidence if the substantive legal principle is more than an abstract enterprise.

⁷ The Institute has undertaken to produce its well-known Restatements since its founding in 1923, but has produced other forms of legal guidance as well. See Bennett Boskey, The American Law Institute: A Glimpse at Its Future, 12 Green Bag 2d 255, 256-58 (2009). For example, its Principles projects have “more flexibility; they fit well in areas where the law is somewhat less settled, or more emerging, than in Restatement areas.” Id. at 261.

⁸ Mark E. Budnitz, The Restatement of the Law of Consumer Contracts: The American Law Institute’s Impossible Dream, 32 Loy. Consumer L. Rev. 369, 371 (2020).

⁹ See Michael D. Green, Symposium Remarks, The American Law Institute and the Restatement (Third) of Torts: Presentation of Michael Green, in 52 Sw. L. Rev. 364, 365–66 (2024). The original Restatement of Torts spanned sixteen years, while its successor took more than two decades to finalize. Stephen D. Sugarman, Rethinking Tort Doctrine: Visions of a Restatement (Fourth) of Torts, 50 UCLA L. Rev. 585, 586–87 (2002).

¹⁰ Hon. Goodwin H. Liu, Symposium Remarks, A Brief Introduction to the American Law Institute and the Restatements of Torts, in 52 Sw. L. Rev. 358, 360 (2024).

¹¹ There have been controversial Restatements provisions before, most notably relating to product design defect liability. See, e.g., Philip H. Corboy, The Not-So-Quiet Revolution: Rebuilding Barriers to Jury Trial in the Proposed Restatement (Third) of Torts: Products Liability, 61 Tenn. L. Rev. 1043 (1994); Douglas E. Schmidt et al., A Critical Analysis of the Proposed Restatement (Third) of Torts: Products Liability, 21 Wm. Mitchell L. Rev. 411 (1995); John F. Vargo, The Emperor’s New Clothes: The American Law Institute Adorns a “New Cloth” for Section 402A Products Liability Design Defects— A Survey of the States Reveals a Different Weave, 26 U. Mem. L. Rev. 493 (1996); Frank J. Vandall, Constructing a Roof Before the Foundation Is Prepared: The Restatement (Third) of Torts: Products Liability, Section 2(b) Design Defect, 30 U. Mich. J. L. Reform 261 (1997). In the decade following its adoption, courts roundly rejected the core elements of those provisions. Larry S. Stewart, Strict Liability for Defective Product Design: The Quest for a Well-Ordered Regime, 74 Brook. L. Rev. 1039, 1040 (2009).

¹² Alan Schwartz & Robert E. Scott, The Political Economy of Private Legislatures, 143 U. Pa. L. Rev. 595, 600 (1995).

¹³ Liu, supra note 10, at 361.

¹⁴ Lawrence J. Latto, The Restatement of the Law Governing Lawyers: A View from the Trenches, 26 Hofstra L. Rev. 697, 707 (1998).

¹⁵ Am. L. Inst., Capturing the Voice of The American Law Institute: A Handbook for ALI Reporters and Those Who Review Their Work 7 (rev. ed. 2015).

¹⁶ Id. at 4-6.

¹⁷ Restatement of the Law Third Torts: Medical Malpractice § 5(a) (Am. L. Inst., Tentative Draft No. 2, 2024) [hereinafter Medical Malpractice].

¹⁸ This reasonable provider standard has been adopted in the pattern jury instructions of all U.S. jurisdictions. See: Alabama: § 25.01 “Standard of Care for Physician;” Alaska: Alaska Civil Pattern Jury Instructions § 8.02 “Health Care Provider Malpractice – Negligence Defined;” Arizona: RAJI (Civil) Medical Negligence 1 (7th ed.): “Definition of Medical Negligence;” Arkansas: § 1501 “Duty of Physician, Surgeon, Dentist or Other Medical Care Provider;” California: § 501 “Standard of Care for Health Care Professionals;” Colorado: §15:2 “Negligence—Nonspecialist—Defined” and § 15:3 Negligence—"Specialist or One Who Has or Claims to Have Special Skill—Defined;” Connecticut: § 3,8-3 “Medical Malpractice;” Delaware: § 7.1A (2000) “Definition of Medical Negligence;” District of Columbia: § 9.02 General Standard of Care of Professionals;” Florida: § 402.4 “Medical Negligence;” Georgia: § 62.300 “Physician, Skill Required of;” Hawaii: § 14.2. “Standard of Care;” Illinois: § 105.01 “Professional Negligence—Duty;” Idaho: § 1600.2 “Negligence - Duty Of Physician” and § 1600.3 “Negligence— Duty Of Specialist;” Indiana: § 1511 “Medical Negligence—Health Care Provider;” Iowa: § 1600.2 “Negligence— Duty of Physician;” Kansas: § 123.01 “Duty of Health Care Provider;” Kentucky: § 23.09 “Liability of Physician or Surgeon to Patient;” Louisiana: § 13:1. “Duty of physician (surgeon) in general practice” and § 13:2. “Duty of physician (surgeon) practicing a specialty;” Maine: § 7–75 “Medical Malpractice: Instruction;” Maryland: § 27:2 “Standard of Care—Defined:” Massachusetts: § 4.3.1 “Duty/Standard of Care;” Michigan: § 30.01 “Professional Negligence/Malpractice;” Minnesota: § 80,10 “Duty of a Doctor, Dentist, or Healthcare Provider Definition of “negligence” by a (professional healthcare provider);” Mississippi: § 2700. “Medical Malpractice—Standard of Care;” Missouri: § 11.06 “Negligence—Health Care Providers;” Nebraska: § 12.01 “Duty of a Health Care Provider;” Nevada: § 9.1 “Definitions;” New Hampshire: § 13.1 “Legal Fault: Negligence and Causation (Professional Negligence Cases);” New Jersey: § 5.50A “Duty and Negligence;” New Mexico: § 13-1101 “Duty of Doctor or Other Health Care Provider;” New York: § 2:150 “Malpractice—Physician;” North Carolina: § 809.00A “Medical Malpractice--Direct Evidence of Negligence Only;” North Dakota: § 14.10 “Physician’s Standard of Care;” Ohio: § 417.03 “Standards of care: physician/surgeon;” Oklahoma: No. 14.1 “Standard of Care—Non-specialist” and No. 14.2 “Standard of Care—Specialist;” Oregon: § 44.01 Duty of Medical Professional” and § 44.02 Duty of Specialist;” Pennsylvania: § 14.10 “Medical Malpractice—Standard of Care;” Rhode Island: § 1701.1 “Duty to Exercise Professional Skill in Treatment;” South Carolina: § 27-2 “Medical Malpractice - Standard of Care of a Physician;” South Dakota: § 14.10 “Physician’s Standard of Care;” Tennessee: § 6.10A “Duty of Physician” and § 6.11 “Duty of Specialist;” Texas: § 50.1 “Physician’s Degree of Care;” Utah: § 301C “’Standard of care’ defined;” Vermont § 7–7.0 “Elements of a Medical Malpractice Claim;” Virgina: No. 35.000 “Statewide Standard of Care for Health Care Providers;” Washington: § 105.01 “Negligence—General Health Care Provider” and § 105.02 “Negligence—Health Care Provider—Specialist;” West Virgina: § 502. “Standard of Care;” Wisconsin: § 1023 “Medical Negligence;” and Wyoming: § 14.02. “Medical Malpractice— Standard of Care— Defined” and § 14.03 “Standard of Care—Duty of a Specialist.”

¹⁹ James O. Pearson, Jr., Annotation, Modern Status of “Locality Rule” in Malpractice Action Against Physician Who is Not a Specialist, 99 A.L.R.3d 1133 (1980).

²⁰ Id.

²¹ Morrison v. MacNamara, 407 A.2d 555, 563 (D.C. Cir. 1979).

²² Hall v. Hilbun, 466 So. 2d 856, 870 (Miss. 1985).

²³ Medical Malpractice, supra note 17, at § 5, cmt. m.

²⁴ Studies conducted by the Justice Department’s Bureau of Justice Statistics consistently show that medical-malpractice plaintiffs prevail in only twenty-three to twenty-seven percent of cases, as compared to an even split in other tort cases. Carol J. DeFrances & Marika F.X. Litras, Bureau Just. Stats., Civil Trial Cases and Verdicts in Large Counties, 1996 6 (1999); Thomas H. Cohen, Bureau Just. Stats., Tort Trials and Verdicts in Large Counties, 2001 4 (2004); Thomas H. Cohen, Bureau Just. Stats., Medical Malpractice Trials and Verdicts in Large Counties, 2001 1 (2004). Moreover, most states have adopted or imposed special and intensive requirements before a medical-malpractice lawsuit may be filed. See generally Steven E. Pegalis, American Law of Medical Malpractice § 9:1 (3d ed. 2024) (discussing malpractice statutes); see also Gabriel H. Teninbaum & Benjamin R. Zimmermann, A Tale of Two Lawsuits, 8 J. Health & Biomedical L. 443, 443 (2013) (describing the differences between “bringing a garden-variety lawsuit for negligence, and bringing a claim for negligent medical care”). In addition, medical-malpractice lawyers must “invest thousands of dollars in deciding whether to take a case, and that expenditure does not include the internalized costs of having nurses, nurse-lawyers, or physician-lawyers on staff.” Stephen Daniels & Joanne Martin, Plaintiffs’ Lawyers, Specialization, and Medical Malpractice, 59 Vand. L. Rev. 1051, 1063 (2006). And then, many states impose artificial limitations on damages solely in medical-malpractice cases. See Carly N. Kelly & Michelle M. Mello, Are Medical Malpractice Damages Caps Constitutional? An Overview of State Litigation, 33 J.L. Med. & Ethics 515, 516 (2005) (reporting that more than half the states cap noneconomic damages as of 2005).

²⁵ A consensus appears to have emerged that the first modern practice guidelines emerged in the 1940s. See John D. Ayres, The Use and Abuse of Medical Practice Guidelines, 15 J. Legal Med. 421, 421 (1994) (indicating the use of medical practice guidelines over the preceding fifty years); Michelle M. Mello, Of Swords and Shields: The Role of Clinical Practice Guidelines in Medical Malpractice Litigation, 149 U. Pa. L. Rev. 645, 649 (2001) (noting that clinical practice guidelines have been “part of medical practice for more than half a century”).

²⁶ See Jerome P. Kassirer, The Quality of Care and the Quality of Measuring It, 329 New Eng. J. Med. 1263, 1263 (1993); Clark C. Havighurst, Practice Guidelines as Legal Standards Governing Physician Liability, 54 Law & Contemp. Probs. 87, 88-89 (1991).

²⁷ Mark R. Chassin et al., Variations in the Use of Medical and Surgical Services by the Medicare Population, 314 New Eng. J. Med. 285, 286–89 (1986).

²⁸ Havighurst, supra note 26, at 89.

²⁹ Omnibus Budget Reconciliation Act of 1989, Pub. L. No. 101-239, § 901, 103 Stat. 2106, 2189 (1989) (codified as amended at 42 U.S.C. § 299).

³⁰ William R. Trail & Brad A. Allen, Government Created Medical Practice Guidelines: The Opening of Pandora’s Box, 10 J.L. & Health 231, 233–34 (1996).

³¹ Id. at 234 (quoting Agency for Health Care Policy and Research, U.S. Dep’t of Health and Human Services, Public Health Service, Clinical Practice Guideline: Depression in Primary Care: Treatment of Major Depression (inside cover) (1993)).

³² Ayres, supra note 25, at 421.

³³ Eleanor D. Kinney, The Brave New World of Medical Standards of Care, 29 J.L. Med. & Ethics 323, 324 (2001).

³⁴ Id.

³⁵ Ayres, supra note 25, at 421. Practice guidelines have continued to grow. They have now burgeoned to a staggering number, numbering nearly 3000, promulgated by more than 350 different entities. Ronen Avraham, Overlooked and Underused: Clinical Practice Guidelines and Malpractice Liability for Independent Physicians, 20 Conn. Ins. L.J. 273, 275 (2014).

³⁶ Ayres, supra note 25, at 421.

³⁷ Christine Laine et al., Trustworthy Clinical Guidelines, 154 Annals Internal Med. 774, 774 (2011).

³⁸ Id.

³⁹ See Melissa Ballengee Alexander, Disclosing Deviations: Using Guidelines to Nudge and Empower Physician-Patient Decision Making, 19 Nev. L.J. 867, 915–16 (2019).

⁴⁰ Gilbert Benavidez & Austin B. Frakt, Fixing Clinical Practice Guidelines, Health Affs. (Aug. 5, 2019), https://www.healthaffairs.org/do/10.1377/forefront.20190730.874541/full/.

⁴¹ Ayres, supra note 25, at 422.

⁴² See Mello, supra note 25, at 668–77.

⁴³ For example, the Office of Technology Assessment (OTA), a congressional research agency, advised that “[i]f courts and legislatures are not selective about which guidelines are introduced as evidence, these conflicts may find their way into the courts and further confuse rather than clarify the process of determining negligence.” Off. of Tech. Assessment, Impact of Legal Reforms on Medical Malpractice Costs, 33 (1993). The RAND Institute for Civil Justice similarly warned that competing guidelines with vastly different advice would not clarify the standard of care but “simply elevate the ‘battle of experts’ that often occurs to a ‘battle of guidelines.”’ Eleanor D. Kinney et al., Report of the Medical Guidelines Panel, in RAND Institute for Civil Justice, Conference Proceedings: Health Care Delivery and Tort: Systems on a Collision Course?, 58 (Elizabeth Rolph ed., 1992).

⁴⁴ See Mark A. Hall, The Defensive Effect of Medical Practice Policies in Malpractice Litigation, 54 L. & Contemp. Probs. 119, 120–21 (1991) (arguing that the optimal use of practice guidelines would be as conclusive evidence of the medical standard of care); Medical Malpractice, supra note 17, at iv (listing the reporters of the Medical Malpractice Restatement).

⁴⁵ E.g., Mello, supra note 25, at 648 (use of practice guidelines as a legal standard of care “is deeply problematic”); Maxwell J. Mehlman, Professional Power and the Standard of Care in Medicine, 44 Ariz. St. L. J. 1165, 1211-25 (2012) (describing the many problems in the use of practice guidelines to establish a standard of care).

⁴⁶ Dan B. Dobbs et al., The Law of Torts § 295 (2d ed. 2011).

⁴⁷ See Jodi M. Finder, The Future of Practice Guidelines: Should They Constitute Conclusive Evidence of the Standard of Care?, 10 Health Matrix 67, 72 (2000).

⁴⁸ Benavidez & Frakt, supra note 40.

⁴⁹ Id.

⁵⁰ Viviane C. Pereira et al., Strategies for the Implementation of Clinical Practice Guidelines in Public Health: An Overview of Systematic Reviews, 20 Health Rsch. Pol’y & Sys. at 2 (2022).

⁵¹ Institute of Medicine, Clinical Practice Guidelines: Directions for a New Program 6 (Marilyn J. Field & Kathleen N. Lohr eds., 1990).

⁵² Justin Kung et al., Failure of Clinical Practice Guidelines to Meet Institute of Medicine Standards: Two More Decades of Little, if Any, Progress, 172 Archives of Internal Med. 1628, 1628 (2012).

⁵³ Ernesto Guerra-Farfan et al., Clinical Practice Guidelines: The Good, The Bad, and The Ugly, 54 Inj. S26, S27 (2023); cf. Stephen H. Woolf et al., Clinical Guidelines: Potential Benefits, Limitations, and Harms of Clinical Guidelines, 318 Brit. Med. J. 527 (1999) (finding that guidelines rely on the absence of scientific evidence or misinterpret that evidence, often fail to account what individual patients require, and frequently adopt “suboptimal, ineffective, or harmful practices” to control costs or “protect special interests,” such as risk managers).

⁵⁴ Kung, supra note 52, at 1628.

⁵⁵ Avraham, supra note 35, at 284.

⁵⁶ Id.

⁵⁷ Substance Abuse & Mental Health Servs. Admin., HHS Pub. No. PEP15-FEDGUIDEOTP, Federal Guidelines for Opioid Treatment Programs 4 (2015)

⁵⁸ Comm. on Quality of Health Care in Am., Inst. of Med., To Err is Human: Building a Safer Health System 132 (Linda T. Kohn et al. eds., 2000).

⁵⁹ Id.

⁶⁰ Am. Psych. Ass’n, APA Clinical Practice Guideline for the Treatment of Depression Across Three Age Cohorts II (2019).

⁶¹ See Comm. on Standards for Developing Trustworthy Clinical Prac. Guidelines, Inst. of Med., Clinical Practice Guidelines We Can Trust 65–66 (Robin Graham et al. eds., 2011).

⁶² Melissa C. Brouwers et al., AGREE II: Advancing Guideline Development, Reporting and Evaluation in Health Care, 182 Canadian Med. Ass’n J. E839, E839 (2010).

⁶³ See Robin W.M. Vernooij et al., Guidance for Updating Clinical Practice Guidelines: A Systemic Review of Methodological Handbooks, 9 Implementation Sci. art. no. 3, at 6–7 (2014).

⁶⁴ Pablo Alonso-Coello et al., The Updating of Clinical Practice Guidelines: Insights from an International Survey, 6 Implementation Sci. art. no. 107, at 1 (2011); see also Paul G. Shekelle et al., When Should Clinical Guidelines be Updated?, 323 Brit. Med. J. 155 (2001)[; Paul G. Shekelle et al., Validity of the Agency for Healthcare Research and Quality Clinical Practice Guidelines: How Quickly Do Guidelines Become Outdated?, 286 J. Am. Med. Ass’n 1461 (2001).

⁶⁵ Kung, supra note 52, at 1630.

⁶⁶ Avraham, supra note 35, at 277.

⁶⁷ See Paolo Bironzo & Massimo Di Maio, A Review of Guidelines for Lung Cancer, 10 J. Thoracic Disease S1556 (2018).

⁶⁸ See id. at S1560.

⁶⁹ See id. at S1561.

⁷⁰ Id. at S1556.

⁷¹ Id. at S1561.

⁷² Id.

⁷³ Id.

⁷⁴ See B. Sonny Bal, The Expert Witness in Medical Malpractice Litigation, 467 Clinical Orthopaedics & Related Rsch. 383, 384 (2008).

⁷⁵ See Benjamin Ikuta, An Opposing Expert’s Personal Practices Are Always Relevant and Should Be Admissible in Your Medical Malpractice Case, 54 Consumer Att’ys Cal. F. 44 (2024).

⁷⁶ Schmitz v. Binette, 857 N.E.2d 846, 856 (Ill. App. Ct. 2006).

⁷⁷ See, e.g., Oaks v. Chamberlain, 76 N.E.3d 941, 950–51 (Ind. Ct. App. 2017); Condra v. Atlanta Orthopaedic Grp., 681 S.E.2d 152, 154 (Ga. 2009); Smethers v. Campion, 108 P.3d 946, 955 (Ariz. Ct. App. 2005); Wallbank v. Rothenberg, 74 P.3d 413, 416–17 (Colo. App. 2003) (letting jury consider whether all the testifying experts personally would have performed additional testing even though the defense experts testified that the additional testing was a personal preference and not a requirement of the standard of care).

⁷⁸ See Adams v. Lab’y Corp. of Am., 760 F.3d 1322, 1331 (11th Cir. 2014) (finding that College of American Pathologists and the American Society of Cytopathology guidelines were created “to limit how the courts can find the members of the organizations liable for professional negligence when they are sued.”). In Adams, the purpose of the guidelines was apparent from the face of the documents. Given the outcome in Adams, it is doubtful that any future guidelines will be even remotely as transparent.

⁷⁹ Medical Malpractice Practice Guidelines, supra note 3, § 6(b), Reporter’s Note, cmt. f. (noting that (“Clinical guidelines often have only limited bearing on disputed aspects of a particular medical situation because they address only some aspects” of the case). The uniqueness of patient cases is sometimes referred to as the “snowflake” effect. For that reason, customary practices do not determine the standard of care. See, e.g., Philip G. Peters, Jr., The Quiet Demise of Deference to Custom: Malpractice Law at the Millennium, 57 Wash. & Lee L. Rev. 163, 187 (2000) (noting that for customary practices, the “variability in patients, illnesses, and possible therapeutic responses often will make the notion of an established custom a quaint fairy tale.”). The same difficulty arises in trying to craft standards of care from practice guidelines.

⁸⁰ Woolf, supra note 53, at 529.

⁸¹ Michelle M. Mello, Using Statistical Evidence to Prove the Malpractice Standard of Care: Bridging Legal, Clinical, and Statistical Thinking, 37 Wake Forest L. Rev. 821, 847 (2002).

⁸² U.S. Preventive Servs. Task Force, Screening for Breast Cancer: U.S. Preventive Services Task Force Recommendation Statement, 151 Annals Internal Med. 716, 716 (2009). The Restatement treats the U.S. Preventive Services Task Force as an authoritative source of guidelines that courts should accept. See Medical Malpractice Practice Guidelines, supra note 3, § 6, Illustration 4. We note, however, that on January 10, the Supreme Court granted certiorari to consider whether appointments to that task force complied with constitutional requirements. Becerra v. Braidwood Mgmt., Inc., No. 24-316, 2025 WL 65913, at *1 (U.S. Jan. 10, 2025). The Fifth Circuit held that the task force members are principal officers who must be constitutionally nominated by the president and approved by the Senate. See Braidwood Mgmt., Inc. v. Becerra, 104 F. 4th 930, 947 (5th Cir. 2024), cert. granted, No. 24-316, 2025 WL 65913 (U.S. Jan. 10, 2025), and cert. denied sub nom. Braidwood Mgmt. Inc v. Becerra, No. 24-475, 2025 WL 76462 (U.S. Jan. 13, 2025). If upheld, the task force had and will have no authority to issue “official” or “authoritative” guidelines.

⁸³ Natalia Gray & Gabriel Picone, The Effect of the 2009 U.S. Preventive Services Task Force Breast Cancer Screening Recommendations on Mammography Rates, 51 Health Servs. Rsch. 1533, 1534 (2016).

⁸⁴ History of ACS Recommendations for the Early Detection of Cancer in People Without Symptoms, Am. Cancer Soc’y (Nov. 1, 2023), https://www.cancer.org/health-care-professionals/american-cancer-society-prevention-early-detection-guidelines/overview/chronological-history-of-acs-recommendations.html [https://perma.cc/5PB9-PXGM].

⁸⁵ A & B Recommendations, U.S. Preventive Servs. Task Force, https://www.uspreventiveservicestaskforce.org/uspstf/recommendation-topics/uspstf-a-and-b-recommendations [https://perma.cc/EC2S-2PQS].

⁸⁶ Kevin C. Oeffinger et al., Breast Cancer Screening for Women at Average Risk: 2015 Guideline Update from the American Cancer Society, 314 J. Am. Med. Ass’n 1599, 1603 (2015).

⁸⁷ See id. at 1609.

⁸⁸ See Elizabeth S. Koh et al., Comparison of US Cancer Center Recommendations for Prostate Cancer Screening with Evidence-Based Guidelines, 182 J. Am. Med. Ass’n Internal Med. 555, 556 (2022).

⁸⁹ Id.

⁹⁰ Id. at 557.

⁹¹ See Susan Ronn, In the Lymelight: Law and Clinical Practice Guidelines, 102 S. Med. J. 626, 626 (2009).

⁹² Tammy Asher, Unprecedented Antitrust Investigation into the Lyme Disease Treatment Guidelines Development Process, 46 Gonz. L. Rev. 117, 122–24 (2010/11).

⁹³ Id. at 122.

⁹⁴ Id. at 124.

⁹⁵ Conn. Att’y Gen.’s Off., Press Release: Attorney General’s Investigation Reveals Flawed Lyme Disease Guideline Process, IDSA Agrees To Reassess Guidelines, Install Independent Arbiter, Richard Wolfram, Esq. (May 1, 2008), https://www.rwolframlex.com/images/Lyme_CT_AG_press_release_re-settlement.pdf [https://perma.cc/8ZKP-T8JK].

⁹⁶ Id.

⁹⁷ Asher, supra note 92, at 125–26.

⁹⁸ Lisa Chamoff, AG Chides Lyme Panel for Not Following Settlement Agreement, ctpost (Feb. 10, 2010), https://www.ctpost.com/local/article/ag-chides-lyme-panel-for-not-following-settlement-360029.php.https://www.ctpost.com/local/article/ag-chides-lyme-panel-for-not-following-settlement-360029.php., https://www.ctpost.com/local/article/ag-chides-lyme-panel-for-not-following-settlement-360029.php.

⁹⁹ Comm. on Standards for Developing Trustworthy Clinical Prac. Guidelines, supra note 61, at ix.

¹⁰⁰ See Megan L. Sheetz, Toward Controlled Clinical Care Through Clinical Practice Guidelines: The Legal Liability for Developers and Issuers of Clinical Pathways, 63 Brook. L. Rev. 1341, 1378–80 (1997).

¹⁰¹ Arnold J. Rosoff, Evidence-Based Medicine and the Law: The Courts Confront Clinical Practice Guidelines, 26 J. Health Pols., Pol’y & L. 327, 345, 349 (2001).

¹⁰² The Reporters’ Note for Section 6(b) acknowledges that some have criticized clinical guidelines as “biased by professional or industry self-interest, or for not being developed with sufficient rigor,” citing only two of the many critiques, and then quickly suggests that “additional case-law development will be needed” to address that problem. Medical Malpractice Practice Guidelines, supra note 3, § 6, Reporters’ Note, cmt. f.

¹⁰³ Medical Malpractice, supra note 17, §6, cmt. f (“Subsection (b)’s endorsement of authoritative guidelines is asymmetric. Although such evidence can also be relevant to a plaintiff’s case to reinforce or rebut expert testimony, this Subsection permits authoritative practice guidelines to substitute for expert testimony only when the guidelines support compliance with, but not to establish a violation of, § 5’s standard of care.”).

¹⁰⁴ Id. § 6, Reporters’ Note, Cmt. f (“[C]ase law is not well developed on the defensive use of authoritative standard-of-care guidelines.”).

¹⁰⁵ Id. § 6, cmt. f.

¹⁰⁶ Id. §§ 5, cmt. a, 6, cmt. a (“This Section does not address the characteristics required to qualify as an expert. It leaves that matter to the evidence law in each jurisdiction.”).

¹⁰⁷ Id. § 6, cmt. f (“[T]here is only limited case-law support for Subsection (b).”).

¹⁰⁸ Frakes v. Cardiology Consultants, P.C., No. 01-A-01-9702-CV-00069, 1997 WL 536949, at *5–6 (Tenn. Ct. App. Aug. 29, 1997) (Koch, Jr., J., concurring).

¹⁰⁹ Id. at *4 (majority opinion).

¹¹⁰ Id.

¹¹¹ Id. at *4–5.

¹¹² Id. at *6 (Koch, Jr., J., concurring).

¹¹³ Id.

¹¹⁴ Id.

¹¹⁵ Medical Malpractice, supra note 17, §6, Reporters’ Note, cmt. f.

¹¹⁶ Id.

¹¹⁷ Arpin v. United States, 521 F.3d 769 (7th Cir. 2008).

¹¹⁸ Dalmia v. Palffy, No. 281706, 2009 WL 4344088 (Mich. Ct. App. Dec. 1, 2009).

¹¹⁹ Arpin, 521 F.3d at 772-73; Dalmia, 2009 WL 4344088, at *1.

¹²⁰ Arpin, 521 F.3d at 772-73.

¹²¹ Id. at 773.

¹²² Medical Malpractice, supra note 17, § 6, Reporters’ Note, cmt. f.

¹²³ Arpin, 521 F.3d at 773.

¹²⁴ Id. at 774.

¹²⁵ Dalmia, 2009 WL 4344088, at *5.

¹²⁶ Id. at *4.

¹²⁷ Yi v. N.Y. State Bd. for Pro. Med. Conduct, 210 N.Y.S.3d 790 (N.Y. App. Div. 2024) (On review of a physician’s license revocation, the court rejected the reviewing physicians’ claim that practice guidelines from the National Comprehensive Cancer Network and the American College of Radiology constituted the standard of care but, based on other evidence presented, affirmed the license revocation); Jewett v. Our Lady of Mercy Hosp. of Mariemont, 612 N.E.2d 724, 727 (Ohio Ct. App. 1992) (In reversing a directed verdict, the court rejected defendants’ contention that American College of Obstetricians and Gynecologist (ACOG) guidelines constituted the applicable standard of care, holding that testimony from plaintiff’s expert created an issue fact notwithstanding the provisions of the ACOG guidelines); Adams v. Lab’y Corp. of Am., 760 F.3d 1332, 1332–34 (11th Cir. 2014) (In reversing a summary judgment, the court rejected defendants’ claim that guidelines from the College of American Pathologists and American Society of Cytopathology constituted a standard of care that compelled rejection of plaintiff expert’s testimony).

¹²⁸ Medical Malpractice, supra note 17, § 6, Reporters’ Note, cmt. f.

¹²⁹ Restatement (Third) of The L. Governing Laws. § 52.2 (Am. L. Inst. 2000) (“(2) Proof of a violation of a rule or statute regulating the conduct of lawyers… (c) may be considered by a trier of fact as an aid in understanding and applying the standard [of care].”); Restatement (Third) of Torts: Liab. for Econ. Harm § 4 cmt. c (Am. L. Inst. 2020) (“A violation of a profession’s internal code of conduct can itself be admitted as evidence of professional negligence, though it is not dispositive.”); Restatement (Third) Torts: Miscellaneous Provisions, § (#) (Am. L. Inst., Preliminary Draft No. 5, 2024).

¹³⁰ Fed. R. Evid. 803(18).

¹³¹ Rosoff, supra note 101, at 344.

¹³² Restatement (Third) of Torts: Liability for Physical & Emotional Harm § 13 cmt. e (Am. L. Inst. 2010).

¹³³ See generally Fed. R. Evid. 401 (“Evidence is relevant if: (a) it has any tendency to make a fact more or less probable than it would be without the evidence; and (b) the fact is of consequence in determining the action.” There is no party requirement in the determination of relevant and admissible evidence).

¹³⁴ Medical Malpractice, supra note 17, § 6, Reporters’ Note, cmt. f.

¹³⁵ Avraham, supra note 35, at 299–300.

¹³⁶ Andrew L. Hyams et al., Practice Guidelines and Malpractice Litigation: A Two-Way Street, 122 Annals Internal Med. 450, 451–52 (1995) (noting that practice guidelines have been used “for both inculpatory and exculpatory purposes.”); see also Mello, supra note 25, at 648 (noting that “empirical evidence indicates that CPGs currently are being used both as exculpatory evidence (by physician defendants) and as inculpatory evidence (by plaintiffs)”).

¹³⁷ Frakes v. Cardiology Consultants, P.C., No. 01-A-01-9702-CV-00069, 1997 WL 536949, at *6 (Tenn. Ct. App. Aug. 29, 1997) (Koch, Jr., J., concurring).

¹³⁸ See Smethers v. Campion, 108 P.3d 946 (Ariz. Ct. App. 2005) (FDA guidelines in LASIK surgery); Van Horn v. Hornbeak, No. CV F 08-1622 LJO DLB, 2010 WL 599885 (E.D. Cal. Feb. 18, 2010) (CDC and ACOG guidelines in prenatal care and delivery); District of Columbia v. Wilson, 721 A.2d 591 (D.C. 1998) (U.S. Public Health Service guidelines in treating an asthma attack); Johnson v. Thompson, 650 S.E.2d 322 (Ga. Ct. App. 2007) (ACOG guidelines in birth-related injury); Trowbridge v. United States, 703 F. Supp. 2d 1129 (D. Idaho 2010) (ACOG guidelines in birth-related injury); Bergman v. Kelsey, 873 N.E.2d 486 (Ill. App. Ct. 2007) (ACOG and AAP guidelines in birth-related injury); Joyner-Wentland v. Waggoner, 890 N.E.2d 730 (Ind. Ct. App. 2008) (American Cancer Society guidelines in breast lift); Campbell v. Hosp. Serv. Dist. No. 1, Caldwell Parish, 768 So.2d 803 (La. Ct. App. 2000) (unidentified heart attack guidelines); Collins v. La. ex rel. La. Health Care Auth., 774 So.2d 167 (La. Ct. App. 2000) (CDC guidelines in treating infection in emergency room); Feeley v. Baer, 669 N.E.2d 456 (Mass. App. Ct. 1996), aff’d in part, rev’d in part, 679 N.E.2d 180 (Mass. 1997) (ACOG guidelines for prenatal care involving newborn death); Darke v. Estate of Isner, 17 Mass. L. Rptr. 689 (Mass. Super. Ct. 2004) (American Society Of Gene Therapy and other guidelines in gene transfer experiment).

¹³⁹ Medical Malpractice, supra note 17, § 6, Reporters’ Note, cmt. f.

¹⁴⁰ Rosoff, supra note 101, at 344.

¹⁴¹ Mello, supra note 25, at 648.

¹⁴² Mehlman, supra note 45, at 1167.

¹⁴³ Id. at 1199: (“More importantly, none of the state programs were successful. Neither Minnesota nor Florida appears to have issued any guidelines, and the project in Vermont seems to have been abandoned.”).

¹⁴⁴ Gordon H. Smith, Maine’s Medical Liability Demonstration Project – Linking Practice Guidelines to Liability Protection, 13 Virtual Mentor 792, 792, 795 (2011). (“The [Maine] project was eventually extended to 8 years, but was allowed to expire by the year 2000 when supporters of the law concluded that the affirmative defense intended to assist physicians had not been used in a single case in court.”).

¹⁴⁵ Md. Code Ann., Health-Gen. §19-1601 – 19-1606 (LexisNexis 2013) (repealed 1999).

¹⁴⁶ Medical Malpractice, supra note 17, § 6, Reporters’ Note, cmt. f.

¹⁴⁷ Id.

¹⁴⁸ Id., Reporters’ Note.

¹⁴⁹ See, e.g., Adams v. Lab’y Corp. of Am., 760 F.3d 1322, 1330 (11th Cir. 2014) (“It is difficult to imagine how Dr. Rosenthal’s experience could have been more extensive and relevant or contributed more to the reliability of the methodology she used.”).

¹⁵⁰ See Daniels & Martin, supra note 24, at 1052.

¹⁵¹ See generally Herbert Jacob, Law and Politics in the United States 118-19 (2d ed. 1995) (discussing the gatekeeping roles of lawyers); see also Herbert M. Kritzer, Contingency Fee Lawyers as Gatekeepers in the Civil Justice System, 81 Judicature 22 (1997); Joanne Martin & Stephen Daniels, Access Denied, 33 Trial 26; Philip H. Corboy, Contingency Fees: The Individual’s Key to the Courthouse Door, 2 Litig. 27 (1976).

¹⁵² See B. Sonny Bal, The Expert Witness in Medical Malpractice Litigation, 467 Clinical Orthopaedics & Related Rsch. 383, 383, 385–87 (2009).

¹⁵³ Id. at 384–85.

¹⁵⁴ See discussion supra Part II.A.

¹⁵⁵ See discussion supra Part II.B.

¹⁵⁶ Medical Malpractice, supra note 17, § 6 cmt. f.

¹⁵⁷ See Charles Alan Wright & Arthur R. Miller, Federal Practice and Procedure § 5191.3 (2d ed. Supp. 2024) (showing that all states have adopted a version of Fed. R. Evid. 402, which limits admissibility to relevant evidence and specifically states that “[i]rrelvant evidence is not admissible.”).

¹⁵⁸ Fed. R. Evid. 803(18)(B).

¹⁵⁹ Id.

¹⁶⁰ Medical Malpractice, supra note 17, § 6 cmt. f.

¹⁶¹ FDA v. All. for Hippocratic Med., 602 U.S. 367 (2024) (holding that the Alliance lacked standing).

¹⁶² All. for Hippocratic Med., https://allianceforhippocraticmedicine.org/ [https://perma.cc/67M4-RNEF].

¹⁶³ Alliance for Hippocratic Medicine, Upholding and Promoting the Fundamental Principles of Hippocratic Medicine, 88 Linacre Q. 321, 321 (2021).

¹⁶⁴ All. for Hippocratic Med. v. FDA, 78 F.4th 210, 222 (5th Cir. 2023), rev’d and remanded, 602 U.S. 367 (2024).

¹⁶⁵ Frakes v. Cardiology Consultants, P.C., No. 01-A-01-9702-CV-00069, 1997 WL 536949, at *6 (Tenn. Ct. App. Aug. 29, 1997) (Koch, Jr., J., concurring) (emphasis added).

¹⁶⁶ See Robert John Kane & Lawrence E. Singer, Illinois Practice Series: The Law of Medical Practice in Illinois § 33:3 & n.14 (3d ed. 2024).

¹⁶⁷ Dan B. Dobbs et al., The Law of Torts § 295 (2d ed. Supp. 2024).

¹⁶⁸ Id.

¹⁶⁹ Medical Malpractice Practice Guidelines, supra note 3, § 6, Reporters’ Note, cmt. f (“Accordingly, additional case-law development will be needed to refine what constitutes appropriate expertise, relevance, and perspective in various situations—and also how current various guidelines need to be, in order to be utilized.”).

¹⁷⁰ See Fed. R. Evid. 803 notes of advisory committee on proposed rules.

¹⁷¹ See discussion supra Part II.B.

¹⁷² See discussion supra Part IV.B.

¹⁷³ Travis W. Franklin, The State of Race and Punishment in America: Is Justice Really Blind?, 59 J. Crim. Just. 18, 18 (2018).

¹⁷⁴ See Fed. R. Evid. 402.

¹⁷⁵ See Regan Kreitzer LaTesta, Rape Shield Statutes and the Admissibility of Evidence Tending to Show a Motive to Fabricate, 46 Clev. St. L. Rev. 489, 490, 509 (1998).

¹⁷⁶ Medical Malpractice, supra note 17, § 6, Reporters’ Note, cmt. f.

¹⁷⁷ Fed. R. Evid. 803, notes of advisory committee on exception 18.

¹⁷⁸ See Marbury v. Madison, 5 U.S. (1 Cranch) 137, 163 (1803) (“The very essence of civil liberty certainly consists in the right of every individual to claim the protection of the laws, whenever he receives an injury.”).

¹⁷⁹ Medical Malpractice, supra note 17, § 5 cmts. c & m (“[T]his reasonable provider standard is assessed on a national, rather than local, basis, with some variation in the standard based on relevant factors and circumstances…. [T]his Section rejects the Second Restatement’s ‘locality rule’ in favor of a ‘national’ standard.”).

¹⁸⁰ See Daniels & Martin, supra note 24, at 1052.

¹⁸¹ Franklin, supra note 173, at 18.

¹⁸² See 5 John Henry Wigmore, Wigmore on Evidence: Evidence in Trials at Common Law §1367 (4th ed. Supp. V 2024).

¹⁸³ See Williams v. Lawrence + Mem’l Hosp., Inc., 273 A.3d 235, 240, 237 n.6 (Conn. App. Ct. 2022).

¹⁸⁴ Fed. R. Civ. P. 1.

¹⁸⁵ Fed. R. Evid. 803, notes of advisory committee on exception 18.

¹⁸⁶ Medical Malpractice Practice Guidelines, supra note 3, § 6, Reporters’ Note, cmt. f.

¹⁸⁷ Id.

¹⁸⁸ Id. § 6 cmt. f (“some expert testimony will usually be needed …”).

¹⁸⁹ Id. § 6, Reporters’ Note, cmt. f (This section “addresses … whether practice guidelines can, standing alone, provide sufficient evidence of compliance with a standard of care to obviate the need for expert testimony concerning the standard of care.”).

¹⁹⁰ Wigmore, supra note 182, §1367.

¹⁹¹ See generally Fed. R. Evid. 802 (stating that hearsay evidence is inadmissible unless it falls into a certain category of exception).

¹⁹² See discussion supra Part II.B.

¹⁹³ Fed. R. Evid. 201(b).

¹⁹⁴ The T.J. Hooper, 60 F.2d 737, 740 (2d Cir. 1932).

¹⁹⁵ See Restatement (Third) of Torts: Liability for Physical & Emotional Harm, supra note 132, §13 cmt. b (“[C]ompliance with custom does not … conclusively show that the actor was free of negligence… . [P]ossibly, the entire community or industry has lagged: all members of the group to which the actor belongs may have been inattentive to new developments or may have been pursuing self-interest in a way that has encouraged the neglect of a reasonable precaution.”).

¹⁹⁶ Adams v. Lab’y Corp. of Am., 760 F.3d 1322, 1334 (11th Cir. 2014).

¹⁹⁷ See, e.g., Certified Fin. Planner Bd. of Standards, Inc., Practice Standards Reference Guide: Reference Guide to the Practice Standards for the Financial Planning Process (2020) (providing guidance for certified financial planners); The Mass. Bd. of Registration of Architects & the Mass. Bd. of Registration of Pro. Eng’rs & Land Surveyors, Professional Practice: A Guide to the Practice of Architecture, Engineering, and Land Surveying in Massachusetts (2023) (assisting architects professional engineers, and professional land surveyors in Massachusetts understand their professional responsibilities); Int’l Fin. Corp., Environmental, Health, and Safety General Guidelines (2007) (discussing general and industry-specific expectations for international industry practices relating to environmental, occupational, and community health).

¹⁹⁸ See Fed. R. Evid. 803(18).

¹⁹⁹ Medical Malpractice Practice Guidelines, supra note 3, § 6 cmt. f (“[T]he guideline must be ‘authoritative.’ Many areas of medical practice have multiple and even conflicting guidelines, and not all would meet this test.”).

²⁰⁰ Id.

²⁰¹ Id.

²⁰² See, e.g., Darling v. Charleston Cmty. Mem’l Hosp., 211 N.E.2d 253, 257 (Ill. 1965) (“[C]ustom should never [sic] be conclusive.”); Palmer v. Biloxi Reg’l Med. Ctr., Inc., 564 So. 2d 1346, 1354 (Miss. 1990) (“Mississippi physicians are bound by nationally-recognized standards of care…”); Travers v. District of Columbia, 672 A.2d 566, 568 (D.C. 1996) (“[T]he applicable standard is a national standard, not just a local custom.”); Norris v. Fritz, 270 P.3d 79, 87 (Mont. 2012) (“A medical malpractice plaintiff must establish that a physician’s conduct breached a national standard of care.”).

²⁰³ See Medical Malpractice, supra note 17, § 5(a), cmts. c & m.

²⁰⁴ Id. § 6(b).

²⁰⁵ See id. §6 cmt. f (“Authoritativeness is best determined by the judge, based on local evidence law, rather than by the factfinder, as is true for other evidentiary rulings.”).

²⁰⁶ Fed. R. Evid.803 (18).

²⁰⁷ See Daubert v. Merrell Dow Pharms., Inc.,509 U.S. 579, 592–93 (1993).

²⁰⁸ Id.

²⁰⁹ Daubert v. Merrell Dow Pharms., Inc., 43 F.3d 1311, 1318 n.10 (9th Cir. 1995), on remand from 509 U.S. 579.

²¹⁰ See Christine P. Bartholomew, Death by Daubert: The Continued Attack on Private Antitrust, 35 Cardozo L. Rev. 2147, 2189 (2014).

²¹¹ United States v. Katz, 178 F.3d 368, 371 (5th Cir. 1999).

²¹² Bartholomew, supra note 210, at 2189–90 (quoting Allapattah Servs., Inc. v. Exxon Corp., 61 F. Supp. 2d 1335, 1342 (S.D. Fla. 1999)).

²¹³ Minner v. Am. Mortg. & Guar. Co., 791 A.2d 826, 845 (Del. Super. Ct. 2000).

²¹⁴ The American Law Institute, Capturing the Voice of The American Law Institute: A Handbook for ALI Reporters and Those Who Review Their Work 6 (rev. ed. 2015).

²¹⁵ See sources cited supra note 24 and accompanying text.

²¹⁶ See sources cited supra note 151.

²¹⁷ See Tom Baker, The Medical Malpractice Myth 37 (2005) (describing studies indicating more occasions of medical malpractice than medical-malpractice lawsuits); David A. Hyman & Charles Silver, Medical Malpractice Litigation and Tort Reform: It’s the Incentives, Stupid, 59 Vand. L. Rev. 1085, 1089–92 (2006) (citing studies showing significant underclaiming of medical malpractice); Douglas A. Kysar et al., Medical Malpractice Myths and Realities: Why an Insurance Crisis Is Not a Lawsuit Crisis, 39 Loy. L.A. L. Rev. 785, 791 (2006) (finding that the medical malpractice cases are underutilized); Michelle M. Mello & Troyen A. Brennan, Deterrence of Medical Errors: Theory and Evidence for Malpractice Reform, 80 Tex. L. Rev. 1595, 1608 (2002) (“[O]nly a tiny fraction of patients injured due to negligence file a claim.”).

²¹⁸ See Inst. of Med., supra note 58, at 1 (explaining that two studies, from Colorado/Utah and New York, respectively supported that 2.9 and 3.7 percent of hospitalizations resulted in adverse events and further noting that U.S. hospital admissions totaled 33.6 million in 1997).

²¹⁹ Medical Liability: New Ideals for Making the System Work Better for Patients: Hearing Before the S. Comm. on Health, Educ., Lab. & Pensions, 109th Cong. 72 (2006) (statement of Neil Vidmar, Russell M. Robinson II Professor of Law, Chair, Duke Law School).

²²⁰ Hyman & Silver, supra note 217, at 1089.

²²¹ Rosoff, supra note 101, at 339.

²²² The Kansas Supreme Court has provided a commonly understood definition of separation of powers: “The basic meaning of the separation of powers doctrine is that the whole power of one department should not be exercised by the same hands which possess the whole power of either of the other departments.” Kansas v. Ponce, 907 P.2d 876, 879 (Kan. 1995). Although the United States Constitution contains no explicit language concerning the separation of powers, the constitutional structure of government makes it a fundamental part of our government. See Cong. Rsch. Serv., Separation of Powers Under the Constitution, Const. Annotated, https://constitution.congress.gov/browse/essay/intro.7-2/ALDE_00000031/ (last visited Dec. 2, 2024). State constitutions often are explicit about separation of powers, including it within the state declaration of rights, such as in Md. Const. Declaration of Rights art. 8 (“That the Legislative, Executive and Judicial powers of Government ought to be forever separate and distinct from each other; and no person exercising the functions of one of said Departments shall assume or discharge the duties of any other.”), or as a stand-alone requirement. See, e.g., Fla. Const. art. 2, § 3 (“No person belonging to one branch shall exercise any powers appertaining to either of the other branches unless expressly provided herein.”).

²²³ Medical Malpractice, supra note 17, § 6 cmt. f.

²²⁴ SAS Inst., Inc. v. Iancu, 584 U.S. 357, 368 (2018).

²²⁵ See, e.g., Borgelt v. Austin Firefighters Ass’n, 692 S.W.3d 288, 301 (Tex. 2024) (“Courts … must also rigorously distinguish between policy conflicts and legal questions. Under our Constitution, policy choices belong to the other branches.”); Teig v. Chavez, 8 N.W.3d 484, 494 (Iowa 2024) (declaring that party’s argument was a “policy consideration best left to the legislative branch”); Mathews v. Becerra, 455 P.3d 277, 298 (Cal. 2019) (“[O]ur role is not to supplant the Legislature’s policymaking role.”); Campaign for Fiscal Equity, Inc. v. New York, 861 N.E.2d 50, 58 (N.Y. 2006) (explaining that an “abiding ‘respect for the separation of powers upon which our system of government is based’” means courts “cannot ‘intrude upon the policy-making and discretionary decisions that are reserved to the legislative and executive branches’”); Ex parte Ankrom, 152 So.3d 397, 420 (Ala. 2013) (“[P]ublic-policy arguments should be directed to the legislature, not to this Court.”); Falco Lime, Inc. v. Mayor of Vicksburg, 836 So.2d 711, 725 (Miss. 2002) (citation omitted) (“Our Constitution provides that if there is a public policy issue to be addressed, it is for the Legislature, not this Court.”); Flynn v. Dep’t of Admin., 576 N.W.2d 245, 252 (Wis. 1998) (“This court has long held that it is the province of the legislature, not the courts, to determine public policy.”).