EXPERT DISCLOSURE: BABY DOE

Joel S. Koenig, M.D., F.A.A.P.

SEPTEMBER 20, 2019

I am a Missouri licensed pediatrician practicing in St. Louis County, Missouri. I am a native of Nashville,
Tennessee and graduated from Vanderbilt University Medical School. I have been certified by the
American Board of Pediatrics in both pediatrics and neonatology. I am a fellow of the American
Academy of Pediatrics. I have had a private practice in pediatrics for thirty years and served as Chief of
Pediatrics at Missouri Baptist Medical Center from 1990 to 2018. I hold the title of Professor of Clinical
Pediatrics at Washington University School of Medicine and teach residents in my clinic. My curriculum
vitae and list of recent cases in which I have provided testimony are submitted hereafter.

I have been retained by Branstetter, Stranch & Jennings, PLLC, to render opinions about the diagnosis
and prognosis of Baby Doe, a minor.1 I have been provided the usual and customary documents
including but not limited to the child’s medical records. For the basis of my opinions I rely on my
education and training, my experience as a neonatologist and pediatrician, and my tenure as Chief of
Pediatrics and Missouri Baptist Medical Center, during which I oversaw the implementation of a
Neonatal Abstinence Syndrome (NAS) protocol and policies. All of the opinions which I render are more
likely than not within a reasonable degree of medical certainty.

Baby Doe was delivered by Cesarean section at Holston Valley Medical Center in Kingsport, Tennessee
on . His mother had been prescribed Subutex, an opioid, so Baby Doe was managed
according to the hospital’s NAS protocol. Further screening per protocol revealed that he had also been
exposed in utero to clonazepam and nicotine but did not suffer from any co-morbid infection or other
condition that might complicate or masquerade as NAS. Baby Doe was evaluated every three hours
during his hospitalization using the Finnegan Neonatal Abstinence Scoring System. Not only did his score
reach the severe level, at one point he manifested sixteen of the twenty-one monitored symptoms.

Baby Doe required placement in the Neonatal Intensive Care Unit, not only for the increased nursing
attention, but also for administration of intravenous fluids and nasogastric tube feedings. He required
treatment with both morphine, clonidine, pantoprazole, and special formula. The length of his hospital
stay was twenty-four days, roughly three weeks longer than is typical for a baby delivered by Cesarean
section.

On Baby Doe was seen by his pediatrician, , for his three year check-
up. At that visit his grandparents expressed concern about abnormal behaviors: he exhibited outbursts
of anger and would throw tantrums and hit people; he was easily frustrated.

Baby Doe’s abnormal behavior, including impulsivity and emotional dysregulation, is a consequence of
his in utero opioid exposure and subsequent NAS. His injury is likely permanent but will have different
manifestations as he ages. He will benefit from evaluation and treatment by a pediatric behavioral
specialist (child psychiatrist, child neurologist, or developmental pediatrician). He will likely benefit from

1
My fee is $500 per hour ($600 for deposition testimony). My compensation is not dependent on the result of this
litigation.

HIGHLY CONFIDENTIAL—ATTORNEY’S EYES ONLY

medical therapies such as guanfacine, methylphenidate, amphetamine, or the like throughout his school
years. He will benefit from evaluation and therapy by an occupational therapist in the short run and
later will benefit from evaluation and treatment by a child psychologist who should provide
psychometric testing and behavioral counseling. Baby Doe will likely qualify for and benefit from
educational accommodations once he has matriculated into the school system.

This opinion is to a reasonable degree of medical certainty. I reserve the right to add to or alter my
opinions.

HIGHLY CONFIDENTIAL—ATTORNEY’S EYES ONLY

2
 NEONATAL ABSTINENCE SYNDROME IN NORTHEAST TENNESSEE:
PUBLIC HEALTH PERSPECTIVE
Joel S. Koenig, M.D., F.A.A.P.
SEPTEMBER 20, 2019

Introduction
Neonatal Abstinence Syndrome (NAS) is a withdrawal syndrome that occurs in newborns exposed to
opioids in utero. Management of newborns so affected requires prolonged hospitalization for nursing
care, social services evaluation, and medical evaluation and intervention. Children exposed to opioids in
utero (with or without NAS) are at risk for developmental abnormalities that require ongoing monitoring
and therapies throughout childhood (1,2).

The incidence of NAS in the United States increased almost five-fold between 2000 and 2014 (from 1.20
to 5.8 per 1000 live births). The incidence rate in Tennessee is among the highest in the country and is
three times the national average. Northeast Tennessee has been particularly affected with some counties
reporting NAS rates exceeding 60 per 1000 live births, more than ten times the national average (3,4).

The alarming rate of NAS in northeastern Tennessee is a public health crisis that is increasing health care
and educational costs while also straining foster care and other social services (4,5).

Screening
Beginning with the first prenatal visit, it is incumbent that obstetricians, family care physicians, and nurse
midwives screen every pregnant patient for use of alcohol and drugs, including prescribed opioids as well
as drugs of abuse. Mothers should be made aware that this screening is routine and should be done in a
non-judgmental caring fashion. There are several validated screening questionnaires including 4 Ps, NIDA
quick screen, and, CRAFFT – Substance Abuse Screen for Adolescents and Young Adults. Urine drug
screening may be appropriate as well. When a pregnant woman has been identified, she should be
counseled regarding her risky behavior, providing feedback and advice. Referral to drug abuse treatment
specialists or other services may be indicated (1).

Considering the extremely high incidence of maternal opioid use in northeastern Tennessee, all newborns
there should be screened for in utero exposure to opioids and other harmful drugs since universal
screening of pregnant women is imperfect and in utero exposure to opioids even without NAS may cause
permanent injury. The preferred method of screening is umbilical cord tissue analysis since the cord is
always available at birth and the results of the assay should be available before the baby is discharged
from the hospital. Umbilical cord testing provides a longer history of prenatal drug exposure but may also
detect drugs delivered during labor and delivery (2,6).
Neonatal Abstinence Syndrome
Symptoms typically become manifest two or three days after birth but may occur on the first day of life
or be delayed for a week and may continue for several weeks. NAS affects the central nervous system, the
autonomic nervous system, and the gastrointestinal tract. Symptoms may include excessive crying and
irritability, sleep disturbances, increased muscle tone and hyperactive reflexes, tremors, seizures, fever,
rapid breathing, nasal congestion, excessive sucking and other feeding problems, vomiting and diarrhea,
and gastroesophageal reflux (1,2). These babies are more likely to have low birth weight (7).

The appearance of NAS symptoms may mimic other disorders so in addition to screening for in utero
exposure to opioids and other drugs, evaluation for hypoglycemia, hypocalcemia, sepsis, or intracranial
hemorrhage may be indicated. When an infant is determined to have suffered in utero opioid exposure
further evaluation for co-morbid conditions such as Hepatitis C Virus exposure (7).

NAS victims often require prolonged hospitalization, accruing hospital and physician charges. Infants
exposed to opioids in utero require frequent monitoring for signs and symptoms of NAS performed by a
knowledgeable nurse. All of the babies require additional laboratory testing and many of them must be
treated with medications such as morphine. The babies often suffer from poor feeding which requires
longer interactions with the nursing staff and may require evaluation by an occupational therapist. Social
services evaluation during the hospital stay is mandatory and may also result in delayed discharge. In
addition to all of these extra costs incurred by the NAS patient, the increased work load may put a strain
on the resources available such as hospital rooms and nursing staff.

All mothers at risk for giving birth to infants with NAS and all infants diagnosed with NAS should be
enrolled in an intensive home visiting program. Because of the medically complex challenges posed by
NAS, home visits should be conducted by nurses trained to provide evidence-based assistance. Each
nurse should have a caseload of no more than ten families, with typical visits conducted at least weekly
from the time a mother or infant is determined to be at risk until the infant is school age. At risk
mothers who give birth to infants not suffering from NAS would cease to need the services of NAS
trained home visit nurses, but might benefit from other visiting programs which are beyond the scope of
this report (9).

Long Term Effects of NAS: Monitoring and Treatment

All infants with a history of in utero exposure to opioids, even without evident NAS, are at-risk for long-
term adverse effects. These effects include but are not limited to behavioral or emotional disorder,
developmental delay, motor function developmental delay, sensory disorder, speech disorder,
strabismus, torticollis and plagiocephaly, and hepatitis C virus exposure. Many of these consequences do
not become evident for several years but may have life-long implications. It is mandatory that each child
exposed to maternal opioid use have access to routine pediatric screenings plus special evaluations and
therapies as indicated (8).

Special evaluations should include audiologic, ophthalmologic, and psychosocial evaluations for each
child prior to school age, timing to be determined by the child’s primary care provider. Any
developmental delays that are determined during routine pediatric visits should prompt referral to the
Tennessee Early Intervention System and to a specialist such as a child neurologist or developmental

2
pediatrician as available. Such children are likely to require ongoing physical, occupational, and speech
therapy. Children with speech delays should be referred to a speech therapist and children with sensory
disorder should be referred to an occupational therapist. If at any time strabismus becomes apparent
the child should be referred to an ophthalmologist. Strabismus may not be clinically obvious but may be
diagnosed with a photo-screening device. Screening should be done annually starting at twelve months
of age (by an ophthalmologist if such a device is not available). If torticollis with or without
plagiocephaly develops the child should be referred to physical therapy promptly and to a plastic
surgeon for an orthotic remolding helmet if the plagiocephaly persists beyond four months. Screening
for Hepatitis C exposure should be done at eighteen months of age (8). Psychometric testing for
Attention Deficit-Hyperactivity Disorder and learning disabilities should be performed about age six or
earlier if deficits are suspected.

It will be important that appropriate care is coordinated so that children who suffer with NAS receive
continuity of care, and that their medical monitoring is evaluated. At a minimum, this will require that
for every fifty children suffering from NAS in the relevant nine-county area, that health departments be
augmented, at minimum, with 1 counselor, 2 social workers and 2 vocational or academic specialists and
one administrative staff member. In addition, the regional effort will require management by an MD
medical director, a licensed psychiatrist, a physical therapist, a speech pathologist, an optometrist, and
appropriate support and research staff.

The lives of these children are often affected by having a mother who suffers from an opioid use
disorder as well as other behavioral or psychiatric diagnoses. It is important that social services, mental
health services, and medical services be available to these mothers so as to minimize the impact of their
condition on their developing children. It is imperative that infants who experienced opioid exposure in
utero be allowed to live with a family member if at all possible (1,5). The costs of monitoring and
treating children who experienced exposure to opioids in utero and their mothers are staggering. The
volume of care required places a burden on the hospitals, the health care providers, social workers, and
the foster care system. All impediments to accessing care should be identified and rectified. Ultimately
emphasis must be placed on preventing maternal opioid use.

References
1) ACOD COMMITTEE OPINION, Opioid Use and Opioid Use Disorder in Pregnancy, Number 711, August
2017.

2) Neonatal Abstinence Syndrome (NAS), North Carolina Pregnancy & Opioid Exposure Project, School of
Social Work, University of North Carolina at Chapel Hill, 2018.

3) Miller, AM and McDonald, M. Neonatal Abstinence Syndrome Surveillance Annual Report 2018,
Tennessee Department of Health, Division of Family Health and Wellness.

4) Patrick SW, Davis MM, Lehman CU, and Cooper WO. Increasing Incidence and Geographic Distribution
of Neonatal Abstinence Syndrome: United States 2009-2012, J Perinatol. August 2015; 35(8) 650-655.

3
5) Wadhwani, A. Driven by Opioid Crisis, More Children in Tennessee Living in Foster Care; DCS Seeks
Additional Funding, Nashville Tennessean, January 28, 2019.

6) Substance-Exposed Infants: State Responses to the Problem, United States Department of Health and
Human Services, Substance Abuse and Mental Health Services Administration, Administration for Children
and Families, 2009.

7) Erwin, PC, Lindley, L, Meschke, LL, and Ehrlich, SF. Neonatal Abstinence Syndrome in East Tennessee:
Characteristics and Risk Factors among Mothers and Infants in one area of Appalachia, J Health Care Poor
Underserved. 2017;28(4): 1393-1408.

8) Hall, ES, McAllister, JM, and Waxelblatt, SC. Developmental Disorders and Medical Complications
Among Infants with Subclinical Intrauterine Opioid Exposures, Population Health Management, Volume
22, Number 1, 2019.

9) Tennessee Home Visiting Annual Report, July 1, 2017 – June 30, 2018, Tennessee Department of Health,
Division of Family Health and Wellness, Nashville, 2018.

4
 CURRICULUM VITAE
Name: Joel S. Koenig, M.D.

Address: 3009 N. Ballas Road, Suite 131A

St. Louis, MO 63131

Date of Birth: March 1, 1956

Education: 1978 B.S., Yale University

1982 M.D., Vanderbilt Medical School

Internship: 1982-1983 St. Louis Children’s Hospital (Pediatrics)

Residency: 1983-1985 St. Louis Children’s Hospital (Pediatrics)

Fellowship: 1985-1987 St. Louis Children’s Hospital (Newborn Medicine)

Licensure: 1984- Missouri

1995-1996 Illinois

Certification: 1982 National Board of Medical Examiners

1987 American Board of Pediatrics
1988 American Board of Pediatrics
(Sub-board of Neonatal/Perinatal Medicine)
1990 Neonatal Advanced Life Support Hospital-based Instructor
(renewed 1992)
2009 American Board of Pediatrics, Maintenance of
Competence Certification (expired)

Employment: 1987-1988 Staff Pediatrician/Neonatologist, DePaul

Health Center, Bridgeton, Missouri
1988-1990 Staff neonatologist, St. Louis Children’s, Barnes, and Jewish
Hospitals
1990-2018 Chief of Pediatrics, Missouri Baptist
Medical Center, Town & Country, Missouri
1990- Private Practice of Pediatrics
3009 N. Ballas Road
Town & Country, Missouri
1990-1996 Neonatologist (part-time) St. Louis Regional
Medical Center, St. Louis, Missouri
1994-2000 Consultant for Pediatric Services, Prudential
Insurance
1995-1996 Neonatologist (part-time) St. Elizabeth’s Hospital
Belleville, Illinois
1997-1999 Assistant Medical Director for Medicaid,
Prudential Insurance
1999 Consultant, Correctional Medical Services
2001-2002 Medical Director, After Hours Pediatric
Urgent Care Center, Inc.
Curriculum Vitae
Page 2
Joel S. Koenig, M.D.

Academic Appointments: 1987-1988 Instructor in Clinical Pediatrics,

Washington University School of Medicine
St. Louis, Missouri
1988-1990 Instructor in Pediatrics,
Washington University School of Medicine
St. Louis, Missouri
1990-1999 Instructor in Clinical Pediatrics,
Washington University School of Medicine
St. Louis, Missouri
1999-2000 Assistant Professor of Clinical Pediatrics,
Washington University School of Medicine
St. Louis, Missouri
2000-2007 Associate Professor of Clinical Pediatrics,
Washington University School of Medicine
St. Louis, Missouri
2007- Professor of Clinical Pediatrics,
Washington University School of Medicine
St. Louis, Missouri

Hospital Appointments: 1987-1988 DePaul Health Center, House Staff

1988- St. Louis Children’s Hospital, Active
1988-1999 Barnes-Jewish Hospital
1988-1995 Jewish Hospital
1988-1996 St. Louis Regional Medical Center,
1989-2005 St. Luke’s Hospital
1990 Christian Hospital, Temporary
1990- Missouri Baptist Medical Center, Active
1990-2009 St. John’s Mercy Medical Center
1990-1996 Cardinal Glennon Children’s Hospital
1991-1996 St. Joseph’s Hospital (Kirkwood)
1995-1996 St. Elizabeth’s Hospital (Belleville, Illinois)

Professional Societies: 1988-1994 American Thoracic Society

1990-2002 St. Louis Pediatric Society
1991- American Academy of Pediatrics
1997-2000 American College of Physician Executives
1997-2000 American Medical Association
1997-2000 St. Louis Metropolitan Medical Society
Curriculum Vitae
Page 3
Joel S. Koenig, M.D.

Committees: 1987-1988 DePaul Health Center Perinatal Committee

(Co-Chairman)
1989-1990 Barnes Hospital Perinatal Outreach Program
1989-1990 St. Luke’s Hospital Transfusion Committee
1990- Missouri Baptist Medical Center
Medical Executive Committee
1990 Missouri Baptist Medical Center
Emergency Room Committee, ex officio
1990-1996 Missouri Baptist Medical Center
Peer Review Committee, ex officio
1991-1992 St. Luke’s Hospital Library Committee
1991-1992 St. Louis Children’s Hospital
Quality Assurance Committee
1992-1999 Prudential Insurance
Pediatric Advisory Committee
1994-1995 Barnes, Jewish, Christian (BJC)
Woman and Infants Steering Committee
1995 Missouri Baptist Medical Center
Pathology Quality Review Committee, ex officio
Anesthesiology Quality Review Committee, ex officio
Radiology Quality Review Committee, ex officio
Surgery Quality Review Committee, ex officio
1995-2001 Pediatric Advisory Group,
St. Louis Children’s Hospital
1996 St. Louis Metropolitan Area Pediatric Council (BJC)
1996-1997 BJC West-South Facilities Planning Team
1996-2001 Missouri Baptist Medical Center
Administration Medical Leadership
1997-2000 Missouri Baptist Medical Center Credentials Committee
Member
2000- Chairman
1997 Missouri Baptist Pediatric Leadership Group
1997-2000 Prudential Insurance Credentials Committee
1998-2000 Prudential Insurance Pharmacy and Therapeutic Committee
1998 Advisory Board for the Community Asthma Program
for Children
1999 Credentials Committee, State of Missouri,
Department of Corrections
1999- By-Laws Committee, Missouri Baptist Medical Center
1999-2000 Missouri Baptist Medical Center Search Committee for
Chief of Family Practice Department
Curriculum Vitae
Page 4
Joel S. Koenig, M.D.

Committees (continued):
1999-2000 Washington University Physician Network,
Pediatric Subcommittee on Integration of Care
1999 Health Management Partners,
Clinical Quality Improvements Committee
2000-2001 Washington University Physician Network,
Board of Director’s Nomination Committee
2001 Missouri Baptist Medical Center,
Strategic Planning Steering Committee

Corporate Boards: 1994-1995 Director, Healthlink Insurance

1996-1997 Director, St. Louis Children’s Hospital Pediatric
Physician Hospital Organization
1997-2002 Director, Washington University Physician Network
1997-2000 Pediatric Council, Washington University Physician Network
1997- Director and Chairman of the Board,
Town & Country Pediatrics, P.C.
2001-2002 Director, After Hours Pediatric Urgent Care Center
2001-2005 Director, St. Louis Pediatric Society
President (2003-2005)

Publications:

• Blocker S, Koenig J, Ternberg J. Congenital fibrosarcoma,

J Ped Surg 2:665-670, 1987

• Davies AM, Koenig JS, Thach BT. Upper airway chemoreflex

R9esponses to saline and water in preterm infants. J Appl Physiologic
64:1412-1420, 1988

• Koenig JS, Thack BT, Upper airway (UAW) mass loading alters
UAW caliber, resistance and closing pressure.
J Appl Physiol 64:2294-2299, 1988

• Thach BT, Davies AM, Koenig JS. Pathophysiology of sudden upper airway
obstruction in sleeping infants and its relevance for Sudden Infant Death Syndrome.
Annals of the NY Acad of Sciences 533:314-328, 1988

• Davies AM, Koenig JS, Thach BT. Characteristics of upper airway chemoreflex
prolonged apnea in human infants. AM Rev Dis 139:668-673, 1989

• Thach BT, Davies AM, Koenig JS, Menon A. Pickens DL.

Reflex induced apneas. In: J Remmers and P Sarrat (eds),
Sleep and Respiration, Wiley-Liss, 1990, 77-87
Curriculum Vitae
Page 5
Joel S. Koenig, M.D.

• Koenig JS, Davies AM, Thach BT. Coordination of breathing, sucking, and swallowing
during bottle feedings in human infants.
J Appl Physiol 69:1623-1629, 1990

Selected Abstracts:

• Davies AM, Koenig JS, Thach BT. Potency of saline water in eliciting prolonged apnea,
a laryngeal chemoreflex response in human infants.
Ped Res 21:447A

• Koenig JS, Davies AM, Thach BT. Mechanism of decreased ventilation during bottle
feedings
in infants. Ped Res 23:513A, 1988

• Koenig JS, Davies AM, Thach BT. Dual mechanisms by which swallowing interferes
with breathing chemoreceptors in man, AM Rev Dis 139:A176, 1989

• Davies AM, Koenig JS, Thach BT. Dual mechanisms by which swallowing interferes
with breathing during bottle feedings in infants. AM Rev Dis 139:A176, 1989

• Thach BT, Davies AM, Koenig JS. Importance of upper airway mechanoreceptors in the
regulation of upper airway patency. Proceedings of the International Union of Physiological Science
XVII, 1989.

• Koenig JS, Davies AM, Thach BT. Relation of physiologic hypoapnea to prolonged
apnea during bottle feedings in human infants. Presented at FASEB meeting.
Washington, D.C. April 1990.

• Khalil S, Benecke J, Koenig JS. Infant hearing screening Missouri Baptist Medical
Center, St. Louis, MO. American Academy of Pediatrics Section of Perinatal Pediatrics, 1995.

Editorships:

2000-2002 St. Louis Pediatric Society Metropolitan Newsletter

Book authored:

2003 Cherokee Chronicles 1540-1840,

Town and Country Publishing,
St. Louis, Missouri, copyright 2003
Second printing 2011 by Armour & Armour Publishing
 EXPERT WITNESS CASE LIST
Joel S. Koenig, M.D.
(September 2015 - September 2019)

VIDA ZOE FLORES, in her capacity as Special Conservator for BRISSA LOPEZ, a
minor vs. NORTHSIDE MEDICAL CLINIC/WALK IN L.L.C., et al
SUPERIOR COURT OF THE STATE OF ARIZONA IN AND FOR THE COUNTY OF
YUMA
No. S1400-CV2012-00550
Deposition given May 10, 2016
Retained by Mr. Jeffrey L. Victor

DONNA HENRY vs. CAROLYN ELLSWORTH, M.D.

CIRCUIT COURT OF HOWELL COUNTY, MISSOURI
Cause No. 08AL-CV00141
Testimony at trial given December 8, 2016 (Butler County, Missouri)
Retained by Mr. J. Thaddeus Eckenrode

JENNIFER DENNISE HARPER v. CHARLES A. JORDAN, M.D.,et al

CIRCUIT COURT OF WILSON COUNTY, TENNESSEE
Case No. 2016CV367
Deposition given August 30, 2017
Retained by Mr. Clinton L. Kelly

LORI FRANK et al vs. MARTA A.SZOKE, M.D.

STATE OF NEW YORK SUPREME COURT
COUNTY OF ST. LAWRENCE
Index no.: CV-2014-0144380
IAS No. 44-1-2014-0820
Testimony at trial given November 14, 2017
Retained by Mr. Robert E. Lahm

SHEQUITA MULLEN, individually and o/b/o ANDREA MULEEN v. IU HEALTH, JEANNE

BALLARD, M.D., IZLIN LIEN, M.D.
STATE OF INDIANA
MARION COUNTY SUPERIOR COURT
Cause No. 49D01-1704-CT-015907
Deposition given January 19, 2018
Retained by Ms. Barbara Germano

MCKAY v. THE UNITED STATES OF AMERICA

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF ARIZONA
Case No.: 16-CV-02447-DLR
Deposition given April 27, 2018
Retained by Mr. Matthew David Karnas
RENEE RAICHE and JONATHAN RAICHE, as Personal Representative of the Estate of
SAIGE M. RAICHE, a deceased minor v. FLORIDA KEYS PEDIATRIC & ADOLESCENT
CENTER, INC., STANLEY M. ZUBA, M.D., AND CLAUDIA KLENCK, M.D.
CIRCUIT COURT OF THE 16TH JUDICIAL CIRCUIT IN AND FOR MONROE COUNTY,
FLORIDA
CASE NO.: 2018-CA-000292
Deposition given December 7, 2018
Retained by Mr. Stephen Cain

ROBERT TORREZ, a single man, individually and as surviving father of decedent

RAFAEL TORREZ, and as personal representative for and on behalf of all statutory
beneficiaries, vs. BANNER —UNIVERSITY MEDICAL CENTER TUCSON CAMPUS
LLC, etc.
ARIZONA SUPERIOR COURT, PIMA COUNTY
Case No: C20184113
Depostion given May 3, 2019
Retained by Mr. David Karnas