Amicus Curiae Brief — Harold R. Berk, Petitioner v. Wilson C. Choy, et al.

Supreme Court briefAug 1, 2025

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No. 24-440

IN THE

Supreme Court of the United States

HAROLD R. BERK,

Petitioner,

WILSON C. CHOY, ET AL.,

Respondents.

On Writ of Certiorari

to the United States Court of Appeals

for the Third Circuit

BRIEF OF THE DRI CENTER FOR LAW AND

PUBLIC POLICY AS AMICUS CURIAE IN

SUPPORT OF RESPONDENTS

HILLARY A. TAYLOR

Counsel of Record

KEATING JONES

HUGHES, PC

200 SW MARKET ST.

Suite 900

Portland, OR 97201

(503) 222-9955

htaylor@keatingjones.com

Counsel for Amicus Curiae

DRI-Center for Law and

Public Policy

TABLE OF CONTENTS

Page

TABLE OF AUTHORITIES....................................... iv

INTEREST OF AMICUS CURIAE ............................ 1

INTRODUCTION AND SUMMARY OF

ARGUMENT ............................................................... 1

ARGUMENT ............................................................... 3

Proper Application of this Court’s

Precedent Compels Affirmance,

Giving Effect to Federalism

Principles .................................................... 3

II.

Contextualizing Delaware’s

Affidavit of Merit Requirement

Against the Background of Medical

Liability Reform ......................................... 3

A. The challenges to healthcare and

the medical community that

affidavit of merit statutes

address. ................................................. 3

B. Responding to the challenges:

medical liability reform ...................... 10

C. Medical malpractice affidavit of

merit laws are an integral part

of state substantive policy

governing healthcare access,

affordability, and quality .................... 12

III.

Medical malpractice claims in

federal court ............................................. 16

IV.

Consistent with the Erie doctrine,

applying state affidavit of merit

statutes in federal court ensures

uniformity and gives effect to

federalism principles ................................ 18

CONCLUSION .......................................................... 20

iii

TABLE OF AUTHORITIES

Page(s)

Cases

Ali v. Fed. Bureau of Prisons,

552 U.S. 214 (2008) ............................................. 17

Berk v. Choy, Case No. 23-2620,

2024 WL 3534482 (3d Cir. Jul. 25, 2024) ........... 19

Cartwright v. Tong,

896 N.W.2d 638 (N.D. 2017) ............................... 10

Cederberg v. Legacy Health,

No. 3:18-CV-02044-HZ, 2020 WL 5809991 (D. Or.

Sept. 28, 2020) aff’d, No. 20-35907, 2022 WL

832067 (9th. Cir. Mar. 21, 2022) ........................ 15

Cichos v. Dakota Eye Inst., P.C.,

933 N.W.2d 452 (N.D. 2019) ............................... 10

Coleman v. United States,

912 F.3d 824 (5th Cir. 2019) ............................... 13

Erie R. Co. v. Tompkins,

304 U.S. 64 (1938) ......................... 3, 18, 19, 20, 21

Felder v. Casey,

487 U.S. 131 (1988) ............................................. 17

Guaranty Trust Co. v. York,

326 U.S. 99 (1945) ............................................... 17

Hanna v. Plummer,

380 U.S. 460 (1965) ............................................. 19

Iverson v. United States,

973 F.3d 843 (8th Cir. 2020) ............................... 17

John v. Saint Francis Hospital, Inc.,

405 P.3d 681 (Okla. 2017)................................... 11

Nat. Fedn. of Indep. Businesses v. Sebelius,

567 U.S. 519 (2012) ...............................................4

Oslund v. United States,

701 F.Supp. 710 (D.Minn. 1988) ........................ 10

Pierce v. Anderson,

912 N.W.2d 291 (N.D. 2018) ............................... 10

Pledger v. Lynch,

5 F.4th 511 (5th Cir. 2021) ................................. 18

Smith v. Providence Health & Servs.—Oregon,

393 P.3d 1106 (Or. 2017) .................................... 12

Stroud v. Hennepin Cnty. Med. Ctr.,

556 N.W.2d 552 (Minn. 1996) ............................. 10

Tomlinson v. Metro. Pediatrics, LLC,

412 P.3d 133 (Or. 2018) ...................................... 13

Willis v. Wu,

607 S.E.2d 63 (S.C. 2004) ................................... 13

Wright v. United States,

892 F.3d 963 (8th Cir. 2018) ............................... 17

Constitution, Statutes, and Rules

28 U.S.C. § 1367 ........................................................ 17

Ariz. Rev. Stat. Ann. § 12-2603................................. 11

Colo. Rev. Stat. § 13-20-602 ...................................... 11

Conn. Gen. Stat. § 52-190a ....................................... 11

Del. Code Ann. tit. 18 § 6853 .............................. 11, 14

Emergency Medical Treatment and Labor Act

(EMTALA) 42 U.S.C. § 1395dd (2018) ............... 17

Federal Tort Claims Act 28 U.S.C. §§1346(b) . ........ 17

Fla. Stat. Ann. § 766.104 .......................................... 11

Ga. Code Ann. § 9-11-9.1........................................... 11

Haw. Rev. Stat. Ann. § 671-12 ............................ 11, 12

Health Insurance Portability and Accountability

Act (HIPAA) 42 U.S.C. § 1320d (2018)............... 17

HIPAA Privacy Rule, 45 C.F.R. § 164.524 (2024) .... 14

Idaho Code Ann. § 6-1001 ......................................... 12

Ill. Comp. Stat. Ann. § 5/2-622.................................. 11

Md. Code Ann. Cts. & Jud. Proc. §3-2A-04 .............. 11

Mich. Comp. Laws Ann. § 600.2912d ....................... 11

Minn. Stat. Ann. § 145.682 ................................. 10, 11

Miss. Code Ann. § 11-1-58......................................... 11

Mo. Ann. Stat. § 538.225 ........................................... 11

N.D. Cent. Code Ann. § 28-01-46 .............................. 11

N.J. Stat. Ann. § 2A:53A-27 ...................................... 11

N.M. Stat. Ann. § 41-5-15 ......................................... 12

N.Y. C.P.L.R. 3012-a ................................................. 11

Nev. Rev. Stat. Ann. § 41A.071................................. 11

Ohio Rev. Code Ann. § 2323.451 ............................... 11

Okla. Stat. tit. 12 § 19.1 ............................................ 11

Pa. R. Civ. P. No. 1042.3 ........................................... 11

S.C. Code Ann. § 15-36-100....................................... 11

Tenn. Code Ann. §29-26-122 ..................................... 11

Tex. Civ. Prac. & Rem. Code Ann. § 74.351 ............. 11

U.S. Const. amend. X ................................................ 18

Utah Code Ann. § 78B-3-423 .................................... 11

Va. Code Ann. § 8.01-20.1 ......................................... 11

Va. Code Ann. § 55-7B-6 ........................................... 11

Vt. Stat. Ann. tit. 12 § 1042 ...................................... 11

W. Va. Code Ann. § 55-7B-6 ...................................... 11

Wash. Rev. Code Ann. § 7.70.150,

Repealed by Wash. Laws 2023, ch. 102, § 10 ..... 11

Other Authorities

Allen Hardiman,

Upward Trajectory of Medical Liability

Premiums Persists for Sixth Year in a Row,

AMA Policy Research Perspectives (2025)...........5

Allen Kachalia, MD, JD & Michelle M. Mello, JD,

PhD,

New Directions in Medical Liability Reform,

364 N. Engl. J. Med. 1564 (2011) ....................... 16

American Medical Association,

Medical Liability Reform Now! (2025) ......... 6, 7, 8

vii

Anupam B. Jena, et al.,

Outcomes of Medical Malpractice Litigation

Against US Physicians, 172:11 Archive of

Internal Med. 892 (2012) ......................................4

Anupam B. Jena, et al,

Malpractice Risk According to Physician

Specialty, 365 N. Engl. J. Med. 629 (2011) ..........5

Brenda E. Sirovich, MD, MS, Steven Woloshin,

MD, MS, & Lisa M. Schwartz, MD, MS,

Too Little? Too Much? Primary Care

Physicians’ Views on US Health Care, 171:17

Archive of Internal Med., 1582 (2011) .................7

David A. Matsa,

Does Malpractice Liability Keep the Doctor

Away? Evidence from Tort Reform Damage

Caps, 36:2 J. Legal Stud. Univ. of Chicago

Press, 36:2 (2007) ................................................ 16

Deanna Arpi Youssoufian,

The Rules of the Malpractice Game: Affidavit

of Merit Statutes, Erie, and the Cautionary

Tale of an Overbroad Application of Rule 11,

87 Brook. L. Rev. 1459 (2022) ..............................9

Fred J. Hellinger & William E. Encinosa,

The Impact of State Laws Limiting

Malpractice Damage Awards on Health Care

Expenditures, 96 Am. J. of Pub. Health 1375

(2006) .....................................................................4

viii

Gary T. Schwartz,

Considering the Proper Federal Role in

American Tort Law, 38 Ariz. L. Rev. 917

(1996) ................................................................... 18

George L. Priest,

The Current Insurance Crisis and Modern

Tort Law, 96 Yale L.J. 1521 (1987) .................. 6, 8

Hearing on HB 2014 Before the S. Comm. on

Judiciary, 80th Sess. (Or. 2019)

(Testimony of Dr. Carrie Miles) ...........................5

Heather Morton,

Medical Liability/Malpractice Merit

Affidavits and Expert Witness, Nat’l Conf. of

State Legislatures (Aug. 11, 2021) ..................... 13

Jose Guardado,

Medical Professional Liability Insurance

Premiums: An Overview of the Market 20092018, AMA Policy Research Perspectives

(2019) .....................................................................6

Jose Guardado,

Medical Professional Liability Insurance

Indemnity Payments, Expenses and Claim

Disposition 2006-2015, AMA Policy Research

Perspectives (2018) ...............................................5

Lauren Guest, David Schap, and Thi Tran,

The “Loss of Chance” Rule as a Special

Category of Damages in Medical Malpractice:

A State-by-State Analysis, 21 J. Legal Econ.

53 (2015) .............................................................. 13

Massachusetts Medical Society,

Massachusetts Medical Society’s 2013

Physician Workforce Study Shows Physician

Shortages, Difficulty in Recruiting (2013) ...........7

Michelle Mello, et al.,

National Costs of the Medical Liability

System, 29 Health Aff. (Mill-wood) 1569 (Sept.

2010) .................................................................. 5, 9

Nat’l Conf. of State Legislatures,

Selected State Legislative Action Re:

Affordability and Availability of Liability

Insurance (August 4, 1986)...................................8

Cary Silverman and Christopher E. Appel, Shook,

Hardy & Bacon LLP (2024),

Nuclear Verdicts, An update on Trends,

Causes, and Solutions ...........................................9

Office of the Assistant Secretary for Planning and

Evaluation, U.S. Dep’t of Health and Human

Servs.,

Addressing the New Health Care Crisis:

Reforming the Medical Litigation System to

Improve the Quality of Health Care (2003) ..........9

U.S. Congress, Joint Economic Committee Study:

Liability for Medical Malpractice: Issues and

Evidence (May 2003) ........................................... 10

U.S. Department of Justice,

Report of the Tort Policy Working Group on

the Causes, Extent and Policy Implications of

the Current Crisis in Insurance Availability

and Affordability ...................................................8

BRIEF OF THE DRI CENTER FOR LAW AND

PUBLIC POLICY AS AMICUS CURIAE IN

SUPPORT OF RESPONDENTS

INTEREST OF AMICUS CURIAE1

The DRI Center for Law and Public Policy is the

public policy “think tank” and advocacy voice of DRI,

Inc.—an international organization of more than

16,000 attorneys who represent businesses in civil

litigation, including attorneys who represent

physicians, medical providers, clinics, and hospitals,

in defense of malpractice cases nationwide. DRI’s

mission includes enhancing the skills, effectiveness,

and professionalism of defense lawyers; promoting

appreciation of the role of defense lawyers in the civil

justice system; and anticipating and addressing

substantive and procedural issues germane to defense

lawyers and the fairness of the civil justice system.

The Center participates as an amicus curiae in this

Court, federal courts of appeals, and state appellate

courts in an ongoing effort to promote fairness,

consistency, and efficiency in the civil justice system.

INTRODUCTION AND SUMMARY OF

ARGUMENT

Affidavit of merit statutes reflect the fundamental

premise that expert support is required to prevail on

a medical malpractice claim. That is, it is universally

required that to get a medical malpractice claim to a

decision by the factfinder, the plaintiff must present

1 Pursuant to Rule 37.6, Amicus affirms that no counsel for any

party authored this brief in whole or in part, and no person or

entity, other than amicus, its members, or its counsel has made

a monetary contribution to its preparation or submission.

expert support that a violation of the standard of care

occurred and caused the plaintiff’s injury. Affidavit of

merit statutes reflecting this reality are critical

components of a state’s medical malpractice cause of

action. Such requirements embody the state’s efforts

to promote access to justice and healthcare and to

reduce costs by decreasing meritless litigation. The

expectation among those who defend medical

malpractice cases is that a case is reviewed and

supported by an expert before a lawsuit is filed,

whenever possible. Requirements such as affidavit of

merit statutes comport with this understanding and

practice.

Similar to other state law that defines who can

bring a medical malpractice claim, when it can be

brought, what must be proven, and what damages are

recoverable, affidavit of merit statutes are not

pleading requirements, and they do not conflict with

the Federal Rules of Civil Procedure. Rather, they are

substantive requirements of state law designed to

weed out meritless claims.

Applying affidavit of merit and similar statutes in

federal court better protects professionals from the illeffects of being haled into court for frivolous lawsuits.

With respect to medical professionals, this also

protects public health by giving effect to a state’s

response to issues such as physician shortages,

availability and affordability of liability insurance,

and access to healthcare. Taking into consideration

an appropriate sensitivity and deference to state law

and promoting the critical principles of federalism and

separation of powers, this Court should affirm.

ARGUMENT

Proper Application of this Court’s

Precedent Compels Affirmance,

Giving Effect to Federalism

Principles.

The briefs of respondents and other amici aptly

describe the correct application of Erie R. Co. v.

Tompkins, 304 U.S. 64 (1938), and its progeny. To

support those arguments and provide context for the

court’s analysis, The Center focuses on the

substantive nature of affidavit of merit statutes, their

background, and purpose. The Center argues that

affidavit of merit requirements must be applied by

federal courts in this case and cases like it. In this

case, when the requirement is applied, it is evident

the plaintiff has no claim under state law for medical

malpractice and that should not differ because of the

forum.

II.

Contextualizing Delaware’s Affidavit

of Merit Requirement Against the

Background of Medical Liability

Reform.

The challenges to healthcare

and the medical community that

affidavit of merit statutes

address.

To understand the nature of affidavit of merit

requirements, it is helpful to start by understanding

why states enact them in the first place. That inquiry

begins with the challenges facing the medical

profession and our healthcare system because those

concerns are directly linked to the medical liability

system. The provision of healthcare is unique in that

it touches everyone at some point in their life. Nat.

Fedn. of Indep. Businesses v. Sebelius, 567 U.S. 519,

590-91, (2012) (“Unlike the market for almost any

other product or service, the market for medical care

is one in which all individuals inevitably participate.”)

(Ginsburg, J., concurring in part, concurring in the

judgment in part, and dissenting in part).

Physicians provide quality healthcare to their

patients, often in unideal or complex circumstances.

The provision of medical care is further complicated

by the reality that in many circumstances,

undesirable and adverse outcomes cannot be avoided

even with the best care. The result is that many

medical malpractice lawsuits are filed even when no

malpractice occurred.

Anupam B. Jena, et al.

Outcomes of Medical Malpractice Litigation Against

US Physicians, 172:11 Archive of Internal Med. 892,

893 (2012); See Fred J. Hellinger & William E.

Encinosa, The Impact of State Laws Limiting

Malpractice Damage Awards on Health Care

Expenditures, 96 Am. J. of Pub. Health 1375, 1375

(2006) (noting that only 2% of negligent medical

injuries resulted in a claim and only 17% of

malpractice claims involved injuries caused by

negligence).2

Physicians today face a different and changing

climate with respect to the public perception of

doctors, healthcare, how care is delivered and paid for,

2 In the simplest of terms, that means that in most cases there is

no expert support for the proposition that the physician’s care

fell below the standard of care and caused harm. Lack of expert

support is even more prevalent in cases where the plaintiff is

proceeding pro se. This case is no outlier. Cases where the

plaintiff is unrepresented command a substantial use of judicial

and defense resources, exacerbating these issues, especially

where the claims are often unfounded.

and their own personal liability risks. Many of today’s

physicians can expect to be sued during their careers.

Anupam B. Jena, et al, Malpractice Risk According to

Physician Specialty, 365 N. Engl. J. Med. 629, 629-636

(2011).

The personal and professional toll that litigation

has on an accused physician cannot be understated.

For example, consider the testimony of Dr. Carrie

Miles before the Oregon Legislature detailing her

personal experience as a defendant in a nearly $47

million lawsuit which arose from a 20-minute visit

with the plaintiff’s mother. Hearing on HB 2014

Before the S. Comm. on Judiciary, 80th Sess. (Or.

2019) (statement of Dr. Carrie Miles). Even though

the jury found for the defense, the potential for tens of

millions in liability and resulting stress on the doctor,

her partners, patients, and family was “terrifying,”

and she considered leaving the state and the practice

of medicine. See, also, Michelle M. Mello, et al.,

National Costs of the Medical Liability System, 29:9

Health Affairs 1569, 1574 (2010) (discussing the

reputational and emotional toll on clinicians).

Regardless of merit, it takes significant resources

to evaluate and defend malpractice claims, even those

that are unfounded. Jose Guardado, Medical

Professional Liability Insurance Indemnity Payments,

Expenses and Claim Disposition 2006-2015, AMA

Policy Research Perspectives, 1, 4 (2018).

The liability climate contributes to rising medical

liability premium rates, causing further problems for

access to healthcare. Allen Hardiman, Upward

Trajectory of Medical Liability Premiums Persists for

Sixth Year in a Row, AMA Policy Research

Perspectives, 1, 2 (2025) (“The overall picture is a

clear upward trend in medical liability premiums

since 2019.”); Jose Guardado, Medical Professional

Liability Insurance Premiums: An Overview of the

Market 2009-2018, AMA Policy Research Perspectives

1, 4 (2019) (In 2009 nearly thirty six percent of

premiums rates decreased, in 2018 only five percent

decreased. Conversely, the number of rates that

increased in 2018 was double the number that

increased in 2009.).

Tort liability has expanded significantly,

increasing the risk of exposure for medical

professionals. In the 1960s, tort liability came to be

viewed as the third-party insurer of society,

compensating injured parties that did not or could not

acquire insurance themselves. In the 1970s the

medical liability insurance industry experienced a

period of crisis when several private insurers left the

market due to rising claims and inadequate rates.

American Medical Association, Medical Liability

Reform Now!, 7 (2025). This exodus created an

availability and affordability crisis for medical

providers. Id. at 7-8.

In the 1980s there were reports of extraordinary

changes

commercial

casualty

insurance

markets. See George L. Priest, The Current Insurance

Crisis and Modern Tort Law, 96 Yale L.J. 1521

(1987). This crisis, characterized by a lack of

affordability, shook the medical liability market as

claim frequency and severity increased. AMA, MLR

at 8. Premiums increased drastically for some

products and services and, for some, insurers even

refused to offer coverage at any premium. Priest,

supra, at 1521.

The affordability crisis had a dramatic effect on

physicians. Those in specialities such as obstetrics

and gynecology cut back on high-risk procedures and

high-risk patients to reduce risk and temper their

premiums. Physicians in high risk, high premium

locales even closed their practices. AMA, MLR at 8.

The insurance crisis rippled across the country,

creating great concern, and prompting assessment

and action. In part because the risk of liability

continues to increase, there are physician shortages

throughout the country. Shortages are especially

pronounced for rural areas and for underserved

populations.3 The omnipresent cloud of potential

liability impacts where physicians decide to practice,

their chosen specialty, what procedures they will

perform, and in certain cases even if they will practice

at all. Brenda E. Sirovich, MD, MS, Steven Woloshin,

MD, MS, & Lisa M. Schwartz, MD, MS, Too Little?

Too Much? Primary Care Physicians’ Views on US

Health Care, 171:17 Archive of Internal Med., 1582

(2011); see also Massachusetts Medical Society,

Massachusetts Medical Society’s 2013 Physician

Workforce Study Shows Physician Shortages,

Difficulty in Recruiting (2013).

There are nationwide shortages that adversely affect the

delivery and quality of care. See William F. Rayburn, MD, MBA,

FACOG, The Obstetrician-Gynecologist Workforce in the United

States: Facts, Figures, and Implications, 2017, Am. Coll. Of

Obstetricians and Gynecologists, 4 (2017) (half of the counties in

the United States already do not have any obstetriciangynecologists). Shortages often occur in areas and ways that

affect the most vulnerable populations. For example, the

shortage of OBGYNs and family practice physicians greatly

affects access to healthcare for women and underserved

communities.

Shortages increase with increased risk for

liability. Eric Helland & Mark H. Showalter, The Impact of

Liability on the Physician Labor Market, 52:4 J. of L. and Econ.

635, 655 (2009).

In 1986, the U.S. Department of Justice issued a

"Report of the Tort Policy Working Group on the

Causes, Extent and Policy Implications of the Current

Crisis in Insurance Availability and Affordability,"

attributing the crisis to modern tort law's expansion

of corporate liability. Priest, supra, at 1523. The

Justice Department Report analyzed the "veritable

explosion of tort liability,” related changes in the law,

and the "explosive growth" in damages awards,

particularly

with

respect

noneconomic

damages. DOJ, Report, at 200-01. The report

included specific data about the increases with respect

to medical malpractice premiums and verdicts. Id. at

220, 234-35.

As a result, within 18 months, "on the basis of the

Department's and other attributions of the crisis to

tort law, forty-two states [had] enacted tort reform or

insurance legislation." Priest, supra, at 1523;. see

Nat’l Conf. of State Legislatures, Selected State

Legislative Action Re: Affordability and Availability of

Liability Insurance (August 4, 1986). State affidavit

of merit requirements, like ceilings on noneconomic

damages, the elimination of no-fault joint liability in

favor of several liability or limits on attorneys’

contingent fees to a sliding scale, are all examples of

substantive state legislation aimed at reform and

enforceable in federal court.

Still again, in the early 2000s, liability premiums

skyrocketed and access to care was threatened. At the

height of this crisis 45% of hospitals reported that it

affected their provision of emergency services and loss

of physicians. AMA, MLR at 8. The American College

of Obstetricians and Gynecologists reported that the

lack of affordable coverage resulted in 70% of its

physicians’ making changes to their practices. Id.

The crisis also affected medical students, influencing

their choice of speciality. Id. Lack of access is a public

health crisis, one that is worsened when limits on

liability are eliminated. Office of the Assistant

Secretary for Planning and Evaluation, U.S. Dept. of

Health and Human Servs., Addressing the New

Health Care Crisis: Reforming the Medical Litigation

System to Improve the Quality of Health Care, 11

(2003).

Challenges to access and affordability of

healthcare continue, as do the calls for medical

liability reform.4 Given these challenges, it is no

surprise that state legislatures enact reforms, like

Delaware’s affidavit of merit statute, to address their

concerns and the significant cost to public health from

meritless litigation. See Deanna Arpi Youssoufian,

The Rules of the Malpractice Game: Affidavit of Merit

Statutes, Erie, and the Cautionary Tale of an

Overbroad Application of Rule 11, 87 Brook. L. Rev.

1459, 1462 (2022); Michelle Mello, et al., National

Costs of the Medical Liability System, 29 Health Aff.

(Mill-wood) 1569, 1574 (Sept. 2010); U.S. Congress,

4 For example, there is growing concern over the prevalence of

“nuclear verdicts,” and how they can be addressed. A nuclear

verdict is a verdict of more than $10 million. Nuclear verdicts

are being awarded with more frequency across the country. See

Nuclear Verdicts, An update on Trends, Causes, and Solutions,

Cary Silverman and Christopher E. Appel, Shook, Hardy &

Bacon LLP (2024). Such verdicts are often reduced post-trial or

on appeal. Id. Nuclear verdicts have a negative effect on society

and the civil justice system. They result in instability in

industries in which they occur, distort the public’s view of the

civil tort system, undermine the rule of law, result in increased

premiums for insurance coverage or lack of availability of the

same, perpetuate unreasonable settlement demands, and result

in prolonged litigation and unnecessary appeals. Id.

Joint Economic Committee Study: Liability for

Medical Malpractice: Issues and Evidence, 2 (May

2003).

Responding to the challenges:

medical liability reform.

For patients to be able to receive quality

healthcare and for our healthcare system to continue

functioning, there must be reasonable limits on

liability.

State law, historically and currently,

imposes and defines those limits.

Affidavit of merit requirements are adopted by

states in furtherance of efforts at medical liability

reform. The intended result is to decrease the number

of unsubstantiated lawsuits against physicians in

favor of affordable liability insurance, thereby

reducing physician shortages and healthcare costs

and increasing access to quality care for patients. See

e.g., Cichos v. Dakota Eye Inst., P.C., 933 N.W.2d 452,

461–62 (N.D. 2019) (“Section 28-01-46, N.D.C.C., was

‘enacted to prevent an actual trial in such cases where

a medical malpractice plaintiff cannot substantiate a

basis for the claim.’ Pierce v. Anderson, 912 N.W.2d

291, 295 (N.D. 2018). The purpose is an ‘attempt[ ] to

minimize frivolous claims by requiring the plaintiff to

produce an expert opinion to support the allegations

of the negligence in the early stages of litigation.’

Cartwright v. Tong, 896 N.W.2d 638, 642 (N.D.

2017)”); Stroud v. Hennepin Cnty. Med. Ctr., 556

N.W.2d 552, 555 (Minn. 1996) (“The Minnesota

legislature enacted Minn. Stat. § 145.682 for the

purpose of eliminating nuisance medical malpractice

lawsuits by requiring plaintiffs to file affidavits

verifying that their allegations of malpractice are

well-founded. Oslund v. United States, 701 F.Supp.

710, 712 (D.Minn. 1988).”).

Twenty-eight states have enacted some type of

affidavit of merit requirement. See Ariz. Rev. Stat.

Ann. § 12-2603; Colo. Rev. Stat. § 13-20-602; Conn.

Gen. Stat. § 52-190a; Del. Code Ann. tit. 18, § 6853;

Fla. Stat. Ann. § 766.104; Ga. Code Ann. § 9-11-9.1;

Haw. Rev. Stat. Ann. § 671-12.5; 735 Ill. Comp. Stat.

Ann. § 5/2-622; Md. Code Ann., Cts. & Jud. Proc. §32A-04; Mich. Comp. Laws Ann. § 600.2912d; Minn.

Stat. Ann. § 145.682; Miss. Code Ann. § 11-1-58; Mo.

Ann. Stat. § 538.225; Nev. Rev. Stat. Ann. § 41A.071;

N.J. Stat. Ann. § 2A:53A-27; N.Y. C.P.L.R. 3012-a;

N.D. Cent. Code Ann. § 28-01-46; Ohio Rev. Code Ann.

§ 2323.451; Okla. Stat. tit. 12, § 19.1 (held

unconstitutional by John v. Saint Francis Hospital,

Inc., 405 P.3d 681 (Okla. 2017)); Pa. R. Civ. P. No.

1042.3; S.C. Code Ann. § 15-36-100; Tenn. Code Ann.

§29-26-122; Tex. Civ. Prac. & Rem. Code Ann. §

74.351; Utah Code Ann. § 78B-3-423; Vt. Stat. Ann.

tit. 12, § 1042; Va. Code Ann. § 8.01-20.1; Wash. Rev.

Code Ann. § 7.70.150 (Repealed by Wash. Laws 2023,

ch. 102, § 10, eff. July 23, 2023); W. Va. Code Ann. §

55-7B-6. Several states require that the affidavit or

certification of merit be filed toward the beginning of

the lawsuit, at the time the complaint is filed, or

within a few months of initiation of the lawsuit, as in

Delaware. See Fla. Stat. Ann. § 766.104; Mich. Comp.

Laws Ann. § 600.2912d; Minn. Stat. Ann. § 145.682;

Miss. Code Ann. 11-1-58; S.C. Code Ann. § 15-36-100;

Va. Code Ann. § 8.01-20.1; W. Va. Code Ann. § 55-7B6. Other statutes require the plaintiff to file the

affidavit with initial discovery disclosures while

others require it to be filed when the defendant files

an answer. Compare Ariz. Rev. Stat. Ann. § 12-2603

with N.J. Stat. Ann. § 2A:53A-27. Still others have

other prelitigation requirements, such as medical

panels that must be consulted before litigation can be

filed. See e.g., Idaho Code Ann. § 6-1001; N.M. Stat.

Ann. § 41-5-15; Haw. Rev. Stat. Ann. § 671-12.

Medical malpractice affidavit of

merit laws are an integral part

of state substantive policy

governing healthcare access,

affordability, and quality.

State statutes governing malpractice actions and

providing who can recover, how, when, and for what,

are a critical part of the state’s response to concerns

about affordability and accessibility of healthcare for

its citizens. The idea that states are laboratories of

innovation is particularly true in healthcare. States

work on innovative ways to enact reform in efforts to

curtail the unpredictability of expansive tort liability.

Failing to defer to state substantive law defining a

medical malpractice cause of action does not give

proper deference to the state’s prerogative. States

must be allowed to continue to do this work, and it

must be given effect, if our healthcare system is going

to adapt and improve.

States differ in what type of medical malpractice

claims they permit. For example, some states permit

claims for “loss of chance,” where the plaintiff claims

their injury is a lost opportunity for a better outcome

rather than a physical injury. Smith v. Providence

Health & Servs.—Oregon, 393 P.3d 1106, (Or. 2017)

(recognizing a claim where plaintiff alleges defendant

did not cause his stroke but caused him not to receive

treatment in a timely fashion that caused loss of an

opportunity for a better recovery from the stroke); See

Lauren Guest, David Schap, and Thi Tran, The “Loss

of Chance” Rule as a Special Category of Damages in

Medical Malpractice: A State-by-State Analysis, 21 J.

Legal Econ. 53, 58-60 (2015) (reviewing case law as of

2014 and concluding that 41 states had addressed loss

of chance, with 24 states having adopted some version

of the theory).

A few states even allow claims for “wrongful life,”

meaning a claim by a child that they were born with

a certain defect or disease that had it been diagnosed

in utero, they would not have been born. See e.g.,

Tomlinson v. Metro. Pediatrics, LLC, 412 P.3d 133,

147 (Or. 2018) (refusing to recognize a medical

malpractice claim for wrongful life and explaining

that “[t]he vast majority of courts that have

considered the question have refused to recognize

such claims. See Willis v. Wu, 607 S.E.2d 63, 68-69

(S.C. 2004) (Twenty-seven states, by judicial opinion,

statute, or both, have either refused to recognize or

limited a wrongful life action. Three states * * * have

allowed such a cause of action.’).” States also differ on

the outer limits of tort liability for medical

malpractice, for example, in areas of vicarious liability

and agency or whether a third party to a physicianpatient relationship can sue for malpractice.

However, the universal and fundamental

requirement to sustain a medical malpractice case is

the requirement of medical expert support. Coleman

v. United States, 912 F.3d 824 (5th Cir. 2019) (Federal

Rule of Evidence 601 requires federal courts to apply

state rules to determine expert witness competency in

medical malpractice claims that turn on questions of

substantive state law); Heather Morton, Medical

Liability/Malpractice Merit Affidavits and Expert

Witness, Nat’l Conf. of State Legislatures, (Aug. 11,

2021). The need for expert support goes to the heart

of any claim. For those defending these claims, it is

expected that a claim will be reviewed by an expert,

and supported by an expert, before a lawsuit is ever

filed. There is no good faith basis for a medical

malpractice claim unless it has been reviewed and

validated by a qualified medical expert, save in very

narrow circumstances. Delaware’s affidavit of merit

statute, for example, makes an exception for cases

that traditionally fall under the res ipsa loquitur

doctrine and would not need an expert for a plaintiff

to prevail on them. Del. Code Ann. tit. 18, § 6853(e).

This includes, for example, cases that involve leftbehind surgical instruments or an operation on the

wrong body part.

In every other medical malpractice case, a

plaintiff is required to put forth their evidence, in the

form of the testimony of experts, to support their

claims that the defendant breached the standard of

care and caused the harm. Whether the expert is of

the right type such that they are qualified to testify

about the school of medicine invoked by the care or

procedure at issue, whether their credentials are

sufficient, and what they testify to are not “satellite”

issues, rather they go to the crux of the allegations

and the ultimate issues the factfinder will decide:

negligence and causation.

Expert support is

determinative. An affidavit of merit statute is one

way a state requires the plaintiff to answer the

ultimate question of whether they can prove their

case.

This is not a barrier to otherwise meritorious

claims nor is it a surprise to the attorneys who

practice in this area. A prospective plaintiff can

access their medical records, for any reason. HIPAA

Privacy Rule, 45 C.F.R. § 164.524 (2024). Obtaining

the pertinent medical records and having them

reviewed is often the first task of the lawyer agreeing

to evaluate the case. That is the expectation and the

standard practice. The fact that some states require

expert support, a fundamental aspect that goes to the

merits of the case, to be secured and communicated at

the outset, rather than at summary judgment, for

example, is the state’s prerogative to decide and is not

in conflict with the Federal Rules. It is not a special

or heightened pleading requirement, it is a tool used

by the state to ensure the claim is supported and to

weed out those that are not, before they drain more

resources from an overburdened system.

Regardless of state variances, a typical medical

malpractice case involves substantive questions of

state law, such as:

•

Does the duty of the defendant to meet the

standard of care extend to this plaintiff?

(E.g., can the defendant physician be held

liable to people other than their patients for

professional negligence).

•

What are the standards of proof for

negligence and causation?

•

Does a state immunity statute preclude

imposing liability on the defendant? See

e.g., Cederberg v. Legacy Health, No. 3:18CV-02044-HZ, 2020 WL 5809991 (D. Or.

Sept. 28, 2020) aff’d, No. 20-35907, 2022

WL 832067 (9th. Cir. Mar. 21, 2022).

•

Are there state privileges that apply, e.g.,

peer review or quality assurance privilege?

•

Is there comparative or contributory fault,

is it joint or several, who is on the verdict

form, and how is fault allocated?

•

How far does vicarious liability extend?

(E.g., is a hospital liable for the negligence

of an independent physician member of the

medical staff? What are the rules for

apparent agency, is it a “captain of the ship”

state?).

•

What damages are recoverable? (E.g.,

standards for noneconomic damages,

punitive damages, collateral source rules).

Federal courts look to state law to supply answers

to those questions. The answers reflect how a state

imposes boundaries on tort liability, and its policy and

efforts to control healthcare costs and ensure

availability and access to quality healthcare for their

citizens. Just as a damages cap or rejecting joint

liability in favor of several liability is a policy decision

of a state with respect to its tort law, so are affidavit

of merit requirements.5

III.

Medical malpractice claims in federal

court.

State medical malpractice claims arrive in federal

court in a variety of ways. As here, federal courts are

the forum when there is diversity. They are also the

5 States with limits on noneconomic damages enjoy a positive

impact among surgical and support specialists locating in rural

counties. David A. Matsa, Does Malpractice Liability Keep the

Doctor Away? Evidence from Tort Reform Damage Caps, 36:2 J.

Legal Stud. Univ. of Chicago Press, 36:2, 143-182 (2007) (for

surgical and support specialties, rural counties in states with

limits had about 10 percent more physicians per capita than

rural counties in states without limits). Allen Kachalia, MD, JD

& Michelle M. Mello, JD, PhD, New Directions in Medical

Liability Reform, 364 N. Engl. J. Med. 1564, 1566 (2011) (studies

of limits on noneconomic damages have nearly uniformly found

limits are an effective means of reducing the size of indemnity

payments).

forum in federal question6 cases in which the state

malpractice claim is pendent to a federal claim,7 and

for malpractice claims against the federal government

under the Federal Tort Claims Act (FTCA).8 When

federal entities are providing healthcare via a

Veteran’s Administration hospital, in a correctional

institution or at a Federally Qualified Health Center,

for example, claims filed under the FTCA must be in

federal court.9 The federal district courts regularly

6 When a district court exercises pendent jurisdiction over state

claims pursuant to 28 U.S.C. § 1367, it applies state law as if

deciding a diversity case. See Felder v. Casey, 487 U.S. 131, 151

(1988) (“[W]hen a federal court exercises diversity or pendent

jurisdiction over state law-claims, ‘the outcome of the litigation

in the federal court should be substantially the same, so far as

legal rules determine the outcome of a litigation, as it would be

if tried in a State court.’” (quoting Guaranty Trust Co. v. York,

326 U.S. 99, 109 (1945))).

Litigants, often those that are pro se, attach state medical

malpractice claims to other claims arising under myriad federal

statutes, including, e.g., the Emergency Medical Treatment and

Labor Act (EMTALA) 42 U.S.C. § 1395dd (2018) and the Health

Insurance Portability and Accountability Act (HIPAA) 42 U.S.C.

§ 1320d (2018). Notwithstanding such federal statutes do not

provide for a private cause of action, plaintiffs nonetheless use

them as access points to federal court and once there, the district

courts often retain jurisdiction of the state law medical

malpractice claims even when other claims are dismissed.

8 28 U.S.C. §§1346(b).

“Generally, sovereign immunity prevents the United States

from being sued without its consent.” Iverson v. United States,

973 F.3d 843, 846 (8th Cir. 2020) (cleaned up). “Congress waived

the United States' sovereign immunity for claims arising out of

torts committed by federal employees.” Ali v. Fed. Bureau of

Prisons, 552 U.S. 214, 217–18 (2008). “The applicable tort law is

‘the law of the place where the act or omission occurred.’” Wright

v. United States, 892 F.3d 963, 966 (8th Cir. 2018) (quoting 28

U.S.C. § 1346(b)(1)).

and routinely adjudicate these claims, looking to and

applying state substantive law.

Tort law generally and healthcare regulation

specifically are traditional state functions. Medical,

legal, and insurance practices are highly localized.

Physicians often practice in a single state, licensed by

their state medical board. Liability insurers write

state-specific, or even locale-specific policies, and

jurisdictional rules limit plaintiffs to the forum in

which they were allegedly injured. Accordingly,

medical malpractice falls within the states’

jurisdiction and sovereignty. See Gary T. Schwartz,

Considering the Proper Federal Role in American Tort

Law, 38 Ariz. L. Rev. 917, 922 (1996). The

requirements to bring a medical malpractice claim,

what is needed to prevail, who can be held liable, and

what damages are recoverable, to name a few, are all

dictated by state substantive law.

IV.

Consistent with the Erie doctrine,

applying state affidavit of merit

statutes in federal court ensures

uniformity and gives effect to

federalism principles.

The Tenth Amendment guarantees to the states

the function of defining the requirements for state law

causes of action. U.S. Const. amend. X; Erie, 304 U.S.

at 78-79. The outcome the petitioner seeks would

impair the state’s ability to perform that function

reserved to it by the constitution. Concluding that

Delaware’s affidavit of merit statute has no

application in federal court would involve ignoring “a

requirement imposed by a separate sovereign in its

effort to fashion a state cause of action that strikes the

right balance between insurance costs and affordable

healthcare[.]” Pledger v. Lynch, 5 F.4th 511, 528 (5th

Cir. 2021) (Quattlebaum, J., concurring in part and

dissenting in part). That cannot be the correct

answer.

The Erie doctrine requires a federal court sitting

in diversity jurisdiction to apply state substantive law

and federal procedural law. Erie, 304 U.S. 77-79

(1938). “There is no federal general common law.” Id.

at 78. This doctrine “preserves the autonomy and

independence of the states” and ensures that the

outcome of the case will not differ because of the

forum. Id.

The Third Circuit concluded that Delaware’s

section 6853 did not conflict with FRCP 8, 9, 11, or 12.

Berk v. Choy, Case No. 23-2620, 2024 WL 3534482, at

*2-3 (3d Cir. Jul. 25, 2024). The Third Circuit was

correct; there is no conflict with the Federal Rules. It

can exist side by side with the Federal Rules. The

statute is substantive, and it should be applied in this

federal court action

Regardless of whether a plaintiff brings a medical

malpractice action in state or federal court, it should

be governed by the substantive components of the

state cause of action and the outcome should be the

same. See Hanna v. Plummer, 380 U.S. 460, 471-472

(1965) (“The Erie rule is rooted in part in a realization

that it would be unfair for the character of result of a

litigation materially to differ because the suit had

been brought in a federal court.”). It undermines Erie

to allow a cause of action that would be dismissed if

filed in state court to continue if filed in federal court.

Concluding that Delaware’s affidavit of merit

requirement should not be enforced in federal court

would lead to improper forum shopping. This concern

is particularly keen because, although physicians may

practice in a single state, those located near interstate

borders may find themselves sued in federal court to

avoid a state’s more stringent affidavit of merit

requirement than that of a neighboring state. In

contrast, giving effect to an affidavit of merit statute

serves the twin aims of Erie by prohibiting unfair

forum shopping and promoting federalism concerns.

Id. at 468.

Concluding that Delaware’s affidavit of merit

statute conflicts with the Federal Rules and therefore

is inapplicable in federal court would effectively

invalidate similar statutory requirements in an endrun around the judgments of state policymakers on

matters of substantive state law. “Supervision over

either the legislative or the judicial action of the states

is in no case permissible except as to matters by the

constitution specifically authorized or delegated to the

United States. Any interference with either, except as

thus permitted, is an invasion of the authority of the

state, and, to that extent, a denial of its independence.

Erie, 304 U.S. at 78-79 (cleaned up). In these matters,

the voice of the state “should utter the last word.” Id.

at 79.

CONCLUSION

For these reasons, and those stated by

respondents, the decision of the Court of Appeals

should be affirmed.

Respectfully submitted,