In this action for medical malpractice plaintiff claims that defendant Dr. Arnold J. Stein was negligent in failing to administer, by injection, a broad-spectrum antibiotic to Menachem Lipschitz upon completion of the cataract surgery he performed on Mr. Lipschitz's left eye and in failing to diagnose and treat Mr. Lipschitz's post-operative endophthalmitis infection of the vitreous humor caused by Bacillus cereus. The plaintiff maintains that a broad-spectrum antibiotic administered at the surgery or when the plaintiff presented at the defendant's office the morning after the surgery would have increased the likelihood of his successful recovery from endophthalmitis. Mr. Lipschitz suffered retinal necrosis resulting in the loss of the eye.

Facts and Procedural History

In May of 2002, the matter was tried and resulted in a verdict in favor of the defendants. On appeal from an order denying plaintiffs' CPLR 4404(a) motion to set aside the verdict as against the weight of the evidence, the Appellate Division reversed the judgment and ordered a new trial. The appellate court stated:

Several theories of malpractice were submitted to the jury, which found, inter alia, that the defendant did not deviate . . . in failing to administer broad spectrum antibiotics by injection at the end of the cataract surgery, that the defendant did not fail to see Mr. Lipschitz from [*2]approximately 9:00 a.m. until approximately 10:45 a.m. in his office on the day following the surgery, and that the defendant's failure to diagnose endophthalmitis during that office visit was not a departure from accepted medical practice. We find that there were errors committed at the trial which could have affected the verdict and therefore cannot be considered harmless . . .

According to the plaintiffs' expert witness . . . , the defendant deviated from the standard of care when he failed to inject a broad spectrum antibiotic into the conjunctiva underneath the eye immediately after the surgery, and the failure to do so was a substantial factor in causing permanent injury to the eye, requiring its evisceration.

. . . [T]he defendant's infectious disease expert testified, over the plaintiffs' objection, that an injection of antibiotics immediately after surgery "would not have made any demonstrable difference" . . . "because there are . . . essentially no properly done randomized or controlled comparison studies of the ethicacy [sic] of any of these preventative approaches in the literature." Although opinion in a publication which an expert deems authoritative may be used to impeach an expert on cross-examination . . . , the introduction of such testimony on direct examination constitutes impermissible hearsay . . . In any event, the expert testified on cross-examination that he did not consider any books or articles in the field of infectious diseases "authoritative."

. . . [T]he plaintiffs' expert testified that the delay in diagnosing endophthalmitis was a substantial factor in the loss of the eye because the bacteria involved was "quite sensitive . . . and . . . treatable in the first 12 to 24 hours." The defendant's infectious disease expert, . . . testified that by the morning of November 11, 1997, the plaintiff's chance of preserving any useful vision had already been reduced to "ten percent or less."

The defendant's infectious disease expert was permitted to testify, over the plaintiffs' objection, with respect to the results of an "Endophthalmitis Vitrectomy Study" (hereinafter the EVS). . . . that the most common sign of endophthalmitis was a hypopyon (pus in the anterior chamber) which was experienced by 86% of patients in the EVS study. . . . [and]. . . that of the 400 patients in the EVS, the median time between surgery and the presentation of endophthalmitis was six days and "only 24 percent presented in three days or fewer. A tiny number presented in one day." The plaintiffs' counsel's . . . objection on the ground that "[n]one of these things are in evidence" was over ruled.

The EVS was not admitted into evidence and its reliability was not established. Accordingly, testimony with respect to the EVS should not have been admitted . . .

. . . [T]he delay in diagnosis was attributed to the defendant's alleged failure to attend to his patient in a timely manner. The plaintiffs' expert testified that if Mr. Lipschitz arrived at the defendant's office at 9:00 a.m. and was not seen until 10:45 a.m., that would be a deviation from accepted medical practice. [*3]

. . . [T]he defendant acknowledged that he did not know when Mr. Lipschitz arrived in his office on November 11, 1997 . . .

Mr. Lipschitz testified that he arrived shortly after 9:00 a.m.

and his daughter-in-law . . . corroborated that testimony. As evidence that the defendant did not see Mr. Lipschitz . . . until approximately 10:45 a.m. . . . plaintiffs referred to the defendant's medical records, which indicated that drops were placed in Mr. Lipschitz's eye at 10:45 a.m. and the defendant first examined Mr. Lipschitz at 11:00 a.m.

. . . . The defendant's receptionist testified that Mr. Lipschitz arrived at approximately 10:00 a.m. . . . Her estimate of the time . . . was based on the order of the names in the patient log. She acknowledged that she could not recall how many names appeared before Mr. Lipschitz's name.

On cross-examination, the plaintiffs' counsel asked the receptionist whether she knew when patients arrived at the office and the order in which they arrived. She replied, "I have my book" and that she knew what it said. The patient log was never produced or introduced into evidence notwithstanding that it was subpoenaed by the plaintiffs.

Since . . . her claim that he arrived at 10:00 a.m. was based upon a document never produced and which was not in evidence, the plaintiffs' objection to her testimony should have been sustained. . . .

Upon remand, the defendant moved, in October 2005, to preclude the plaintiff's expert testimony that plaintiff's sight could have been recaptured on November 11, 1997, when he arrived at Dr. Stein's office within 24 hours of his cataract surgery, as such theory lacked general acceptance in the medical community. Defendant argues that the theory that a patient could regain sight by administering antibiotics 24 hours [*5]following cataract surgery in which a patient developed endophthalmitis caused by a rare and virulent Bacillus cereus, is a novel and scientifically unaccepted theory. Alternatively, the defendant sought a Frye hearing (Frye v. U.S., 293 F 1013 [1923]).

On January 3, 2006 (Levine, J.) (2006 WL 4682089) defendant's motion was granted to the extent of ordering a Frye hearing.

Thereafter, plaintiff moved to reargue and the defendant cross-moved for summary judgment. By a June 30, 2006 order (Levine, J.) the motion to reargue was granted and the plaintiff's application to take the deposition of Yael Gordon, the defendant's office manager, was granted and the defendant's cross-motion was denied.

A hearing was held before this court on August 15, 2008 and October 31, 2008, during which Dr. Rene Rodriguez-Sains a specialist in ophthalmology and plastic reconstructive surgery testified for the plaintiff, and Dr. Bruce Hirsch an infectious disease specialist testified for the defendant.

The purpose of the Frye test is to ensure that courts "do not rely upon an expert's testimony regarding a novel procedure, methodology or theory unless it has been generally accepted' within the relevant scientific community as leading to reliable results (citations omitted). The focus of the Frye test is to distinguish between scientific principles which are demonstrable' and those which are experimental' (citations omitted) . . . [T]he particular procedure need not be unanimously [e]ndorsed' by the scientific community but must be generally accepted as reliable'" (Marsh v. Smyth, 12 AD3d 307, 310 [2004], citing People v. Wesley, 83 NY2d 417, 422, 423 [1994] and Frye, 293 F at 1014).

"Under the Frye standard, the burden of proving general acceptance rests upon the party offering the disputed expert testimony" (Del Maestro v. Grecco, 16 AD3d 364, 365 [2005], citing People v. Wesley, 83 NY2d at 422).

Deciding whether the reliability of a procedure or theory is generally accepted may be established by "court opinions, texts, laboratory standards or scholarly articles" (Wesley, 83 NY2d at 437), and often involves considering whether a sufficient quantum of other experts in the same field accept the reliability of the theory or process, that is whether there is consensus in the scientific community as to its reliability (Marsh, 12 AD3d at 311, citing Wesley, 83 NY2d at 437, 439). As Chief Judge Kaye noted in her concurring opinion in Wesley, the Frye test emphasizes "counting scientists' votes, rather than on verifying the soundness of a scientific conclusion" (id.).

When the proposed expert testimony concerns a claim that plaintiff's injury was caused by the actions taken by a defendant physician, and thus relate to the mechanism of the injury, the Frye test has been "adapted to the situation" (Marsh v. Smyth, 12 AD3d at 312). In Marsh (supra ) the court reasoned that "in circumstances such as these, the question of whether the challenged testimony is admissible should not involve weighing the number of experts that concur in the expert's opinion against the number that [*6]do not, or independently deciding on the soundness of the competing experts' views. Rather, the challenge should only be successful where the challenged theory of causation finds no objective support, and instead is based solely upon the expert's own unsupported beliefs. Accordingly, the court's concern must be limited to making sure that within the scientific field in question there is a substantive, demonstrable, objective basis for the expert's conclusion. The appropriate question for the court at such a hearing is the somewhat limited question of whether the proffered expert opinion properly relates existing data, studies or literature to the plaintiff's situation or whether, instead, it is connected to existing data only by the ipse dixit of the expert' [see General Electric v. Joiner, 522 US 136, 146, 118 S. Ct 512 . . . (1997)]," (Marsh, 12 AD3d at 312).

Moreover, the focus of the inquiry should not be upon how widespread the theory's acceptance is, but instead upon whether a "reasonable quantum of legitimate support exists in the literature for the expert's views" (id.). Nor, need 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 at 312-313; see also Zito v. Zabarsky, 28 AD3d 42, 44 [2006], quoting concurring opinion in Marsh, 12 AD3d at 312-313).

The issue of the Frye hearing, as framed by the defendant, who moved for the hearing, was to determine:

"not whether antibiotics and vitrectomy therapy is an appropriate treatment for endophthalmitis generally, but whether such treatment would have restored vision at the time plaintiff presented to Dr. Stein's office on the morning of November 11, 1997, 24 hours after the cataract surgery, in light of the fact that the infection was caused by Bacillus " (Defendant's Frye Hearing Summation Brief p. 3).

The articles submitted by the defendant involving Bacillus cereus infection arising as a result of cataract surgery make it clear that there is no particular time line following the surgical procedure in which the infection must be treated. This is unquestionably so due to the fact that there may be no symptoms of the infection for many hours or for as long as several months (see Defendant's Frye Hearing Summation Brief, Exhibit "M") following surgery cases and a review of the literature reveals that there are incidents of successful treatment regardless of how long after the surgery the condition manifested itself (see Exhibit "M").

Moreover, the literature and studies submitted by the defendant do not establish any uniform time line by which treatment must be initiated once the symptoms of a Bacillus cereus condition have appeared.

While there does appear to be consensus among the experts that prompt treatment increased the likelihood that the treatment will be successful, there is no consensus of opinion that there is any significance to the 24 hour time frame posited by the defendant. [*7]

As such, it is the defendant who seeks to have his expert testify to a theory that is novel and not generally accepted in the scientific community; that a party who presents with a Bacillus cereus infection more than 24 hours after surgery has presented too late for any remedial steps to be effectively taken. The burden of proving general acceptance rests on the part offering the disputed testimony (see Cumerbatch v. Blanchette, 35 AD3d 341 [2005]; Del Mastro v. Grecco, 16 AD3d 364 [2005]).

In light of the fact that this theory is not generally accepted in the scientific community, the defendant is precluded from having his expert testify at trial that there is scientific evidence that a Bacillus cereus infection that arises during cataract surgery cannot be treated effectively more than 24 hours after the conclusion of such surgery.

The foregoing constitutes the decision and order of the Court.

ENTER,

_________________

J.S.C.