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NYSCEF DOC. NO. 128 RECEIVED NYSCEF: 01/13/2020
Short Form Order
SUPREME COURT - STATE OF NEW YORK
PART 7 - SUFFOLK Ct
PRESENT:
WILLIAM B. REBOLINI
Justice
xxxxxx xxxxxxxx on behalfof C.S., index No.: 26910/2012E.
an infant under the age of 18 years,
and xxxxxx xxxxxxxx, individually, [Attomeys See Rider Annexed]
Plaintiff, Motion Sequence No.: 004; MG
Motion Date: 2/13/19
-against- submitted: 5/22/19
Ronald J. Tadeo, M.D., Richard Pitch, M.D., Motion Sequence No.: 005; MOTD “~~
Scott Berlin, M.D., Shore Psychiatric Center, Motion Date: 2/13/19
Family Psychology of Long Island, Berlin Submitted: 5/22/19
OB/GYN Associates, Janssen Pharmaceuticals, Inc.
k/n/a Ortho-McNeil-Janssen Pharmaceuticals, Inc., Motion Sequence No.: 007; MG ~~
and Zydus Pharmaceuticals USA, Inc., Motion Date: 2/20/19
Submitted: 5/22/19
Defendants.
Motion Sequence No.: 008; MG
Motion Date: 2/20/19
Submitte 22/19
Motion Sequence No.: 009; MD “~~
Motion Date: 2/20/19
Submitted: 5/22/19
Upon the following papers read on these motions for summary judgment: Notice of Motion
and supporting papers by defendants Scott Berlin, M.D., and Berlin OB/GYN Associates, dated
January 3, 2019; Notice of Motion and supporting papers by defendants Ronald Taddeo, M.D., and
Shore Psychiatric Center, dated January 9, 2019; Notice of Motion and supporting papers by
defendant Family Psychology of Long Island, P.C., dated January 9, 2019; Notice of Motion and
supporting papers by defendant Richard Pitch, M.D., dated January 10, 2019; Notice of Cross
Motion and supporting papers by defendant Family Psychology of Long Island, P.C., dated February
12, 2019; Answering Affidavits and supporting papers by the plaintiffs, dated May 6, 2019; Reply
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Affidavits and supporting papers by defendants Scott Berlin, M.D., and Berlin OB/GYN Associates,
dated May 16, 2019; Reply Affidavits and supporting papers by defendant Richard Pitch, M.D.,
dated May 20, 2019; Reply Affidavits and supporting papers by defendants Ronald Taddeo, M.D.,
and Shore Psychiatric Center, dated May 21, 2019; Reply Affidavits and supporting papers by
defendant Family Psychology of Long Island, P.C., dated May 21, 2019; it is
ORDERED that the motion (seq. 004) by defendants Scott Berlin, M.D., and Berlin
OB/GYN Associates, the motion (seq. 005) by defendants Ronald Taddeo, M.D., and Shore
Psychiatric Center, the motion (seq. 007) by defendant Family Psychology of Long Island, P.C., the
motion (seq. 008) by defendant Richard Pitch, M.D., and the cross motion (seq. 009) by defendant
Family Psychology of Long Island, P.C., are consolidated for purposes of this determination; and
itis
ORDERED that the motion by defendants Scott Berlin, M.D., and Berlin OB/GYN
Associates for summary judgment dismissing the complaint against them is granted; and it is
ORDERED that the motion by defendants Ronald Taddeo, .D., and Shore Psychiatric
Center for summary judgment dismissing the complaint against them is granted to the extent
provided herein, and is otherwise denied; and it is
ORDERED that the motion by defendant Family Psychology of Long Island, P.C., for
summary judgment dismissing the complaint against it is granted; and it is
ORDERED that the motion by defendant Richard Pitch, M.D., for summary judgment
dismissing the complaint against him is granted; and it is further
ORDERED that the cross motion by defendant Family Psychology of Long Island, P.C., for
summary judgment dismissing the complaint against it is denied, as moot.
This action was commenced by plaintiff xxxxxx xxxxxxxx, individually, and on behalf
of her
son, CS., an infant under the age of 18, seeking damages for injuries they allegedly sustained as a
result of defendants’ negligence. Generally, plaintiffs allege that C.S. was born with, among other
things, a cleft lip and cleft palate as a result of xxxxxx xxxxxxxx’s ingestion of the prescribed
medication Topamax and/or its generic equivalent, topiramate, both prior to, and during, her
pregnancy. For the purposes of this decision, the use of the term “Topamax” by the Court will
signify both Topamax and its generic equivalent. It is undisputed that Mrs. xxxxxxxx has a history
of various psychological conditions, including depression, resulting in multiple suicide attempts.
It is further undisputed that Mrs. xxxxxxxx’s psychiatrist, defendant Dr. Ronald Taddeo, prescribed
Topamax, in addition to many other medications, in an attempt to treat her disorders. Plaintiffs
assert causes of action against the medical provider defendants, alleging medical malpractice, lack
of informed consent, and vicarious liability. Plaintiffs also assert causes of action against the
pharmaceutical defendants, alleging strict products liability, negligence, negligent design, fraud,
misrepresentation, suppression, constructive fraud, breach of express and implied warranties, and
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gross negligence. An infant compromise order was signed on January 30, 2019, memorializing a
settlement of plaintiffs’ claims against the pharmaceutical company defendants Janssen
Pharmaceuticals, Inc., and Zydus Pharmaceuticals (USA), Inc., only.
Defendants Scott Berlin, M.D. and Berlin OB/GYN Associates (collectively, the Berlin
defendants) now move for summary judgment in their favor, arguing that they did not depart from
the standard of care, that they did not prescribe the medications in question, that their treatment of
plaintiffs was not a substantial contributing factor to the alleged injuries, and that they cautioned
against all medications. In support of their motion, they submit, among other things, transcripts of
deposition testimony, certified medical records, and the expert affirmations of Dr. Howard
Nathanson and Dr. Steven Fayer.
Defendants Ronald Taddeo, M.D. and Shore Psychiatric Center (collectively, the Taddeo
defendants) also now move for summary judgmentin their favor, arguing that Dr. Taddeo performed
a thorough analysis of the risks and benefits inherent in the medications he prescribed Mrs. xxxxxxxx,
that the medications’ efficacy in reducing Mrs. xxxxxxxx’s instances of self-harm outweighed the
potential harm to her fetus, that Topamax use by pregnant patients was not contraindicated at the
time he treated Mrs. xxxxxxxx, that she was fully informed of the potential for harm from her
medications, and that his psychiatric care of her was at all times within the standard of care at the
time such treatment was rendered. The Taddeo defendants further argue that Mrs. xxxxxxxx’s
derivative claims are time-barred, as they were asserted more than two years and six months from
the cessation of treatment, In support of their motion, they submit, among other things, transcripts
of deposition testimony, medical records, and the expert affirmation of Michael Liebowitz, M.D.
Defendant Family Psychology of Long Island, P.C. (Family Psychology) moves for summary
judgment in its favor, arguing that it did not treat plaintiffs, that Dr. Richard Pitch was not its
employee or agent, and that it cannot be held vicariously liable for any acts of Dr. Pitch. In support
of his motion, he submits, among other things, an affidavit of Mark Furshpan, Ph.D., and a copy of
a rental agreement.
Defendant Richard Pitch, M.D., moves for summary judgment in his favor, arguing he did
not depart from the standard of care, that he appropriately informed xxxxxx xxxxxxxx of the risks
associated with her medications, that any injury to C.S. had already occurred priorto his first session
with Mrs. xxxxxxxx, and that Mrs. xxxxxxxx’s derivative claims are time-barred. In support of his
motion, he submits, among other things, transcripts of deposition testimony, medical records, and
an expert affirmation of Jason E. Hershberger, M.D.
Further, Family Psychology cross-moves, submitting additional arguments to supplement its
motion in chief, contending that it cannot be held vicariously liable for the actions of Dr. Richard
Pitch because Dr. Pitch did not deviate from the standard of care.
xxxxxx xxxxxxxx testified that she has suffered from various forms of mental illness
throughout her life, including suicidal ideation, punctuated by two serious suicide attempts in 2007.
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She indicated that she gave birth to three healthy children, but then miscarried three fetuses in the
years 2005 through 2007. The latter two miscarriages occurred while receiving obstetrical and
gynecological care from the Berlin defendants. Ms. xxxxxxxx stated that her grief related to her
miscarriages exacerbated her psychiatric conditions and may have contributed to her attempts at
suicide by overdose of pills. Following her suicide attempts, she began seeing Dr. Ronald Taddeo
for psychiatric care, and was prescribed various medications, including Topamax. Upon questioning,
Mrs. xxxxxxxx admitted that while she considered the risks that her psychiatric medications would
have if she became pregnant, she continued to have unprotected sexual intercourse. At a point in
August or September of 2009, Mrs. xxxxxxxx suspected that she was pregnant, and purchased “many”
home pregnancy tests. She stated that upon the first positive pregnancy test result she called Dr.
Taddeo to inform him. Mrs. xxxxxxxx indicated that she discussed with Dr. Taddeo the fact that she
was taking various medications, but that Dr. Taddeo informed her that “the benefits outweigh the
risks.”
Mrs. xxxxxxxx testified that following an almost two year lapse in treatment with the Berlin
defendants, she again visited their office on September 25, 2009, and September 28, 2009, for blood
tests to confirm her pregnancy. She did not see a physician on either date. Her pregnancy was
subsequently confirmed, and her first prenatal doctor visit was scheduled for October 15, 2009. She
indicated that she saw Dr. Scott Berlin on October 15, 2009, and engaged in extensive discussion
with him regarding her medical history and the medications that she was currently taking. She
testified that Dr. Berlin used a Physician's Desk Reference book to research each of her medications,
then advised her to “[c]ome off the medications.” Mrs. xxxxxxxx indicated that despite Dr. Berlin’s
recommendation, she continued taking her medications.
Mrs. xxxxxxxx testified that because she had heard some negative things about Dr. Taddeo,
and had decided instead to see Dr. Richard Pitch for her psychiatric treatment, she scheduled an
appointment with him for November 3, 2009. Mrs. xxxxxxxx acknowledged that she had scheduled
such appointment “months before,” prior to learning that she was pregnant, but did not inform Dr.
Pitch of her pregnancy prior to her first visit. Despite having made an appointment with Dr. Pitch,
Mrs. xxxxxxxx attended a final appointment with Dr. Taddeo on September 24, 2009, at which he
reiterated his opinion that the benefits of her medications outweighed their risks.
Ather first visit with Dr. Pitch he reviewed her current medications, which included Prozac
and discussed the
and Topamax, commented that her Topamax prescription was especially high, acknowledged
tisks of those medications to her pregnancy. Upon questioning, Mrs. xxxxxxxx that
Topamax provided a “clear and substantial benefit,” and that it was Dr. Pitch’s opinion that its
benefits outweighed its risks, which included hypospadias in male fetuses. However, she stated that
Dr. Pitch never advised her of a risk of cleft lip or palate. She further stated that Dr. Pitch began
‘weaning her off the Prozac, which he told her could cause complications in the third trimester ‘of her
pregnancy, and on November 19, 2009, reduced her Topamax dose from 1000 mg daily to 800 mg
daily. Mrs. xxxxxxxx indicated that the symptoms of her psychiatric disorders increased in severity
following the reduction in dosage of Topamax, which prompted Dr. Pitch, on December 7, 2009, to
recommend she return to her prior dose of 1000 mg daily.
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Tony xxxxxxxx testified that he is xxxxxx xxxxxxxx’s husband and the father of plaintiff C.S.
He stated that Mrs. xxxxxxxx has been diagnosed with bipolar disorder, depression, and borderline
personality disorder. Mr. xxxxxxxx stated that soon after his wife told him that she was pregnant with
C.S., they visited the Berlin defendants’ office. He indicated that Dr. Berlin informed them that Mrs.
‘xxxxxxxx was pregnant, scheduled a sonogram, and discussed her medications. Mr. xxxxxxxx testified
that Dr. Berlin explained that certain of Mrs. xxxxxxxx’s medications were more “severe” than others,
but that “it was the purview of her psychiatrist to take her off the meds.”"
Mr. xxxxxxxx testified that he and Mrs. xxxxxxxx saw Dr. Pitch for the first time soon after their
visit with Dr. Berlin, and that Dr. Pitch used a computer to research each of Mrs. xxxxxxxx’s
medications. Mr, xxxxxxxx indicated that Dr. Pitch was most concerned with the drug Topamax,
because it was classified as a category C medication, and that it could cause the birth defect of
hypospadias. Mr. xxxxxxxx stated that he and his wife asked Dr. Pitch about the possibility of
removing Topamax from her medication regimen, but Dr. Pitch responded that “it is already the first
trimester so whatever damage is done, is done already.” Upon questioning, Mr. xxxxxxxx agreed that
his wife “did not handle it well” when Dr. Pitch attempted to decrease her Topamax dose on one
occasion.
Dr. Scott Berlin testified that he has been licensed to practice medicine in New York since
1994, and that he has been board certified in obstetrics and gynecology since 1991. He stated that
he has never spoken to Dr. Taddeo or Dr. Pitch, and was unfamiliar with the medication Topamax
prior to treating Mrs. xxxxxxxx in 2009. Dr. Berlin indicated that he first saw Mrs. xxxxxxxx on
October 15, 2009 for her pregnancy with C.S., recorded that she was taking Prozac, Abilify,
Topamax, and Wellbutrin, but did not know “when she started [taking those medications] or why.”
However, he remembered advising Mrs. xxxxxxxx that she “should not be on any medications,
especially psychiatric medications, during an early pregnancy.” Further, he testified that he did not,
engage in any risk/benefit analysis regarding Mrs. xxxxxxxx’s psychiatric medications, because “{t]hat
is not [his] scope of practice.”
Dr. Howard Nathanson submits an expert affirmation on behalfof the Berlin defendants.
Therein, he states that he has been licensed to practice medicine in New York since 1972 and that
he has been board certified in obstetrics and gynecology since 1981. He indicates that in forming
his opinions as to the Berlin defendants’ conduct, he reviewed the pleadings, plaintiffs’ bills of
particulars, the parties’ deposition testimony, a certified copy of Dr. Scott Berlin's medical records
relating to xxxxxx xxxxxxxx, and a copy of Dr. Taddeo’s medical records relevant to this matter. Dr.
‘Nathanson states that xxxxxx xxxxxxxx had not seen Dr. Berlin at any time between July 5, 2007 and
September 24, 2009, and that it was not the standard of care to contact a patient during a lapse in
care, He further states that it is “standard practice for an office to verify the pregnancy before
makingan initial pre-natal appointment with the physician.” Thus, Dr. Nathanson concludes, Mrs.
xxxxxxxx “was provided with an initial pre-natal appointment [with Dr. Berlin on October 15, 2009]
ina timely fashion following confirmation of her pregnancy [with C.S.].” Regarding Mrs. xxxxxxxx’s
initial pre-natal appointment with Dr. Berlin on October 15, 2009, Dr. Nathanson avers that she was
seven weeks pregnant at such time, that “the lips form between the fourth and seventh weeks of
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pregnancy,” that “the palate forms between the sixth and ninth weeks of pregnancy,” and that “it is
likely that [C.S.’s] lips were already completely formed and the palate would have been in the
process of formation.” Therefore, he opines that “in order to have avoided injury to the fetus
altogether, (Mrs. xxxxxxxx] would have had to have been completely offall medications by October
1, 2009” [emphasis in original]. Dr. Nathanson states that Dr. Berlin’s “admonition to (Mrs.
xxxxxxxx] that she should ideally come off all of her medications, including Topamax” was
“appropriate,” that “the management of the medications would have to be performed by her
psychiatrist,” and that “it would have been a departure from the standard of care had Dr. Berlin
advised [Mrs. xxxxxxxx] to stop taking her medications immediately.” Rather, he indicates that “Dr.
Berlin, as an obstetrician with no knowledge of [Mrs. xxxxxxxx’s] psychiatric history . .. would not
have known the danger he could have placed Mrs. xxxxxxxx and C.S.] in . . . by stopping the
medications.” In addition, Dr. Nathanson avers that “cleft lip and palate are birth defects that occur
in the absence of any medication involvement” and that “especially in the setting of unknown
paternity,” it is unclear that [C.S.’s] injuries are the result of medication taken by [Mrs. xxxxxxxx].”
Inconclusion, Dr. Nathanson opines that, to a reasonable degree of medical certainty, the care and
treatment rendered by the Berlin defendants “was within the accepted standard of care, did not
constitute negligence and/or malpractice, does not support a claim for lack of informed consent, and
was not a proximate cause of any of the alleged injuries or damages sustained in this matter.”
Dr. Steven Fayer, also supplying an expert affirmation on behalfof the Berlin defendants,
states that he has been licensed to practice medicine in New York since 1974, and that he has been
board certified in neurology and psychiatry since 1977. After reviewing documents identical to those
reviewed by Dr. Nathanson, Dr. Fayer states that Dr. Berlin’s instruction that Mrs. xxxxxxxx should
speak with her psychiatrist regarding discontinuing her medicati ons He indicates that
was “typical.”
Dr. Berlin, “as a doctor of gynecology and obstetrics, has no expertise or experience in managing.
psychiatric medications or psychiatric conditions.” Dr. Fayer avers that “even if Dr. Berlin.
started to wean [Mrs. xxxxxxxx] off her Category C medications on October 15, 2009. . . she couldIn
not have been successfully weaned in time to avoid the injuries to [C.S.’s] lips and palate.”
conclusion, Dr. Fayer opines that the care and treatment rendered by the Berlin defendants “
deferring management of [Mrs. xxxxxxxx’s] psychiatric state and medications to her treating
psychiatrists was appropriate and did not constitute negligence and/or medical malpractice, that the
allegations as made do not support a claim for lack of informed consent, and that the care provided
|. Was not a proximate cause of any of the alleged injuries or damages sustained in this matter.”
Dr. Ronald Taddeo testified that during the dates in question, defendant Shore Psychiatric
Center was the “d/b/a” of “Ronald J. Taddeo, M.D., P.C.” He stated that he has been licensed to
practice medicine in New York since 1975, and that he has been board certified in psychiatry and
neurology since 1979. Dr. Taddeo indicated that during the times in question, he had a collaborative
practice agreement with JoEllen Anderson, a nurse practitioner working in his office. He testified
that Mrs, xxxxxxxx had been attending sessions with Ms. Anderson to address her mental health
needs, and was diagnosed by her as having borderline personality disorder. Dr. Taddeo stated that
in 2008, Ms. Anderson referred Mrs. xxxxxxxx to him, after determining Mrs. xxxxxxxx’s condition
was beyond her abilityto treat effectively. Dr. Taddeo first saw Mrs. xxxxxxxx on February 21, 2008,
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at which time she was currently taking Klonopin, Zoloft, and Lamictal. Afier evaluating Mrs.
xxxxxxxx, Dr. Taddeo diagnosed her with bipolar disorder, mixed type on March 27, 2008. Dr.
Taddeo testified that Mrs. xxxxxxxx complained that the Lamictal had given her a rash and, in its
place, he began prescribing Topamax.
Asked to explain his familiarity with Topamax, Dr. Taddeo stated that while it was marketed
as an anti-seizure and anti-migraine medication, he attended a conference in the early 2000s where
he learned that it “can also be used as a mood stabilizer for bipolar conditions.” He began
prescribing it to his patients for bipolar disorder soon thereafter, because it was “unique in that it did
not cause weight gain and actually limited appetite.” He also stated that it showed “some efficacy
in anger management and control of impulsive disorders.” He acknowledged that the Food and Drug
Administration had not approved Topamax’s use as a mood stabilizer. Questioned regarding
Topamax’s safety, Dr. Taddeo explained that at the time Mrs. xxxxxxxx was taking it, it was classified
as category “C,” meaning that it “has not been proven to be damaging during pregnancy, but animal
studies seem to indicate that there may be a potential danger during pregnancy.” Dr. Taddeo denied
knowledge of any studies, conducted between 2007 and 2009, determining Topamax was dangerous
to human pregnancies, unaware of any literature linking it to cleft lips or cleft palates, and that
categoryC medications can be prescribed to pregnant women ona case-by-case basis, after weighing
“[rlisk and reward.” He testified that he would generally advise his psychiatric patients to avoid
pregnancy, as it representsa large change in a person’ life, potentially disrupting the positive strides
she may be making in her treatment. Though, he stated that in the 2007-2009 time period he had no
reason to advise women not to become pregnant based solely on the fact that they were taking
Topamax.
Dr. Taddeo testified that he was seeing Mrs, xxxxxxxx on an approximately monthly basis and,
in addition to the many other medications she was prescribed, she was taking 1000 mg of Topamax
daily as of November 7, 2008. He stated that on September 24, 2009, Mrs. xxxxxxxx informed him
that she was pregnant, and that he advised her to immediately discontinue her use of Klonopin,
class D medication, to wean herself off of Zoloft, and that he would contact Dr. Berlin to coordinate
her medications with him. Dr. Taddeo indicated that all of Mrs. xxxxxxxx’s other medications were
class C and that he “had concerns about her stopping those medications because of her bipolar
condition,” but that he “wanted to maintain her safety.” Shown what purported to be a 2008
Topamax label, Dr. Taddeo acknowledged it indicates findings of “craniofacial birth defects” in
animal studies.
Dr. Michael Liebowitz supplied an expert affirmation on behalf of the Taddeo defendants,
wherein he states that he is licensed to practice medicine in New York, and that he has been board
certified in psychiatry continuously since 1978. He indicates that he reviewed xxxxxx xxxxxxxx’s
medical records, the pleadings, the bills of particulars, and the parties’ deposition transcripts. Based
upon his review of the aforementioned materials, Dr. Liebowitz formulated several opinions.
Initially, Dr. Liebowitz states that at the time Dr. Taddeo prescribed Topamax to Mrs. xxxxxxxx, it
was classified as a “pregnancy category C drug,” meaning that “its potential effects on the fetus had
to be weighed against the risk of taking a patient off of the drug and stopping treatment.” Dr.
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Liebowitz opines that based upon Mrs. xxxxxxxx’s symptoms, and “based upon his prior experience
in successfully using Topamax for patients with mood disorders and poor impulse control, it was
entirely appropriate for Dr. Taddeo [to] prescribe it to [her].” Dr. Liebowitz further states that Dr.
Taddeo appropriately weighed the risks and benefits of Topamax, determined that Mrs. xxxxxxxx
“would need to remain on the drug to ensure her safety, as her suicidality would return off the
medication,” and that it would have been a deviation from the standard of care to immediately
discontinue her use of the medication upon learning of her pregnancy because Topamax “needs to
be weaned.” Dr. Liebowitz avers that palate formation in a fetus occurs between the fourth and ninth
weeks of gestation, “making it unlikely that [Mrs. xxxxxxxx] could have been taken fully off the
medication before the palate and or the cleft developed.” Dr. Liebowitz indicates that Mrs. xxxxxxxx
“was fully cautioned about the risks and side effects of [her medications), which included counseling
to continue to use birth control and to avoid pregnancy fora variety of reasons.” In conclusion, Dr.
Liebowitz opines, within a reasonable degree of medical certainty, that “at all relevant times herein,
Dr. Taddeo acted properly and appropriately and within the standard of care.”
Dr. Richard Pitch testified that he has been licensed to practice medicine in New York since
1991 and has been board certified in psychiatry since 1997. He stated that while he rents office
space from Family Psychology, he is not employed by it, and does his own billing. Dr. Pitch
indicated that he first saw Mrs. xxxxxxxx on November 3, 2009, when she was 10 weeks pregnant.
He testified that she was “on quite a few medications,” that hers was a “high risk pregnancy” because
of “all of them,” but that “she said the Topamax really helped.” He further testified that at her first
visit he diagnosed her as having depression, obsessive compulsive disorder with features of post-
traumatic stress disorder, and borderline personality disorder. Dr. Pitch stated that he discussed the
risks of her medications to her pregnancy, including the risk of hypospadias in the fetus due to
Topamax, but also the dangers ofdiscontinuing them. Regarding Topamax, he indicated that fetal
organ development “happens mostly in the first trimester,” and that he informed Mrs. xxxxxxxx that
“most ofthe damage will have been done during the first trimester and . .. it was probably going to
be too late to prevent any harm by stopping the Topamax now.”
Dr. Pitch testified that at her next visit with him, on November 19, 2009, Mrs. xxxxxxxx
sought to reduce her medication consumption, beginning with Topamax. Following an extensive
conversation regarding the risks and benefits of Topamax, he reduced her dosage. However, he
indicated that on December 7, 2009, he received a telephone call from Mrs. xxxxxxxx informing him
that she “was doing poorly” on the reduced dosage of Topamax and, accordingly, restored its level
to 1000 mg daily.
Dr. Jason Hershberger supplied an expert affirmation on behalfof Dr. Pitch, wherein he
states that he is licensed to practice medicine in New York, that he is board certified in psychiatry
and neurology, and that he maintains a board sub-certification in forensic psychiatry. He indicates
that he reviewed the pleadings, plaintiffs’ bill of particulars, the pertinent medical records, and
transcripts of the witnesses’ deposition testimony. Dr. Hershberger avers that Topamax is an anti-
seizure medication which is utilized as a mood stabilizer for bipolar and impulse disorders. He states
that its use in a psychiatric setting “is accepted practice in the medical community and standard of
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care in the industry.” Dr. Hershberger indicates that Dr. Pitch had no obligation to accept Mrs.
xxxxxxxx as a patient prior to her initial appointment oi November 3, 2009, and that at such time she
was already 10 weeks pregnant and that her various medications included 1000 mg of Topamax
daily. He states that Dr. Pitch properly informed Mrs. xxxxxxxx of the risk of organ malformation in
fetuses, specifically hypospadias, and was justified in seeking to wean her off of the Topamax
slowly. However, Dr. Hershberger opines that the dosage of Topamax prescribed by Dr. Taddeo for
Mrs. xxxxxxxx was too high to fully wean her off of the drug prior to the end of the first trimester of
her pregnancy, “at which time the major organs of the body are formed.” Dr. Hershberger states that
the known risks associated with Topamax had to be balanced against the risk of Mrs. xxxxxxxx
relapsing and causing harm to herself and her fetus. Further, he opines that “in 2009, the particular
tisk of craniofacial deformity was not understood or known in the medical community,” and that “[iJt
was not until 2011 . that the classification for Topamax was changed by the FDA to a Category
‘D,’ indicating positive evidence of human fetal risk.” Dr. Hershberger indicated that it is significant
to Dr. Pitch’s risk/benefit analysis that when he attempted to decrease Mrs. xxxxxxxx’s Topamax
dosage, she experienced a marked increase in negative psychiatric symptoms, and demonstrated that
“a reasonably prudent person in [Mrs. xxxxxxxx’s] position would not have declined to continue to
undergo treatment with Topamax.” In conclusion, Dr. Hershberger opines that Dr. Pitch “acted
within good and accepted standards of medical practice at all times, and that neither his actions, nor
a lack of informed consent was a substantial causative factor of the claimed injuries.”
A party moving for summary judgment “must make a prima facie showing ofentitlement to
judgment asa matter of law, tendering sufficient evidence to demonstrate the absence of any material
issues of fact” (Alvarez v Prospect Hosp., 68 NY24 320, 324, 508 NYS2d 923, 925 [1986]). Failure
to make such showing requires denial of the motion, regardless of the sufficiency of the opposing
papers (Winegrad v New York Univ. Med. Ctr., 64 NY2d 851, 853, 487 NYS2d 316, 318 [1985].
If the moving party produces the requisite evidence, the burden then shifts to the nonmoving party
to establish the existence of material issues of fact which require a trial of the action (see Vega v
Restani Constr. Corp., 18 NY3d 499, 942 NYS2d 13 [2012]). Mere conclusions, expressions of
hope, or unsubstantiated allegations are insufficient to raise a triable issue (see Zuckerman v City
of New York, 49 NY2d 557, 427 NYS2d 595 [1980]). In deciding the motion, the Court must view
all evidence in the light most favorable to the nonmoving party (see Ortiz v Varsity Holdings, LLC,
18 NY3d 335, 339, 937 NYS2d 157, 159 [2011}).
A defendant seeking summary judgmentin a medical malpractice action “must make a prima
facie showing either that he or she did not depart from the accepted standard of care or that any
alleged departure was not a proximate cause of the plaintiff's injuries” (Keane v Dayani,
AD3d. 2019 NY Slip Op 08834, *1-2 [2d Dept 2019]). Once the defendant has made such
a showing, e plaintiff, in opposition, must submit evidentiary facts or materials to rebut the
defendant’s prima facie showing, but only as to those elements on which the defendant met the prima
facie burden” (id.). However, summary judgment “is not appropriate in a medical malpractice action
where the parties adduce conflicting medical expert opinions... . {and] [sJuch credibility issues can
only be resolved by a jury” (Feinberg v Feit, 23 AD3d 517, 519, 806 NYS2d 661 [2d Dept 2005]
[internal citations omitted).
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v. Tadeo, et al.
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Lack of informed consent means “the failure of the person providing the professional
treatment or diagnosis to disclose to the patient such alternatives thereto and the reasonably
foreseeable risks and benefits involved as areasonable medical, dental or podiatric practitioner under
similar circumstances would have disclosed, in a manner permitting the patient to make a
knowledgeable evaluation” (Public Health Law § 2805-D [1]). It must also be established that “a
reasonably prudent person in the patient’s position would not have undergone the treatment or
diagnosis if he [or she] had been fully informed and that the lack of informed consent is a proximate
cause of the injury or condition for which recovery is sought” (Public Health Law § 2805-D [3]).
The Court finds that the moving defendants have established prima facie cases of entitlement
to summary judgment in their favor (see generally Alvarez v Prospect Hosp., supra). First, Family
Psychology established its prima facie case through the testimony of Dr. Pitch, wherein he stated that
he was not an employee of Family Psychology, but an independent contractor leasing office space
therefrom. Dr. Pitch’s contentions are supported by an affidavit of Mark Furshpan, Ph.D., in which
he states that he is a clinical psychologist, as well as the CEO and sole shareholder of Family
Psychology. He indicates that during the time in question, he was the only mental health
professional employed by Family Psychology. Furthermore, he states that Dr. Pitch received no
salary from Family Psychology, set his own hours, paid monthly rent, maintained his own
professional liability insurance and, pursuant to his lease agreement, was provided with limited
administrative services.
Dr. Pitch established a prima facie case by demonstrating that he did not see Mrs. xxxxxxxx
until she was already 10 weeks pregnant with C.S., and that if Topamax was a proximate cause of
plaintiffs’ alleged injuries, he could not have weaned Mrs. xxxxxxxx off such medication fast enough
to prevent those injuries. The Berlin defendants established their prima facie case by demonstrating
that they did not prescribe the Topamax, and that Dr. Berlin advised Mrs. xxxxxxxx to avoid all
medications during pregnancy. Finally, the Taddeo defendants established their prima facie case by
demonstrating through the testimony of Dr. Taddeo, and their expert witness’s affirmation, that the
dangers of Topamax to human fetuses were not known at the time Mrs. xxxxxxxx was prescribed that
medication, that Dr. Taddeo performed a risk/benefit analysis with regard to Topamax's known risks
in 2007-2009, and that it was within the standard of care to prescribe Topamax for Mrs. xxxxxxxx’s
condition.
Furthermore, the Taddeo defendants demonstrated, prima facie, that xxxxxx xxxxxxxx’s
derivative claim for loss of services is time-barred. “An action for medical, dental or podiatric
malpractice must be commenced within two years and six months of the act, omission or failure
complained of or last treatment where there is continuous treatment for the same illness, injury or
condition which gave rise to the said act, omission or failure” (CPLR 214-a). “Ifa person entitled
to commence an action is under a disability because of infancy or insanity at the time the cause of
action accrues . . . the time [within which the action must be commenced] shall be extended by the
period of disability . . . [but] shall not be extended by this provision beyond ten years after the cause
‘of action accrues” (CPLR 208 [a]). Plaintiffs’ complaint is dated August 28, 2012, and was filed on
August 30, 2012. Ms. xxxxxxxx testified that she last visited the Taddeo defendants’ office on
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September 24, 2009, and began seeing Dr. Pitch on November 3, 2009. Even were the Court to
accept the later date of November 3, 2009 as Ms. xxxxxxxx’s final date of treatment with the Taddeo
defendants, plaintiffs’ claims were asserted more than two years and six months therefrom. The
tolling provisions of CPLR 208 (a) permitted plaintiff C.S.’s causes of action to be timely in the
instant matter. However, “the toll for infancy pursuant to CPLR 208 does not apply to a parent’s
derivative cause of action” (Palacios v Town of N. Hempstead, 165 AD3d 967, 969, 86 NYS3d 117
[2d Dept 2018]). The burden then shifted to Mrs. xxxxxxxx “to raise a triable issue of fact as to the
applicability of an exception to, or toll of, the statute of limitations” (Yanez v Watkins, 164 AD3d
547, 548, 82 NYS3d 76 [2d Dept 2018]).
In opposition to the defendants’ instant motions, plaintiffs submit, among other things, an
affirmation of a physician, and a copy of'a Topamax warning label. In his or her affirmation,
plaintiffs’ expert states that he or she is licensed to practice medicine in New York, and is board
certified in psychiatry, neurology, child and adolescent psychiatry, and forensic psychiatry. Initially,
the Court notes that while the fifth and sixth paragraphs of the expert’s affirmation state that Dr.
Pitch and Family Psychology deviated from accepted standards of medical care in their treatment of
Mrs. xxxxxxxx, there is no further discussion of how or when those defendants departed from the
the Berlin
standard of care. In addition, plaintiffs’ expert does not attribute any acts of negligence todefendants,
defendants, Thus, such expert affirmation fails to raise a triable issue as to the Berlin
Family Psychology, and Dr. Pitch, and plaintiffs’ counsel sets forth no opposition to those
defendants’ motions in their affirmation in opposition. Accordingly, the motion by defendants Scott
Berlin, M.D., and Berlin OB/GYN Associates, the motion by defendant Family Psychology of Long
Island, P. nd the motion by defendant Richard Pitch, M.D., for summary judgment dismissing,
the complaints against them, are granted. The cross motion by defendant Family Psychology of Long
Island, P.C., for summary judgment dismissing the complaint against it is denied, as moot.
‘Asto the Taddeo defendants, however, plaintiffs argue that they deviated fromto the standard
fully inform
‘of medical care by failing to properly monitor Mrs. xxxxxxxx’s medications, by failing
Mrs. xxxxxxxx of the potential risks of Topamax to a fetus, and by preseribing such medication at from:
more than double the recommended dosage. Plaintiffs’ expert avers that they “departed
accepted standards of medical care in failing to discuss the risks of dangerous and teratogenic
medication with Mrs. xxxxxxxx,” failed to discuss birth control with Mrs. xxxxxxxx while prescribing
said medications, failed to “conduct risk-benefit analyses with Mrs. xxxxxxxx,” failed to “recommend
‘or consider safer alternatives,” prescribed Topamax at “an excessively high rate without a legitimate
medical purpose, ” and improperly managed Mrs. xxxxxxxx’s medications. Particularly, plaintiffs’
expert states that “while the FDA had not yet established the causal link between topiramate and cleft
lip/cleft palate that is known today, FDA warnings for the drug in 2009 included the statement,
‘Topiramate has demonstrated selective developmental toxicity, 20,including teratogenicity, in
experimental animal studies . [and that] [wJhen oral doses of 100, or 500 mg/kg were
administered to pregnant mice during the period of organogenesis, theTheincidence of fetal
expert states that
‘malformations (primarily craniofacial defects) was increased at all doses.”
Dr. Taddeo did not have any discussions of Topamax’s risks to fetuses, including craniofacial
defects, with Mrs. xxxxxxxx, which was a departure from the standard of care. The expert further
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states that “[w]hile it is possible that Topamax was the best medication for Mrs. xxxxxxxx at the time,
Dr. Taddeo did not evaluate, consider, or recommend, non-teratogenic alternatives.” In conclusion,
the expert opines, based upon his or her review of the records, as well as his or her knowledge and
experience in the field of psychiatry, that “Mrs. xxxxxxxx had alternatives available to her, and that
had she been fully apprised to the risks associated with her medications, would have chosen either
different medications or different family planning methods, such that she would not have taken
teratogenic medications while trying to conceive and the injuries to [C.S.] likely would have been
prevented or at least minimized.”
The Court finds plaintiffs have succeeded in raising triable issues as to the Taddeo
defendants, and that there exists a conflict in the opinion of two experts (see Feinberg v Feit, supra).
While there is some dispute regarding Mrs. xxxxxxxx’s intentions regarding future pregnancies while
treating with Dr. Taddeo, it is undisputed that he did not discuss the findings of “craniofacial
defects” in the offspring of pregnant mice receiving dosages of Topamax in laboratory studies.with a
Other triable issues raised by plaintiffs include whether the failure to discuss such findings
female patient of childbearing age was a departure from the standard of ‘medical care, whether the
dosage of Topamax as prescribed by Dr. Taddeo was appropriate, whether there were safer, but
equally effective medications available, whether Topamax was a proximate positioncause of plaintiffs’
alleged injuries, and whether a reasonably prudent person in Mrs. xxxxxxxx’s would have
foregone treatment with Topamax had they been informed of animal studies resulting in craniofacial
defects. As to the Taddeo defendants’ argument that xxxxxx xxxxxxxx’s derivative claim for loss of
services is time-barred, plaintiffs offer no opposition. Thus, that cause of action is dismissed (see
Taddeo, M.D.,
‘generally Yanez v Watkins, supra). Accordingly, the motion by defendants Ronald against
and Shore Psychiatric Center for summary judgment dismissing the complaint