B.B.A. v VanegasAnnotate this Case
Decided on June 14, 2019
Supreme Court, Bronx County
B.B.A., an Infant by her Mother and Natural Guardian, BIANKA BRITO, Plaintiff,
Myriam F. Vanegas, MD, BRONX CARE AT OGDEN, MARC GREENSTEIN, M.D., WEST RIDGE OBSTETRICS AND GYNECOLOGY, LLP, KAREN ANN GRONAU, MD, SUFFOLK OB/GYN GROUP, PC, CONCEPCION G. SIA, MD, THE BRONX- LEBANON HOSPITAL CENTER and HUNTINGTON HOSPITAL, Defendants.
James N. LiCalzi, Esq.
Duffy & Duffy, PLLC
1370 RXR Plaza
Uniondale, New York 11556
Edward Kim, Esq.
Shaub, Ahmuty, Citrin & Spratt, LLP
1983 Marcus Avenue
Lake Success, New York 11042
Dr. Gronau & Suffolk OB/GYN Attny:
Laura Yenchman, Esq.
Schiavetti, Corgan, DiEdwards et al
575 Eighth Avenue
New York, New York 10018
Joseph E. Capella, J.
The following papers numbered 1 to 5 read on this motion, noticed on January 25, 2019, and duly submitted on May 28, 2019.
NOTICE OF MOTION AND CROSS-MOTION 1, 2
ANSWERING AFFIDAVIT AND EXHIBITS 3
REPLY AFFIDAVIT AND EXHIBITS4, 5
UPON THE FOREGOING CITED PAPERS, THE DECISION/ORDER IN THIS MOTION IS AS FOLLOWS:
The instant complaint is one sounding in medical malpractice whereby plaintiff alleges that the defendants improperly managed the labor and delivery of plaintiff-infant and failed to timely and properly order and perform a Cesarean section when the fetal heart tracings demonstrated evidence of intrapartum [FN1] insult and compromise, including prolonged episodes of hypoxia and ischemia as demonstrated by repetitive fetal heart rate decelerations and diminished long term variability, thereby causing plaintiff-infant to sustain severe and permanent injuries, including brain damage. By notice of motion and cross-motion,[FN2] the defendants seek an order pursuant to Frye v United States (293 F 1013 [DC Cir 1923]), precluding plaintiff's expert from testifying that plaintiff-infant was subject to an intrapartum insult during labor and delivery (emphasis added) that is proximately related to the findings on a brain MRI of cystic encephalomalacia and volume loss within the left frontoparietal region and right parietal lobe, on the premise that such an opinion does not constitute a generally accepted theory in the medical community.
A brief summary of the facts are warranted. Plaintiff-infant's mother, Bianka Brito, was admitted to the labor and delivery unit of defendant, Huntington Hospital, on April 14, 2006. A Caesarean section was undertaken based on non-reassuring fetal heart monitor findings, and defendant, Karen Ann Gronau, MD, delivered plaintiff-infant at 23:53. Normal Apgar scores were noted, and lab reports revealed that all arterial blood gas findings were within normal range. Plaintiff-infant was transferred to the regular nursery on April 16, 2005, and discharged on April 18, 2006. According to Ms. Brito, she first noticed plaintiff-infant's condition during the second or third month of life when she observed no movement of the right hand, as it was kept closed in [*2]a fist most of the time. An MRI performed on March 5, 2007, revealed a chronic infarct (dead tissue due to lack of blood) in the left frontoparietal lobe. A CT scan taken April 9, 2008, revealed focal encephalomalacia (softened brain tissue) and gliosis (scarring) in the left frontal lobe. On April 9, 2008, plaintiff-infant was admitted to North Short-LIJ, at which time it was noted that she had an episode involving bilateral shaking of the extremities, and assessed to have possible seizure activity. On July 22, 2008, a brain MRI was performed at Long Island Jewish Medical Center, revealing cystic encephalomalacia and volume loss within the left frontoparietal region and right parietal lobe consistent with sequelae from a remote cerebral insult.
Before addressing the defendants' Frye challenge, the Court will first address plaintiff's argument that this same causation issue was raised (and denied) in an earlier summary judgment (CPLR 3212) motion by defendants. A review of this earlier decision by Justice Guzman reveals that issues of fact were found to exists as to whether plaintiff-infant's injury occurred during the prenatal period, prior to the labor and delivery, or whether the labor and delivery itself is causally related to the injury. In addressing defendants' earlier summary judgment motion, the Court was confronted with competing expert theories as to causation (or the mechanism of an injury), which do not entail a Frye analysis, but entail a weighing of the evidence that was left for the jury to resolve. (Barnett v Fashakin, 85 AD3d 832 [2nd Dept 2011]; Frye v Montefiore, 70 AD3d 15 [1st Dept 2009].) This is very different from the issue raised in the instant Frye motion, which is whether there is general acceptance within the medical community that a retrospective diagnosis of the timing of a stroke during the perinatal [FN3] period can be made within a reasonable medical degree of certainty some months or years after the fact.
The prevailing standard of care governing the conduct of medical professionals demands that doctors exercise a reasonable degree of learning and skill that is ordinarily possessed by physicians and surgeons in the locality where they practice. (Pike v Hosinger, 155 NY 201 .) They are charged with the duty to exercise due care, which is measured against the conduct of their peers (i.e., the reasonably prudent doctor standard), and implicit in this concept is the principle that doctors must employ their best judgment in exercising their skill and knowledge. (Nestorowich v Ricotta, 97 NY2d 393 .) Within the context of a medical malpractice action, as with any negligence action, plaintiff must establish that defendants' negligence, which in this case is the alleged departure from good and accepted medical practice, proximately caused the injury claimed. (Mortensen v Memorial Hospital, 105 AD2d 151 .) Here the court is called upon to address the defendants' challenge to the opinion of plaintiff's expert regarding causation. Specifically, the opinion that plaintiff-infant was subject to an intrapartum insult during labor and delivery that is proximately related to the findings on brain MRI of cystic encephalomalacia and volume loss within the left frontoparietal region and right parietal lobe, does not constitute a generally accepted theory in the medical community. Under the test enunciated in Frye, which is the standard applied in New York courts, a proponent of novel science must establish its general acceptance among scientists within the relevant discipline to justify its admission. (293 F 1013; People v Angelo, 88 NY2d 217 .) This test ensures that courts do not rely upon an expert's testimony regarding a novel theory or procedure unless it has been generally accepted within the relevant scientific community as [*3]leading to reliable results, and essentially distinguishes between principles which are "demonstrable" versus "experimental."
In support of the relief requested, the defendants' expert, Dr. Molofsky, states that if a child suffered a stroke and/or cerebral vascular accident, either during the labor and delivery period (the only time defendant, Dr. Gronau, was involved in the case), or during the newborn period, the child would be expected to demonstrate symptoms characteristic of acute, or recent, onset of a stroke and/or cerebral vascular accident, the majority of which present during the neonatal period.[FN4] The medical literature cited by Dr. Molofsky includes Stroke In The Newborn: Classification, Manifestations, and Diagnosis, (Rebecca Ichord, MD; Wolters Kluwer, 2018), and Perinatal Aterial Ischemic Stroke: Presentation, Risk Factors, Evaluation and Outcome, (Laura L. Lehman, MD, Michael J. Rivkin, MD; Pediatric Neurology 51, 2014). Dr. Molofsky notes that a study of 86 cases of neonatal hemorrhagic stroke referenced in Clinical Characteristics, Risk Factors and Outcome Associated with Neonatal Hemorrhagic Stroke (Lauran Cole, BscH, Deborah Dewey, PHD, et al; JAMA Pediatrics, March 2017, Vol. 171), revealed Apgar scores of less than 5 at one minute in 36 cases (47%) and at five minutes in 12 cases (16%), and neonatal intensive care unit admission was common (88%).
According to Dr. Molofsky, the aforementioned medical literature stands for the proposition that an infant who suffers a stroke or brain injury during labor, delivery or the newborn (i.e., neonatal) period, demonstrates corresponding symptoms, most notably newborn seizures. He goes on to opine that the timing of a brain injury in a perinatal stroke is difficult to determine, and where as here the diagnosis is a retrospective one, it is thought the injury may have occurred in utero (i.e., during the pregnancy and not during labor and delivery). Dr. Molofsky notes that plaintiff-infant was born without any symptoms, and demonstrated no symptoms during the neonatal period. He states that plaintiff-infant, born April 14, 2006, had a normal newborn course in the hospital: normal Apgar scores of 9 (out of 10), able to move her extremities, normal respiration, fully awake, normal circulation, and a healthy pink color at birth. The first indication of any problem was during the second or third month of life when the mother claims she observed that the child held her hand in a fist. Seizure activity was reported in 2008, and MRIs performed in 2007 and 2008 confirmed that a stroke had occurred. Dr. Molofsky concludes that the opinion by plaintiff's expert regarding the timing (emphasis added) of the infant's injury is a novel one because the medical literature states that this cannot be done.
In opposition, plaintiff's expert, a physician who specializes in neonatal-perinatal and pediatric medicine, argues that Dr. Molofsky misstates the meaning of the literature he cites as authority to support his allegation that plaintiff relies upon a novel theory. For example, in Stroke In The Newborn: Classification, Manifestations, and Diagnosis, (Wolters, Kluwer, 2018), Dr. Molofsky chose the following quote: "Perinatal stroke is a common cause of acute neonatal encephalopathy, and may manifest as seizures, altered mental status, sensory motor deficits. It is an important cause of chronic neurological disability . . ." According to plaintiff's expert, this quote, which uses the word "may," does not stand for the suggested proposition that perinatal stroke must (emphasis added) manifest as seizures, etc. Multiple subsequent pages of this article discuss numerous types and causes of perinatal stroke, including numerous times and manner [*4]when such perinatal stroke manifests itself, which plaintiff's expert notes is the "precise opposite of the misuse of this literature by Dr. Molofsky." Another excerpt used by Dr. Molofsky from this article is as follows: "Most infants who are acutely symptomatic with stroke present with seizures, warranting a complete evaluation to exclude other etiologies of seizures, including systemic infection." According to plaintiff's expert, this quote does not stand for the proposition that perinatal stroke must (emphasis added) demonstrate immediate symptoms, nor that such symptomatology must (emphasis added) manifest as seizures. Instead, the expert notes that this is "clearly a statement that of those infants that are in fact acutely symptomatic with stroke, most of that category of patient (sic) will present with seizures."
Plaintiff's expert cites the following quote from the article, Stroke In The Newborn, that Dr. Molofsky does not mention:
"Presumed perinatal ischemic stroke (PPIS): events whose exact time of onset are inferred as perinatal (birth to 28 days of life) based upon clinical and imaging findings; the clinical presentation involves a chronic, static, focal neurologic deficit emerging during the first year of life in the absence of an acute neonatal encephalopathy (emphasis added) and imaging may reveal either an arterial territory infarction or a periventricular venous infarction."
According to plaintiff's expert, "this is precisely the situation we are dealing with in the instant case. The neurological deficit was not manifested during the neonatal period, but emerged during the first year of life, and when the imaging confirmed the evidence of prior stroke, the stroke is designated as Presumed Perinatal Ischemic Stroke (obviously this is in the circumstances where there are not events between birth and diagnosis that would provide a different etiology for the stroke)."
From Perinatal Aterial Ischemic Stroke: Presentation, Risk Factors, Evaluation and Outcome, (Lehman, Rivkin, Pediatric Neurology 51, 2014), Dr. Molofsky presents the following quote:
"Newborns who sustain AIS (Arterial Ischemic Stroke) present 58-68% of the time during the neonatal period . . . the remainder presents after 28 days of age usually because of detection of a focal neurological abnormality which, in turn, leads to discovery of an old cerebral infarct that is classified as presumed perinatal AIS. The most common presenting feature of neonatal term infants with AIS is seizure. Seizures constitute the initial sign in 69-90% of the term of newborns with neonatal AIS . . ."
Dr. Molofsky then comments: "please note that the word 'perinatal' refers to the period ranging from 20 weeks of gestation to 28 days post birth. The 'neonatal period' is generally considered to be from birth to one month of life." Plaintiff's expert notes that at the outset of this article, the authors wrote under the heading "classification" the following: "Perinatal AIS can be subclassified according to the time of diagnosis (emphasis added) as fetal, neonatal or presumed perinatal AIS . . . Neonatal AIS constitutes an acute presentation of encephalopathy manifesting as seizure, altered mental status, and/or neurological deficit between birth and the twenty-ninth postnatal day . . ." According to plaintiff's expert, "the authors were not utilizing the terms 'perinatal period' and 'neonatal period' to discuss time of occurrence of the stroke — as is the context improperly suggested by Dr. Molofsky. Rather they were clearly utilizing the terms to [*5]discuss the time of detection (emphasis added)."
Plaintiff's expert also notes that Dr. Molofsky omitted the following from the article, Perinatal Aterial Ischemic Stroke: "Presumed perinatal AIS usually presents after 2 months of age with a median age of presentation of 6 months. Most infants (81-86%) with presumed perinatal AIS present with early hand preference or fisting." According to plaintiff's expert, this omitted material precisely describes the situation that occurred in this action. "When [plaintiff-infant] was approaching her third month of life, her mother noted that the child held her hand in a fist (asymmetry of reach or grasp including 'fisting' are a neurological signs)."
From Clinical Characteristics, Risk Factors and Outcome Associated with Neonatal Hemorrhagic Stroke (JAMA Pediatrics, Kirton, et al, March 2017, Vol. 171), Dr. Molofsky quotes the following: ". . . Apgar scores were less than 5 at one minute in 36 cases (47%) and at five minutes in 12 cases (16%). Neonatal intensive care unit admission was common." Dr. Molofsky uses this quote to opine that plaintiff-infant's near perfect Apgar scores and subsequent transfer to a regular nursery instead of the NICU means that plaintiff-infant could not have suffered a perinatal stroke. According to plaintiff's expert, Dr. Molofsky fails to disclose the following subsequent section in this article: "Five cases presented outside the first 28 days of life with imaging confirming remote hemorrhage consistent with presumed perinatal hemorrhagic stroke." Given this, plaintiff's expert argues that this article does not support Dr. Molofsky's opinion because the article makes it clear that there is a significant segment of infants who suffer perinatal stroke who do not exhibit symptomatology in the first 28 days, and go on to present symptomatology after such period, sometime during the first year of life.
Besides challenging defendants' expert's interpretation of the medical literature, plaintiff's expert reiterates his opinion that the medical records clearly document evidence of an intrapartum insult, including partial prolonged episodes of hypoxia-ischemia prior to delivery. For example, the fetal monitoring tracings demonstrate repetitive late decelerations in early labor, coupled with diminished long term variability. And at the time of delivery, there was the presence of thick meconium that had stained the umbilical cord and nailbeds of the fetus indicating that it had been passed hours before delivery. Also, an hour or so before delivery, fetal intrauterine resuscitation measures were implemented with the aim of increasing oxygen delivery to the placenta and umbilical blood flow in order to reverse the effects of hypoxia/ischemia and acidosis. According to plaintiff's expert, the presence of normal Apgar scores with an umbilical cord blood gas PH of 7.26, PO2 of 49 and PCO2 of 10, merely indicates that the fetus recovered with the assistance of intrauterine resuscitation prior to birth. Plaintiff's expert alleges that plaintiff-infant was being subject to a hostile intrauterine environment which resulted in a call at 10:50 p.m. for an urgent Cesarean section; however, it was not until 11:53 p.m. that delivery took place. He opines that these facts are evidence of an intrapartum insult and compromise, and "the timing of the stroke was during and as a result of the obstetric management of Dr. Gronau."
As previously mentioned, the test enunciated in Frye requires the proponent of novel science to establish its general acceptance among scientists within the relevant discipline to justify its admission. (293 F 1013; Angelo, 88 NY2d 217.) But as noted by Justice Saxe, since Frye entails a process of weighing the views of each side's experts, some trial courts are erroneously tempted to weigh the relative merits of each expert's testimony to determine reliability; however, the court's function is not to decide which expert's conclusion is correct. [*6](Marsh v Smyth, 12 AD3d 307 [1st Dept 2004].) Competing expert theories as to causation or the mechanism of an injury do not warrant a Frye hearing, but entails a weighing of the evidence that falls within the domain of the jury. (Barnett, 85 AD3d 832; Frye, 70 AD3d 15.) To hold a hearing in this context would simply provide the defendants with an extra opportunity to cross-examine plaintiff's expert and pinpoint perceived weaknesses (Marsh, 12 AD3d 307).
An appropriate Frye challenge exists when the expert's theory of causation finds no objective support, and instead is based solely on the expert's own unsupported beliefs. And the limited question to address at a Frye hearing is whether the expert's opinion properly relates existing data, studies or literature to plaintiff's situation, or whether it is connected to existing data only by the ipse dixit of the expert (General Electric v Joiner, 522 US 136 ). Also keep in mind that general acceptance does not necessarily mean that the majority of scientists subscribe to the conclusion. (Zito v Zabarsky, 28 AD3d 42 [2nd Dept 2006].) Instead it means that those espousing the theory or opinion have followed generally accepted scientific principles and methodology in evaluating clinical data to reach their conclusions. (Id.) Where there is no novel test or technique involved, and the proposed testimony involves a novel theory of causation, where such opinion is supported by generally accepted scientific methods, then you proceed to the foundational inquiry of admissibility, which is whether the theory is founded on generally accepted scientific methods or principles. (Parker v Mobil, 7 NY3d 434 ; Ratner v McNeil, 91 AD3d 63 [2nd Dept 2011]; Zito, 28 AD3d 42.) For example, the plaintiff in Parker alleged that his exposure to benzene in gasoline caused him to develop leukemia. The Court of Appeals in Parker was called upon to address defendants' motion to preclude the testimony of plaintiff's expert pursuant to Frye, because said testimony did not, inter alia, quantify the benzene exposure, and was therefore scientifically unreliable. The Court of Appeals found that it was not always necessary for a plaintiff to quantify exposure levels precisely, provided that whatever methods an expert uses to establish causation are generally accepted in the scientific community. Thus, the inquiry was more akin to whether there was an appropriate foundation for the expert's opinion, rather than whether the opinion is admissible under Frye.
In Ratner, defendants sought to preclude plaintiff's expert from testifying as to a causal connection between the therapeutic use of acetaminophen, and a subsequent development of liver cirrhosis. (91 AD3d 63.) The parties did not dispute that acetaminophen is toxic to the liver in overdose, and in cases of massive overdose, acetaminophen can cause acute liver failure. However, defendants argued that the opinion of plaintiff's expert that long-term acetaminophen use at therapeutic doses can cause cirrhosis, was not generally accepted in the medical and scientific community. The Second Department found that plaintiff's expert was not utilizing any novel scientific technique or evidence — rather, said expert sought to set forth the novel theory that therapeutic acetaminophen use caused the plaintiff's liver cirrhosis primarily based upon the fact that acetaminophen is a hepatotoxin and that certain case studies suggest a relationship between acetaminophen and cirrhosis. The Court then held that when an expert seeks to introduce a novel theory of medical causation without relying on a novel test or technique, the proper inquiry begins with whether the opinion is properly founded on generally accepted methodology, rather than whether the causal theory is generally accepted in the relevant scientific community. And in Zito, the Second Department held that "while it is conceded that the plaintiff's expert did not produce medical literature which expressly supported their view that an [*7]excessive dose of Zocor caused the plaintiff to develop polymyositis, they supported their theory of a causal nexus between an excessive dose of Zocor and polymyositis with generally accepted scientific principles and existing data" (28 AD3d at 45).
It does not appear that the parties dispute that the following events occurred during labor and delivery (facts relied upon by plaintiff's expert): (1) non-reassuring fetal heart rate tracings (fetal distress), (2) repetitive late fetal heart rate decelerations, (3) the presence of thick meconium at delivery (present long enough to stain the umbilical cord, fetal membranes and nailbeds), and (4) the need for fetal intrauterine resuscitation. There also appears to be no dispute that these events may suggest hypoxia and asphyxia, which are recognized and generally accepted causes of brain damage. Instead, the opinion of defendants' expert first relies upon the series of previously discussed, yet different and undisputed, set of facts suggesting that this opinion can easily be broken down into two parts. First, that plaintiff-infant's normal newborn course in the hospital (i.e., normal Apgar scores, able to move her extremities, normal respiration, fully awake, normal circulation, and a healthy pink color at birth) and the relatively quick transfer from the special care nursery to the regular nursery, do not support a finding of stroke or brain injury during labor and delivery. On this point alone, what we have is plaintiff's expert relying on certain facts in the medical records to suggest one theory, and defendants' expert relying on certain other facts to suggest another theory.[FN5] The result being two experts asserting diametrically opposed positions, each relying on scientific literature to support their claims (People v Wesley, 83 NY2d 417 ), and a factual disagreement as to causation. (Lustenring v AC & S, 13 AD3d 69 [1st Dept 2004].) This in fact engenders a weighing of the evidence, which is outside the scope of this Court's function in performing a Frye analysis.
Second, defendants' expert opines that if you take plaintiff-infant's normal newborn course in the hospital, and you couple that with a retrospective (not made until months after birth) diagnosis of brain injury, then given the medical literature, the opinion by plaintiff-infant's expert regarding the timing of the injury (i.e., that plaintiff-infant was subject to an intrapartum insult during the course of labor and delivery (emphasis added)) is a novel one. But as Justice Saxe noted in March v Smyth, it is not necessary "that the underlying support for the theory of causation consist of cases or studies considering circumstances exactly parallel to those under consideration in the litigation. It is sufficient if a synthesis of various studies or cases reasonably permits the conclusion reached by the plaintiff's expert." (12 AD3d 307.) Here, a complete reading of the medical literature relied upon by defendants' expert reveals that said literature does not conclusively establish a lack of support within the medical community for the opinion of plaintiff's expert. Moreover, plaintiff's expert supports his theory by applying generally accepted scientific principals to existing data. (Zito, 28 AD3d 42.) In other words, plaintiff's expert ineluctably connected those portions of the medical records that support his deduction that an intrapartum insult and compromise occurred resulting in a stroke, and a causal nexus between the stroke and the obstetric management of Dr. Gronau, through the use of scientifically accepted methodology and reasoning.
Therefore, based on the aforementioned, the motion and cross-motion are denied. The plaintiff is directed to serve a copy of this decision/order with notice of entry by first class mail upon all sides within 30 days of receipt of copy of same. This constitutes the decision and order of this court.
Joseph E. Capella, J.S.C. Footnotes
Footnote 1:Intrapartum - during child birth.
Footnote 2:As the cross-motion is not seeking relief against the co-defendants who made the motion, it's erroneously labeled as a cross-motion. (Siegel, NY Prac § 249 [6th ed].)
Footnote 3:Perinatal - the time immediately before and after birth.
Footnote 4:Neonatal period - birth to 1 month.
Footnote 5:To the extent that defendants may also be suggesting that the opinion by plaintiff's expert is somehow conclusory, unsubstantiated or unsupported by evidence in the medical record, this too would not warrant a Frye hearing. (Krackmalnick v Maimonides, 142 AD3d 1143[2nd Dept 2016].)