Eduardo Nobre, Jr. an Infant by his Mother and Natural Guardian JENNIFER FERRARO, Individually, Plaintiff,
James Shanahan, M.D., JAMES BROCKUNIER, M.D. and ST. ANTHONY COMMUNITY HOSPITAL, Defendants.
James M. Lichtenstein, Esq. Law Office of James M. Lichtenstein, P.C.
Wayne M. Rubin, Esq. Feldman, Kleidman & Coffey, L.L.P.
HON. PAUL I. MARX, J.S.C.
Upon reading the foregoing papers and hearing oral arguments and testimony, it is ORDERED that Plaintiffs' motion to preclude is granted, for the reasons which follow.
Plaintiffs Eduardo Nobre, Jr., by his mother and natural guardian, Jennifer Ferraro, and Jennifer Ferraro, individually, brought this medical malpractice action against Defendants James Shanahan, M.D., James Brockunier, M.D., and St. Anthony Community Hospital,  alleging personal injuries to Plaintiffs resulting from Defendants' improper treatment. Dr. Brockunier provided the majority of Ms. Ferraro's prenatal care but did not participate in the delivery of Eduardo. Dr. Shanahan delivered Eduardo on September 3, 2006. Of relevance to the instant motion is Plaintiffs' allegation that following delivery of Eduardo's head, he suffered shoulder dystocia,  a condition whereby his shoulder became stuck on his mother's symphysis pubis — a cartilaginous joint at the top center of the pelvic outlet; the last portion of the pelvis through which the infant passes prior to delivery.
Ms. Ferraro was admitted to St. Anthony's for delivery of Eduardo at 12:25 a.m. on September 3, 2006. The delivery notes and deposition testimony of Dr. Shanahan show that Ms. Ferraro was fully dilated at 11:55 a.m., pushed poorly initially but then improved with coaching. The nurse's entries show that she was pushing well at 1:30 p.m., 2:00 p.m., 2:30 p.m. and 2:40 p.m. There is no note of maternal pushing after 2:40 p.m. There is no evidence of a contraction at 2:45 p.m. when Dr. Shanahan noted delivery of the infant's head and a turtle sign,  indicating shoulder dystocia. Dr. Shanahan initially tried the McRoberts' maneuver  to relieve the shoulder dystocia and performed a 4th degree episiotomy. Affidavit of James Shanahan, M.D. at ¶ 2. He stated that when these efforts proved unsuccessful, he followed up with rotation of the infant's shoulders with his fingers to effectuate delivery at 2:46 p.m. Id. Notably, Dr. Shanahan has denied that he applied excess downward traction after the baby's head was delivered. Id. at ¶ 3.
Upon delivery, Eduardo was floppy, but he quickly responded to resuscitative efforts. His Apgar scores at one minute and five minutes were 5 and 9, respectively.  He weighed 7 pounds, 15 ounces and measured 19 inches in length. His head circumference measured 13 inches, his chest 13.5 inches and his abdomen 13 inches. His right arm was flaccid and a right brachial plexus injury  was noted. Plaintiffs alleged in their bill of particulars that Eduardo:
"suffered from Erb's palsy;  shoulder dystocia; fetal distress; lack of muscle control in the arm, hand, or wrist, and lack of feeling or sensation in the arm or hand; inability to crawl without the use of therapeutic devices; low muscle tone and weakness; a limp and/or paralyzed arm neurological injury; immobilized right arm; right sided upper extremity injury; lack of development; decreased sensation, occupational therapy and physical therapy; severe physical dysfunction; pain and suffering; loss of ability to develop independence in activities of daily living; loss of quality and enjoyment of life." [Plaintiff's Exhibit F, Book 4, Pleadings, Tab 10, Corrected Further Supplemental Verified Bill of Particulars at ¶ 12]
The Parties' Arguments
Plaintiffs move to preclude Defendants from arguing at trial that Eduardo's injuries were caused by the maternal, or natural forces of labor, i.e., uterine contractions and maternal pushing. Plaintiffs contend that Eduardo's shoulder dystocia rendered him susceptible to brachial plexus injury from the delivering physician applying lateral traction — a downward or upward or rotational pulling force — to the infant's head and neck in an effort to dislodge the infant and effectuate delivery. Plaintiffs claim that as a result of Dr. Shanahan's actions, Eduardo suffered a permanent brachial plexus injury. See Plaintiffs' Memorandum of Law at p. 8. They contend that Dr. Shanahan "failed to utilize the appropriate maneuvers to dislodge the [infant's] anterior shoulder before continuing the vaginal delivery" and "improperly utilized force and traction in attempting to deliver the infant." See Plaintiff's Exhibit F, Book 4, Pleadings, Tab 10, Corrected Further Supplemental Verified Bill of Particulars at ¶ 5(h) and (m).
Plaintiffs allege that Dr. Shanahan applied excessive lateral traction to Eduardo's neck and head in order to dislodge his shoulder. Plaintiffs state that it has been generally accepted for over 100 years that a permanent brachial plexus injury in an otherwise healthy newborn delivered vaginally is caused by the delivering physician applying lateral traction during a shoulder dystocia.  In fact, Plaintiffs allege in their bills of particulars that they are relying "on the theory of res ipsa loquitor [sic]." Id. at ¶ 5(bb).
Plaintiffs state that in the past 20 years another theory has emerged from defense experts in litigated cases, which contends that in some instances a brachial plexus injury in a newborn can result from the maternal, or natural forces of labor and delivery. Affirmation of Joseph M. Lichenstein, Esq. at ¶ 4. Plaintiffs assert that this theory gained some traction after these defense experts published their hypotheses in obstetrical journals, which were then cited in an increasing number of subsequent medical journals. Id. Plaintiffs contend, however, that the "hypothesis is unscientific" and critically flawed, because the literature proffered by Defendants "is based on a retrospective analysis of cases, where they fail to distinguish permanent BPI [brachial plexus injury] and temporary BPI." Id. at ¶ 5. Plaintiffs explain that the distinction between permanent and temporary brachial plexus injury is significant, because the maternal forces of labor, in rare instances, can cause the brachial plexus to experience enough stretch to cause a temporary brachial plexus injury but cannot exert enough force to result in a permanent brachial plexus injury. See Notice of Motion, Exhibit B, Affidavit of Robert H. Allen, PhD at ¶ 20-21. They assert that the hypothesis advanced by Defendants in this case has been disproven by quantitative scientific testing conducted by Robert H. Allen, PhD, a research professor in biomechanical engineering and gynecology and obstetrics and a well-recognized expert in the area of shoulder dystocia and brachial plexus injuries. 
Dr. Allen opined in his affidavit that "mechanically, it is not possible for uterine forces to stretch the fetal brachial plexus nerves to cause a mechanical permanent injury in a cephalic delivery." Id. at ¶ 28. Dr. Allen performed "[c]adaver research on 16 brachial plexi in full term infants...". Id. at ¶ 30. The results of his research "demonstrated that upper brachial plexus ruptures require at least 40 pounds of lateral force on the head, and increasing lateral forces to more than 80 pounds causes lower and middle root ruptures and avulsions." Id. He stated that "a fetal nerve needs to be stretched 50% or more beyond its original length for it to rupture and thereby cause a permanent injury." Id. Dr. Allen conducted an experiment, the results of which he published in 2007, wherein he simulated the second stage of labor and "measured anterior and posterior brachial plexus stretch as the fetus [was] pushed through the pelvis [using an amount of uterine force comparable to uterine forces in actual labor]... for routine and shoulder dystocia deliveries." Id. at 34. He found that the amount of brachial plexus stretch as the infant moves through the pelvis varies between 0 and 25%, "which the is the normal amount of stretch when the head rotates or flexes to one side... and is not injurious." Id. at ¶ 36. Dr. Allen also found that the amount of "stretch is significantly less for shoulder dystocia deliveries than for routine deliveries as a result of maternal contractions and pushing." Id. He concluded that a permanent brachial plexus injury "can only result from physician applied lateral traction after delivery of the fetal head." Id. at ¶ 37.
Plaintiffs requested the Court to conduct a hearing under Frye v U.S., 293 F. 1013 [D.C. Cir. 1923] and Parker v Mobil Oil Corp., 7 N.Y.3d 434, 447, rearg. denied 8 N.Y.3d 828 . Plaintiffs urge the Court to follow the decision in Muhammad v Fitzpatrick, 91 A.D.3d 1353 [4th Dept 2012], which applied Frye and Parker in a brachial plexus birth injury case and precluded the defendants from offering the theory of causation that is at issue here. Muhammad held that the defendants were not able to establish that the theory they espoused was generally accepted within the relevant medical community, as required under Frye, supra.  The court also found that even if the theory was admissible under Frye, it still needed to satisfy the question of admissibility that applies to all evidence, as provided for in Parker, supra at 447, "whether there is a proper foundation — to determine whether the accepted methods were appropriately employed in a particular case." Muhammad, supra at 1354 (citing Parker, supra at 447). The court determined that Parker was applicable even though Parker was a toxic tort case. Id. (citing Lugo v New York City Health & Hosps. Corp., 89 A.D.3d 42, 62 [2nd Dept 2011] and Rowe v Fisher, 82 A.D.3d 490, 491 [1st Dept. 2011]). Adapting Parker's causation test to the case before it, the court stated that: "the opinion of defendants' experts on causation should set forth the exposure [of plaintiff's daughter] to a [harmful in utero event], that the [event] is capable of causing the particular [injury] (general causation) and the plaintiff[ s daughter] was exposed to [a sufficiently harmful event] to cause the [injury] (specific causation)." Id. (citing Parker, supra at 448). After applying the test, the court found that the evidence was properly precluded, because the defendants did not satisfy "the specific causation and general causation prongs." Id.
Relying on Ratner v McNeil-PPC, Inc., 91 A.D.3d 63 [2nd Dept 2011], Plaintiffs assert that Defendants bear the burden of proof on their theory of causation. They argue that Defendants cannot meet their burden because the analytical gap between the available data and their causation theory is too great to make it sufficiently reliable to present to a jury.
In opposition, Defendants contend that the maternal forces of labor theory is not novel and is generally accepted. Defendants explain that "stretch" can cause "a spectrum of injuries", which their bioengineering expert, Dr. Michele Grimm, stated includes "neurapraxia (focal damage to the myelin sheath that interferes with nerve conduction but without axonal disruption and is not permanent), axonotmesis (disruption of multiple axonal fibers without myelin or connective tissue disruption), and neurotmesis (complete loss of axonal continuity along with partial or complete discontinuity of the myelin sheath and supporting connective tissue fibers, as occurs in a rupture or avulsion)."  Defendants' Memorandum of Law in Opposition at p.1, citing Affidavit of Michele Grimm at ¶ 13. They argue that Eduardo suffered a mild axonotmesis, which they describe as "disruption of multiple axonal fibers without myelin or connective tissue disruption". Id. Hence, they argue, Plaintiffs' attempt to negate their defense of maternal forces is misplaced based on the nature of the injury sustained.
In essence, Defendants assert that it is Plaintiffs' theory of the case which is inapplicable,  because it is limited to injuries that result from a rupture or avulsion of the brachial plexus nerves. They argue that Eduardo did not experience a rupture or avulsion of the brachial plexus nerves; instead, he suffered axonotmesis, which they characterize as a mild injury. In support of their opposition, Defendants submit the affidavit of Defendant James Shanahan, M.D.; the affidavit of pediatric neurologist Sandra ...