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NYSCEF DOC. NO. 58 RECEIVED NYSCEF: 01/09/2019
"L"
EXHIBIT
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SUPREME COURT OF THE STATE OF NEW YORK
COUNTY OF SUFFOLK
--- ---- --- x
xxxxxx xxxxxxxx on behalf of C.S., an infant under Index No.: 026910/12
The age of 18, and xxxxxx xxxxxxxx, Individually,
Plaintiffs, AFFIRMATION
-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, HANSSEN PHARMACEUTICALS, INC.
k/n/a ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS,
INC., and ZYDUS PHARMACEUTICALS USA, INC.,
Defendants.
--------------------------------------------------- .. ---------------X
I, Michael Liebowitz, M.D., am a physician duly licensed to practice medicine in
the State of New York, as such I set forth the following under the penalty of perjury and
pursuant to CPLR §2106:
1. I am a licensed medical doctor in the State of New York and I set forth the
following in support of the motion for summary judgment submitted on behalf of Dr.
Taddeo, in the above reference case.
2. I set forth the following based upon my review of the pertinent medical
records of the plaintiff mother in this case, xxxxxx xxxxxxxx, as it pertains to her care and
treatment from 2007 through her delivery of the infant plaintiff in 2010, and after,as well
as a review of the pleadings, Bills of Particulars, deposition transcripts of the parties, as
well as my training and experience in medicine and the specific areas of psychiatry.
3. I am a Board Certified Psychiatrist, and have been continuously since 1978.
I am a graduate of Yale University School of Medicine. I attended and completed an
Internship and a year of Residency in internal medicine at Harlem Hospital and then a
residency and Fellowship in psychiatry at the New York State Psychiatric Institute. I was
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the Director of the Anxiety Disorders Clinic at the New York State Psychiatric Institute
and a Professor of Clinical Psychiatry at the College of Physicians and Surgeons at
Columbia University. As such I am fully familiar with the standards of care applicable to
the practice of psychiatry as it existed during the time and treatment of this case.
4. Unless so stated, I set forth the following opinions within a reasonable
degree of medical certainty, based upon my review of the file and my training and
experience.
Allegations
5. A review of the Bill of Particulars demonstrates that there is only one
possible allegation that can be levied against Dr. Taddeo, who was plaintiff's treating
psychiatrist, and that is that from July 2007 through September 2009, he improperly
prescribed medication to the plaintiff mother that caused a birth defect in the infant
plaintiff. It isclaimed that due to the use of the medication the infant developed, in utero,
a cleft palate and lip.
6. The remainder of the allegations is that the defendant herein failed to
diagnose and properly treat the infant-plaintiff, which, as will be evident, are improper
allegations to wage against Dr. Taddeo.
Facts
7. The following facts are pertinent for the assessment of the case and the care
rendered by Dr. Taddeo, but they are fully set forth in the attorney affidavit of Ms. Monte.
8. The patient, xxxxxx xxxxxxxx, was first referred to Dr. Taddeo's office in
July 2007, by her marriage counselor and therapist Amira Baum. The record demonstrates
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that she was first seen in consultation by Joellen Anderson, a Nurse Practitioner, who
practiced with Dr. Taddeo, in his psychiatry office, Shore Psychiatric. Just prior to this
July 2007 initial consultation the record demonstrates that Mrs. xxxxxxxx attempted suicide,
during which she took an overdose of Xanax and was seen in the hospital. Following that
suicide attempt Ms. Baum referred her for psychiatric treatment. (See plaintiff's
deposition, Dr. Taddeo's records.)
9. The medical record and deposition testimony from Mrs. xxxxxxxx
demonstrate that the suicide attempt was the result of depression that followed after her
third miscarriage in a row. The series of pregnancy losses led to a deep depression, in the
setting of a struggling marriage.
10. A further review of Dr. Taddeo's records and the testimony reveals that
Mrs. xxxxxxxx made a further suicide attempt in August 2008, only one month after starting
treatment with NP Anderson. On that occasion she took an overdose of 33 Benadryl
tablets, combined with large quantities of alcohol. This attempt was done while she was
the sole adult home with her three minor children.
11. Mrs. xxxxxxxx was admitted to the psychiatric unit at Southside Hospital in
August 2008, for several days. During that admission she was diagnosed with Borderline
Personality Disorder, with depressive mood. After several days of treatment and an
increase in her medication (Zoloft 100mg) she was discharged to the care of her therapist
(Ms. Baum) and NP Anderson.
12. In reviewing the records maintained about the plaintiff mother's psychiatric
treatment, which is supported by her deposition testimony, we learn that her suicidal
ideation started when she was a young teenager. She reported suicidal ideation starting at
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about 14 years old, with two attempts at that time. She did seek for those events
counseling
from a local counseling center. Plaintiff mother reports a of depressive
family history
disorders and a personal history of self-mutilation, poor impulse control, and suicidal
ideation, in the setting of a turbulent and dysfunctional early childhood and an unstable
marriage.
13. A review of the medical record maintained by Dr. Taddeo and Dr. Cavuto,
the plaintiff's DBT demonstrates that the period of time in 2007-
therapist, during question,
2009, the plaintiff mother had significant issues and behaviors, which were self-injurious.
"cutting"
These included or self-mutilation; attempting to jump out of moving cars; several
attempted drug overdoses; unprotected extramarital sexual encounters with strangers;
compulsive shopping leading to bankruptcy; as well as online dating and online sex. Mrs.
xxxxxxxx describes herself as volatile, in a depressed mood and having problems with
impulse control.
14. There are several important chart notes made by NP Anderson during the
period of time that she treated Mrs. xxxxxxxx. The firstof these is on August 30, 2007, just
after the admission to Southside for the drug overdose. This chart note indicates that the
plaintiff's husband, Tony xxxxxxxx, was monitoring her prescription drugs, and that he
assumed the responsibility for the use of birth control.
15. In fact, Mrs. xxxxxxxx admitted during her deposition testimony that NP
Anderson counseled her regarding the risks that her prescription medications could have
on a pregnancy, as well as the risks of her getting pregnant to her emotional wellbeing. NP
Anderson noted that plaintiff mother was not stable and she was cautioned to not get
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pregnant for a variety of reasons, which included the potential risks the medication could
have on the fetus.
16. In November 2007, the records demonstrate that the plaintiff mother
continued to have suicidal thoughts, but had no current plan to commit suicide. She was
cautioned to keep pictures of her children close and to reach out if needed.
17. Shortly thereafter, NP Anderson transferred the plaintiff mother's care to
Dr. Taddeo, and as he explained during his deposition, it was felt that her case was too
complicated for NP Anderson and that she would be better managed by him.
18. During this time the plaintiff's medications were changed. She was on an
increasing dose of Zoloft and was given a starter pack for a drug called Lamictal. Lamictal
is an antiepileptic drug used off label to address mood disorders in patients with Bipolar
disorder. The record demonstrates that the patient did some research regarding Lamictal
and then called NP Anderson and told her that she would start the drug.
19. With the change in her drug therapy, the plaintiff noticed a positive
response, and her next office visit was with Dr. Taddeo on February 21, 2008. Dr. Taddeo
explained during testimony that itwas feltthat the patient's condition was complicated and
serious; itwas felt that she would be better managed by him, rather than NP Anderson. Dr.
Taddeo increased the dose of the Lamictal and added other medications to try to reach an
even balance.
20. Dr. Taddeo testified that he was aware that NP Anderson had counseled the
plaintiff to not get pregnant in August 2007. It was his understanding that Mr. xxxxxxxx,
plaintiff's husband, had assumed responsibility for the birth control. Itwas also his further
understanding that Mr. xxxxxxxx was in control of the plaintiff's drugs (to avoid overdose).
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When plaintiff mother started with Dr. Taddeo, he reinforced these messages and cautioned
her to not make any major life changes, which could add to her instability. This included
getting pregnant.
21. In March 2008, the patient reported a dermatologic side effect from the
Lamictal and itwas liniñediately discontinued to avoid Steven Johnson syndrome. During
this next office visit, the record demonstrates that the plaintiff told Dr. Taddeo that she had
an unreported suicide attempt wherein she took 10 Klonopin, but did not go to the hospital.
She also informed him that the couple were filing for bankruptcy due to impulsive spending
on her part.
22. When Dr. Taddeo took over the care of the patient from NP Anderson, one
of the things that he considered was that the diagnosis of Borderline Personality Disorder
was incorrect. During this March 2008 office visit, he changed the diagnosis to Bipolar
disorder, mixed type. It was his opinion that the patient's depression, combined with her
impulsive outbursts more appropriately fitinto that diagnosis and that ithelped to explain
her continuing symptoms.
23. During the March 2008 visit, Dr. Taddeo started the patient on Topamax, to
be taken along with other medications she was already on. At the time, he was trying to
obtain a stabilizing effect on the plaintiff and was of the opinion that Topamax would
address her impulsive behaviors that at times were lifethreatening.
24. Dr. Taddeo testified that Topamax was the same class of antiepileptic drug
as Lamictal. In his clinical experience, when used off label in patients such as plaintiff
mother who had Bipolar disorder, Topamax helped with impulse control and erratic
behavior. The Lamictal seemed to be working with good effect, so itwas reasonable for
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him to try a different drug, of the same class, in an effort to stabilize the plaintiff's
behaviors.
25. There are notes throughout the record that demonstrate that the plaintiff still
continued with erratic and self-injurious behavior. In April 2008, plaintiff mother admitted
to an overdose of Lamictal. The husband reaffirmed his commitment to hold allof the
plaintiff's medications. Dr. Taddeo added Wellbutrin, to address the depressive mood. In
August 2008, there is documentation that the plaintiff threatened suicide, ran away, and
also tried to use a razor blade to cut her wrists. In September 2008, plaintiff mother
reported dissociative experiences; self-mutilation fantasies; and increased frustration. Her
medications were adjusted and her Topamax was increased.
26. Plaintiff mother had sporadic compliance with follow up in late 2008 into
early 2009. In March 2009, even though her medications had been slowly increased,
plaintiff mother reported a return of her symptoms, which were worsening and she was
unstable. She reported inconsistent use of her medications, and once again there was an
adjustment of her medications. At this juncture, she was taking Zoloft 200 mg; Topamax
1000 mg; Wellbutrin 150 mg; Zyprexa 5 mg; and Klonopin.
27. During this same time period, the record of Dr. Cavuto, the plaintiff's
therapist, demonstrated that she continued with her erratic behaviors. She describes herself
as addicted to internet dating, chat rooms, and internet sex. Plaintiff was meeting men on
the internet and then arranging to have sex with them. She continued her compulsive
shopping despite the bankruptcy and was inconsistent with following up with Dr. Taddeo.
28. There was an August 25, 2009 office visit with Dr. Taddeo where some
adjustments were made to her medication, but she was otherwise reporting she feltgood.
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29. Then, on September 24, 2009, plaintiff was seen by Dr. Taddeo and reported
to him that she recently found out that she was pregnant with the use of a home pregnancy
kit. She reported that she was fearful because her prior miscarriages were what caused the
increase in her depressive symptoms. She also expressed concern about the use of her
medications and their potential effect on the fetus. She had already stopped taking
Klonopin.
30. The record and testimony show that Dr. Taddeo developed a plan for further
treatment that day. He agreed with the discontinuance of Klonopin. He continued to wean
her off of Zoloft and a call was made to her obstetrician to discuss the other medications
and the risk of taking her off of the medication and seeing a return of her worst symptoms
(erratic behavior and suicidal tendency) versus the risk to the fetus by keeping her on the
medications.
31. Dr. Taddeo testified that the risk benefit analysis would be done in
conjunction with her obstetrician, but that he stopped the Klonopin because it was a
pregnancy category D medication and was known to cause birth defects in the first
trimester. The remainder of the drugs were pregnancy category C drugs, which could not
be suddenly stopped due to the risks of a return or an exacerbation of her previous
symptoms. Dr. Taddeo felt the risk of rapidly stopping her other medications was greater
than continuing them.
32. The plaintiff never returned to Dr. Taddeo, and instead we learn from the
record that she started to treat with Dr. Pitch, our co-defendant, in December 2009.
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Opinions
33. As basic background, to set forth the following opinions, I should state that
at the time that this care and treatment was given the drug at issue, Topamax (generically
Topiramate) was classified as a pregnancy category C drug. In essence, this means that
there were no human studies available about the use of the drug in the pregnant population;
so, the risk of use during pregnancy and itspotential effects on the fetus had to be weighed
against the risk of taking a patient off of the drug and stopping treatment.
34. As a further point of information, Topamax is an antiepileptic drug,
approved for use by the FDA. In 2007 to 2009, itwas used off label to treat mood disorders
such as Bipolar disorder and Borderline Personality disorder. The drug effects the brain's
neurotransmitters and is helpful in stabilizing anxiety, impulsive behavior, and extreme
mood fluctuations.
35. In this instant case, the record is clear that the plaintiff mother was entirely
unstable and in a crisis state when she first began treatment with Dr. Taddeo and his
associate NP Anderson. The plaintiff mother was started on a course of medical treatment
to treat her mood disorder and address her self-injurious behavior. But despite the treatment
rendered by NP Anderson, the record clearly depicts a woman who remained highly
unstable and suicidal. This is what properly prompted the assumption of her care by Dr.
Taddeo in the winter of 2008.
36. The record demonstrates that Dr. Taddeo considered the current drug
therapy and its limitations. Shortly after he assumed her care, she had an adverse reaction
to Lamictal. He then properly considered other medications that were used for Bipolar
disorder, but the record is clear that these were not good choices for this patient.
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37. For example, Lithium is a drug used in this patient population. But itneeds
to be monitored to prevent toxicity and this particular patient was not stable enough to be
able to adhere to the strict monitoring that was required for Lithium use. Depakote was
not an ideal choice for the patient, who was already overweight and struggling with body
image, as it is known to cause weight gain. Lamictal was already tried, but given the
patient's reaction to it,itwas not a viable choice.
38. Therefore, based upon his prior experience in successfully using Topamax
for patients with mood disorders and poor impulse control, itwas entirely appropriate for
Dr. Taddeo prescribe itto plaintiff mother.
39. The record demonstrates that Dr. Taddeo was familiar with the drug and
properly educated himself by attending seminars, reading journals, and staying informed
with practice journals as to the use of Topamax in this off label maññer, as well as in
educating himself by reading the package insert and using the PDR.
40. The record further supports, and the plaintiff admits in her deposition
testimony, that she was counseled about the risks and side effects of the drugs, she was
encouraged to do her own research, she was cautioned to ensure that she was using birth
control, and she was told not to make any major life changes, such as getting pregnant, due
to the various drugs she was on and because such changes could cause a relapse of her
symptoms.
41. Yet, the plaintiff mother got pregnant, and then informed Dr. Taddeo, who
acted prudently and appropriately when he learned this information. The record clearly
demonstrates that he immediately took the plaintiff off of Klonopin, which was the only
pregnancy class D drug she was on at the time.
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42. Further he properly continued to wean the plaintiff off Zoloft.
43. The record then demonstrates that he engaged in a discussion with the
plaintiff and reached out to her obstetrician about the risks of taking her off of the
medication versus the risk of the medications to the fetus.
44. Dr. Taddeo properly weighed the facts as we know them about the plaintiff,
namely that off of the medication she was highly suicidal, with erratic and unsafe behavior
and depression.
45. This was compared to the risk of the then category C drug to the fetus.
Plaintiff will no doubt discuss the fact that AFTER this care and treatment the drug
classification for Topamax was changed to a category D. After the care and treatment at
issue, there was evidence and studies published that discussed that there was an incidence
fetus'
of cleft lip and palate in born to pregnant mothers who were on the drug, prompting
the FDA to change the pregnancy category. But AT THE TIME of the care in question,
"C"
the drug was categorized as and therefore there was no immediate or known danger to
the fetus. The standard of care, therefore, required Dr. Taddeo to engage in a risk benefit
analysis before determining the best course of action.
46. Thus, given her symptoms and the severity of her illness, it was entirely
appropriate for Dr. Taddeo to weigh the risk and the benefit of the drug and to determine
that she would need to remain on the drug to ensure her safety, as her suicidality would
return off the medication.
47. In fact, it would have been a deviation of the standard of care to wean her
off of the drug and take her off all of the medications. Further, a drug such as Topamax
cannot be suddenly stopped. It needs to be weaned. A review of the records of Dr. Pitch
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demonstrate that when they attempted to wean the plaintiff off of Topamax in December
2009 and January 2010, the plaintiff could not tolerate the lower doses and her symptoms
returned, requiring her to remain on her 1000 mg dose throughout the pregnancy.
48. This further supports Dr. Taddeo's thought process and demonstrates that
for this patient the risk and benefits weighted in favor of remaining on the medication.
49. It istherefore my opinion, within a reasonable degree of medical certainty
that at alltimes during the course of the treatment of the plaintiff mother, xxxxxx xxxxxxxx,
Dr. Taddeo acted properly and appropriately and within the standard of care.
50. Dr. Taddeo properly exercised his professional medical judgment in
the treatment options for Mrs. xxxxxxxx the course ofhis treatment in 2007-
weighing during
2009. The record clearly demonstrates that several methods of medical treatment were
tried, until more stable and less impulsive behavior was achieved with a combiñation of
drugs, which included Topamax. Further, the record properly and fully documents that the
patient was counseled about the types of drugs that were being used, the risks of those
drugs as known at the time, and she was fully cautioned about the risks and side effects of
those drugs, which included counseling to continue to use birth control and to avoid
pregnancy for a variety of reasons.
51. The record further reflects that when informed that the patient was pregnant
in September 2009, Dr. Taddeo properly stopped all category D drugs. He further
discussed with her the plan of treatment for the additional medications, and that he would
discuss the risks of the medications with her and with her treating obstetrician so that they
could develop a treatment plan for her. This demonstrates that he properly exercised his
medical judgment and that he acted within the standard of care.
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52. Given the well documented unstable nature of the plaintiff's illness it was
entirely appropriate and within the standard of care for Dr. Taddeo to continue the plaintiff
.on her medical therapy, which included the then category C drug, Topamax, as the risk of
sudden removal would lead to a return of her symptoms.
53. Plaintiff never returned to Dr. Taddeo after that September 24, 2009 office
visit, depriving him of any opportunity to change the course of treatment, should that have
been warranted. But for the purposes of this case, italso severs any liability that he would
have for her further treatment as she terminated the doctor patient relationship with him at
that time.
54. Further, the record demonstrates that there was some dispute as to the
paternity of the infant plaintiff, in that the mother admitted to having sexual intercourse
with two different men outside of her marriage. Cleft lip and palate are known to be
genetic, but itis unknown if the two sexual partners had cleft lip and palate in their family
history.
55. Further, as discussed above, assuming itwas appropriate to discontinue the
Topamax, it could not be suddenly stopped. Rather it would need to be weaned over a
4th
course of a few weeks, yet palate formation in the fetus occurs spanning the week of
9th
gestation to the Week of gestation, making itunlikely that the plaintiff could have been
taken fully of the medication before the palate and or the cleft developed.
56. As to causation at the time in question, the incidence of cleft palate was not
a well reported or proven consequence of using Topamax during pregnancy. Thus, the
FDA categorized the drug as a Class C. Further, the palate forms early in a gestation
(weeks 4-9), making it almost impossible for Dr. Taddeo to have been able to wean the
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plaintiff mother off the drug, had it been indicated, before the palate would have been
formed.
57. I can therefore state, within a reasonable degree of medical certainty that at
all relevant times herein Dr. Taddeo acted properly and appropriately and within the
st=±rd of care. Further, nothing he did or did not do caused or contributed to the injuries
claimed herein. The record fully demonstrates that at all times during his treatment of the
plaintiff mother, Dr. Taddeo and ev± d the patient, and exercised hisbest
properly fully
professional medical judgmeñt for a practicing psychiatrist. Further, he fully counseled
plaintiff mother as to her treatment options and allalternatives, properly weighing the risks
and benefits. The trestinent choices had proper madical and were
foundaticñ, properly
based upon a thorough and careful consideration of the patient's risks, her medical history,
and the benefits of continuing the drug as treatment. Thus there was no departure from the
standard of care, and further acthing that Dr. Taddeo did or failed to do to cause the injury
claimed of herein.
Ill
Michael Liebowitz, M.D.
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FILED: SUFFOLK COUNTY CLERK 01/09/2019 02:38 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 58 RECEIVED NYSCEF: 01/09/2019 "L" EXHIBIT {F:/STAFF/MICHELE/EXHIBITPAGES} FILED: SUFFOLK COUNTY CLERK 01/09/2019 02:38 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 58 RECEIVED NYSCEF: 01/09/2019 SUPREME COURT OF THE STATE OF NEW YORK COUNTY OF SUFFOLK --- ---- --- x xxxxxx xxxxxxxx on behalf of C.S., an infant under Index No.: 026910/12 The age of 18, and xxxxxx xxxxxxxx, Individually, Plaintiffs, AFFIRMATION -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, HANSSEN PHARMACEUTICALS, INC. k/n/a ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, INC., and ZYDUS PHARMACEUTICALS USA, INC., Defendants. --------------------------------------------------- .. ---------------X I, Michael Liebowitz, M.D., am a physician duly licensed to practice medicine in the State of New York, as such I set forth the following under the penalty of perjury and pursuant to CPLR §2106: 1. I am a licensed medical doctor in the State of New York and I set forth the following in support of the motion for summary judgment submitted on behalf of Dr. Taddeo, in the above reference case. 2. I set forth the following based upon my review of the pertinent medical records of the plaintiff mother in this case, xxxxxx xxxxxxxx, as it pertains to her care and treatment from 2007 through her delivery of the infant plaintiff in 2010, and after,as well as a review of the pleadings, Bills of Particulars, deposition transcripts of the parties, as well as my training and experience in medicine and the specific areas of psychiatry. 3. I am a Board Certified Psychiatrist, and have been continuously since 1978. I am a graduate of Yale University School of Medicine. I attended and completed an Internship and a year of Residency in internal medicine at Harlem Hospital and then a residency and Fellowship in psychiatry at the New York State Psychiatric Institute. I was {G:/CASES/xxxxxxxx-C/LEGAL/AFF/expaff final } FILED: SUFFOLK COUNTY CLERK 01/09/2019 02:38 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 58 RECEIVED NYSCEF: 01/09/2019 the Director of the Anxiety Disorders Clinic at the New York State Psychiatric Institute and a Professor of Clinical Psychiatry at the College of Physicians and Surgeons at Columbia University. As such I am fully familiar with the standards of care applicable to the practice of psychiatry as it existed during the time and treatment of this case. 4. Unless so stated, I set forth the following opinions within a reasonable degree of medical certainty, based upon my review of the file and my training and experience. Allegations 5. A review of the Bill of Particulars demonstrates that there is only one possible allegation that can be levied against Dr. Taddeo, who was plaintiff's treating psychiatrist, and that is that from July 2007 through September 2009, he improperly prescribed medication to the plaintiff mother that caused a birth defect in the infant plaintiff. It isclaimed that due to the use of the medication the infant developed, in utero, a cleft palate and lip. 6. The remainder of the allegations is that the defendant herein failed to diagnose and properly treat the infant-plaintiff, which, as will be evident, are improper allegations to wage against Dr. Taddeo. Facts 7. The following facts are pertinent for the assessment of the case and the care rendered by Dr. Taddeo, but they are fully set forth in the attorney affidavit of Ms. Monte. 8. The patient, xxxxxx xxxxxxxx, was first referred to Dr. Taddeo's office in July 2007, by her marriage counselor and therapist Amira Baum. The record demonstrates {G:/CASES/xxxxxxxx-C/LEGAL/AFF/expaff final } FILED: SUFFOLK COUNTY CLERK 01/09/2019 02:38 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 58 RECEIVED NYSCEF: 01/09/2019 that she was first seen in consultation by Joellen Anderson, a Nurse Practitioner, who practiced with Dr. Taddeo, in his psychiatry office, Shore Psychiatric. Just prior to this July 2007 initial consultation the record demonstrates that Mrs. xxxxxxxx attempted suicide, during which she took an overdose of Xanax and was seen in the hospital. Following that suicide attempt Ms. Baum referred her for psychiatric treatment. (See plaintiff's deposition, Dr. Taddeo's records.) 9. The medical record and deposition testimony from Mrs. xxxxxxxx demonstrate that the suicide attempt was the result of depression that followed after her third miscarriage in a row. The series of pregnancy losses led to a deep depression, in the setting of a struggling marriage. 10. A further review of Dr. Taddeo's records and the testimony reveals that Mrs. xxxxxxxx made a further suicide attempt in August 2008, only one month after starting treatment with NP Anderson. On that occasion she took an overdose of 33 Benadryl tablets, combined with large quantities of alcohol. This attempt was done while she was the sole adult home with her three minor children. 11. Mrs. xxxxxxxx was admitted to the psychiatric unit at Southside Hospital in August 2008, for several days. During that admission she was diagnosed with Borderline Personality Disorder, with depressive mood. After several days of treatment and an increase in her medication (Zoloft 100mg) she was discharged to the care of her therapist (Ms. Baum) and NP Anderson. 12. In reviewing the records maintained about the plaintiff mother's psychiatric treatment, which is supported by her deposition testimony, we learn that her suicidal ideation started when she was a young teenager. She reported suicidal ideation starting at {G:/CASES/xxxxxxxx-C/LEGAL/AFF/expaff final } FILED: SUFFOLK COUNTY CLERK 01/09/2019 02:38 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 58 RECEIVED NYSCEF: 01/09/2019 about 14 years old, with two attempts at that time. She did seek for those events counseling from a local counseling center. Plaintiff mother reports a of depressive family history disorders and a personal history of self-mutilation, poor impulse control, and suicidal ideation, in the setting of a turbulent and dysfunctional early childhood and an unstable marriage. 13. A review of the medical record maintained by Dr. Taddeo and Dr. Cavuto, the plaintiff's DBT demonstrates that the period of time in 2007- therapist, during question, 2009, the plaintiff mother had significant issues and behaviors, which were self-injurious. "cutting" These included or self-mutilation; attempting to jump out of moving cars; several attempted drug overdoses; unprotected extramarital sexual encounters with strangers; compulsive shopping leading to bankruptcy; as well as online dating and online sex. Mrs. xxxxxxxx describes herself as volatile, in a depressed mood and having problems with impulse control. 14. There are several important chart notes made by NP Anderson during the period of time that she treated Mrs. xxxxxxxx. The firstof these is on August 30, 2007, just after the admission to Southside for the drug overdose. This chart note indicates that the plaintiff's husband, Tony xxxxxxxx, was monitoring her prescription drugs, and that he assumed the responsibility for the use of birth control. 15. In fact, Mrs. xxxxxxxx admitted during her deposition testimony that NP Anderson counseled her regarding the risks that her prescription medications could have on a pregnancy, as well as the risks of her getting pregnant to her emotional wellbeing. NP Anderson noted that plaintiff mother was not stable and she was cautioned to not get {G:/CASES/xxxxxxxx-C/LEGAL/AFF/expaff final } FILED: SUFFOLK COUNTY CLERK 01/09/2019 02:38 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 58 RECEIVED NYSCEF: 01/09/2019 pregnant for a variety of reasons, which included the potential risks the medication could have on the fetus. 16. In November 2007, the records demonstrate that the plaintiff mother continued to have suicidal thoughts, but had no current plan to commit suicide. She was cautioned to keep pictures of her children close and to reach out if needed. 17. Shortly thereafter, NP Anderson transferred the plaintiff mother's care to Dr. Taddeo, and as he explained during his deposition, it was felt that her case was too complicated for NP Anderson and that she would be better managed by him. 18. During this time the plaintiff's medications were changed. She was on an increasing dose of Zoloft and was given a starter pack for a drug called Lamictal. Lamictal is an antiepileptic drug used off label to address mood disorders in patients with Bipolar disorder. The record demonstrates that the patient did some research regarding Lamictal and then called NP Anderson and told her that she would start the drug. 19. With the change in her drug therapy, the plaintiff noticed a positive response, and her next office visit was with Dr. Taddeo on February 21, 2008. Dr. Taddeo explained during testimony that itwas feltthat the patient's condition was complicated and serious; itwas felt that she would be better managed by him, rather than NP Anderson. Dr. Taddeo increased the dose of the Lamictal and added other medications to try to reach an even balance. 20. Dr. Taddeo testified that he was aware that NP Anderson had counseled the plaintiff to not get pregnant in August 2007. It was his understanding that Mr. xxxxxxxx, plaintiff's husband, had assumed responsibility for the birth control. Itwas also his further understanding that Mr. xxxxxxxx was in control of the plaintiff's drugs (to avoid overdose). {G:/CASES/xxxxxxxx-C/LEGAL/AFF/expaff final } FILED: SUFFOLK COUNTY CLERK 01/09/2019 02:38 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 58 RECEIVED NYSCEF: 01/09/2019 When plaintiff mother started with Dr. Taddeo, he reinforced these messages and cautioned her to not make any major life changes, which could add to her instability. This included getting pregnant. 21. In March 2008, the patient reported a dermatologic side effect from the Lamictal and itwas liniñediately discontinued to avoid Steven Johnson syndrome. During this next office visit, the record demonstrates that the plaintiff told Dr. Taddeo that she had an unreported suicide attempt wherein she took 10 Klonopin, but did not go to the hospital. She also informed him that the couple were filing for bankruptcy due to impulsive spending on her part. 22. When Dr. Taddeo took over the care of the patient from NP Anderson, one of the things that he considered was that the diagnosis of Borderline Personality Disorder was incorrect. During this March 2008 office visit, he changed the diagnosis to Bipolar disorder, mixed type. It was his opinion that the patient's depression, combined with her impulsive outbursts more appropriately fitinto that diagnosis and that ithelped to explain her continuing symptoms. 23. During the March 2008 visit, Dr. Taddeo started the patient on Topamax, to be taken along with other medications she was already on. At the time, he was trying to obtain a stabilizing effect on the plaintiff and was of the opinion that Topamax would address her impulsive behaviors that at times were lifethreatening. 24. Dr. Taddeo testified that Topamax was the same class of antiepileptic drug as Lamictal. In his clinical experience, when used off label in patients such as plaintiff mother who had Bipolar disorder, Topamax helped with impulse control and erratic behavior. The Lamictal seemed to be working with good effect, so itwas reasonable for {G:/CASES/xxxxxxxx-C/LEGAL/AFF/expaff final } FILED: SUFFOLK COUNTY CLERK 01/09/2019 02:38 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 58 RECEIVED NYSCEF: 01/09/2019 him to try a different drug, of the same class, in an effort to stabilize the plaintiff's behaviors. 25. There are notes throughout the record that demonstrate that the plaintiff still continued with erratic and self-injurious behavior. In April 2008, plaintiff mother admitted to an overdose of Lamictal. The husband reaffirmed his commitment to hold allof the plaintiff's medications. Dr. Taddeo added Wellbutrin, to address the depressive mood. In August 2008, there is documentation that the plaintiff threatened suicide, ran away, and also tried to use a razor blade to cut her wrists. In September 2008, plaintiff mother reported dissociative experiences; self-mutilation fantasies; and increased frustration. Her medications were adjusted and her Topamax was increased. 26. Plaintiff mother had sporadic compliance with follow up in late 2008 into early 2009. In March 2009, even though her medications had been slowly increased, plaintiff mother reported a return of her symptoms, which were worsening and she was unstable. She reported inconsistent use of her medications, and once again there was an adjustment of her medications. At this juncture, she was taking Zoloft 200 mg; Topamax 1000 mg; Wellbutrin 150 mg; Zyprexa 5 mg; and Klonopin. 27. During this same time period, the record of Dr. Cavuto, the plaintiff's therapist, demonstrated that she continued with her erratic behaviors. She describes herself as addicted to internet dating, chat rooms, and internet sex. Plaintiff was meeting men on the internet and then arranging to have sex with them. She continued her compulsive shopping despite the bankruptcy and was inconsistent with following up with Dr. Taddeo. 28. There was an August 25, 2009 office visit with Dr. Taddeo where some adjustments were made to her medication, but she was otherwise reporting she feltgood. {G:/CASES/xxxxxxxx-C/LEGAL/AFF/expaff final } FILED: SUFFOLK COUNTY CLERK 01/09/2019 02:38 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 58 RECEIVED NYSCEF: 01/09/2019 29. Then, on September 24, 2009, plaintiff was seen by Dr. Taddeo and reported to him that she recently found out that she was pregnant with the use of a home pregnancy kit. She reported that she was fearful because her prior miscarriages were what caused the increase in her depressive symptoms. She also expressed concern about the use of her medications and their potential effect on the fetus. She had already stopped taking Klonopin. 30. The record and testimony show that Dr. Taddeo developed a plan for further treatment that day. He agreed with the discontinuance of Klonopin. He continued to wean her off of Zoloft and a call was made to her obstetrician to discuss the other medications and the risk of taking her off of the medication and seeing a return of her worst symptoms (erratic behavior and suicidal tendency) versus the risk to the fetus by keeping her on the medications. 31. Dr. Taddeo testified that the risk benefit analysis would be done in conjunction with her obstetrician, but that he stopped the Klonopin because it was a pregnancy category D medication and was known to cause birth defects in the first trimester. The remainder of the drugs were pregnancy category C drugs, which could not be suddenly stopped due to the risks of a return or an exacerbation of her previous symptoms. Dr. Taddeo felt the risk of rapidly stopping her other medications was greater than continuing them. 32. The plaintiff never returned to Dr. Taddeo, and instead we learn from the record that she started to treat with Dr. Pitch, our co-defendant, in December 2009. {G:/CASES/xxxxxxxx-C/LEGAL/AFF/expaff final } FILED: SUFFOLK COUNTY CLERK 01/09/2019 02:38 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 58 RECEIVED NYSCEF: 01/09/2019 Opinions 33. As basic background, to set forth the following opinions, I should state that at the time that this care and treatment was given the drug at issue, Topamax (generically Topiramate) was classified as a pregnancy category C drug. In essence, this means that there were no human studies available about the use of the drug in the pregnant population; so, the risk of use during pregnancy and itspotential effects on the fetus had to be weighed against the risk of taking a patient off of the drug and stopping treatment. 34. As a further point of information, Topamax is an antiepileptic drug, approved for use by the FDA. In 2007 to 2009, itwas used off label to treat mood disorders such as Bipolar disorder and Borderline Personality disorder. The drug effects the brain's neurotransmitters and is helpful in stabilizing anxiety, impulsive behavior, and extreme mood fluctuations. 35. In this instant case, the record is clear that the plaintiff mother was entirely unstable and in a crisis state when she first began treatment with Dr. Taddeo and his associate NP Anderson. The plaintiff mother was started on a course of medical treatment to treat her mood disorder and address her self-injurious behavior. But despite the treatment rendered by NP Anderson, the record clearly depicts a woman who remained highly unstable and suicidal. This is what properly prompted the assumption of her care by Dr. Taddeo in the winter of 2008. 36. The record demonstrates that Dr. Taddeo considered the current drug therapy and its limitations. Shortly after he assumed her care, she had an adverse reaction to Lamictal. He then properly considered other medications that were used for Bipolar disorder, but the record is clear that these were not good choices for this patient. {G:/CASES/xxxxxxxx-C/LEGAL/AFF/expaff final } FILED: SUFFOLK COUNTY CLERK 01/09/2019 02:38 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 58 RECEIVED NYSCEF: 01/09/2019 37. For example, Lithium is a drug used in this patient population. But itneeds to be monitored to prevent toxicity and this particular patient was not stable enough to be able to adhere to the strict monitoring that was required for Lithium use. Depakote was not an ideal choice for the patient, who was already overweight and struggling with body image, as it is known to cause weight gain. Lamictal was already tried, but given the patient's reaction to it,itwas not a viable choice. 38. Therefore, based upon his prior experience in successfully using Topamax for patients with mood disorders and poor impulse control, itwas entirely appropriate for Dr. Taddeo prescribe itto plaintiff mother. 39. The record demonstrates that Dr. Taddeo was familiar with the drug and properly educated himself by attending seminars, reading journals, and staying informed with practice journals as to the use of Topamax in this off label maññer, as well as in educating himself by reading the package insert and using the PDR. 40. The record further supports, and the plaintiff admits in her deposition testimony, that she was counseled about the risks and side effects of the drugs, she was encouraged to do her own research, she was cautioned to ensure that she was using birth control, and she was told not to make any major life changes, such as getting pregnant, due to the various drugs she was on and because such changes could cause a relapse of her symptoms. 41. Yet, the plaintiff mother got pregnant, and then informed Dr. Taddeo, who acted prudently and appropriately when he learned this information. The record clearly demonstrates that he immediately took the plaintiff off of Klonopin, which was the only pregnancy class D drug she was on at the time. {G:/CASES/xxxxxxxx-C/LEGAL/AFF/expaff final } FILED: SUFFOLK COUNTY CLERK 01/09/2019 02:38 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 58 RECEIVED NYSCEF: 01/09/2019 42. Further he properly continued to wean the plaintiff off Zoloft. 43. The record then demonstrates that he engaged in a discussion with the plaintiff and reached out to her obstetrician about the risks of taking her off of the medication versus the risk of the medications to the fetus. 44. Dr. Taddeo properly weighed the facts as we know them about the plaintiff, namely that off of the medication she was highly suicidal, with erratic and unsafe behavior and depression. 45. This was compared to the risk of the then category C drug to the fetus. Plaintiff will no doubt discuss the fact that AFTER this care and treatment the drug classification for Topamax was changed to a category D. After the care and treatment at issue, there was evidence and studies published that discussed that there was an incidence fetus' of cleft lip and palate in born to pregnant mothers who were on the drug, prompting the FDA to change the pregnancy category. But AT THE TIME of the care in question, "C" the drug was categorized as and therefore there was no immediate or known danger to the fetus. The standard of care, therefore, required Dr. Taddeo to engage in a risk benefit analysis before determining the best course of action. 46. Thus, given her symptoms and the severity of her illness, it was entirely appropriate for Dr. Taddeo to weigh the risk and the benefit of the drug and to determine that she would need to remain on the drug to ensure her safety, as her suicidality would return off the medication. 47. In fact, it would have been a deviation of the standard of care to wean her off of the drug and take her off all of the medications. Further, a drug such as Topamax cannot be suddenly stopped. It needs to be weaned. A review of the records of Dr. Pitch {G:/CASES/xxxxxxxx-C/LEGAL/AFF/expaff final } FILED: SUFFOLK COUNTY CLERK 01/09/2019 02:38 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 58 RECEIVED NYSCEF: 01/09/2019 demonstrate that when they attempted to wean the plaintiff off of Topamax in December 2009 and January 2010, the plaintiff could not tolerate the lower doses and her symptoms returned, requiring her to remain on her 1000 mg dose throughout the pregnancy. 48. This further supports Dr. Taddeo's thought process and demonstrates that for this patient the risk and benefits weighted in favor of remaining on the medication. 49. It istherefore my opinion, within a reasonable degree of medical certainty that at alltimes during the course of the treatment of the plaintiff mother, xxxxxx xxxxxxxx, Dr. Taddeo acted properly and appropriately and within the standard of care. 50. Dr. Taddeo properly exercised his professional medical judgment in the treatment options for Mrs. xxxxxxxx the course ofhis treatment in 2007- weighing during 2009. The record clearly demonstrates that several methods of medical treatment were tried, until more stable and less impulsive behavior was achieved with a combiñation of drugs, which included Topamax. Further, the record properly and fully documents that the patient was counseled about the types of drugs that were being used, the risks of those drugs as known at the time, and she was fully cautioned about the risks and side effects of those drugs, which included counseling to continue to use birth control and to avoid pregnancy for a variety of reasons. 51. The record further reflects that when informed that the patient was pregnant in September 2009, Dr. Taddeo properly stopped all category D drugs. He further discussed with her the plan of treatment for the additional medications, and that he would discuss the risks of the medications with her and with her treating obstetrician so that they could develop a treatment plan for her. This demonstrates that he properly exercised his medical judgment and that he acted within the standard of care. {G:/CASES/xxxxxxxx-C/LEGAL/AFF/expaff final } FILED: SUFFOLK COUNTY CLERK 01/09/2019 02:38 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 58 RECEIVED NYSCEF: 01/09/2019 52. Given the well documented unstable nature of the plaintiff's illness it was entirely appropriate and within the standard of care for Dr. Taddeo to continue the plaintiff .on her medical therapy, which included the then category C drug, Topamax, as the risk of sudden removal would lead to a return of her symptoms. 53. Plaintiff never returned to Dr. Taddeo after that September 24, 2009 office visit, depriving him of any opportunity to change the course of treatment, should that have been warranted. But for the purposes of this case, italso severs any liability that he would have for her further treatment as she terminated the doctor patient relationship with him at that time. 54. Further, the record demonstrates that there was some dispute as to the paternity of the infant plaintiff, in that the mother admitted to having sexual intercourse with two different men outside of her marriage. Cleft lip and palate are known to be genetic, but itis unknown if the two sexual partners had cleft lip and palate in their family history. 55. Further, as discussed above, assuming itwas appropriate to discontinue the Topamax, it could not be suddenly stopped. Rather it would need to be weaned over a 4th course of a few weeks, yet palate formation in the fetus occurs spanning the week of 9th gestation to the Week of gestation, making itunlikely that the plaintiff could have been taken fully of the medication before the palate and or the cleft developed. 56. As to causation at the time in question, the incidence of cleft palate was not a well reported or proven consequence of using Topamax during pregnancy. Thus, the FDA categorized the drug as a Class C. Further, the palate forms early in a gestation (weeks 4-9), making it almost impossible for Dr. Taddeo to have been able to wean the {G:/CASES/xxxxxxxx-C/LEGAL/AFF/expaff final } FILED: SUFFOLK COUNTY CLERK 01/09/2019 02:38 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 58 RECEIVED NYSCEF: 01/09/2019 plaintiff mother off the drug, had it been indicated, before the palate would have been formed. 57. I can therefore state, within a reasonable degree of medical certainty that at all relevant times herein Dr. Taddeo acted properly and appropriately and within the st=±rd of care. Further, nothing he did or did not do caused or contributed to the injuries claimed herein. The record fully demonstrates that at all times during his treatment of the plaintiff mother, Dr. Taddeo and ev± d the patient, and exercised hisbest properly fully professional medical judgmeñt for a practicing psychiatrist. Further, he fully counseled plaintiff mother as to her treatment options and allalternatives, properly weighing the risks and benefits. The trestinent choices had proper madical and were foundaticñ, properly based upon a thorough and careful consideration of the patient's risks, her medical history, and the benefits of continuing the drug as treatment. Thus there was no departure from the standard of care, and further acthing that Dr. Taddeo did or failed to do to cause the injury claimed of herein. Ill Michael Liebowitz, M.D. {G:/CASES/EMALER-C/LEGAt/AFF/exp aff final }