Preview
FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012
NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023
EXHIBIT
F
FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012
NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023
SUPREME COURT OF THE STATE OF NEW YORK
COUNTY OF SUFFOLK
Index Number: 26910/12
xxxxxx xxxxxxxx, on behalf of , an
infant under the age of 18, and xxxxxx xxxxxxxx, PLAINTIFF’S EXPERT
Individually, WITNESS EXCHANGE
Teratology
Plaintiffs,
-against-
RONALD J. TADEO, M.D., RICHARD PITCH, M.D.,
SCOTT BERLIN, M.D., SHORE PSYCHIATRIC CENTER,
FAMILY PSYCHOLOGY OF LONG ISLAND, BERLIN
OBGYN ASSOCIATES, JANSSEN PHARMACEUTICALS,
INC. and ZYDUS PHARMACEUTICALS (USA), INC.,
Defendants.
Plaintiffs, by their attorneys, NAPOLI SHKOLNIK PLLC, as and for an Expert Witness
Disclosure pursuant to CPLR §3101(d), reserves the right to call the following witness at the
time of trial:
Richard H. Finnell, PhD, DABMG
Baylor College of Medicine
One Baylor Plaza
Neurosensory Bldg, BCM 946
Houston, TX 77030
1. Annexed hereto is the curriculum vitae of Richard H. Finnell, Ph.D., which sets
out his qualifications, educational background, training, membership in societies, academic
appointments and committees and publication and teaching experience.
2. In particular, Dr. Finnell is an experienced Medical Geneticist who has devoted
his clinical and academic work teratology, and in particular to the teratogenicity of anti-epileptic
drugs. He is board certified by the American Board of Plastic Surgery. He received his Masters
FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012
NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023
of Science in Medical Genetics from the University of British Columbia in 1978. He completed
his doctoral training in medical genetics at the University of Oregon School of Medicine (Ph.D.,
1980). He was recognized for his early work in teratogenesis in embryonic mice and was
awarded the Roche Foundation for Scientific Exchange fellowship for postdoctoral training at
the Anatomisches lnstitot of the Universitat Zurich in Switzerland. He has published hundreds of
articles on teratogens, genetics and birth defects, and has been an invited lecturer to over 100
national and international conferences on the issues of genetics, epilepsy and teratology.
3. Dr. Finnell is a Professor of Molecular and Human Genetics at Baylor College of
Medicine; he is also a Professor in the Baylor College of Medicine Center for Precision
Environmental Health as well as the Department of Molecular and Cell Biology and in the
Department of Medicine. He heads the Finnell Birth Defects Laboratory at Baylor College of
Medicine. A pediatric geneticist, he has been involved in investigating genetic susceptibility to
environmentally induced birth defects.
4. Dr. Finnell is expected to opine at the time of trial, on behalf of infant plaintiff,
, with regard to the permanent disability of plaintiff, as a result of
teratogenic injuries he sustained in utero from Topamax/topiramate, which resulted in a bilateral
cleft lip and palate, developmental delays, hearing delays, and severe mental anguish and
distress. More particularly, Dr. Finnell is expected to testify pertaining to the teratogenic nature
of Topamax/topiramate and the how that is causally linked to the cleft lip and cleft palate
developed in utero.
5. Dr. Finnell will opine that due to the subject malpractice, plaintiff,
while in utero, was caused to come into contact with the teratogenic medications
prescribed to his mother, and that as a result his embryonic and fetal development were directly
FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012
NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023
and adversely affected.
6. Dr. Finnell will opine that Topamax (topiramate) is a teratogen, both in animals
and in humans, when ingested during pregnancy; Topamax's (topiramate) teratogenicity has been
amply demonstrated in animal studies, as well as in a number of human epidemiological and
registry studies. Further, Dr. Finnell will opine how Topamax (topiramate) is a teratogenic
compound capable of inducing a range of congenital malformations in multiple organ systems,
including but not limited to the following: craniofacial, skeletal, cardiovascular, genitourinary,
central nervous system, and gastrointestinal systems.
7. Dr. Finnell is expected to opine on Topamax/topiramate’s interaction with a
developing fetus and how it works to disrupt embryonic development---that exposure of the
fetus to the drug results in significantly altered activity of a protein known as vascular
endothelial growth factor (VEGF). VEGF is a signaling protein produced by cells that stimulates
vasculogenesis and angiogenesis, the two key processes in establishing the network of blood
vessels essential for the embryo's growth and development. TPM exposure directly
downregulates Osteopontin, an extracellular matrix protein that is produced by cells and
transported to the extracellular space within the tissues. Osteopontin serves as a scaffolding to
hold tissues together and also helps to define tissue characteristics. TPM exposure limits
Osteopontin activity or expression (or both), which subsequently inhibits VEGF activity. This
reduction in VEGF function impacts angiogenic sprouts in endothelial cells, altering
hemodynamics in the developing embryo. It is this adverse effect on embryonic hemodynamics
that ultimately impairs embryonic cellular differentiation and growth, and leads to the production
of congenital defects.
8. It is Dr. Finnell’s opinion that the relationship between Topamax/topiramate and
FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012
NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023
congenital malformations is causal, including its effect on bilateral cleft lip and palate.
Dr. Finnell will explain the scientific basis for his opinion, including the consistency of the
evidence, the strength of the relationship, experimental evidence, biologic rationale, along with
temporality, biologic gradience, specificity, and coherence.
9. Dr. Finnell will opine that cleft lip and palate ate consistent with the
congenital malformations seen in children born to mothers who ingested Topamax/topiramate
during pregnancy. This is supported by the facts that mother ingested this medication
during the first trimester and the lack of other statistically significant comorbidities.
10. Dr. Finnell’s opinion is based his education, training, experience and specialized
knowledge in genetics, embryology, the role of teratogens in the development of birth defects
(teratology), developmental/reproductive toxicology and from my study and specialized work in
the development of teratology models, and in conducting teratology studies and experiments. All
of his opinions are based upon methodologies and materials which are generally accepted and
reasonably relied upon by experts in the fields of genetics and teratology, as well as other
scientific disciplines.
11. Dr. Finnell will opine that Topamax/topiramate is causally associated with oral
clefts in infants born to mothers who ingest this medication during the first trimester and in
particular that injuries are of a direct causal relationship the subject
malpractice.
12. Dr. Finnell will also rebut defendants’ medical expert’s testimony and will
comment on any and all evidence and exhibits used at the time of trial.
13. Plaintiff reserves his right to submit additional expert information when and if it
becomes available to plaintiffs and their counsel, including a supplemental report.
FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012
NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023
Dated: Melville, New York
July 12, 2022
Yours, etc.
___________________________
xxxxxx xxxxxxx
NAPOLI SHKOLNIK PLLC
Attorneys for Plaintiff
400 Broadhollow Road, Suite 305
Melville, NY 11747
(212) 397-1000
To:
MARTIN CLEARWATER & BELL LLP
Attorneys for Defendants
RONALD J. TADEO, M.D. and SHORE PSYCHIATRIC CENTER
90 Merrick Ave, Suite 401
East Meadow, NY 11554
516-222-8500
FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012
NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023
1
CURRICULUM VITAE
RICHARD H. FINNELL
01-18-2013
Personal Data
Date of birth: 1954
Place of birth: Santa Monica, California
Scholastic Record
B.S. 1975 University of Oregon, Eugene (anthropology/biology)
M.Sc. 1978 University of British Columbia, Vancouver (genetics)
Ph.D. 1980 University of Oregon Health Sciences Center, Portland (genetics)
Professional Experience:
1980-1981 Postdoctoral Research Associate in Developmental Neurogenetics, Good
Samaritan Hospital and Medical Center, Portland, Oregon
1981-1982 Postdoctoral Fellow, Anatomisches Institut, Universitat Zurich, Switzerland
1982-1988 Assistant Professor, Department of Veterinary and Comparative Anatomy,
Pharmacology and Physiology, Washington State University, Pullman,
Washington
1988-1991 Associate Professor (as above)
1985 Visiting Professor, Institut fur Toxikologie und Embryonalpharmakologie
Freie Universitat Berlin, Berlin, Germany
1990-1991 Visiting Professor, Department of Pharmacology, University of Pennsylvania
School of Medicine, Philadelphia, Pennsylvania
1991-1995 Associate Professor, Department of Veterinary Anatomy and Public Health
Texas College of Veterinary Medicine, Texas A&M University, College
Station, Texas
1995-1999 Professor and Assistant Head, Department of Veterinary Anatomy and Public
Health, Texas College of Veterinary Medicine, Texas A&M University,
College Station, Texas
1997-1999 Acting Associate Dean for Research, Texas College of Veterinary Medicine,
Texas A&M University, College Station, Texas
1998-present Professor, Department of Environmental and Occupational Health, School of
Rural Public Health, Texas A&M University, College Station, Texas
1998- present Professor, Department of Biomedical Sciences, Baylor College of
Dentistry-Texas A&M University System, Dallas, Texas
1999-2001 Director, Center for Human Molecular Genetics, University of Nebraska
Medical Center, Omaha, Nebraska
FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012
NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023
2
1999-2001 Professor, Department of Cell Biology and Anatomy, University of Nebraska
Medical Center, Omaha, Nebraska
1999-2006 Professor and Section Head for Molecular Diagnostics, Department of
Pediatrics, University of Nebraska Medical Center, Omaha, Nebraska
2001-2006 Professor and Director, Institute of Biosciences and Technology, The Texas
A&M University System Health Science Center, The Texas Medical Center,
Houston, Texas
2005-2010 Regents Professor, Texas A&M University System Health Science Center
2005-2010 Executive Director, The Texas A&M Institute of Genomic Medicine, Houston,
Texas
2005-2010 Margaret M. Alkek Professor of Medical Genetics, Institute of Biosciences and
Technology, Texas A&M University Health Science Center
2007-2009 BBVA Foundation Visiting Professor, CICbioGUNE Research Institute, Bilbao,
Spain
2009-2010 Professor, Department of Molecular and Cellular Medicine, College of
Medicine, Texas A&M Health Science Center, College Station, Texas
2010-present Professor, Department of Nutritional Sciences and Department of Chemistry
and Biochemistry, University of Texas, Austin, Texas
2010-present Director, Genomic Research, Dell Children’s Medical Center, Austin, Texas
2011-present Member, Center for Cell and Molecular Biology Graduate Program, The
University of Texas at Austin
2011-present Member, Center Molecular and Cellular Toxicology, The College of
Pharmacy, The University of Texas at Austin
2011-present Member, Center for Research on Environmental Diseases, The MD Anderson
Cancer Center at Smithville, and the University of Texas at Austin
2011-present Adjunct Professor, Shanghai Institute of Medical Genetics, Shanghai Jiaotong
University, Shanghai, PRC
Honors and Awards
Outstanding Student Abstract Award - Int’l Congress Human Genetics, Montreal 1977
Roche Foundation for Scientific Exchange Fellowship - Zurich, Switzerland, 1981
Basil O’Connor Fellow - March of Dimes - 1982-1984
Cold Spring Harbor Summer Course Fellowship -1990
Pfizer Animal Health Award for Research Excellence -1995
Texas A&M University Distinguished Achievement Award in Research -1997
Teratology Society Wilson Publication Award-2000, 2004
Warkany Lecturer, Teratology Society, 2008
FASEB One Carbon Metabolism Conference Co-Chair, 2010
FILED: SUFFOLK COUNTY CLERKFILED
05/25/2023 09:52 AM INDEX NO. 026910/2012
NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023
Civil Administration 3
Scientific Organizations
American Board of Medical Genetics, diplomat, 1982
American Society of Human Genetics
Teratology Society-National Council, 1997-2001
Editorial Board
Teratology. Section Editor for Genetics and Cytogenetics (1992-1997); Molecular Genetics
(1997-2000)
Guest Referee Editor: American Journal of Medical Genetics
Associate Editor: Environmental Health Perspectives: Toxicogenomics (2002-2004)
Associate Editor: Birth Defects Research: Clinical and Molecular Teratology
The Open Toxicology Journal
Manuscript Reviewer
Science
Nature
Nature Genetics
Journal American Medical Association
Genomics
American Journal of Medical Genetics
Drug and Chemical Toxicology
Epilepsia
Proceedings of the National Academy of Sciences
The Journal of Neuroscience
Reproductive Toxicology
Birth Defects Research
The Medical Letter
Pediatric Research
Society for Experimental Biology and Medicine
Fundamental and Applied Toxicology
Journal of Obstetrics and Gynecology
The Journal of Experimental Zoology
Analytical Biochemistry
American Journal of Clinical Nutrition
Obstetrics and Gynecology
Journal of Clinical Investigation
Journal of Toxicology and Environmental Health
Experimental Cell Research
In Vitro Cellular and Developmental Biology
Molecular Genetics and Metabolism
Clinical Genetics
European Journal of Human and Clinical Genetics
The FASEB Journal
Toxicological Sciences
Human Molecular Genetics
J. Pharmacology Science and Physical Therapy
International Journal of Developmental Biology
Nature Reviews-Genetics
Am. J. Physiology
Pediatrics
Developmental Brain Research
Human Reproduction
Experimental Neurology
FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012
NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023
4
Acta Neurologia
Clinical Genetics
Antioxdants and Redox Signaling
Physiological Genomics
New England Journal of Medicine
Journal of Pediatric Hematology and Oncology
Grant Reviewer
Public Health Service
Standing Member, Oral Biology and Medicine Study Section, (OBM I) 1991-1995
NIH Reviewer’s Reserve, 1995-present
Medical Research Council of Canada
Medical Research Council- United Kingdom
USDA National Research Initiative Competitive Grants Program
Veterans Administration Medical Research Service
Air Force Office of Scientific Research
March of Dimes - Birth Defects Foundation
National Science Foundation
WellBeing Foundation
The Wellcome Trust
The Netherlands Organization for Health Research and Development
Israel Science Foundation
Qatar National Research Fund
Health Research Board of Ireland
Scientific Advisory Panels
Advisory Commission - Texas Birth Defects Monitoring Division; Vice-Chairperson
1995-1997; Chairperson, 1997-2005
World Health Organization Technical Consultation on Craniofacial Malformations,
November, 2000.
University of Wisconsin Environmental Health Sciences Center for Developmental and
Molecular Toxicology, Colin Jefcoate, PI. 2001-2005.
University of Florida School of Medicine-Fetal Antiepileptic Drug Neurodevelopment
Program, Kimford Meador, PI. 2000-2008.
Emory University School of Medicine-Fetal Antiepileptic Drug Neurodevelopment Program,
Kimford Meador, PI. 2008-present.
Duke University Environmental Health Sciences Center for Comparative Biology of
Vulnerable Populations, David Schwartz, PI. 2002-2006.
International League Against Epilepsy Commission on Genetics. Member, 2003-present.
EURAP Congenital Malformation Registry. Scientific Advisory Board. 2002-2007.
Case Western Reserve University Fetal and Environmental Exposures Training Grant.
Scientific Advisory Board. 2005-2009.
FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012
NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023
5
American Academy of Neurology Practice Parameter for the Management of Women with
Epilepsy. Committee member. 2005-present.
World Health Organization Technical Consultation on Folate and Vitamin B12 Deficiencies,
November, 2005.
Children’s Environmental Health Centers Review Board on behalf of the NIEHS National
Advisory Environmental Health Sciences Council, 2006-2007.
University of Texas San Antonio Biology Program Scientific Advisory Board. 2006-present.
Global Environmental Health Strategic Planning Workshop Participant on behalf of the
NIEHS National Advisory Environmental Health Sciences Council, January, 2007.
University of Houston Center for Life Sciences Technology Advisory Board of Directors.
2007-2010.
International Mouse Knockout Consortium Steering Committee, 2007-2011.
NIEHS National Advisory Environmental Health Sciences Council, National Institutes of
Health, Council Member, 2007-2011.
CICbioGUNE Scientific Advisory Board, Bilbao, Spain, 2009-present. Chairperson.
Dartmouth Medical School, Children's Environmental Health and Disease Prevention
Research Center, Scientific Advisory Board member. 2010-present.
Consulting Services
HESI DART Committee's Skeletal Variants Consultation. 1998-2001.
Johnson and Johnson Pharmaceutical-PRI Division. Global team for Topirimate. 1999-
2006.
GlaxoSmithKline Pharmaceutical Division. Global team for Lamictal. 2003-2006.
Eli Lily and Company, Oncology Research Platform, ALIMTA Advisory Board. 20005-2006.
HESI DART Committee's In Vitro Assays. 2005-2009.
Shire Pharmaceutics, Valrocemide Advisory Board. 2006-2007.
Courses Taught
University of British Columbia
Biology 310 28 lectures (human heredity and evolution)
Washington State University
VAn 308 18 lectures (anatomy, histology and physiology of domestic animals)
VAn 405 16 lectures (embryology, developmental anatomy)
Gen 430 15 lectures (medical genetics)
PIT 505 5 lectures (environmental toxicology)
VPh 516 30 lectures (embryology, veterinary medical genetics)
VAn 515 15 laboratories (Advanced Experimental Embryology)
P/T 565 12 lectures (teratology and reproductive toxicology)
VM 406 15 lectures, 30 laboratories (embryology, histology)
VPh 525 Pathological Embryology
PIT 565 Advanced Toxicology (reproductive toxicology) Course director
PIT 597 Graduate Seminar in Teratogenesis
FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012
NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023
6
Texas A&M University
VAPH 913 Mammalian Embryology
GENE 482 Senior Seminar in Human Genetics
GENE 320 Human Genetics
VAPH 612 Advanced Mammalian Embryology
GENE 421 Advanced Human Genetics
VAPH 640 Neurobiology
Bavlor College of Dentistry
BMS 5V72 Craniofacial Anomalies
BMS 5V73 Adv. Human Craniofacial Development and Growth
BMS 5V69 Growth and Mechanisms of Development
University of Nebraska Medical Center
M1 Cellular Processes Core Course
Former Students and Fellows
Muhammad, A. M. (MS, 1983) Faculty member
Kampus IKIP / Gunungsari Baru
Ujung Panandang
Indonesia
Baer, J.F. (MS, 1985; DVM, 1990) Research Veterinarian
California Institute of Technology
Pasadena, California
Moon, S.P. (MS, 1986; MD, 1990) Private Practice
Portland, Oregon
Bennett, G.D. (PhD, 1988) Associate Professor
Department of Genetics, Cell Biology
and Anatomy
Univ. Nebraska Medical Center
Omaha, Nebraska
Mohl, V.K. (PhD, 1988; MD, 1992) Assistant Professor
Department of Family Practice
University of Wyoming
Laramie, Wyoming
Toloyan S. (Postdoctoral Fellow) Private Practice
Savannah, Georgia
Taylor, S.M. (Postdoctoral Fellow) Professor
Department of Pharmacology
University of Queensland
Brisbane, Australia
Abbott, L.C. (Postdoctoral Fellow) Associate Professor
FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012
NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023
7
Department of Veterinary Anatomy and
Public Health
Texas A&M University
College Station, Texas
Silver, J.K. (Postdoctoral Fellow) Private Practice
Crescent City, California
van Waes, M. (MS, 1990) Technical Support-Quantitative PCR
Stratagene Inc.
La Jolla, California
Englen, M.D. (Postdoctoral Fellow) Research Associate
USDA
Athens, Georgia
Taylor, L.E. (MS, 1994) Research Associate
Jackson Laboratory
Bar Harbor, Maine
Glasser, J. (DVM, MS, 1996) Private Practice
Mesa, Arizona
Jie, An (Postdoctoral Fellow) Research Scientist
Department of Internal Medicine
University of Texas Southwestern School
of Medicine
Dallas, Texas
Wlodarczyk, B. (Postdoctoral Fellow) Asst. Professor
Dell Pediatric Research Institute
The University of Texas at Austin
Austin, Texas
Greer, K.A. (MS, 1996) Asst. Professor
Indiana University East
Richmond, IN
Bielec, B.Y. (MS, 1997) Education Specialist
BioPharmaceutical Technology Center
Madison, Wisconsin
Barber, R.C. (PhD, 1997; Postdoc) Associate Professor
Department of Pharmacology and
Neuroscience
University of North Texas Health Science
Center
Fort Worth, Texas
Vacha, S.J. (PhD, 1997) Technical Scientist
Aligent
FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012
NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023
8
Foster City, CA
Gefrides, L.A. (MS, 1998) Research Associate
Department of Forensics
Harris County Justice Department
Houston, Texas
van Waes, J. (Postdoctoral Fellow) Associate Professor
Department of Pharmacology
Creighton Univ. Medical Center
Omaha, Nebraska
Mitchell, D. (Postdoctoral Fellow) Assistant Research Scientist
Texas A&M University
College Station, Texas
Craig, J.C. (Ph.D., 1998) Research Scientist
Virginia Bioinformatics Institute
Blacksburg, VA 24061
Xiong, Wanfen (Postdoctoral Fellow) Research Associate
Department of Surgery
University of Nebraska Medical Center
Omaha, Nebraska
Spiegelstein, Ofer (Postdoctoral Fellow) Phase-1 and Clinical
Pharmacology, Unit head
Innovative R&D
Teva Pharmaceutics
Israel
Tang, Louisa Shuk Chun (Postdoctoral Fellow) Research Associate
Department of Cell and Molecular
Biology
Hong Kong University of Science and
Technology
Hong Kong, China
Zhu, Huiping (Postdoctoral Fellow) Asst. Professor
Department of Nutritional Sciences
The University of Texas at Austin
Austin, Texas
Gould, Amy (Postdoctoral Fellow) Manager, Program Animal Research
Institute of Biosciences and Technology
Texas A&M University System HSC
Houston, Texas
FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012
NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023
9
Volcik, Kelly (Postdoctoral Fellow) Assistant Professor
University of Texas School of Public
Houston, Texas
Lu, Wei (Postdoctoral Fellow) Asst. Res. Scientist
Department of Pediatrics
Univ. Texas HSC
Houston, Texas
Wong, LeeYean (Postdoctoral Fellow) Assoc. Res. Scientist
Institute of Biosciences and Technology
Texas A&M University System HSC
Houston, Texas
Zhang, Jing (M.S., 2004; Postdoctoral Fellow) Staff Pathologist
Peking University Health Science Center
Beijing, China
Taparia, Shveta (Postdoctoral Fellow) On Indefinite Maternity Leave
Gorman, Elisabeth (Postdoctoral Fellow) Research Fellow
Baylor College of Medicine
Houston, Texas
Cabrera, Robert M. (Ph.D., 2006) Research Scientist
Dell Pediatric Research Institute
The University of Texas at Austin
Austin, Texas
Ballard, Jonathan (Postdoctoral Fellow) Texas A&M Institute for Genomic
Medicine
College Station, Texas
Hill, Denise S. (Ph.D. 2007) Toxicology Consultant
Houston, Texas
Wen, Shu (Ph.D. 2008) Medical Genetics Fellowship
• Baylor College of Medicine
Houston, Texas
Kartiko, Susan (Ph.D. 2009) Surgical Resident
Albert Einstein Medical Center
Philadelphia, PA
Conde, Javier (Postdoctoral Fellow) Dell Pediatric Research Institute
The University of Texas at Austin
Austin, Texas
Chantada Vasquez, Mercedes (Postdoctoral Fellow) Dell Pediatric Research Institute
The University of Texas at Austin
Austin, Texas
FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012
NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023
10
Wang, Xueqian (Postdoctoral Fellow) Dell Pediatric Research Institute
The University of Texas at Austin
Austin, Texas
Sabbatical Professors
Vorce, Roseann Department of Pharmacology
University of Nebraska Medical Center
Omaha, Nebraska
Park, Kyung Ran Department of Anatomy
Seoul, Korea
Min, Kyung Soo Department of Neurosurgery
University of Seoul
Seoul, Korea
Taylor, Stephen M. Department of Pharmacology
University of Queensland
Brisbane, Qld. Australia
Invited Participant in Symposia and Congresses-Selected Listing (Does not include invited lectures
at Universities and Medical Centers)
1. Fifth International Congress of Birth Defects, Montreal, Quebec, Canada, August 1977.
2. International Epilepsy Symposium, Vancouver, British Columbia, Canada, September 1978.
3. International Symposium of Phenytoin-lnduced Teratology and Gingival Pathology, Chapel
Hill, North Carolina, May 1979.
4. International Workshop on the Genetics of Epilepsy, Minneapolis, Minnesota, July 1980.
5. Visiting Lecturer in Teratology, Institut fur Medizinische Genetik, Universitat Zurich, fall
1981.
6. Fall Congress on Epileptic Disorders, Freie Universitat Berlin, Berlin, Germany, October
1981.
7. Ninth European Teratology Society Meeting, Basel, Switzerland, September 1981.
8. Eleventh European Teratology Society Meeting, Paris, France, September 1983.
9. Fall Congress on Epileptic Disorders, Freie Universitat Berlin, Berlin, Germany, September
1983.
10. International Workshop on Epilepsy, Pregnancy and the Child, St. Adele, Quebec, Canada,
October 1983.
11. International Symposium - Pharmacokinetics in Teratogenesis, Freie Universitat Berlin,
Berlin, Germany, September 1985.
12. Thirteenth European Teratology Society Meeting, Rostock, Germany, September 1985.
FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012
NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023
11
13. Seventh International Congress of Human Genetics, Berlin, Germany, September 1986.
14. International Workshop on the Genetics of Epilepsy, Berlin, Germany, September 1986.
15. Eighteenth International Epilepsy Congress and International Workshop on Epilepsy,
Genetics, Pregnancy and the Child, New Delhi, India, October 1989.
16. International Symposium on Pregnancy, Teratogenesis and Genetics in Epilepsy, Los
Angeles, California, July 1990.
17. Third International Cleveland Clinic Symposium on Epilepsy, Cleveland, Ohio, June 1992.
18. Gesellschaft fur Humangenetik, Wurzburg, Germany, March 1993.
19. First International Conference on Neural Tube Defects, Harlingen, Texas, October 1993.
20. Session Chairperson, Gordon Research Conference on Mechanisms of Toxicity, Meriden,
New Hampshire, August 1995.
21. Fourth International Society for the Study of Xenobiotics Meeting, Seattle, Washington
August 1995.
22. Binational Conference on Neural Tube Defects, El Paso, Texas, January 1996.
23. Third Eilat Conference on New Antiepileptic Drugs, Eilat, Israel, May 1996.
24. Twenty-second Congress on Epilepsy, Dublin, Ireland, June 1997.
25. Twenty-fifth Conference of the European Teratology Society, Cannes, France, September
1997.
26. Instructor, Advanced Course, Society of Toxicology Meeting, Seattle, Washington, March
1998.
27. Fourth Eilat Conference on New Antiepileptic Drugs, Eilat, Israel, September 1998.
28. Second International Conference on Homocysteine Metabolism, Nijmegen, The
Netherlands, April 1998.
29. FASEB Summer Conference on Folate, B12, and One Carbon Metabolism, Snowmass
Village, Colorado, August, 1998.
30. ASPET Symposium on Molecular Mechanisms of Chemical Teratogenesis,
Washington, D.C. April, 1999.
31. IBC’s 4th Annual Conference on Molecular Toxicology, Washington, D.C. April 1999.
32. Neural Tube Defects 2000 Workshop. Organizer and Co-chairman. Schlangenbad,
Germany, August 1999.
33. New York Academy of Sciences Conference -“Toxicology For The Next Millennium,” Airlie
Conference Center, September, 1999.
FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012
NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023
12
34. 39th Annual Meeting, Society of Toxicology. “Altered Gene Expression Patterns to Predict
and Understand Chemical Teratogenesis.” Philadelphia, Pennsylvania, March, 2000.
35. Fifth EILAT Conference on New Antiepileptic Drugs, Eilat, Israel, June 2000.
36. FASEB Summer Conference on Folate, B12, and One-Carbon Metabolism, Snowmass
Colorado, August 2000.
37. 24th International Epilepsy Congress-"Symposium on Pharmacogenomics", Buenos Aires,
Argentina, May, 2001.
38. Doctoral Opponent and Symposium Speaker. College of Pharmacy, Uppsala, Sweden, May,
2001.
39. Japanese Society of Toxicology Annual Meeting, Tokyo, Japan, June, 2001.
40. 3rd International Conference on Homocysteine Metabolism, Sorrento, Italy, July, 2001.
41. 2nd International Conference on Neural Tube Defects, Organizer and Co-chair, Seabrook,
So. Carolina, September 2001.
42. 14th World Congress of Pharmacology, San Francisco, CA, July, 2002.
43. Session Chairperson, Gordon Research Conference on Mechanisms of Toxicity, Maine, July,
2002.
44. FASEB Summer Conference on Folate, B12, and One-Carbon Metabolism, Snowmass
Colorado, August 2002.
45. 3rd Workshop on Advances in Molecular Medicine, Pamplona, Spain, November 2002.
46. Malformations: What's a Doctor to Do? Neural Tube Defects from Bench to Bedside,
American Epilepsy Society Meeting Symposium. Seattle, Washington, December 2002.
47. 4th International Conference on Homocysteine Metabolism, Basel, Switzerland, July 2003.
48. 3rd International Conference on Neural Tube Defects, Organizer and Co-chair, Seabrook, So.
Carolina, September 2003.
49. Twenty-fifth Congress on Epilepsy, Lisbon, Portugal. October, 2003.
50. FASEB Summer Conference on Folate, B12, and One-Carbon Metabolism, Snowmass
Colorado, August 2004. Session Chairperson and speaker.
51. 25th Annual Meeting of the Netherlands Society of Toxicology. Bilthoven, The Netherlands,
June, 2004.
52. International Workshop on Neural Tube Defects, Genoa, Italy, November, 2004.
53. Institut European des Genomutations Spring Scientific Forum, Lyon, France, March, 2004.
FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012
NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023
13
54. Korean Society of Toxicology, Keynote speaker. Seoul, Korea, November, 2004.
55. 5th International Conference on Homocysteine Metabolism, Milan, Italy June, 2005
56. 8th World Congress of Biological Psychiatry, Vienna, Austria, June, 2005
57. 13th International Symposium on Chemistry and Biology of Pteridines and Folates, Egmond
ann Zee, The Netherlands, June, 2005
58. 4th In
Preview
FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012 NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023 EXHIBIT F FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012 NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023 SUPREME COURT OF THE STATE OF NEW YORK COUNTY OF SUFFOLK Index Number: 26910/12 xxxxxx xxxxxxxx, on behalf of , an infant under the age of 18, and xxxxxx xxxxxxxx, PLAINTIFF’S EXPERT Individually, WITNESS EXCHANGE Teratology Plaintiffs, -against- RONALD J. TADEO, M.D., RICHARD PITCH, M.D., SCOTT BERLIN, M.D., SHORE PSYCHIATRIC CENTER, FAMILY PSYCHOLOGY OF LONG ISLAND, BERLIN OBGYN ASSOCIATES, JANSSEN PHARMACEUTICALS, INC. and ZYDUS PHARMACEUTICALS (USA), INC., Defendants. Plaintiffs, by their attorneys, NAPOLI SHKOLNIK PLLC, as and for an Expert Witness Disclosure pursuant to CPLR §3101(d), reserves the right to call the following witness at the time of trial: Richard H. Finnell, PhD, DABMG Baylor College of Medicine One Baylor Plaza Neurosensory Bldg, BCM 946 Houston, TX 77030 1. Annexed hereto is the curriculum vitae of Richard H. Finnell, Ph.D., which sets out his qualifications, educational background, training, membership in societies, academic appointments and committees and publication and teaching experience. 2. In particular, Dr. Finnell is an experienced Medical Geneticist who has devoted his clinical and academic work teratology, and in particular to the teratogenicity of anti-epileptic drugs. He is board certified by the American Board of Plastic Surgery. He received his Masters FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012 NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023 of Science in Medical Genetics from the University of British Columbia in 1978. He completed his doctoral training in medical genetics at the University of Oregon School of Medicine (Ph.D., 1980). He was recognized for his early work in teratogenesis in embryonic mice and was awarded the Roche Foundation for Scientific Exchange fellowship for postdoctoral training at the Anatomisches lnstitot of the Universitat Zurich in Switzerland. He has published hundreds of articles on teratogens, genetics and birth defects, and has been an invited lecturer to over 100 national and international conferences on the issues of genetics, epilepsy and teratology. 3. Dr. Finnell is a Professor of Molecular and Human Genetics at Baylor College of Medicine; he is also a Professor in the Baylor College of Medicine Center for Precision Environmental Health as well as the Department of Molecular and Cell Biology and in the Department of Medicine. He heads the Finnell Birth Defects Laboratory at Baylor College of Medicine. A pediatric geneticist, he has been involved in investigating genetic susceptibility to environmentally induced birth defects. 4. Dr. Finnell is expected to opine at the time of trial, on behalf of infant plaintiff, , with regard to the permanent disability of plaintiff, as a result of teratogenic injuries he sustained in utero from Topamax/topiramate, which resulted in a bilateral cleft lip and palate, developmental delays, hearing delays, and severe mental anguish and distress. More particularly, Dr. Finnell is expected to testify pertaining to the teratogenic nature of Topamax/topiramate and the how that is causally linked to the cleft lip and cleft palate developed in utero. 5. Dr. Finnell will opine that due to the subject malpractice, plaintiff, while in utero, was caused to come into contact with the teratogenic medications prescribed to his mother, and that as a result his embryonic and fetal development were directly FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012 NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023 and adversely affected. 6. Dr. Finnell will opine that Topamax (topiramate) is a teratogen, both in animals and in humans, when ingested during pregnancy; Topamax's (topiramate) teratogenicity has been amply demonstrated in animal studies, as well as in a number of human epidemiological and registry studies. Further, Dr. Finnell will opine how Topamax (topiramate) is a teratogenic compound capable of inducing a range of congenital malformations in multiple organ systems, including but not limited to the following: craniofacial, skeletal, cardiovascular, genitourinary, central nervous system, and gastrointestinal systems. 7. Dr. Finnell is expected to opine on Topamax/topiramate’s interaction with a developing fetus and how it works to disrupt embryonic development---that exposure of the fetus to the drug results in significantly altered activity of a protein known as vascular endothelial growth factor (VEGF). VEGF is a signaling protein produced by cells that stimulates vasculogenesis and angiogenesis, the two key processes in establishing the network of blood vessels essential for the embryo's growth and development. TPM exposure directly downregulates Osteopontin, an extracellular matrix protein that is produced by cells and transported to the extracellular space within the tissues. Osteopontin serves as a scaffolding to hold tissues together and also helps to define tissue characteristics. TPM exposure limits Osteopontin activity or expression (or both), which subsequently inhibits VEGF activity. This reduction in VEGF function impacts angiogenic sprouts in endothelial cells, altering hemodynamics in the developing embryo. It is this adverse effect on embryonic hemodynamics that ultimately impairs embryonic cellular differentiation and growth, and leads to the production of congenital defects. 8. It is Dr. Finnell’s opinion that the relationship between Topamax/topiramate and FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012 NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023 congenital malformations is causal, including its effect on bilateral cleft lip and palate. Dr. Finnell will explain the scientific basis for his opinion, including the consistency of the evidence, the strength of the relationship, experimental evidence, biologic rationale, along with temporality, biologic gradience, specificity, and coherence. 9. Dr. Finnell will opine that cleft lip and palate ate consistent with the congenital malformations seen in children born to mothers who ingested Topamax/topiramate during pregnancy. This is supported by the facts that mother ingested this medication during the first trimester and the lack of other statistically significant comorbidities. 10. Dr. Finnell’s opinion is based his education, training, experience and specialized knowledge in genetics, embryology, the role of teratogens in the development of birth defects (teratology), developmental/reproductive toxicology and from my study and specialized work in the development of teratology models, and in conducting teratology studies and experiments. All of his opinions are based upon methodologies and materials which are generally accepted and reasonably relied upon by experts in the fields of genetics and teratology, as well as other scientific disciplines. 11. Dr. Finnell will opine that Topamax/topiramate is causally associated with oral clefts in infants born to mothers who ingest this medication during the first trimester and in particular that injuries are of a direct causal relationship the subject malpractice. 12. Dr. Finnell will also rebut defendants’ medical expert’s testimony and will comment on any and all evidence and exhibits used at the time of trial. 13. Plaintiff reserves his right to submit additional expert information when and if it becomes available to plaintiffs and their counsel, including a supplemental report. FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012 NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023 Dated: Melville, New York July 12, 2022 Yours, etc. ___________________________ xxxxxx xxxxxxx NAPOLI SHKOLNIK PLLC Attorneys for Plaintiff 400 Broadhollow Road, Suite 305 Melville, NY 11747 (212) 397-1000 To: MARTIN CLEARWATER & BELL LLP Attorneys for Defendants RONALD J. TADEO, M.D. and SHORE PSYCHIATRIC CENTER 90 Merrick Ave, Suite 401 East Meadow, NY 11554 516-222-8500 FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012 NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023 1 CURRICULUM VITAE RICHARD H. FINNELL 01-18-2013 Personal Data Date of birth: 1954 Place of birth: Santa Monica, California Scholastic Record B.S. 1975 University of Oregon, Eugene (anthropology/biology) M.Sc. 1978 University of British Columbia, Vancouver (genetics) Ph.D. 1980 University of Oregon Health Sciences Center, Portland (genetics) Professional Experience: 1980-1981 Postdoctoral Research Associate in Developmental Neurogenetics, Good Samaritan Hospital and Medical Center, Portland, Oregon 1981-1982 Postdoctoral Fellow, Anatomisches Institut, Universitat Zurich, Switzerland 1982-1988 Assistant Professor, Department of Veterinary and Comparative Anatomy, Pharmacology and Physiology, Washington State University, Pullman, Washington 1988-1991 Associate Professor (as above) 1985 Visiting Professor, Institut fur Toxikologie und Embryonalpharmakologie Freie Universitat Berlin, Berlin, Germany 1990-1991 Visiting Professor, Department of Pharmacology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 1991-1995 Associate Professor, Department of Veterinary Anatomy and Public Health Texas College of Veterinary Medicine, Texas A&M University, College Station, Texas 1995-1999 Professor and Assistant Head, Department of Veterinary Anatomy and Public Health, Texas College of Veterinary Medicine, Texas A&M University, College Station, Texas 1997-1999 Acting Associate Dean for Research, Texas College of Veterinary Medicine, Texas A&M University, College Station, Texas 1998-present Professor, Department of Environmental and Occupational Health, School of Rural Public Health, Texas A&M University, College Station, Texas 1998- present Professor, Department of Biomedical Sciences, Baylor College of Dentistry-Texas A&M University System, Dallas, Texas 1999-2001 Director, Center for Human Molecular Genetics, University of Nebraska Medical Center, Omaha, Nebraska FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012 NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023 2 1999-2001 Professor, Department of Cell Biology and Anatomy, University of Nebraska Medical Center, Omaha, Nebraska 1999-2006 Professor and Section Head for Molecular Diagnostics, Department of Pediatrics, University of Nebraska Medical Center, Omaha, Nebraska 2001-2006 Professor and Director, Institute of Biosciences and Technology, The Texas A&M University System Health Science Center, The Texas Medical Center, Houston, Texas 2005-2010 Regents Professor, Texas A&M University System Health Science Center 2005-2010 Executive Director, The Texas A&M Institute of Genomic Medicine, Houston, Texas 2005-2010 Margaret M. Alkek Professor of Medical Genetics, Institute of Biosciences and Technology, Texas A&M University Health Science Center 2007-2009 BBVA Foundation Visiting Professor, CICbioGUNE Research Institute, Bilbao, Spain 2009-2010 Professor, Department of Molecular and Cellular Medicine, College of Medicine, Texas A&M Health Science Center, College Station, Texas 2010-present Professor, Department of Nutritional Sciences and Department of Chemistry and Biochemistry, University of Texas, Austin, Texas 2010-present Director, Genomic Research, Dell Children’s Medical Center, Austin, Texas 2011-present Member, Center for Cell and Molecular Biology Graduate Program, The University of Texas at Austin 2011-present Member, Center Molecular and Cellular Toxicology, The College of Pharmacy, The University of Texas at Austin 2011-present Member, Center for Research on Environmental Diseases, The MD Anderson Cancer Center at Smithville, and the University of Texas at Austin 2011-present Adjunct Professor, Shanghai Institute of Medical Genetics, Shanghai Jiaotong University, Shanghai, PRC Honors and Awards Outstanding Student Abstract Award - Int’l Congress Human Genetics, Montreal 1977 Roche Foundation for Scientific Exchange Fellowship - Zurich, Switzerland, 1981 Basil O’Connor Fellow - March of Dimes - 1982-1984 Cold Spring Harbor Summer Course Fellowship -1990 Pfizer Animal Health Award for Research Excellence -1995 Texas A&M University Distinguished Achievement Award in Research -1997 Teratology Society Wilson Publication Award-2000, 2004 Warkany Lecturer, Teratology Society, 2008 FASEB One Carbon Metabolism Conference Co-Chair, 2010 FILED: SUFFOLK COUNTY CLERKFILED 05/25/2023 09:52 AM INDEX NO. 026910/2012 NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023 Civil Administration 3 Scientific Organizations American Board of Medical Genetics, diplomat, 1982 American Society of Human Genetics Teratology Society-National Council, 1997-2001 Editorial Board Teratology. Section Editor for Genetics and Cytogenetics (1992-1997); Molecular Genetics (1997-2000) Guest Referee Editor: American Journal of Medical Genetics Associate Editor: Environmental Health Perspectives: Toxicogenomics (2002-2004) Associate Editor: Birth Defects Research: Clinical and Molecular Teratology The Open Toxicology Journal Manuscript Reviewer Science Nature Nature Genetics Journal American Medical Association Genomics American Journal of Medical Genetics Drug and Chemical Toxicology Epilepsia Proceedings of the National Academy of Sciences The Journal of Neuroscience Reproductive Toxicology Birth Defects Research The Medical Letter Pediatric Research Society for Experimental Biology and Medicine Fundamental and Applied Toxicology Journal of Obstetrics and Gynecology The Journal of Experimental Zoology Analytical Biochemistry American Journal of Clinical Nutrition Obstetrics and Gynecology Journal of Clinical Investigation Journal of Toxicology and Environmental Health Experimental Cell Research In Vitro Cellular and Developmental Biology Molecular Genetics and Metabolism Clinical Genetics European Journal of Human and Clinical Genetics The FASEB Journal Toxicological Sciences Human Molecular Genetics J. Pharmacology Science and Physical Therapy International Journal of Developmental Biology Nature Reviews-Genetics Am. J. Physiology Pediatrics Developmental Brain Research Human Reproduction Experimental Neurology FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012 NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023 4 Acta Neurologia Clinical Genetics Antioxdants and Redox Signaling Physiological Genomics New England Journal of Medicine Journal of Pediatric Hematology and Oncology Grant Reviewer Public Health Service Standing Member, Oral Biology and Medicine Study Section, (OBM I) 1991-1995 NIH Reviewer’s Reserve, 1995-present Medical Research Council of Canada Medical Research Council- United Kingdom USDA National Research Initiative Competitive Grants Program Veterans Administration Medical Research Service Air Force Office of Scientific Research March of Dimes - Birth Defects Foundation National Science Foundation WellBeing Foundation The Wellcome Trust The Netherlands Organization for Health Research and Development Israel Science Foundation Qatar National Research Fund Health Research Board of Ireland Scientific Advisory Panels Advisory Commission - Texas Birth Defects Monitoring Division; Vice-Chairperson 1995-1997; Chairperson, 1997-2005 World Health Organization Technical Consultation on Craniofacial Malformations, November, 2000. University of Wisconsin Environmental Health Sciences Center for Developmental and Molecular Toxicology, Colin Jefcoate, PI. 2001-2005. University of Florida School of Medicine-Fetal Antiepileptic Drug Neurodevelopment Program, Kimford Meador, PI. 2000-2008. Emory University School of Medicine-Fetal Antiepileptic Drug Neurodevelopment Program, Kimford Meador, PI. 2008-present. Duke University Environmental Health Sciences Center for Comparative Biology of Vulnerable Populations, David Schwartz, PI. 2002-2006. International League Against Epilepsy Commission on Genetics. Member, 2003-present. EURAP Congenital Malformation Registry. Scientific Advisory Board. 2002-2007. Case Western Reserve University Fetal and Environmental Exposures Training Grant. Scientific Advisory Board. 2005-2009. FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012 NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023 5 American Academy of Neurology Practice Parameter for the Management of Women with Epilepsy. Committee member. 2005-present. World Health Organization Technical Consultation on Folate and Vitamin B12 Deficiencies, November, 2005. Children’s Environmental Health Centers Review Board on behalf of the NIEHS National Advisory Environmental Health Sciences Council, 2006-2007. University of Texas San Antonio Biology Program Scientific Advisory Board. 2006-present. Global Environmental Health Strategic Planning Workshop Participant on behalf of the NIEHS National Advisory Environmental Health Sciences Council, January, 2007. University of Houston Center for Life Sciences Technology Advisory Board of Directors. 2007-2010. International Mouse Knockout Consortium Steering Committee, 2007-2011. NIEHS National Advisory Environmental Health Sciences Council, National Institutes of Health, Council Member, 2007-2011. CICbioGUNE Scientific Advisory Board, Bilbao, Spain, 2009-present. Chairperson. Dartmouth Medical School, Children's Environmental Health and Disease Prevention Research Center, Scientific Advisory Board member. 2010-present. Consulting Services HESI DART Committee's Skeletal Variants Consultation. 1998-2001. Johnson and Johnson Pharmaceutical-PRI Division. Global team for Topirimate. 1999- 2006. GlaxoSmithKline Pharmaceutical Division. Global team for Lamictal. 2003-2006. Eli Lily and Company, Oncology Research Platform, ALIMTA Advisory Board. 20005-2006. HESI DART Committee's In Vitro Assays. 2005-2009. Shire Pharmaceutics, Valrocemide Advisory Board. 2006-2007. Courses Taught University of British Columbia Biology 310 28 lectures (human heredity and evolution) Washington State University VAn 308 18 lectures (anatomy, histology and physiology of domestic animals) VAn 405 16 lectures (embryology, developmental anatomy) Gen 430 15 lectures (medical genetics) PIT 505 5 lectures (environmental toxicology) VPh 516 30 lectures (embryology, veterinary medical genetics) VAn 515 15 laboratories (Advanced Experimental Embryology) P/T 565 12 lectures (teratology and reproductive toxicology) VM 406 15 lectures, 30 laboratories (embryology, histology) VPh 525 Pathological Embryology PIT 565 Advanced Toxicology (reproductive toxicology) Course director PIT 597 Graduate Seminar in Teratogenesis FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012 NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023 6 Texas A&M University VAPH 913 Mammalian Embryology GENE 482 Senior Seminar in Human Genetics GENE 320 Human Genetics VAPH 612 Advanced Mammalian Embryology GENE 421 Advanced Human Genetics VAPH 640 Neurobiology Bavlor College of Dentistry BMS 5V72 Craniofacial Anomalies BMS 5V73 Adv. Human Craniofacial Development and Growth BMS 5V69 Growth and Mechanisms of Development University of Nebraska Medical Center M1 Cellular Processes Core Course Former Students and Fellows Muhammad, A. M. (MS, 1983) Faculty member Kampus IKIP / Gunungsari Baru Ujung Panandang Indonesia Baer, J.F. (MS, 1985; DVM, 1990) Research Veterinarian California Institute of Technology Pasadena, California Moon, S.P. (MS, 1986; MD, 1990) Private Practice Portland, Oregon Bennett, G.D. (PhD, 1988) Associate Professor Department of Genetics, Cell Biology and Anatomy Univ. Nebraska Medical Center Omaha, Nebraska Mohl, V.K. (PhD, 1988; MD, 1992) Assistant Professor Department of Family Practice University of Wyoming Laramie, Wyoming Toloyan S. (Postdoctoral Fellow) Private Practice Savannah, Georgia Taylor, S.M. (Postdoctoral Fellow) Professor Department of Pharmacology University of Queensland Brisbane, Australia Abbott, L.C. (Postdoctoral Fellow) Associate Professor FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012 NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023 7 Department of Veterinary Anatomy and Public Health Texas A&M University College Station, Texas Silver, J.K. (Postdoctoral Fellow) Private Practice Crescent City, California van Waes, M. (MS, 1990) Technical Support-Quantitative PCR Stratagene Inc. La Jolla, California Englen, M.D. (Postdoctoral Fellow) Research Associate USDA Athens, Georgia Taylor, L.E. (MS, 1994) Research Associate Jackson Laboratory Bar Harbor, Maine Glasser, J. (DVM, MS, 1996) Private Practice Mesa, Arizona Jie, An (Postdoctoral Fellow) Research Scientist Department of Internal Medicine University of Texas Southwestern School of Medicine Dallas, Texas Wlodarczyk, B. (Postdoctoral Fellow) Asst. Professor Dell Pediatric Research Institute The University of Texas at Austin Austin, Texas Greer, K.A. (MS, 1996) Asst. Professor Indiana University East Richmond, IN Bielec, B.Y. (MS, 1997) Education Specialist BioPharmaceutical Technology Center Madison, Wisconsin Barber, R.C. (PhD, 1997; Postdoc) Associate Professor Department of Pharmacology and Neuroscience University of North Texas Health Science Center Fort Worth, Texas Vacha, S.J. (PhD, 1997) Technical Scientist Aligent FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012 NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023 8 Foster City, CA Gefrides, L.A. (MS, 1998) Research Associate Department of Forensics Harris County Justice Department Houston, Texas van Waes, J. (Postdoctoral Fellow) Associate Professor Department of Pharmacology Creighton Univ. Medical Center Omaha, Nebraska Mitchell, D. (Postdoctoral Fellow) Assistant Research Scientist Texas A&M University College Station, Texas Craig, J.C. (Ph.D., 1998) Research Scientist Virginia Bioinformatics Institute Blacksburg, VA 24061 Xiong, Wanfen (Postdoctoral Fellow) Research Associate Department of Surgery University of Nebraska Medical Center Omaha, Nebraska Spiegelstein, Ofer (Postdoctoral Fellow) Phase-1 and Clinical Pharmacology, Unit head Innovative R&D Teva Pharmaceutics Israel Tang, Louisa Shuk Chun (Postdoctoral Fellow) Research Associate Department of Cell and Molecular Biology Hong Kong University of Science and Technology Hong Kong, China Zhu, Huiping (Postdoctoral Fellow) Asst. Professor Department of Nutritional Sciences The University of Texas at Austin Austin, Texas Gould, Amy (Postdoctoral Fellow) Manager, Program Animal Research Institute of Biosciences and Technology Texas A&M University System HSC Houston, Texas FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012 NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023 9 Volcik, Kelly (Postdoctoral Fellow) Assistant Professor University of Texas School of Public Houston, Texas Lu, Wei (Postdoctoral Fellow) Asst. Res. Scientist Department of Pediatrics Univ. Texas HSC Houston, Texas Wong, LeeYean (Postdoctoral Fellow) Assoc. Res. Scientist Institute of Biosciences and Technology Texas A&M University System HSC Houston, Texas Zhang, Jing (M.S., 2004; Postdoctoral Fellow) Staff Pathologist Peking University Health Science Center Beijing, China Taparia, Shveta (Postdoctoral Fellow) On Indefinite Maternity Leave Gorman, Elisabeth (Postdoctoral Fellow) Research Fellow Baylor College of Medicine Houston, Texas Cabrera, Robert M. (Ph.D., 2006) Research Scientist Dell Pediatric Research Institute The University of Texas at Austin Austin, Texas Ballard, Jonathan (Postdoctoral Fellow) Texas A&M Institute for Genomic Medicine College Station, Texas Hill, Denise S. (Ph.D. 2007) Toxicology Consultant Houston, Texas Wen, Shu (Ph.D. 2008) Medical Genetics Fellowship • Baylor College of Medicine Houston, Texas Kartiko, Susan (Ph.D. 2009) Surgical Resident Albert Einstein Medical Center Philadelphia, PA Conde, Javier (Postdoctoral Fellow) Dell Pediatric Research Institute The University of Texas at Austin Austin, Texas Chantada Vasquez, Mercedes (Postdoctoral Fellow) Dell Pediatric Research Institute The University of Texas at Austin Austin, Texas FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012 NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023 10 Wang, Xueqian (Postdoctoral Fellow) Dell Pediatric Research Institute The University of Texas at Austin Austin, Texas Sabbatical Professors Vorce, Roseann Department of Pharmacology University of Nebraska Medical Center Omaha, Nebraska Park, Kyung Ran Department of Anatomy Seoul, Korea Min, Kyung Soo Department of Neurosurgery University of Seoul Seoul, Korea Taylor, Stephen M. Department of Pharmacology University of Queensland Brisbane, Qld. Australia Invited Participant in Symposia and Congresses-Selected Listing (Does not include invited lectures at Universities and Medical Centers) 1. Fifth International Congress of Birth Defects, Montreal, Quebec, Canada, August 1977. 2. International Epilepsy Symposium, Vancouver, British Columbia, Canada, September 1978. 3. International Symposium of Phenytoin-lnduced Teratology and Gingival Pathology, Chapel Hill, North Carolina, May 1979. 4. International Workshop on the Genetics of Epilepsy, Minneapolis, Minnesota, July 1980. 5. Visiting Lecturer in Teratology, Institut fur Medizinische Genetik, Universitat Zurich, fall 1981. 6. Fall Congress on Epileptic Disorders, Freie Universitat Berlin, Berlin, Germany, October 1981. 7. Ninth European Teratology Society Meeting, Basel, Switzerland, September 1981. 8. Eleventh European Teratology Society Meeting, Paris, France, September 1983. 9. Fall Congress on Epileptic Disorders, Freie Universitat Berlin, Berlin, Germany, September 1983. 10. International Workshop on Epilepsy, Pregnancy and the Child, St. Adele, Quebec, Canada, October 1983. 11. International Symposium - Pharmacokinetics in Teratogenesis, Freie Universitat Berlin, Berlin, Germany, September 1985. 12. Thirteenth European Teratology Society Meeting, Rostock, Germany, September 1985. FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012 NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023 11 13. Seventh International Congress of Human Genetics, Berlin, Germany, September 1986. 14. International Workshop on the Genetics of Epilepsy, Berlin, Germany, September 1986. 15. Eighteenth International Epilepsy Congress and International Workshop on Epilepsy, Genetics, Pregnancy and the Child, New Delhi, India, October 1989. 16. International Symposium on Pregnancy, Teratogenesis and Genetics in Epilepsy, Los Angeles, California, July 1990. 17. Third International Cleveland Clinic Symposium on Epilepsy, Cleveland, Ohio, June 1992. 18. Gesellschaft fur Humangenetik, Wurzburg, Germany, March 1993. 19. First International Conference on Neural Tube Defects, Harlingen, Texas, October 1993. 20. Session Chairperson, Gordon Research Conference on Mechanisms of Toxicity, Meriden, New Hampshire, August 1995. 21. Fourth International Society for the Study of Xenobiotics Meeting, Seattle, Washington August 1995. 22. Binational Conference on Neural Tube Defects, El Paso, Texas, January 1996. 23. Third Eilat Conference on New Antiepileptic Drugs, Eilat, Israel, May 1996. 24. Twenty-second Congress on Epilepsy, Dublin, Ireland, June 1997. 25. Twenty-fifth Conference of the European Teratology Society, Cannes, France, September 1997. 26. Instructor, Advanced Course, Society of Toxicology Meeting, Seattle, Washington, March 1998. 27. Fourth Eilat Conference on New Antiepileptic Drugs, Eilat, Israel, September 1998. 28. Second International Conference on Homocysteine Metabolism, Nijmegen, The Netherlands, April 1998. 29. FASEB Summer Conference on Folate, B12, and One Carbon Metabolism, Snowmass Village, Colorado, August, 1998. 30. ASPET Symposium on Molecular Mechanisms of Chemical Teratogenesis, Washington, D.C. April, 1999. 31. IBC’s 4th Annual Conference on Molecular Toxicology, Washington, D.C. April 1999. 32. Neural Tube Defects 2000 Workshop. Organizer and Co-chairman. Schlangenbad, Germany, August 1999. 33. New York Academy of Sciences Conference -“Toxicology For The Next Millennium,” Airlie Conference Center, September, 1999. FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012 NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023 12 34. 39th Annual Meeting, Society of Toxicology. “Altered Gene Expression Patterns to Predict and Understand Chemical Teratogenesis.” Philadelphia, Pennsylvania, March, 2000. 35. Fifth EILAT Conference on New Antiepileptic Drugs, Eilat, Israel, June 2000. 36. FASEB Summer Conference on Folate, B12, and One-Carbon Metabolism, Snowmass Colorado, August 2000. 37. 24th International Epilepsy Congress-"Symposium on Pharmacogenomics", Buenos Aires, Argentina, May, 2001. 38. Doctoral Opponent and Symposium Speaker. College of Pharmacy, Uppsala, Sweden, May, 2001. 39. Japanese Society of Toxicology Annual Meeting, Tokyo, Japan, June, 2001. 40. 3rd International Conference on Homocysteine Metabolism, Sorrento, Italy, July, 2001. 41. 2nd International Conference on Neural Tube Defects, Organizer and Co-chair, Seabrook, So. Carolina, September 2001. 42. 14th World Congress of Pharmacology, San Francisco, CA, July, 2002. 43. Session Chairperson, Gordon Research Conference on Mechanisms of Toxicity, Maine, July, 2002. 44. FASEB Summer Conference on Folate, B12, and One-Carbon Metabolism, Snowmass Colorado, August 2002. 45. 3rd Workshop on Advances in Molecular Medicine, Pamplona, Spain, November 2002. 46. Malformations: What's a Doctor to Do? Neural Tube Defects from Bench to Bedside, American Epilepsy Society Meeting Symposium. Seattle, Washington, December 2002. 47. 4th International Conference on Homocysteine Metabolism, Basel, Switzerland, July 2003. 48. 3rd International Conference on Neural Tube Defects, Organizer and Co-chair, Seabrook, So. Carolina, September 2003. 49. Twenty-fifth Congress on Epilepsy, Lisbon, Portugal. October, 2003. 50. FASEB Summer Conference on Folate, B12, and One-Carbon Metabolism, Snowmass Colorado, August 2004. Session Chairperson and speaker. 51. 25th Annual Meeting of the Netherlands Society of Toxicology. Bilthoven, The Netherlands, June, 2004. 52. International Workshop on Neural Tube Defects, Genoa, Italy, November, 2004. 53. Institut European des Genomutations Spring Scientific Forum, Lyon, France, March, 2004. FILED: SUFFOLK COUNTY CLERK 05/25/2023 09:52 AM INDEX NO. 026910/2012 NYSCEF DOC. NO. 212 RECEIVED NYSCEF: 05/25/2023 13 54. Korean Society of Toxicology, Keynote speaker. Seoul, Korea, November, 2004. 55. 5th International Conference on Homocysteine Metabolism, Milan, Italy June, 2005 56. 8th World Congress of Biological Psychiatry, Vienna, Austria, June, 2005 57. 13th International Symposium on Chemistry and Biology of Pteridines and Folates, Egmond ann Zee, The Netherlands, June, 2005 58. 4th In