Preview
FILED: SUFFOLK COUNTY CLERK 05/07/2019 04:22 PM INDEX NO. 026910/2012
NYSCEF DOC. NO. 119 RECEIVED NYSCEF: 05/07/2019
SUPREME COURT OF THE STATE OF NEW YORK
COUNTY OF SUFFOLK
xxxxxx xxxxxxxx, on behalf of C xxxxxxxx, an
infant under the age of 18, and xxxxxx xxxxxxxx, EXPERT
Individually, PHYSICIAN AFFIDAVIT
Plaintiffs, PSYCHIATRY
-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.
being duly sworn, deposes and says:
1. I am a physician duly licensed to practice medicine in the State of New York. I
am board certified in Board Certified in Psychiatry, Neurology, Child and Adolescent
Psychiatry, and Forensic Psychiatry.
2. I earned my medical degree from New York University School of Medicine in
1979 and completed a residency in Psychiatry at Yale University School of Medicine in 1983, a
residency in Child Psychiatry at the Children's Hospital in Boston, MA in 1985. I coñipleted a
fellowship in Advanced Psychotherapy at Adams House in Boston, MA 1987, and a fellowship
Vincent'
in Forensic Psychiatry at St. s Hospital in 2002.
3. I am practicing psychiatrist currently engaged in private practice. I am both
educated and experienced in the standards of practice in the field of psychiatry, including the
diagnosis and treatment of psychiatric illnesses, including but not limited to bipolar and
borderline disorders, and the psychotropic medicines associated therewith.
FILED: SUFFOLK COUNTY CLERK 05/07/2019 04:22 PM INDEX NO. 026910/2012
NYSCEF DOC. NO. 119 RECEIVED NYSCEF: 05/07/2019
4. I have reviewed the medical records, pleadings, and depositions in this matter. I
defendants'
have also reviewed the motion for summary judgment, including their expert
affirmations/affidavits in support of their motion.
5. As detailed below, it is my opinion within a reasonable degree of medical
certainty that the defendants in this action RONALD J. TADEO, M.D., RICHARD PITCH,
M.D., SHORE PSYCHIATRIC CENTER, and FAMILY PSYCHOLOGY OF LONG ISLAND,
departed from standards of care causing the iñjurics and death suffered by the plaintiff-decedent.
SUMMARY OF OPINIONS
6. It is my opinion, within a reasonable degree of medical certainty that the
defendants RONALD J. TADEO, M.D., RICHARD PITCH, M.D., SHORE PSYCHIATRIC
CENTER, and FAMILY PSYCHOLOGY OF LONG ISLAND deviated from accepted standards
of medical care in the treatment of the plaintiff, xxxxxx xxxxxxxx, causing injury and damage to
the infant-plaintiff W xxxxxxxx.
7. Based upon a review of the above-referenced documentation, as well as, my
experience and knowledge in the field of Psychiatry, it is my opinion, to a reasonable degree of
medical certainty, that as result of the negligence by defendants, xxxxx xxxxxxxx sustained the
following injuries: bilateral cleft lip, bilateral cleft palate, hearing loss, developmental delays,
speech impediment; dental and plastic surgeries, and pain and suffering.
8. In sum, Mrs. xxxxxxxx sought treatinent from the defendants herein for
psychological care and treatment following several miscarriages. During that time, her
psychiatrist Dr. Taddeo prescribed the anti-seizure medication Topamax off-label, at excessively
high rates, without any discussions or warñiñgs as to the risks of Topamax and other psychiatric
medications, the risks of taking said medications while not using birth control, and the potential
harm said medications pose to a fetus.
9. It is my opinion, within a reasonable degree of medical certainty, that while Mrs.
xxxxxxxx was in need of psychiatric care and treatment, she was still entitled to the same warnings
and discussions of benefits and risks that all patients should receive-and in particular, she
FILED: SUFFOLK COUNTY CLERK 05/07/2019 04:22 PM INDEX NO. 026910/2012
NYSCEF DOC. NO. 119 RECEIVED NYSCEF: 05/07/2019
should have been fully apprised of her options, and the risks and benefits regarding contraception
and Topamax. Additionally, Mrs. xxxxxxxx should not have received Topamax at excessively
high dosages without a full understanding of the risks associated therewith.
10. It is further my opinion, that as a direct result of the aforemêñtioned departures of
the defendants herein, Mrs. xxxxxxxx sustained an injury to her then-unborn son. Specifically,
that the defendants herein departed from good accepted medical practice in the improper
prescribing of dangerous medications without properly warning Mrs. xxxxxxxx of the attendant
risks, which caused and contributed to C xxxxxxxx's injuries.
FACTS AND OPINIONS
11. Mrs. xxxxxxxx sought psychiatric treatment from Dr. Taddeo at Shore Psychiatric
Center following three miscarriages that occurred in 2006 and 2007.
12. From approximately 2007 through 2009, she was treating with a psychiatrist, Dr.
Taddeo, for diagnosis of obsessive compulsive disorder, borderline disorder and bipolar
disorder. In 2008, Dr. Taddeo started prescribing Ms. xxxxxxxx Topamax, which she first filled
on March 27th, 2008At this time, Topamax was a Schedule C drug approved for treating
seizures and migraines and was not approved by the FDA for treating for psychiatric conditions.
"off-label"
However. Dr. Taddeo prescribed the drug to Mrs. xxxxxxxx for treatmcñt of her
bipolar disorder and borderline personality disorder.
13. During this time, Mrs. xxxxxxxx was taking no other medications apart from the
various drugs prescribed by Dr. Taddeo/Shore Psychiatric. Specifically, she was not taking oral
contraceptives and did not have an IUD. She also was not using any other form of birth control
and in fact was actively trying to become pregnant.
14. Dr. Taddeo did not have any discussions regarding the risks of Topamax or any of
the other medications prescribed, on a fetus, despite knowing Mrs. xxxxxxxx was sexually active
and not using birth control.
15. Dr. Taddeo did not recommend birth control or contraceptives to Mrs. xxxxxxxx,
despite knowing she was sexually active and not using birth control, while taking Topamax and
other medications.
FILED: SUFFOLK COUNTY CLERK 05/07/2019 04:22 PM INDEX NO. 026910/2012
NYSCEF DOC. NO. 119 RECEIVED NYSCEF: 05/07/2019
16. Dr. Taddeo did not have any discussions about pregnancy and Topamax,
inchiding what Mrs. xxxxxxxx should do if she became pregnant: there are no mentions of such
discussions in Dr. Taddeo's notes and Mrs. xxxxxxxx testified that no conversations took place in
her deposition.
17. Mrs. xxxxxxxx's initial dosage of Topamax was 25mg twice per day-she received
a 30-day supply.
18. On April 8, 2008. Dr. Taddeo increased Mrs. xxxxxxxx's Topamax dosage to 100
mg and prescribed her 30 days of 100 mg pills.
19. On May 15, 2008, Dr. Taddeo increased Mrs. xxxxxxxx's Topamax dosage to 200
mg (100 mg twice per day) and prescribed a 30-day supply. This dosage remaiñêd the same in
June 2008, when Mrs. xxxxxxxx was prescribed a 90-day supply.
20. Two months on August 23 Mrs. xxxxxxxx was prescribed another 90-
later, 2008,
day supply at the 200 mg total daily dosage.
21. Less than two months later, on October 3, 2008, Mrs. xxxxxxxx's Topamax
prescription was quadrupled to 800 mg per day, at 4 daily 200 mg pills. She received a 15-day
supply. The maximum recommended dose of Topamax and generic topiramate (at 2009 and still
to the present day) was 400 mg total. 400 mgs are typically prescribed for severe seizure
disorders. No conversations were had between Dr. Taddeo and the patient to indicate the risks
associated with this extremely high dosage.
22. On October 14, 2008, Mrs. xxxxxxxx filled a 90-day prescription of Topamax at the
800 mg total daily dosage (360 pills).
23. Less than one week later, on October 20, 2008, Mrs. xxxxxxxx filled a prescription
from Dr. Taddeo for a 14 day supply of Topamax at the 800 mg total daily dosage.
24. Mrs. xxxxxxxx received another 90-day supply of Topamax at the 800 mg dosage
in January and again in March 2009.
25. On March 31st, 2009, Ms. xxxxxxxx filled her final prescription of branded
Topamax, a 90 day prescription. She was next prescribed the generic form, topiramate.
FILED: SUFFOLK COUNTY CLERK 05/07/2019 04:22 PM INDEX NO. 026910/2012
NYSCEF DOC. NO. 119 RECEIVED NYSCEF: 05/07/2019
However, as discussed below Ms. xxxxxxxx had additional Topamax pills re ing at the time
of her final prescription, allowing her to continue to take Topamax well into her prcgñañcy.
26. On June 2nd, 2009, Dr. Taddeo increased Mrs. xxxxxxxx's prescription to 1200 mg,
prescribing her 450 topiramate pills to last 75 days.
27. In August of 2009, Ms. xxxxxxxx became pregnant.
28. On September 8, 2009, Mrs. xxxxxxxx filled topiramate prescription of 1000 mg
per day, to last 90 days.
29. On September 24th, 2009, she visited Dr. Taddeo for the first time since learning
she was pregnant. Dr. Taddeo stops her schedule D drugs, and states that he will discuss the rest
of her medications with her obstetrician (a conversation that never happcñcd). Dr, Taddeo does
not have a risk-benefit analysis with Mrs. xxxxxxxx regarding birth defects from medications, in
particular Topamax.
30. Especially considering the fact that Mrs. xxxxxxxx's mental health declined
following miscarriages, it is concerning that Dr. Taddeo did not discuss theses risks with her.
31. Dr. Taddeo does not have any discussions to warn Mrs. xxxxxxxx of the risk of
birth defects. In 2009, Topamax/topiramate was a Class C Drug, mcañiñg animal reproduction
studies had shown an adverse effect on the fetus and there were no adequate and well-controlled
studies in humans, but potential benefits may warrant use of the drug in pregnant women
despite potential risks.
32. Specifically, in 2009, while the FDA had not yet established the causal link
between topiramate and cleft lip/cleft palate that is known today, FDA warnings for the drug in
2009 included the statement, "Topiramate has demonstrated selective developmental toxicity,
including teratogenicity, in experimental animal studies. When oral doses of 20, 100, or 500
mg/kg were administered to pregnant mice during the period of organogenesis, the incidence of
doses."
fetal malformations (primarily craniofacial defects) was increased at all However, Dr.
Taddeo did not have any discussions of risks, including craniofacial defects, with Mrs. xxxxxxxx.
33. On November 3rd, 2009, Ms. xxxxxxxx switched her psychiatrists and had her first
visit with Dr. Pitch. At this point she was about ten weeks pregnant. Dr. Pitch continued her on
FILED: SUFFOLK COUNTY CLERK 05/07/2019 04:22 PM INDEX NO. 026910/2012
NYSCEF DOC. NO. 119 RECEIVED NYSCEF: 05/07/2019
1000 mg daily dose of Topamax, as he notes that the patient is reporting "clear and substantial
benefit and she's already in 10th week pregnant. Dose too high to wean fully before end of 1st
trimester[.]"
34. Ms. xxxxxxxx remained on 1000 mgs of topiramate per day throughout the rest of
her pregñañcy, including both branded Topamax and generic topiramate.
35. On January 15th, 2010 a sonogram was taken. The results appeared consistent
with cleft lip and palate. It was based on this sonogram that Ms. xxxxxxxx first learned that her
son would be born with birth defects.
36. On May 27th, 2010 CM xxxxxxxx was born. He was born with a cleft lip and
palate and immediately admitted to the NICU. . At birth, he failed the newborn hearing
screening in the right ear and was found to have hearing loss in both ears.
37. C is currently 9 years old. Throughout his 9 years of life, he has undergone
numerous surgeries to repair his cleft lip and palate, as well as to address other related issues.
He has undergone an incredible amount of medical testing and treatment with an assortment of
documents, including plastic surgeons, oral surgeons, and ENTs. He has treated with speech
therapist, occupational therapists, and physical therapists. C has and continues to received
special care and screening related to his development disabilities. Despite undergoing all of this
treatment, C still suffers from developmental disability, speech impairment, physical
disfigurement, as well as numerous other life altering affects related to birth defects.
OPINIONS
38. Again, it is my opinion within a reasonable degree of medical certainty that the
defendants herein departed from accepted stañdards of medical care in failing to discuss the risks
of dangerous and teratogenic medication with Mrs. xxxxxxxx, for failing to discuss birth control
with Mrs. xxxxxxxx while prescribing said medications, for failing to conduct risk-benefit
analyses with Mrs. xxxxxxxx, for failing to recommend or consider safer alternatives, for
prescribing Topamax at an excessively high rate without a legitimate medical purpose, and for
improper medication mañagcment. The departures by the defendants herein described below
FILED: SUFFOLK COUNTY CLERK 05/07/2019 04:22 PM INDEX NO. 026910/2012
NYSCEF DOC. NO. 119 RECEIVED NYSCEF: 05/07/2019
proximately caused the injuries sustained by Mrs. xxxxxxxx's infant son-bilateral cleft lip and
cleft palate, hearing loss, developmental delays, and need for multiple dental and plastic
surgeries.
39. It is clear from the records that while Mrs. xxxxxxxx was in mental and emotional
distress, and in need of medication maiiagement, that does not erase all other obligations on the
part of the treating psychiatrist.
40. Dr. Taddeo admits that he knew Mrs. xxxxxxxx was not using birth control and was
trying for another child. Yet he also admits that in the year he treated Mrs. xxxxxxxx prior to
pregnancy, he did not discuss the risks of Topamax/topiramate or any of the other medications
he prescribed with Mrs. xxxxxxxx. This was a departure of the standard of care.
41. Additionally, a treating physician is still obligated to have these discussions-he
cannot shift responsibility to a patient's kmbañd, or to a previous medical provider, especially
considering he did not actually discuss same with these individuals.
42. Dr. Taddeo knew Mrs. xxxxxxxx was trying to become pregnant, yet never
counseled her on birth control, or to discuss same with her OB; never advised against becoming
pregnant; never specifically discussed risks to the fetus while taking psychiatric medications;
never spoke to Mrs. xxxxxxxx's OB directly, and never discussed alternatives. Thus no actual risk-
benefit analysis was performed. This was a departure from the accepted standard of care.
43. While it is possible that Topamax was the best medication for Mrs. xxxxxxxx at the
time, Dr. Taddeo did not evaluate, consider, or recommend, non-teratogenic alternatives. Dr.
Taddeo did not consult with Mrs. xxxxxxxx's OB, nor did he seek an opinion from a speciâlist
such as a reproductive psychiatrist.
44. It is my opinion that the ultimate conclusions from Michael Liebowitz are
incorrect. First, he mischaracterized and minimized the risks associated with Class C
medications. Class C medications are not without risks-indeed, the 2009 FDA labeling for
Topamax references fetal craniofacial injuries at all dosage levels.
45. Dr. Liebowitz in ignoring the duty a physician has to the patient to warn her of
risks, especially given that Dr. Taddeo himself admits that he ordinarily would discuss risks of a
FILED: SUFFOLK COUNTY CLERK 05/07/2019 04:22 PM INDEX NO. 026910/2012
NYSCEF DOC. NO. 119 RECEIVED NYSCEF: 05/07/2019
Class C medication with a patient, as well as risks pertaining to pregnancy. Yet Dr. Taddeo never
discussed risks to a fetus, despite admitting he knew Mrs. xxxxxxxx was trying to become
pregnant.
46. Dr. Leibowitz only states that in this case the benefits outweighed the risks, but he
glosses over the fact that Mrs. xxxxxxxx was not informed of the risks.
47. Given that Mrs. xxxxxxxx elected to wean off Klonapin when she knew she was
pregnant, had she known of any risks to her fetus associated with topiramate, she would have
elected to taper that medication as well, or at least would still have had choices. Mrs. xxxxxxxx did
not know that her son had a cleft lip/cleft palate until she was 5 months pregnant. The key is that
the patient needs to be informed. She was not, despite Dr. Taddeo admitting that having such
conversations are appropriate.
48. Additionally, while prescribing medication off-label is not in and of itself a
departure from the accepted standard of care, it was a departure for Dr. Taddeo to prescribe
Topamax at a level more than double the recommcñded dosage. The risks posed to Mrs. xxxxxxxx
from weaning off of Topamax were largely caused by the excessively-high dosage, as confirmed
by Dr. Pitch in the November 2009 appointment.
49. Based on my review of records, my knowledge and experience in the field of
psychiatry, I believe that Mrs. xxxxxxxx had alternatives available to her; and that had she been
fully apprised to the risks associated with her medications, would have chosen either different
medications or different family phing methods, such that she would not have taken
teratogenic medications while trying to conceive and the injuries to her son likely would have
been prevented or at least minimized.
50. The foregoing are my opinions within a reasonable degree of medical certainty.
Dated: May 1, 2019
FILED: SUFFOLK COUNTY CLERK 05/07/2019 04:22 PM INDEX NO. 026910/2012
NYSCEF DOC. NO. 119 RECEIVED NYSCEF: 05/07/2019
Preview
FILED: SUFFOLK COUNTY CLERK 05/07/2019 04:22 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 119 RECEIVED NYSCEF: 05/07/2019 SUPREME COURT OF THE STATE OF NEW YORK COUNTY OF SUFFOLK xxxxxx xxxxxxxx, on behalf of C xxxxxxxx, an infant under the age of 18, and xxxxxx xxxxxxxx, EXPERT Individually, PHYSICIAN AFFIDAVIT Plaintiffs, PSYCHIATRY -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. being duly sworn, deposes and says: 1. I am a physician duly licensed to practice medicine in the State of New York. I am board certified in Board Certified in Psychiatry, Neurology, Child and Adolescent Psychiatry, and Forensic Psychiatry. 2. I earned my medical degree from New York University School of Medicine in 1979 and completed a residency in Psychiatry at Yale University School of Medicine in 1983, a residency in Child Psychiatry at the Children's Hospital in Boston, MA in 1985. I coñipleted a fellowship in Advanced Psychotherapy at Adams House in Boston, MA 1987, and a fellowship Vincent' in Forensic Psychiatry at St. s Hospital in 2002. 3. I am practicing psychiatrist currently engaged in private practice. I am both educated and experienced in the standards of practice in the field of psychiatry, including the diagnosis and treatment of psychiatric illnesses, including but not limited to bipolar and borderline disorders, and the psychotropic medicines associated therewith. FILED: SUFFOLK COUNTY CLERK 05/07/2019 04:22 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 119 RECEIVED NYSCEF: 05/07/2019 4. I have reviewed the medical records, pleadings, and depositions in this matter. I defendants' have also reviewed the motion for summary judgment, including their expert affirmations/affidavits in support of their motion. 5. As detailed below, it is my opinion within a reasonable degree of medical certainty that the defendants in this action RONALD J. TADEO, M.D., RICHARD PITCH, M.D., SHORE PSYCHIATRIC CENTER, and FAMILY PSYCHOLOGY OF LONG ISLAND, departed from standards of care causing the iñjurics and death suffered by the plaintiff-decedent. SUMMARY OF OPINIONS 6. It is my opinion, within a reasonable degree of medical certainty that the defendants RONALD J. TADEO, M.D., RICHARD PITCH, M.D., SHORE PSYCHIATRIC CENTER, and FAMILY PSYCHOLOGY OF LONG ISLAND deviated from accepted standards of medical care in the treatment of the plaintiff, xxxxxx xxxxxxxx, causing injury and damage to the infant-plaintiff W xxxxxxxx. 7. Based upon a review of the above-referenced documentation, as well as, my experience and knowledge in the field of Psychiatry, it is my opinion, to a reasonable degree of medical certainty, that as result of the negligence by defendants, xxxxx xxxxxxxx sustained the following injuries: bilateral cleft lip, bilateral cleft palate, hearing loss, developmental delays, speech impediment; dental and plastic surgeries, and pain and suffering. 8. In sum, Mrs. xxxxxxxx sought treatinent from the defendants herein for psychological care and treatment following several miscarriages. During that time, her psychiatrist Dr. Taddeo prescribed the anti-seizure medication Topamax off-label, at excessively high rates, without any discussions or warñiñgs as to the risks of Topamax and other psychiatric medications, the risks of taking said medications while not using birth control, and the potential harm said medications pose to a fetus. 9. It is my opinion, within a reasonable degree of medical certainty, that while Mrs. xxxxxxxx was in need of psychiatric care and treatment, she was still entitled to the same warnings and discussions of benefits and risks that all patients should receive-and in particular, she FILED: SUFFOLK COUNTY CLERK 05/07/2019 04:22 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 119 RECEIVED NYSCEF: 05/07/2019 should have been fully apprised of her options, and the risks and benefits regarding contraception and Topamax. Additionally, Mrs. xxxxxxxx should not have received Topamax at excessively high dosages without a full understanding of the risks associated therewith. 10. It is further my opinion, that as a direct result of the aforemêñtioned departures of the defendants herein, Mrs. xxxxxxxx sustained an injury to her then-unborn son. Specifically, that the defendants herein departed from good accepted medical practice in the improper prescribing of dangerous medications without properly warning Mrs. xxxxxxxx of the attendant risks, which caused and contributed to C xxxxxxxx's injuries. FACTS AND OPINIONS 11. Mrs. xxxxxxxx sought psychiatric treatment from Dr. Taddeo at Shore Psychiatric Center following three miscarriages that occurred in 2006 and 2007. 12. From approximately 2007 through 2009, she was treating with a psychiatrist, Dr. Taddeo, for diagnosis of obsessive compulsive disorder, borderline disorder and bipolar disorder. In 2008, Dr. Taddeo started prescribing Ms. xxxxxxxx Topamax, which she first filled on March 27th, 2008At this time, Topamax was a Schedule C drug approved for treating seizures and migraines and was not approved by the FDA for treating for psychiatric conditions. "off-label" However. Dr. Taddeo prescribed the drug to Mrs. xxxxxxxx for treatmcñt of her bipolar disorder and borderline personality disorder. 13. During this time, Mrs. xxxxxxxx was taking no other medications apart from the various drugs prescribed by Dr. Taddeo/Shore Psychiatric. Specifically, she was not taking oral contraceptives and did not have an IUD. She also was not using any other form of birth control and in fact was actively trying to become pregnant. 14. Dr. Taddeo did not have any discussions regarding the risks of Topamax or any of the other medications prescribed, on a fetus, despite knowing Mrs. xxxxxxxx was sexually active and not using birth control. 15. Dr. Taddeo did not recommend birth control or contraceptives to Mrs. xxxxxxxx, despite knowing she was sexually active and not using birth control, while taking Topamax and other medications. FILED: SUFFOLK COUNTY CLERK 05/07/2019 04:22 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 119 RECEIVED NYSCEF: 05/07/2019 16. Dr. Taddeo did not have any discussions about pregnancy and Topamax, inchiding what Mrs. xxxxxxxx should do if she became pregnant: there are no mentions of such discussions in Dr. Taddeo's notes and Mrs. xxxxxxxx testified that no conversations took place in her deposition. 17. Mrs. xxxxxxxx's initial dosage of Topamax was 25mg twice per day-she received a 30-day supply. 18. On April 8, 2008. Dr. Taddeo increased Mrs. xxxxxxxx's Topamax dosage to 100 mg and prescribed her 30 days of 100 mg pills. 19. On May 15, 2008, Dr. Taddeo increased Mrs. xxxxxxxx's Topamax dosage to 200 mg (100 mg twice per day) and prescribed a 30-day supply. This dosage remaiñêd the same in June 2008, when Mrs. xxxxxxxx was prescribed a 90-day supply. 20. Two months on August 23 Mrs. xxxxxxxx was prescribed another 90- later, 2008, day supply at the 200 mg total daily dosage. 21. Less than two months later, on October 3, 2008, Mrs. xxxxxxxx's Topamax prescription was quadrupled to 800 mg per day, at 4 daily 200 mg pills. She received a 15-day supply. The maximum recommended dose of Topamax and generic topiramate (at 2009 and still to the present day) was 400 mg total. 400 mgs are typically prescribed for severe seizure disorders. No conversations were had between Dr. Taddeo and the patient to indicate the risks associated with this extremely high dosage. 22. On October 14, 2008, Mrs. xxxxxxxx filled a 90-day prescription of Topamax at the 800 mg total daily dosage (360 pills). 23. Less than one week later, on October 20, 2008, Mrs. xxxxxxxx filled a prescription from Dr. Taddeo for a 14 day supply of Topamax at the 800 mg total daily dosage. 24. Mrs. xxxxxxxx received another 90-day supply of Topamax at the 800 mg dosage in January and again in March 2009. 25. On March 31st, 2009, Ms. xxxxxxxx filled her final prescription of branded Topamax, a 90 day prescription. She was next prescribed the generic form, topiramate. FILED: SUFFOLK COUNTY CLERK 05/07/2019 04:22 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 119 RECEIVED NYSCEF: 05/07/2019 However, as discussed below Ms. xxxxxxxx had additional Topamax pills re ing at the time of her final prescription, allowing her to continue to take Topamax well into her prcgñañcy. 26. On June 2nd, 2009, Dr. Taddeo increased Mrs. xxxxxxxx's prescription to 1200 mg, prescribing her 450 topiramate pills to last 75 days. 27. In August of 2009, Ms. xxxxxxxx became pregnant. 28. On September 8, 2009, Mrs. xxxxxxxx filled topiramate prescription of 1000 mg per day, to last 90 days. 29. On September 24th, 2009, she visited Dr. Taddeo for the first time since learning she was pregnant. Dr. Taddeo stops her schedule D drugs, and states that he will discuss the rest of her medications with her obstetrician (a conversation that never happcñcd). Dr, Taddeo does not have a risk-benefit analysis with Mrs. xxxxxxxx regarding birth defects from medications, in particular Topamax. 30. Especially considering the fact that Mrs. xxxxxxxx's mental health declined following miscarriages, it is concerning that Dr. Taddeo did not discuss theses risks with her. 31. Dr. Taddeo does not have any discussions to warn Mrs. xxxxxxxx of the risk of birth defects. In 2009, Topamax/topiramate was a Class C Drug, mcañiñg animal reproduction studies had shown an adverse effect on the fetus and there were no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. 32. Specifically, in 2009, while the FDA had not yet established the causal link between topiramate and cleft lip/cleft palate that is known today, FDA warnings for the drug in 2009 included the statement, "Topiramate has demonstrated selective developmental toxicity, including teratogenicity, in experimental animal studies. When oral doses of 20, 100, or 500 mg/kg were administered to pregnant mice during the period of organogenesis, the incidence of doses." fetal malformations (primarily craniofacial defects) was increased at all However, Dr. Taddeo did not have any discussions of risks, including craniofacial defects, with Mrs. xxxxxxxx. 33. On November 3rd, 2009, Ms. xxxxxxxx switched her psychiatrists and had her first visit with Dr. Pitch. At this point she was about ten weeks pregnant. Dr. Pitch continued her on FILED: SUFFOLK COUNTY CLERK 05/07/2019 04:22 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 119 RECEIVED NYSCEF: 05/07/2019 1000 mg daily dose of Topamax, as he notes that the patient is reporting "clear and substantial benefit and she's already in 10th week pregnant. Dose too high to wean fully before end of 1st trimester[.]" 34. Ms. xxxxxxxx remained on 1000 mgs of topiramate per day throughout the rest of her pregñañcy, including both branded Topamax and generic topiramate. 35. On January 15th, 2010 a sonogram was taken. The results appeared consistent with cleft lip and palate. It was based on this sonogram that Ms. xxxxxxxx first learned that her son would be born with birth defects. 36. On May 27th, 2010 CM xxxxxxxx was born. He was born with a cleft lip and palate and immediately admitted to the NICU. . At birth, he failed the newborn hearing screening in the right ear and was found to have hearing loss in both ears. 37. C is currently 9 years old. Throughout his 9 years of life, he has undergone numerous surgeries to repair his cleft lip and palate, as well as to address other related issues. He has undergone an incredible amount of medical testing and treatment with an assortment of documents, including plastic surgeons, oral surgeons, and ENTs. He has treated with speech therapist, occupational therapists, and physical therapists. C has and continues to received special care and screening related to his development disabilities. Despite undergoing all of this treatment, C still suffers from developmental disability, speech impairment, physical disfigurement, as well as numerous other life altering affects related to birth defects. OPINIONS 38. Again, it is my opinion within a reasonable degree of medical certainty that the defendants herein departed from accepted stañdards of medical care in failing to discuss the risks of dangerous and teratogenic medication with Mrs. xxxxxxxx, for failing to discuss birth control with Mrs. xxxxxxxx while prescribing said medications, for failing to conduct risk-benefit analyses with Mrs. xxxxxxxx, for failing to recommend or consider safer alternatives, for prescribing Topamax at an excessively high rate without a legitimate medical purpose, and for improper medication mañagcment. The departures by the defendants herein described below FILED: SUFFOLK COUNTY CLERK 05/07/2019 04:22 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 119 RECEIVED NYSCEF: 05/07/2019 proximately caused the injuries sustained by Mrs. xxxxxxxx's infant son-bilateral cleft lip and cleft palate, hearing loss, developmental delays, and need for multiple dental and plastic surgeries. 39. It is clear from the records that while Mrs. xxxxxxxx was in mental and emotional distress, and in need of medication maiiagement, that does not erase all other obligations on the part of the treating psychiatrist. 40. Dr. Taddeo admits that he knew Mrs. xxxxxxxx was not using birth control and was trying for another child. Yet he also admits that in the year he treated Mrs. xxxxxxxx prior to pregnancy, he did not discuss the risks of Topamax/topiramate or any of the other medications he prescribed with Mrs. xxxxxxxx. This was a departure of the standard of care. 41. Additionally, a treating physician is still obligated to have these discussions-he cannot shift responsibility to a patient's kmbañd, or to a previous medical provider, especially considering he did not actually discuss same with these individuals. 42. Dr. Taddeo knew Mrs. xxxxxxxx was trying to become pregnant, yet never counseled her on birth control, or to discuss same with her OB; never advised against becoming pregnant; never specifically discussed risks to the fetus while taking psychiatric medications; never spoke to Mrs. xxxxxxxx's OB directly, and never discussed alternatives. Thus no actual risk- benefit analysis was performed. This was a departure from the accepted standard of care. 43. While it is possible that Topamax was the best medication for Mrs. xxxxxxxx at the time, Dr. Taddeo did not evaluate, consider, or recommend, non-teratogenic alternatives. Dr. Taddeo did not consult with Mrs. xxxxxxxx's OB, nor did he seek an opinion from a speciâlist such as a reproductive psychiatrist. 44. It is my opinion that the ultimate conclusions from Michael Liebowitz are incorrect. First, he mischaracterized and minimized the risks associated with Class C medications. Class C medications are not without risks-indeed, the 2009 FDA labeling for Topamax references fetal craniofacial injuries at all dosage levels. 45. Dr. Liebowitz in ignoring the duty a physician has to the patient to warn her of risks, especially given that Dr. Taddeo himself admits that he ordinarily would discuss risks of a FILED: SUFFOLK COUNTY CLERK 05/07/2019 04:22 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 119 RECEIVED NYSCEF: 05/07/2019 Class C medication with a patient, as well as risks pertaining to pregnancy. Yet Dr. Taddeo never discussed risks to a fetus, despite admitting he knew Mrs. xxxxxxxx was trying to become pregnant. 46. Dr. Leibowitz only states that in this case the benefits outweighed the risks, but he glosses over the fact that Mrs. xxxxxxxx was not informed of the risks. 47. Given that Mrs. xxxxxxxx elected to wean off Klonapin when she knew she was pregnant, had she known of any risks to her fetus associated with topiramate, she would have elected to taper that medication as well, or at least would still have had choices. Mrs. xxxxxxxx did not know that her son had a cleft lip/cleft palate until she was 5 months pregnant. The key is that the patient needs to be informed. She was not, despite Dr. Taddeo admitting that having such conversations are appropriate. 48. Additionally, while prescribing medication off-label is not in and of itself a departure from the accepted standard of care, it was a departure for Dr. Taddeo to prescribe Topamax at a level more than double the recommcñded dosage. The risks posed to Mrs. xxxxxxxx from weaning off of Topamax were largely caused by the excessively-high dosage, as confirmed by Dr. Pitch in the November 2009 appointment. 49. Based on my review of records, my knowledge and experience in the field of psychiatry, I believe that Mrs. xxxxxxxx had alternatives available to her; and that had she been fully apprised to the risks associated with her medications, would have chosen either different medications or different family phing methods, such that she would not have taken teratogenic medications while trying to conceive and the injuries to her son likely would have been prevented or at least minimized. 50. The foregoing are my opinions within a reasonable degree of medical certainty. Dated: May 1, 2019 FILED: SUFFOLK COUNTY CLERK 05/07/2019 04:22 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 119 RECEIVED NYSCEF: 05/07/2019