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BDG/AHM
00033-087918
SUPREME COURT OF THE STATE OF NEW YORK
COUNTY OF SUFFOLK
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xxxxxx xxxxxxxx on behalf of C.S., an infant under AFFIRMATION IN SUPPORT
the age of 18, and xxxxxx xxxxxxxx, Individually,
Index No.: 026910/2012
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, HANSSEN
PHARMACEUTICALS, INC. k/n/a ORTHO-MCNEIL-
JANSSEN PHARMACEUTICALS, INC., and ZYDUS
PHARMACEUTICALS USA, INC.,
Defendants.
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Barbara D. Goldberg, an attorney duly admitted to practice in the courts of the State of
New York, affirms the following to be true under the penalties of perjury:
1. I am a member of the firm of MARTIN CLEARWATER & BELL LLP, the attorneys
of record for the Defendants RONALD J. TADDEO, M.D. (“Dr. Taddeo”) and SHORE
PSYCHIATRIC CENTER (“Shore Psychiatric”) in this action. I am familiar with the facts and
circumstances herein by virtue of a review of the transcript of the trial held before this Court from
May 30, 2023 through June 15, 2023 and the relevant exhibits introduced at the trial. I make this
Affirmation in support of Defendants’ motion for an Order, pursuant to CPLR 4404(a), setting
aside the verdict in favor of the Plaintiff and granting judgment as a matter of law in favor of
Defendants on the ground that the verdict is unsupported by the evidence as a matter of law; or in
the alternative, granting a new trial on the ground that the verdict is against the weight of the
evidence and in the interests of justice; or as a further alternative, conditionally ordering a new
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trial as to damages unless Plaintiff stipulates to a substantial reduction in the award of damages for
pain and suffering; and, in accordance with General Obligations Law (GOL) § 15-108, directing a
set-off against any recovery by Plaintiff in the amount of $900,000, representing the amount of
Plaintiff’s settlement with the former Co-Defendants Janssen Pharmaceuticals, Inc., k/n/a Ortho-
McNeil-Janssen Pharmaceuticals, Inc. and Zydus Pharmaceuticals US, Inc. (hereinafter,
collectively, “Janssen”); together with such other and further relief as the Court deems just and
proper.
2. By virtue of having presided at the trial, the Court is well acquainted with the
relevant facts and pertinent testimony. Briefly, this action involves allegations that Dr. Taddeo, a
psychiatrist, departed from accepted medical practice while treating Plaintiff xxxxxx
xxxxxxxx (“Plaintiff” or “Mrs. xxxxxxxx”) for bipolar disorder, borderline personality disorder
and related mental health issues after she attempted suicide following a series of miscarriages.
Plaintiff alleged that his use of Topamax (Topiramate) to treat her mood swings resulted in injury
to the infant Plaintiff, C.S., specifically, a cleft lip and cleft palate. Topamax is approved by the
Food and Drug Administration (FDA) for treatment of seizure disorders and migraine headaches,
but is frequently used “off-label” by psychiatrists for treatment of other conditions, including
bipolar disorder, borderline personality disorder, depression and mood swings.
3. As the Court is aware, the jury unanimously found that Dr. Taddeo did not depart
from accepted standards of medical practice in prescribing Topamax to Mrs. xxxxxxxx, but
inconsistently found, by a vote of 5-1, that it was a departure to increase the dosage of Topamax
beyond the recommended dosage, and that this was a substantial factor in causing C.S.’s injuries.
The jury also found that Dr. Taddeo departed from accepted medical practice in failing to advise
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Mrs. xxxxxxxx, prior to pregnancy, on the use of birth control while taking Topamax and that this
was a substantial factor in causing injury to C.S. Finally, the jury found that Dr. Taddeo did not
obtain Mrs. xxxxxxxx’s informed consent to use of the medication, and that the Topamax she
consumed was a substantial factor in causing C.S.’s injuries. The jury awarded $3,000,000 for past
and $1,000,000 for future pain and suffering.
4. As set forth below and in the accompanying Memorandum of Law, the verdict
should be set aside and judgment as a matter of law entered in favor of Dr. Taddeo. In the
alternative, a new trial should be ordered. Viewed in its entirety, Plaintiff’s case was based on
giving the jury the false impression that Topamax was contraindicated for pregnant women or
women who could become pregnant because of a risk of cleft lip/cleft palate noted in the
Physician’s Desk Reference (PDR). In fact, it was not known by the medical profession during the
relevant time period in 2008-2009 that Topamax was associated with cleft lip/cleft palate
deformities in a developing human fetus. At that time, Topamax, like other anti-psychotic
medications prescribed for Mrs. xxxxxxxx, was classified as a pregnancy “Category C” medication,
meaning that some birth defects had been detected in animal studies, but that there was no
conclusive evidence of birth defects in humans. By contrast, a medication classified as Category
D, based on objective proof of birth defects in humans, would be contraindicated during
pregnancy. Here, given Mrs. xxxxxxxx’s severe mental illness and serious suicide attempts, the
benefits of the dosages prescribed by Dr. Taddeo clearly outweighed the risks and may even have
saved the life of this severely mentally ill patient.
5. The evidence was legally insufficient to establish liability or proximate causation
as to the theories of liability on which the jury found in Plaintiff’s favor. The jury could not
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logically have found that Dr. Taddeo departed from accepted practice by increasing the dosage of
Topamax beyond the recommended dosage (Question 2-A), while at the same time finding no
departure in prescribing Topamax (Question 1-A). These were interrelated theories of liability
since the issue of increasing the dosage was subsumed within the question of whether Topamax
should have been prescribed for Mrs. xxxxxxxx in the first instance. Furthermore, the evidence,
including Mrs. xxxxxxxx’s own testimony, as well as the deposition testimony of Joellen Anderson
(“Joellen”), a psychiatric Nurse Practitioner who worked in Dr. Taddeo’s office and initially
treated Mrs. xxxxxxxx, and entries she made in the chart, established unequivocally that Mrs.
xxxxxxxx knew she should not become pregnant while undergoing treatment for her mental illness,
both because of the possibility of another miscarriage and the potential risks her medications posed
to a developing fetus. Accordingly, proximate causation is lacking. Since Mrs. xxxxxxxx already
knew that she should not become pregnant, it is speculative to suggest that different or additional
advice by Dr. Taddeo would have prevented her pregnancy. For the same reasons, the proof is
legally insufficient to establish a lack of informed consent.
6. Alternatively, a new trial should be ordered on the ground that the verdict is against
the weight of the evidence for the reasons stated above. It is respectfully submitted that a new trial
is also warranted in the interests of justice due to errors in the admission of evidence, prejudicial
comments by Plaintiff’s counsel in summation, and confusing language in the Court’s charge and
jury interrogatories. More specifically, the Court improperly allowed Plaintiff’s counsel to utilize
the PDR entry concerning Topamax to establish the standard of care regarding the dosage. In
addition, the Court granted plaintiff’s motion in limine and improperly precluded defense counsel
from submitting evidence as to Mrs. xxxxxxxx’s internet dating, sexual addiction and promiscuity,
which was relevant to Dr. Taddeo’s decision making process in treating her for what was aptly
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described as a mental health “crisis.” This evidence was potentially relevant to proximate causation
as well, since a genetic cause of C.S.’s cleft lip/cleft palate has never been ruled out. Notably,
although he was sent for genetic testing, Plaintiff declined such testing, raising the question of
what she was trying to hide. In sharp contrast, the Court, over defense counsel’s objection, allowed
Plaintiff’s counsel to read irrelevant and prejudicial deposition testimony from Joellen that she and
a social worker were terminated from their employment with one week’s notice, and that she
believed this was done so Dr. Taddeo could save money and hire someone less experienced.
Plaintiff’s counsel raised the issue of Joellen’s firing in his cross-examination of Philip Muskin,
M.D., Defendants’ expert psychiatrist, and again in his summation, where he suggested that Dr.
Taddeo was motivated by saving money rather than the best interests of his patients. In addition,
the jury interrogatories submitted over defense counsel’s objection were confusing and redundant,
as demonstrated by the inconsistent responses to Questions 1-A and 2-A, and presented interrelated
theories of liability. In its charge, the Court instructed the jury, with respect to Plaintiff’s burden
of proof, that “[b]asically it’s 51/49, right,” thereby effectively diluting the burden; and the Court
instructed the jury as to damages for the cost of future medical care and the like, although such
damages were not submitted to the jury, nor was there any proof regarding same. Cumulatively,
these errors deprived Dr. Taddeo of a fair trial.
7. Finally, the total award of $4,000,000 for pain and suffering is excessive. C.S.’s
cleft lip and palate were successfully repaired before he was three years old. While he will require
orthodontic work and possibly surgery on his jaw in the future, he exhibits only minimal facial
scarring, speaks normally and is essentially a typical thirteen year old boy who enjoys activities
with his friends and family. Although Plaintiff’s counsel, in summation, emphasized an instance
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of bullying in the second grade, when another child reportedly told C.S. to kill himself because of
his appearance, C.S. himself testified such teasing/bullying had ceased as he and his peers matured.
8. The following Exhibits are submitted in support of the instant motion:
A. Trial transcript1
B. Verdict sheet
C. Shore Psychiatric Center records
D. Dr. Nicholas Cavuoto’s records
E. Dr. Richard Pitch’s records
F. Plaintiff’s motion in limine
G. Defendants’ opposition to motion in limine
H. Excerpts from deposition of xxxxxx xxxxxxxx
I. 2008-2009 PDR entry for Topamax/Topiramate
J. Excerpts of treatment records of C.S.
K. Photographs of C.S.
L. Verified Complaint
Background
1
References to the transcript are designated by “T” in parentheses.
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9. Before seeking treatment from Shore Psychiatric, Mrs. xxxxxxxx, who had three
young children, had recently experienced three miscarriages over a period of fifteen months,
plunging her into a deep depression. On June 28, 2007 she attempted suicide by ingesting 16 Xanax
tablets (Exhibit C, p.143). Mrs. xxxxxxxx also had a family history of bipolar disorder and a difficult
childhood which apparently included abuse by a babysitter at age 4, resulting in Child Protective
Services (CPS) being called, as well as abuse by her parents and sister (Id., p. 118; Exhibit E,
p.13). She had a history of cutting herself dating back to age 13, and before her marriage to Tony
xxxxxxxx, she had been in an abusive relationship (Exhibit C, p.118). Moreover, her marriage was
far from stable. As demonstrated by the records in evidence, she and Tony quarreled frequently,
often over problems with money and babysitters, and she experienced episodes of suicidal ideation.
She also engaged in impulsive and risk-seeking behavior, including impulse shopping, internet
dating, promiscuity and extramarital sex.
Treatment by Joellen Anderson
10. Following the Xanax overdose, Mrs. xxxxxxxx was seen in the Emergency
Department at Southside Hospital (Exhibit C, p.118). She first presented to Shore Psychiatric on
July 5, 2007, and was seen by Joellen Anderson (T767). Joellen documented that this was a
“serious” case, and that she would contact a social worker from whom Plaintiff had been receiving
therapy and marital counseling (Exhibit C, p.142). On August 2, 2007, Joellen documented that
Plaintiff was on Zoloft 50 mg and Klonopin .5 mg (Id., p.137).
11. On August 18, 2007, while alone at home with her three young children, Mrs.
xxxxxxxx again attempted suicide by ingesting 33 Benadryl tablets (T341-342). Tony found her and
took her to Southside Hospital. During group therapy sessions at Southside Hospital, Plaintiff
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advised the therapist that she had decided not to have any more children (T349). Following her
discharge, she was again treated by Joellen Anderson.
12. Plaintiff readily admitted that Joellen told her not to become pregnant because of
her mental health condition. While at trial she initially would not agree that this was also because
of the medications prescribed for her, at her deposition she acknowledged that she was aware she
should try not to get pregnant while taking the medications (T359-360). She also conceded that
she would assume she was told not to get pregnant because of potential harm to the fetus; that she
had an understanding she was not supposed to get pregnant; and that she also understood from Dr.
Masiar, her treating physician at Southside Hospital, that she was not supposed to get pregnant
(T362-363).
13. Joellen testified that she advised Plaintiff that the medications she was taking were
Category C, and that Plaintiff acknowledged and understood the risk they posed (T770). Joellen
specifically documented that she instructed Plaintiff not to become pregnant, and that, at a visit on
August 20, 2007, Tony indicated he had assumed responsibility for birth control (T772, Exhibit C,
p.104), and would either give Plaintiff her birth control pills, or use a condom (T775). They
discussed these matters each time she saw Plaintiff, including when she saw Plaintiff and Tony
together (T775).
14. Plaintiff continued treating with Joellen through February 2008, and was prescribed
Zoloft, Klonopin and Lamictal.
Treatment by Dr. Taddeo
15. Joellen and a social worker were terminated by Dr. Taddeo in February 2008.
Thereafter, Plaintiff was treated by Dr. Taddeo on approximately a monthly basis until the final
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visit on September 24, 2009, when she told him she was pregnant. At the first visit with Dr. Taddeo
on February 21, 2008, Plaintiff told him suicide was still an option for her (T79-80). Dr. Taddeo
first prescribed Topamax (which Joellen had not prescribed) on March 27, 2008 at a dosage of 25
mg daily (T82). Dr. Taddeo testified that he was aware Topamax was Category C and potentially
posed risks to a fetus; that he would have reviewed the PDR before prescribing it; and that in
animal studies it had caused birth defects (T71, 73, 78).
16. On March 27, 2008, Dr. Taddeo documented that he increased Plaintiff’s Topamax
dosage to 50 mg (Exhibit C, p.43). On April 18, 2008, he documented that Plaintiff had some
response to Topamax, that she admitted having taken an overdose of Lamictal the previous week
and lying to her husband about it, and that “husband will now hold all her pills.” The Topamax
dosage was increased to 100 mg daily (Id., p. 42).
17. On August 7, 2008, Dr. Taddeo documented that Plaintiff “ran away and threatened
suicide. She grabbed a razor blade, but Tony took it away.” At that same visit he increased her
Topamax dosage to 200 mg daily. She was also on Zoloft, Wellbutrin and Seroquel. On September
8, 2008, he documented that the “increase in Topamax has been somewhat helpful,” but that there
had been an incident with Tony when she got out of a moving car. Plaintiff admitted as much
(T379). She also expressed vague suicidal ideation and self-mutilating fantasies. The Topamax
dosage was increased to 200 mg three times a day (600 mg). Plaintiff was also taking Wellbutrin,
Zyprexa, Klonopin and Zoloft, but Seroquel was discontinued (Exhibit C, p.38).
18. On October 3, 2008, Dr. Taddeo documented that Plaintiff continued to have mood
swings, and that they discussed increasing both Klonopin and Topamax. Klonopin was increased
to 1 mg four times a day and Topamax was increased to 200 mg four times a day (Id., p.37). On
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November 7, 2008, Dr. Taddeo increased the Topamax dosage to 200 mg five times a day (Id.,
p.36). On December 22, 2008, he documented that there was “some stability with increase in
Topamax,” and that Plaintiff was able to ward off impulsive behavior (Id., p.35). Plaintiff
acknowledged that after her dosage of Topamax had been increased to 1000 mg daily, she finally
reported that she had some stability (T382).
19. On March 20, 2009, Dr. Taddeo documented that there had been a return of
depressive symptoms and that Plaintiff had screamed at her children the previous day. She
continued to take Klonopin and Zyprexa as well as Topamax (Exhibit C, p.34). On June 2, 2009,
Dr. Taddeo documented that she had a good response to Abilify, and discontinued Zyprexa.
Thereafter, Plaintiff missed an appointment on August 3, 2009 (Id., p.23). On August 25, 2009,
Dr. Taddeo documented a good response to Prozac. Zoloft was decreased to 100 mg once daily,
and Prozac was increased to 20 mg twice a day (Id., p.31). Topamax remained at the level of 1000
mg daily.
20. At the September 24, 2009 visit, when Plaintiff told Dr. Taddeo she was pregnant,
Dr. Taddeo documented that she asked for some direction with her medications. He also
documented that he left a telephone message for her obstetrician, Dr. Scott Berlin; that he
discontinued Klonopin and that he would wean her off Zoloft by decreasing the dosage to 50 mg
and then discontinuing it (Exhibit C, p.30). The call to Dr. Berlin was not returned.
21. Plaintiff testified that she was nervous when she went to Dr. Taddeo that day
because she was pregnant and her previous miscarriages had triggered her mental health crisis.
She was also nervous about being on so many medications (T401). She acknowledged that Dr.
Taddeo discontinued Klonopin, and weighed the risks and benefits of some of the other drugs
(T402-403). Plaintiff also conceded that the pregnancy was not planned (T233).
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Treatment by Dr. Cavuoto
22. During much of this same time period, Plaintiff was also undergoing dialectical
behavioral therapy (DBT) with Dr. Nicholas Cavuoto, a psychotherapist. Dr. Cavuoto’s records
(Exhibit D) are replete with references to suicidal ideations and impulsive behavior, including
extramarital sex. For example, on June 1, 2009, Plaintiff told Dr. Cavuoto she still felt the need to
engage in risky types of behavior (T388). As of July 2009 she was still experiencing suicidal
ideation (T395). In August 2009, around the time C.S. was conceived, Dr. Cavuoto documented
an extramarital sexual liaison that led to further discord in Plaintiff’s marriage (Exhibit D, pp. 255-
256). On September 8, 2009, Plaintiff told Dr. Cavuoto that she had had a bad weekend, and was
still experiencing occasional suicidal ideation (T399).
Plaintiff’s Subsequent Treatment
23. Rather than return to Dr. Taddeo after the September 24th appointment, Plaintiff
scheduled a visit with Dr. Pitch, who was in the same practice group as Dr. Cavuoto, on November
9, 2009 (T237). She was then ten weeks pregnant. She testified that Dr. Pitch showed her the PDR
entries for certain drugs and that she knew he could not take her off certain medications (T405-
406). Notably, Dr. Pitch did not attempt to wean her from Topamax at that visit.
24. Dr. Pitch’s chart documents that the pregnancy was “unexpected” and that they
discussed the risks of her current medications versus the risk of being off the medications. He
noted that “Topamax poses highest known risk among her current med[ication]s,” but that Plaintiff
had reported a clear and substantial benefit, and was already in the 10th week of her pregnancy
(Exhibit E, p.13). Dr. Pitch also documented that the dose was too high to wean her fully before
the end of the first trimester, the period of organogenesis when the facial structures form.
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Accordingly, he decided to maintain her on her current medications, namely, Abilify, Prozac,
Wellbutrin and Klonopin as well as Topamax (Id., p. 14).
25. On November 19th, Dr. Pitch reduced Topamax to 800 mg a day, but on December
7th Plaintiff called to report decreased mood stability. Dr. Pitch documented that she displayed
“more impulsive speech (poor editing) + less mood stability on [decreased] Topamax 800 mg dose.
Do not [decrease] further” (Exhibit E, p. 14). He increased the dosage of Topamax by 200 mg back
up to 1000 mg a day (Id.).
26. Dr. Pitch maintained Plaintiff on that dosage for the next several months (Exhibit
C, pp.22-23).
C.S.’s Birth and Successful Treatment
27. C.S. was born in late May, 2010 (T247). Apart from his cleft lip/cleft palate, he was
normal and healthy. While Plaintiff testified that she was told he was deaf when she brought him
home from the hospital and that this was related to the cleft palate (T249, 251), he was successfully
treated by having tubes placed in his ears, following which his hearing was normal (T255-256,
Exhibit J, p.7).
28. Plaintiff testified that C.S. has undergone six surgeries to date. Before the surgeries
were performed, Dr. Gibbs, an orthodontist, made him an obturator, an oral prosthesis to cover the
opening in the roof of his mouth (T252). He also treated with Dr. Smith, an otolaryngologist, and
Dr. xxxxxx Gallagher, a plastic surgeon (Exhibit J). The first surgery, performed when he was
around 5-6 months old, was performed under anesthesia and repaired his cleft lip (T255-257).
29. When C.S. was between 1-2 years old, Dr. Gallagher, the plastic surgeon,
successfully performed staged surgery to close the cleft palate (T257, 263, Exhibit J). The third
and fourth procedures, which were performed before C.S. was 3 years old, involved affixing the
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obturator to the roof of his mouth and repairing the hard palate (T267-268). Dr. Michael Proothi,
a maxillofacial surgeon, affixed the obturator and Dr. Proothi and Dr. Gallagher operated to close
the hard palate in September 2012 (T270-272, 429). Plaintiff acknowledged that by December
2012, C.S. was doing well with no problems and speaking well (T429-430). This is also
documented in Dr. Gallagher’s records (Exhibit J). The fifth surgery, also performed by Dr.
Proothi when C.S. was around 3 years old, involved replacing the obturator (T277). Finally, in
2018, Dr. Proothi performed the sixth procedure, which involved placing liquid bone around the
gum line (T280).
30. Regarding possible future procedures, Plaintiff testified that C.S. may need surgery
to repair his hard palate, surgery on his jaw, and orthodontic treatment (T287-290). On cross-
examination, however, she acknowledged that no surgeries are currently scheduled (T434).
Photographs of C.S. introduced into evidence show barely discernible scarring on his lip line
(Exhibit K).
31. As noted previously, genetic testing was recommended to determine whether the
cause of C.S.’s cleft lip/cleft palate is congenital, but Plaintiff declined it. Thus, a genetic cause
has never been ruled out. This is particularly significant because Plaintiff was sexually active with
other men at the time of C.S.’s conception, as documented in Dr. Cavuoto’s records (Exhibit D,
pp. 255-256). Notably, none of Plaintiff’s other children has an oral cleft. This was known to the
jury and the jury would therefore have assumed that C.S. had no genetic predisposition to a cleft
lip/cleft palate. Had the Court not granted Plaintiff’s motion in limine to preclude evidence of
extramarital sexual activity (T335-336), defense counsel would have read from or questioned
Plaintiff regarding her deposition testimony in which she admitted to an affair with a man of
apparent “Colombian” descent around the time C.S. was conceived, and acknowledged having
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concerns as to C.S.’s paternity (Exhibit H). As noted in the accompanying Memorandum of Law,
it was Plaintiff’s burden to prove a non-genetic cause of the cleft injuries. It was not Defendants’
burden to prove genetic causation. Evidence at the trial also established that Mrs. xxxxxxxx smoked
while pregnant with C.S. and that smoking during pregnancy can contribute to cleft injuries; and
that numerous other medications prescribed for her were classified as pregnancy Category C, in
addition to Klonopin, which was a pregnancy Category D, with known association for cleft lip and
palate.
Plaintiff’s Expert Testimony
Dr. Reid
32. Plaintiff’s expert plastic surgeon, Dr. Russell Reid, specializes in pediatric plastic
surgery and craniofacial surgery, focusing on the treatment of cleft lips and cleft palates (T541).
He testified that Topamax is a teratogen, and that there is a clearly known association with cleft
palate, without noting that the relevant research was done after the treatment at issue in 2008-2009.
He also opined that Topamax was the most likely cause of C.S.’s injuries, but acknowledged there
are other causes, including genetics and smoking during pregnancy (T553). He acknowledged that
Mrs. xxxxxxxx continued smoking while pregnant, and that no genetic testing was done.
33. Dr. Reid further opined that the greater the exposure, the more severe the defect.
He considered Topamax the most likely cause of C.S.’s injuries (T554-557), and opined that
Plaintiff’s continuing to take Topamax after the final visit to Dr. Taddeo likely contributed to the
injury as well (T560). Improperly relying on hearsay, Dr. Reid opined that “in some papers,”
Topamax has a risk that is 6.10 to 13 times higher than average, which is higher than the risk of
smoking and genetics.
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34. On cross-examination, Dr. Reid admitted that he is not a geneticist (T569). He also
revealed that he has testified on behalf of plaintiffs who sued Janssen for oral cleft injuries (T570).
He reiterated that there are genetic and environmental causes of clefts, and again acknowledged
that Plaintiff smoked during her pregnancy (T571-572). He also conceded that clefts occur more
frequently than other types of birth defects, with a frequency of 1/700 live births in the United
States alone (T573).
35. Although Dr. Reid opined on direct examination that C.S. might need orthognathic
surgery when he reaches his maximum skeletal age, around 18 years (T562), he acknowledged on
cross-examination that Dr. Gallagher did not recommend any other surgeries when she released
C.S. from her care in 2015, and that whether future surgery will be required in such cases is
“patient-dependent” (T575-576). Finally, Dr. Reid testified that C.S. has not undergone any
genetic testing (T580), thereby conceding. implicitly, that a genetic cause of his condition has not
been ruled out.
Dr. Kurani
36. Plaintiff’s expert psychiatrist, Dr. Devendra Kurani, who has a private community-
based practice in New Jersey, was first contacted after the jury was selected, when Plaintiff’s
original expert in psychiatry became unavailable. Dr. Kurani’s fee for testifying was $13,000
(T667).
37. Dr. Kurani testified that in 2007-2009, Topamax/Topiramate was not FDA-
approved for the treatment of bipolar disorder (T625); that one of the side effects that had been
reported was a teratogenic effect, and that this was known in 2008 and 2009 (T625-626).
Regarding the Category C classification, he explained that this meant there may be evidence of
teratogenic effects but there is no definitive proof, and accordingly, physicians should “use
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caution” when prescribing Topamax for a pregnant woman or one who could become pregnant. In
practice, this would take the form of cautioning the patient to practice contraception (T628).
38. Dr. Kurani further testified that he would look at the PDR entry for Topamax, which
was introduced into evidence as Plaintiff’s Exhibit 14 (here Exhibit I), and that he reviews the
PDR before he prescribes medication (T630-632). He had reviewed the PDR entry for Topamax
in 2008 and 2009 (Exhibit I), and testified that he would regularly check the PDR for updates when
he prescribed a drug (T637).
39. After the PDR entry was admitted into evidence, Dr. Kurani was allowed to testify,
over defense counsel’s objections, that it indicated Topamax could lead to fetal malformation, and
that the highest risk would be during the period of organogenesis, the first trimester (T638). He
admitted that there were no studies involving the use of Topamax in pregnant women, but said it
should be used only if the potential benefits outweighed the risks, that is, if there were no other
choices (T639).
40. Dr. Kurani further testified that Dr. Taddeo deviated from accepted practice by
prescribing Topamax to Plaintiff and using it at a dosage much higher than the maximum
recommended dosage for seizure disorder, which was 400 mg a day in two divided doses (T640-
641). He opined that a physician should tell a patient what the potential risks are, and that it was a
deviation to prescribe the increased dosage given the “clear warning” in the PDR (T641).
41. Dr. Kurani also testified that there was no indication in Dr. Taddeo’s notes or
testimony that he ever counseled Plaintiff regarding the risks of Topamax, and that the alleged
failure to counsel her was a departure from accepted practice (T649). Finally, Dr. Kurani testified
that it was a deviation from the standard of care to raise the dosage to 1000 mg a day, and that
Plaintiff should have been counseled about birth control (T662).
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42. On cross-examination, Dr. Kurani conceded that suicide is one of the risks of
bipolar disorder, and that this is especially true in patients (such as Mrs. xxxxxxxx) who have
experienced prior attempts (T678). Interestingly, although this action involves a patient who had
also been diagnosed with borderline personality disorder, Dr. Kurani testified that he does not treat
patients with that condition (T681). He did acknowledge, however, that patients with both bipolar
and borderline personality disorders can be manipulative, impulsive and have difficulty
maintaining healthy relationships (T682).
43. Dr. Kurani also agreed that a physician must weigh the risks and benefits when
prescribing medications, and admitted that he did not know whether, in 2008, there were any
warnings from the pharmaceutical companies that Topamax could cause cleft lip and cleft palate
(T686). He admitted that the other medications prescribed for Plaintiff – Klonopin, Zoloft,
Lamictal, Abilify and Prozac – were all Category C and D as well, and that in fact most medications
available to psychiatrists in 2008 were either Category C or Category D (T689-690). Thus, he
implicitly conceded that C.S.’s injuries could have been caused by other medications prescribed
for Plaintiff, such as Klonopin.
44. Dr. Kurani conceded that withdrawing medications from a bipolar patient who is
pregnant may pose a risk to the patient, and that a patient who is not treated for bipolar disorder is
at risk of self-harm (T695-698). He estimated there is a 1% risk of cleft lip/cleft palate in the
population generally, and acknowledged that not all cases are medication-related (T697).
45. Dr. Kurani conceded that Plaintiff had been told by Joellen Anderson not to get
pregnant, and that she was in a mental health crisis when she first went to Shore Psychiatric in July
2007, since she had just attempted suicide with Xanax (T701). He also acknowledged the
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subsequent overdose with 33 sleeping pills in August 2007, as well as multiple additional attempts2
over the year and a half Plaintiff was treating with Dr. Taddeo, together with episodes of cutting
herself and impulsive spending, which, based on Dr. Cavuoto’s records, continued to September
2009 (T701-703). Dr. Kurani likewise acknowledged that Plaintiff told Dr. Pitch she had a clear
and substantial benefit from Topamax, and that when Dr. Pitch lowered the dosage to 800 mg a
day, she developed new symptoms (T704).
46. Finally, cross-examination revealed that in 2007, Dr. Kurani had received a penalty
letter from the New Jersey Attorney General’s Office because he had not completed all his
continuing medical education (CME) requirements, despite representing that he had done so
(T709).
Defendants’ Case
Deposition Testimony
47. Defense counsel read into evidence pertinent portions of the deposition testimony
of Dr. Scott Berlin, Plaintiff’s obstetrician-gynecologist; Dr. Pitch; and Joellen Anderson. This
included Dr. Berlin’s testimony that “cleft lips happen in nature” (T745), and Dr. Pitch’s testimony
that Plaintiff advised him that Topamax helped level her moods better than not being on it; that
“she said the Topamax really helped” (T748-749); that she had serious medical issues; and that it
was important to control those conditions (T758).
48. The excerpts from Joellen’s testimony read by defense counsel included her
discussions advising Plaintiff that she should not become pregnant, and that Tony xxxxxxxx
indicated he would assume responsibility for birth control (T767-775). Plaintiff’s counsel then
2
These included an overdose of 10 Klonopin tablets in the winter of 2008 and an overdose of Lamictal in
August 2008 (T702).
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insisted on reading additional portions of the testimony, including Joellen’s description of her
firing by Dr. Taddeo (T784-786), over defense counsel’s objection that this was unrelated and
irrelevant (T784). In response to a question from the Court, the attorneys acknowledged that they
had agreed to read deposition testimony during trial; however, defense counsel noted that they did
not waive objections to the testimony that were reserved for the time of trial (T785). Nevertheless,
the Court allowed Plaintiff’s counsel to read Joellen’s testimony that Dr. Taddeo “left a note for
the social worker and I that we were no longer needed. In fact, he hired, my feeling is, less
experienced people at a lower rate of pay so he would have to pay less.”
Dr. Muskin
49. Dr. Philip Muskin, a psychiatrist, testified as Defendants’ liability expert. He
Preview
FILED: SUFFOLK COUNTY CLERK 08/14/2023 01:54 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 249 RECEIVED NYSCEF: 08/14/2023 BDG/AHM 00033-087918 SUPREME COURT OF THE STATE OF NEW YORK COUNTY OF SUFFOLK -----------------------------------------------------------------X xxxxxx xxxxxxxx on behalf of C.S., an infant under AFFIRMATION IN SUPPORT the age of 18, and xxxxxx xxxxxxxx, Individually, Index No.: 026910/2012 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, HANSSEN PHARMACEUTICALS, INC. k/n/a ORTHO-MCNEIL- JANSSEN PHARMACEUTICALS, INC., and ZYDUS PHARMACEUTICALS USA, INC., Defendants. -----------------------------------------------------------------X Barbara D. Goldberg, an attorney duly admitted to practice in the courts of the State of New York, affirms the following to be true under the penalties of perjury: 1. I am a member of the firm of MARTIN CLEARWATER & BELL LLP, the attorneys of record for the Defendants RONALD J. TADDEO, M.D. (“Dr. Taddeo”) and SHORE PSYCHIATRIC CENTER (“Shore Psychiatric”) in this action. I am familiar with the facts and circumstances herein by virtue of a review of the transcript of the trial held before this Court from May 30, 2023 through June 15, 2023 and the relevant exhibits introduced at the trial. I make this Affirmation in support of Defendants’ motion for an Order, pursuant to CPLR 4404(a), setting aside the verdict in favor of the Plaintiff and granting judgment as a matter of law in favor of Defendants on the ground that the verdict is unsupported by the evidence as a matter of law; or in the alternative, granting a new trial on the ground that the verdict is against the weight of the evidence and in the interests of justice; or as a further alternative, conditionally ordering a new 4933464 1 of 25 FILED: SUFFOLK COUNTY CLERK 08/14/2023 01:54 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 249 RECEIVED NYSCEF: 08/14/2023 trial as to damages unless Plaintiff stipulates to a substantial reduction in the award of damages for pain and suffering; and, in accordance with General Obligations Law (GOL) § 15-108, directing a set-off against any recovery by Plaintiff in the amount of $900,000, representing the amount of Plaintiff’s settlement with the former Co-Defendants Janssen Pharmaceuticals, Inc., k/n/a Ortho- McNeil-Janssen Pharmaceuticals, Inc. and Zydus Pharmaceuticals US, Inc. (hereinafter, collectively, “Janssen”); together with such other and further relief as the Court deems just and proper. 2. By virtue of having presided at the trial, the Court is well acquainted with the relevant facts and pertinent testimony. Briefly, this action involves allegations that Dr. Taddeo, a psychiatrist, departed from accepted medical practice while treating Plaintiff xxxxxx xxxxxxxx (“Plaintiff” or “Mrs. xxxxxxxx”) for bipolar disorder, borderline personality disorder and related mental health issues after she attempted suicide following a series of miscarriages. Plaintiff alleged that his use of Topamax (Topiramate) to treat her mood swings resulted in injury to the infant Plaintiff, C.S., specifically, a cleft lip and cleft palate. Topamax is approved by the Food and Drug Administration (FDA) for treatment of seizure disorders and migraine headaches, but is frequently used “off-label” by psychiatrists for treatment of other conditions, including bipolar disorder, borderline personality disorder, depression and mood swings. 3. As the Court is aware, the jury unanimously found that Dr. Taddeo did not depart from accepted standards of medical practice in prescribing Topamax to Mrs. xxxxxxxx, but inconsistently found, by a vote of 5-1, that it was a departure to increase the dosage of Topamax beyond the recommended dosage, and that this was a substantial factor in causing C.S.’s injuries. The jury also found that Dr. Taddeo departed from accepted medical practice in failing to advise 2 4933464 2 of 25 FILED: SUFFOLK COUNTY CLERK 08/14/2023 01:54 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 249 RECEIVED NYSCEF: 08/14/2023 Mrs. xxxxxxxx, prior to pregnancy, on the use of birth control while taking Topamax and that this was a substantial factor in causing injury to C.S. Finally, the jury found that Dr. Taddeo did not obtain Mrs. xxxxxxxx’s informed consent to use of the medication, and that the Topamax she consumed was a substantial factor in causing C.S.’s injuries. The jury awarded $3,000,000 for past and $1,000,000 for future pain and suffering. 4. As set forth below and in the accompanying Memorandum of Law, the verdict should be set aside and judgment as a matter of law entered in favor of Dr. Taddeo. In the alternative, a new trial should be ordered. Viewed in its entirety, Plaintiff’s case was based on giving the jury the false impression that Topamax was contraindicated for pregnant women or women who could become pregnant because of a risk of cleft lip/cleft palate noted in the Physician’s Desk Reference (PDR). In fact, it was not known by the medical profession during the relevant time period in 2008-2009 that Topamax was associated with cleft lip/cleft palate deformities in a developing human fetus. At that time, Topamax, like other anti-psychotic medications prescribed for Mrs. xxxxxxxx, was classified as a pregnancy “Category C” medication, meaning that some birth defects had been detected in animal studies, but that there was no conclusive evidence of birth defects in humans. By contrast, a medication classified as Category D, based on objective proof of birth defects in humans, would be contraindicated during pregnancy. Here, given Mrs. xxxxxxxx’s severe mental illness and serious suicide attempts, the benefits of the dosages prescribed by Dr. Taddeo clearly outweighed the risks and may even have saved the life of this severely mentally ill patient. 5. The evidence was legally insufficient to establish liability or proximate causation as to the theories of liability on which the jury found in Plaintiff’s favor. The jury could not 3 4933464 3 of 25 FILED: SUFFOLK COUNTY CLERK 08/14/2023 01:54 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 249 RECEIVED NYSCEF: 08/14/2023 logically have found that Dr. Taddeo departed from accepted practice by increasing the dosage of Topamax beyond the recommended dosage (Question 2-A), while at the same time finding no departure in prescribing Topamax (Question 1-A). These were interrelated theories of liability since the issue of increasing the dosage was subsumed within the question of whether Topamax should have been prescribed for Mrs. xxxxxxxx in the first instance. Furthermore, the evidence, including Mrs. xxxxxxxx’s own testimony, as well as the deposition testimony of Joellen Anderson (“Joellen”), a psychiatric Nurse Practitioner who worked in Dr. Taddeo’s office and initially treated Mrs. xxxxxxxx, and entries she made in the chart, established unequivocally that Mrs. xxxxxxxx knew she should not become pregnant while undergoing treatment for her mental illness, both because of the possibility of another miscarriage and the potential risks her medications posed to a developing fetus. Accordingly, proximate causation is lacking. Since Mrs. xxxxxxxx already knew that she should not become pregnant, it is speculative to suggest that different or additional advice by Dr. Taddeo would have prevented her pregnancy. For the same reasons, the proof is legally insufficient to establish a lack of informed consent. 6. Alternatively, a new trial should be ordered on the ground that the verdict is against the weight of the evidence for the reasons stated above. It is respectfully submitted that a new trial is also warranted in the interests of justice due to errors in the admission of evidence, prejudicial comments by Plaintiff’s counsel in summation, and confusing language in the Court’s charge and jury interrogatories. More specifically, the Court improperly allowed Plaintiff’s counsel to utilize the PDR entry concerning Topamax to establish the standard of care regarding the dosage. In addition, the Court granted plaintiff’s motion in limine and improperly precluded defense counsel from submitting evidence as to Mrs. xxxxxxxx’s internet dating, sexual addiction and promiscuity, which was relevant to Dr. Taddeo’s decision making process in treating her for what was aptly 4 4933464 4 of 25 FILED: SUFFOLK COUNTY CLERK 08/14/2023 01:54 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 249 RECEIVED NYSCEF: 08/14/2023 described as a mental health “crisis.” This evidence was potentially relevant to proximate causation as well, since a genetic cause of C.S.’s cleft lip/cleft palate has never been ruled out. Notably, although he was sent for genetic testing, Plaintiff declined such testing, raising the question of what she was trying to hide. In sharp contrast, the Court, over defense counsel’s objection, allowed Plaintiff’s counsel to read irrelevant and prejudicial deposition testimony from Joellen that she and a social worker were terminated from their employment with one week’s notice, and that she believed this was done so Dr. Taddeo could save money and hire someone less experienced. Plaintiff’s counsel raised the issue of Joellen’s firing in his cross-examination of Philip Muskin, M.D., Defendants’ expert psychiatrist, and again in his summation, where he suggested that Dr. Taddeo was motivated by saving money rather than the best interests of his patients. In addition, the jury interrogatories submitted over defense counsel’s objection were confusing and redundant, as demonstrated by the inconsistent responses to Questions 1-A and 2-A, and presented interrelated theories of liability. In its charge, the Court instructed the jury, with respect to Plaintiff’s burden of proof, that “[b]asically it’s 51/49, right,” thereby effectively diluting the burden; and the Court instructed the jury as to damages for the cost of future medical care and the like, although such damages were not submitted to the jury, nor was there any proof regarding same. Cumulatively, these errors deprived Dr. Taddeo of a fair trial. 7. Finally, the total award of $4,000,000 for pain and suffering is excessive. C.S.’s cleft lip and palate were successfully repaired before he was three years old. While he will require orthodontic work and possibly surgery on his jaw in the future, he exhibits only minimal facial scarring, speaks normally and is essentially a typical thirteen year old boy who enjoys activities with his friends and family. Although Plaintiff’s counsel, in summation, emphasized an instance 5 4933464 5 of 25 FILED: SUFFOLK COUNTY CLERK 08/14/2023 01:54 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 249 RECEIVED NYSCEF: 08/14/2023 of bullying in the second grade, when another child reportedly told C.S. to kill himself because of his appearance, C.S. himself testified such teasing/bullying had ceased as he and his peers matured. 8. The following Exhibits are submitted in support of the instant motion: A. Trial transcript1 B. Verdict sheet C. Shore Psychiatric Center records D. Dr. Nicholas Cavuoto’s records E. Dr. Richard Pitch’s records F. Plaintiff’s motion in limine G. Defendants’ opposition to motion in limine H. Excerpts from deposition of xxxxxx xxxxxxxx I. 2008-2009 PDR entry for Topamax/Topiramate J. Excerpts of treatment records of C.S. K. Photographs of C.S. L. Verified Complaint Background 1 References to the transcript are designated by “T” in parentheses. 6 4933464 6 of 25 FILED: SUFFOLK COUNTY CLERK 08/14/2023 01:54 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 249 RECEIVED NYSCEF: 08/14/2023 9. Before seeking treatment from Shore Psychiatric, Mrs. xxxxxxxx, who had three young children, had recently experienced three miscarriages over a period of fifteen months, plunging her into a deep depression. On June 28, 2007 she attempted suicide by ingesting 16 Xanax tablets (Exhibit C, p.143). Mrs. xxxxxxxx also had a family history of bipolar disorder and a difficult childhood which apparently included abuse by a babysitter at age 4, resulting in Child Protective Services (CPS) being called, as well as abuse by her parents and sister (Id., p. 118; Exhibit E, p.13). She had a history of cutting herself dating back to age 13, and before her marriage to Tony xxxxxxxx, she had been in an abusive relationship (Exhibit C, p.118). Moreover, her marriage was far from stable. As demonstrated by the records in evidence, she and Tony quarreled frequently, often over problems with money and babysitters, and she experienced episodes of suicidal ideation. She also engaged in impulsive and risk-seeking behavior, including impulse shopping, internet dating, promiscuity and extramarital sex. Treatment by Joellen Anderson 10. Following the Xanax overdose, Mrs. xxxxxxxx was seen in the Emergency Department at Southside Hospital (Exhibit C, p.118). She first presented to Shore Psychiatric on July 5, 2007, and was seen by Joellen Anderson (T767). Joellen documented that this was a “serious” case, and that she would contact a social worker from whom Plaintiff had been receiving therapy and marital counseling (Exhibit C, p.142). On August 2, 2007, Joellen documented that Plaintiff was on Zoloft 50 mg and Klonopin .5 mg (Id., p.137). 11. On August 18, 2007, while alone at home with her three young children, Mrs. xxxxxxxx again attempted suicide by ingesting 33 Benadryl tablets (T341-342). Tony found her and took her to Southside Hospital. During group therapy sessions at Southside Hospital, Plaintiff 7 4933464 7 of 25 FILED: SUFFOLK COUNTY CLERK 08/14/2023 01:54 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 249 RECEIVED NYSCEF: 08/14/2023 advised the therapist that she had decided not to have any more children (T349). Following her discharge, she was again treated by Joellen Anderson. 12. Plaintiff readily admitted that Joellen told her not to become pregnant because of her mental health condition. While at trial she initially would not agree that this was also because of the medications prescribed for her, at her deposition she acknowledged that she was aware she should try not to get pregnant while taking the medications (T359-360). She also conceded that she would assume she was told not to get pregnant because of potential harm to the fetus; that she had an understanding she was not supposed to get pregnant; and that she also understood from Dr. Masiar, her treating physician at Southside Hospital, that she was not supposed to get pregnant (T362-363). 13. Joellen testified that she advised Plaintiff that the medications she was taking were Category C, and that Plaintiff acknowledged and understood the risk they posed (T770). Joellen specifically documented that she instructed Plaintiff not to become pregnant, and that, at a visit on August 20, 2007, Tony indicated he had assumed responsibility for birth control (T772, Exhibit C, p.104), and would either give Plaintiff her birth control pills, or use a condom (T775). They discussed these matters each time she saw Plaintiff, including when she saw Plaintiff and Tony together (T775). 14. Plaintiff continued treating with Joellen through February 2008, and was prescribed Zoloft, Klonopin and Lamictal. Treatment by Dr. Taddeo 15. Joellen and a social worker were terminated by Dr. Taddeo in February 2008. Thereafter, Plaintiff was treated by Dr. Taddeo on approximately a monthly basis until the final 8 4933464 8 of 25 FILED: SUFFOLK COUNTY CLERK 08/14/2023 01:54 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 249 RECEIVED NYSCEF: 08/14/2023 visit on September 24, 2009, when she told him she was pregnant. At the first visit with Dr. Taddeo on February 21, 2008, Plaintiff told him suicide was still an option for her (T79-80). Dr. Taddeo first prescribed Topamax (which Joellen had not prescribed) on March 27, 2008 at a dosage of 25 mg daily (T82). Dr. Taddeo testified that he was aware Topamax was Category C and potentially posed risks to a fetus; that he would have reviewed the PDR before prescribing it; and that in animal studies it had caused birth defects (T71, 73, 78). 16. On March 27, 2008, Dr. Taddeo documented that he increased Plaintiff’s Topamax dosage to 50 mg (Exhibit C, p.43). On April 18, 2008, he documented that Plaintiff had some response to Topamax, that she admitted having taken an overdose of Lamictal the previous week and lying to her husband about it, and that “husband will now hold all her pills.” The Topamax dosage was increased to 100 mg daily (Id., p. 42). 17. On August 7, 2008, Dr. Taddeo documented that Plaintiff “ran away and threatened suicide. She grabbed a razor blade, but Tony took it away.” At that same visit he increased her Topamax dosage to 200 mg daily. She was also on Zoloft, Wellbutrin and Seroquel. On September 8, 2008, he documented that the “increase in Topamax has been somewhat helpful,” but that there had been an incident with Tony when she got out of a moving car. Plaintiff admitted as much (T379). She also expressed vague suicidal ideation and self-mutilating fantasies. The Topamax dosage was increased to 200 mg three times a day (600 mg). Plaintiff was also taking Wellbutrin, Zyprexa, Klonopin and Zoloft, but Seroquel was discontinued (Exhibit C, p.38). 18. On October 3, 2008, Dr. Taddeo documented that Plaintiff continued to have mood swings, and that they discussed increasing both Klonopin and Topamax. Klonopin was increased to 1 mg four times a day and Topamax was increased to 200 mg four times a day (Id., p.37). On 9 4933464 9 of 25 FILED: SUFFOLK COUNTY CLERK 08/14/2023 01:54 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 249 RECEIVED NYSCEF: 08/14/2023 November 7, 2008, Dr. Taddeo increased the Topamax dosage to 200 mg five times a day (Id., p.36). On December 22, 2008, he documented that there was “some stability with increase in Topamax,” and that Plaintiff was able to ward off impulsive behavior (Id., p.35). Plaintiff acknowledged that after her dosage of Topamax had been increased to 1000 mg daily, she finally reported that she had some stability (T382). 19. On March 20, 2009, Dr. Taddeo documented that there had been a return of depressive symptoms and that Plaintiff had screamed at her children the previous day. She continued to take Klonopin and Zyprexa as well as Topamax (Exhibit C, p.34). On June 2, 2009, Dr. Taddeo documented that she had a good response to Abilify, and discontinued Zyprexa. Thereafter, Plaintiff missed an appointment on August 3, 2009 (Id., p.23). On August 25, 2009, Dr. Taddeo documented a good response to Prozac. Zoloft was decreased to 100 mg once daily, and Prozac was increased to 20 mg twice a day (Id., p.31). Topamax remained at the level of 1000 mg daily. 20. At the September 24, 2009 visit, when Plaintiff told Dr. Taddeo she was pregnant, Dr. Taddeo documented that she asked for some direction with her medications. He also documented that he left a telephone message for her obstetrician, Dr. Scott Berlin; that he discontinued Klonopin and that he would wean her off Zoloft by decreasing the dosage to 50 mg and then discontinuing it (Exhibit C, p.30). The call to Dr. Berlin was not returned. 21. Plaintiff testified that she was nervous when she went to Dr. Taddeo that day because she was pregnant and her previous miscarriages had triggered her mental health crisis. She was also nervous about being on so many medications (T401). She acknowledged that Dr. Taddeo discontinued Klonopin, and weighed the risks and benefits of some of the other drugs (T402-403). Plaintiff also conceded that the pregnancy was not planned (T233). 10 4933464 10 of 25 FILED: SUFFOLK COUNTY CLERK 08/14/2023 01:54 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 249 RECEIVED NYSCEF: 08/14/2023 Treatment by Dr. Cavuoto 22. During much of this same time period, Plaintiff was also undergoing dialectical behavioral therapy (DBT) with Dr. Nicholas Cavuoto, a psychotherapist. Dr. Cavuoto’s records (Exhibit D) are replete with references to suicidal ideations and impulsive behavior, including extramarital sex. For example, on June 1, 2009, Plaintiff told Dr. Cavuoto she still felt the need to engage in risky types of behavior (T388). As of July 2009 she was still experiencing suicidal ideation (T395). In August 2009, around the time C.S. was conceived, Dr. Cavuoto documented an extramarital sexual liaison that led to further discord in Plaintiff’s marriage (Exhibit D, pp. 255- 256). On September 8, 2009, Plaintiff told Dr. Cavuoto that she had had a bad weekend, and was still experiencing occasional suicidal ideation (T399). Plaintiff’s Subsequent Treatment 23. Rather than return to Dr. Taddeo after the September 24th appointment, Plaintiff scheduled a visit with Dr. Pitch, who was in the same practice group as Dr. Cavuoto, on November 9, 2009 (T237). She was then ten weeks pregnant. She testified that Dr. Pitch showed her the PDR entries for certain drugs and that she knew he could not take her off certain medications (T405- 406). Notably, Dr. Pitch did not attempt to wean her from Topamax at that visit. 24. Dr. Pitch’s chart documents that the pregnancy was “unexpected” and that they discussed the risks of her current medications versus the risk of being off the medications. He noted that “Topamax poses highest known risk among her current med[ication]s,” but that Plaintiff had reported a clear and substantial benefit, and was already in the 10th week of her pregnancy (Exhibit E, p.13). Dr. Pitch also documented that the dose was too high to wean her fully before the end of the first trimester, the period of organogenesis when the facial structures form. 11 4933464 11 of 25 FILED: SUFFOLK COUNTY CLERK 08/14/2023 01:54 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 249 RECEIVED NYSCEF: 08/14/2023 Accordingly, he decided to maintain her on her current medications, namely, Abilify, Prozac, Wellbutrin and Klonopin as well as Topamax (Id., p. 14). 25. On November 19th, Dr. Pitch reduced Topamax to 800 mg a day, but on December 7th Plaintiff called to report decreased mood stability. Dr. Pitch documented that she displayed “more impulsive speech (poor editing) + less mood stability on [decreased] Topamax 800 mg dose. Do not [decrease] further” (Exhibit E, p. 14). He increased the dosage of Topamax by 200 mg back up to 1000 mg a day (Id.). 26. Dr. Pitch maintained Plaintiff on that dosage for the next several months (Exhibit C, pp.22-23). C.S.’s Birth and Successful Treatment 27. C.S. was born in late May, 2010 (T247). Apart from his cleft lip/cleft palate, he was normal and healthy. While Plaintiff testified that she was told he was deaf when she brought him home from the hospital and that this was related to the cleft palate (T249, 251), he was successfully treated by having tubes placed in his ears, following which his hearing was normal (T255-256, Exhibit J, p.7). 28. Plaintiff testified that C.S. has undergone six surgeries to date. Before the surgeries were performed, Dr. Gibbs, an orthodontist, made him an obturator, an oral prosthesis to cover the opening in the roof of his mouth (T252). He also treated with Dr. Smith, an otolaryngologist, and Dr. xxxxxx Gallagher, a plastic surgeon (Exhibit J). The first surgery, performed when he was around 5-6 months old, was performed under anesthesia and repaired his cleft lip (T255-257). 29. When C.S. was between 1-2 years old, Dr. Gallagher, the plastic surgeon, successfully performed staged surgery to close the cleft palate (T257, 263, Exhibit J). The third and fourth procedures, which were performed before C.S. was 3 years old, involved affixing the 12 4933464 12 of 25 FILED: SUFFOLK COUNTY CLERK 08/14/2023 01:54 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 249 RECEIVED NYSCEF: 08/14/2023 obturator to the roof of his mouth and repairing the hard palate (T267-268). Dr. Michael Proothi, a maxillofacial surgeon, affixed the obturator and Dr. Proothi and Dr. Gallagher operated to close the hard palate in September 2012 (T270-272, 429). Plaintiff acknowledged that by December 2012, C.S. was doing well with no problems and speaking well (T429-430). This is also documented in Dr. Gallagher’s records (Exhibit J). The fifth surgery, also performed by Dr. Proothi when C.S. was around 3 years old, involved replacing the obturator (T277). Finally, in 2018, Dr. Proothi performed the sixth procedure, which involved placing liquid bone around the gum line (T280). 30. Regarding possible future procedures, Plaintiff testified that C.S. may need surgery to repair his hard palate, surgery on his jaw, and orthodontic treatment (T287-290). On cross- examination, however, she acknowledged that no surgeries are currently scheduled (T434). Photographs of C.S. introduced into evidence show barely discernible scarring on his lip line (Exhibit K). 31. As noted previously, genetic testing was recommended to determine whether the cause of C.S.’s cleft lip/cleft palate is congenital, but Plaintiff declined it. Thus, a genetic cause has never been ruled out. This is particularly significant because Plaintiff was sexually active with other men at the time of C.S.’s conception, as documented in Dr. Cavuoto’s records (Exhibit D, pp. 255-256). Notably, none of Plaintiff’s other children has an oral cleft. This was known to the jury and the jury would therefore have assumed that C.S. had no genetic predisposition to a cleft lip/cleft palate. Had the Court not granted Plaintiff’s motion in limine to preclude evidence of extramarital sexual activity (T335-336), defense counsel would have read from or questioned Plaintiff regarding her deposition testimony in which she admitted to an affair with a man of apparent “Colombian” descent around the time C.S. was conceived, and acknowledged having 13 4933464 13 of 25 FILED: SUFFOLK COUNTY CLERK 08/14/2023 01:54 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 249 RECEIVED NYSCEF: 08/14/2023 concerns as to C.S.’s paternity (Exhibit H). As noted in the accompanying Memorandum of Law, it was Plaintiff’s burden to prove a non-genetic cause of the cleft injuries. It was not Defendants’ burden to prove genetic causation. Evidence at the trial also established that Mrs. xxxxxxxx smoked while pregnant with C.S. and that smoking during pregnancy can contribute to cleft injuries; and that numerous other medications prescribed for her were classified as pregnancy Category C, in addition to Klonopin, which was a pregnancy Category D, with known association for cleft lip and palate. Plaintiff’s Expert Testimony Dr. Reid 32. Plaintiff’s expert plastic surgeon, Dr. Russell Reid, specializes in pediatric plastic surgery and craniofacial surgery, focusing on the treatment of cleft lips and cleft palates (T541). He testified that Topamax is a teratogen, and that there is a clearly known association with cleft palate, without noting that the relevant research was done after the treatment at issue in 2008-2009. He also opined that Topamax was the most likely cause of C.S.’s injuries, but acknowledged there are other causes, including genetics and smoking during pregnancy (T553). He acknowledged that Mrs. xxxxxxxx continued smoking while pregnant, and that no genetic testing was done. 33. Dr. Reid further opined that the greater the exposure, the more severe the defect. He considered Topamax the most likely cause of C.S.’s injuries (T554-557), and opined that Plaintiff’s continuing to take Topamax after the final visit to Dr. Taddeo likely contributed to the injury as well (T560). Improperly relying on hearsay, Dr. Reid opined that “in some papers,” Topamax has a risk that is 6.10 to 13 times higher than average, which is higher than the risk of smoking and genetics. 14 4933464 14 of 25 FILED: SUFFOLK COUNTY CLERK 08/14/2023 01:54 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 249 RECEIVED NYSCEF: 08/14/2023 34. On cross-examination, Dr. Reid admitted that he is not a geneticist (T569). He also revealed that he has testified on behalf of plaintiffs who sued Janssen for oral cleft injuries (T570). He reiterated that there are genetic and environmental causes of clefts, and again acknowledged that Plaintiff smoked during her pregnancy (T571-572). He also conceded that clefts occur more frequently than other types of birth defects, with a frequency of 1/700 live births in the United States alone (T573). 35. Although Dr. Reid opined on direct examination that C.S. might need orthognathic surgery when he reaches his maximum skeletal age, around 18 years (T562), he acknowledged on cross-examination that Dr. Gallagher did not recommend any other surgeries when she released C.S. from her care in 2015, and that whether future surgery will be required in such cases is “patient-dependent” (T575-576). Finally, Dr. Reid testified that C.S. has not undergone any genetic testing (T580), thereby conceding. implicitly, that a genetic cause of his condition has not been ruled out. Dr. Kurani 36. Plaintiff’s expert psychiatrist, Dr. Devendra Kurani, who has a private community- based practice in New Jersey, was first contacted after the jury was selected, when Plaintiff’s original expert in psychiatry became unavailable. Dr. Kurani’s fee for testifying was $13,000 (T667). 37. Dr. Kurani testified that in 2007-2009, Topamax/Topiramate was not FDA- approved for the treatment of bipolar disorder (T625); that one of the side effects that had been reported was a teratogenic effect, and that this was known in 2008 and 2009 (T625-626). Regarding the Category C classification, he explained that this meant there may be evidence of teratogenic effects but there is no definitive proof, and accordingly, physicians should “use 15 4933464 15 of 25 FILED: SUFFOLK COUNTY CLERK 08/14/2023 01:54 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 249 RECEIVED NYSCEF: 08/14/2023 caution” when prescribing Topamax for a pregnant woman or one who could become pregnant. In practice, this would take the form of cautioning the patient to practice contraception (T628). 38. Dr. Kurani further testified that he would look at the PDR entry for Topamax, which was introduced into evidence as Plaintiff’s Exhibit 14 (here Exhibit I), and that he reviews the PDR before he prescribes medication (T630-632). He had reviewed the PDR entry for Topamax in 2008 and 2009 (Exhibit I), and testified that he would regularly check the PDR for updates when he prescribed a drug (T637). 39. After the PDR entry was admitted into evidence, Dr. Kurani was allowed to testify, over defense counsel’s objections, that it indicated Topamax could lead to fetal malformation, and that the highest risk would be during the period of organogenesis, the first trimester (T638). He admitted that there were no studies involving the use of Topamax in pregnant women, but said it should be used only if the potential benefits outweighed the risks, that is, if there were no other choices (T639). 40. Dr. Kurani further testified that Dr. Taddeo deviated from accepted practice by prescribing Topamax to Plaintiff and using it at a dosage much higher than the maximum recommended dosage for seizure disorder, which was 400 mg a day in two divided doses (T640- 641). He opined that a physician should tell a patient what the potential risks are, and that it was a deviation to prescribe the increased dosage given the “clear warning” in the PDR (T641). 41. Dr. Kurani also testified that there was no indication in Dr. Taddeo’s notes or testimony that he ever counseled Plaintiff regarding the risks of Topamax, and that the alleged failure to counsel her was a departure from accepted practice (T649). Finally, Dr. Kurani testified that it was a deviation from the standard of care to raise the dosage to 1000 mg a day, and that Plaintiff should have been counseled about birth control (T662). 16 4933464 16 of 25 FILED: SUFFOLK COUNTY CLERK 08/14/2023 01:54 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 249 RECEIVED NYSCEF: 08/14/2023 42. On cross-examination, Dr. Kurani conceded that suicide is one of the risks of bipolar disorder, and that this is especially true in patients (such as Mrs. xxxxxxxx) who have experienced prior attempts (T678). Interestingly, although this action involves a patient who had also been diagnosed with borderline personality disorder, Dr. Kurani testified that he does not treat patients with that condition (T681). He did acknowledge, however, that patients with both bipolar and borderline personality disorders can be manipulative, impulsive and have difficulty maintaining healthy relationships (T682). 43. Dr. Kurani also agreed that a physician must weigh the risks and benefits when prescribing medications, and admitted that he did not know whether, in 2008, there were any warnings from the pharmaceutical companies that Topamax could cause cleft lip and cleft palate (T686). He admitted that the other medications prescribed for Plaintiff – Klonopin, Zoloft, Lamictal, Abilify and Prozac – were all Category C and D as well, and that in fact most medications available to psychiatrists in 2008 were either Category C or Category D (T689-690). Thus, he implicitly conceded that C.S.’s injuries could have been caused by other medications prescribed for Plaintiff, such as Klonopin. 44. Dr. Kurani conceded that withdrawing medications from a bipolar patient who is pregnant may pose a risk to the patient, and that a patient who is not treated for bipolar disorder is at risk of self-harm (T695-698). He estimated there is a 1% risk of cleft lip/cleft palate in the population generally, and acknowledged that not all cases are medication-related (T697). 45. Dr. Kurani conceded that Plaintiff had been told by Joellen Anderson not to get pregnant, and that she was in a mental health crisis when she first went to Shore Psychiatric in July 2007, since she had just attempted suicide with Xanax (T701). He also acknowledged the 17 4933464 17 of 25 FILED: SUFFOLK COUNTY CLERK 08/14/2023 01:54 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 249 RECEIVED NYSCEF: 08/14/2023 subsequent overdose with 33 sleeping pills in August 2007, as well as multiple additional attempts2 over the year and a half Plaintiff was treating with Dr. Taddeo, together with episodes of cutting herself and impulsive spending, which, based on Dr. Cavuoto’s records, continued to September 2009 (T701-703). Dr. Kurani likewise acknowledged that Plaintiff told Dr. Pitch she had a clear and substantial benefit from Topamax, and that when Dr. Pitch lowered the dosage to 800 mg a day, she developed new symptoms (T704). 46. Finally, cross-examination revealed that in 2007, Dr. Kurani had received a penalty letter from the New Jersey Attorney General’s Office because he had not completed all his continuing medical education (CME) requirements, despite representing that he had done so (T709). Defendants’ Case Deposition Testimony 47. Defense counsel read into evidence pertinent portions of the deposition testimony of Dr. Scott Berlin, Plaintiff’s obstetrician-gynecologist; Dr. Pitch; and Joellen Anderson. This included Dr. Berlin’s testimony that “cleft lips happen in nature” (T745), and Dr. Pitch’s testimony that Plaintiff advised him that Topamax helped level her moods better than not being on it; that “she said the Topamax really helped” (T748-749); that she had serious medical issues; and that it was important to control those conditions (T758). 48. The excerpts from Joellen’s testimony read by defense counsel included her discussions advising Plaintiff that she should not become pregnant, and that Tony xxxxxxxx indicated he would assume responsibility for birth control (T767-775). Plaintiff’s counsel then 2 These included an overdose of 10 Klonopin tablets in the winter of 2008 and an overdose of Lamictal in August 2008 (T702). 18 4933464 18 of 25 FILED: SUFFOLK COUNTY CLERK 08/14/2023 01:54 PM INDEX NO. 026910/2012 NYSCEF DOC. NO. 249 RECEIVED NYSCEF: 08/14/2023 insisted on reading additional portions of the testimony, including Joellen’s description of her firing by Dr. Taddeo (T784-786), over defense counsel’s objection that this was unrelated and irrelevant (T784). In response to a question from the Court, the attorneys acknowledged that they had agreed to read deposition testimony during trial; however, defense counsel noted that they did not waive objections to the testimony that were reserved for the time of trial (T785). Nevertheless, the Court allowed Plaintiff’s counsel to read Joellen’s testimony that Dr. Taddeo “left a note for the social worker and I that we were no longer needed. In fact, he hired, my feeling is, less experienced people at a lower rate of pay so he would have to pay less.” Dr. Muskin 49. Dr. Philip Muskin, a psychiatrist, testified as Defendants’ liability expert. He