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17-1777-cv 

Bruestle-Kumra v. Abbott Laboratories 

UNITED STATES COURT OF APPEALS 

FOR THE SECOND CIRCUIT 

SUMMARY ORDER 

Rulings by summary order do not have precedential effect. Citation to a summary order filed 

on or after January 1, 2007, is permitted and is governed by Federal Rule of Appellate 

Procedure 32.1 and this Court’s Local Rule 32.1.1. When citing a summary order in a 

document filed with this Court, a party must cite either the Federal Appendix or an 

electronic database (with the notation “summary order”). A party citing a summary order 

must serve a copy of it on any party not represented by counsel. 

At a stated term of the United States Court of Appeals for the Second Circuit, held at 

the Thurgood Marshall United States Courthouse, 40 Foley Square, in the City of New York, 

on the 23rd day of April, two thousand eighteen. 

PRESENT: JOSÉ A. CABRANES, 

RAYMOND J. LOHIER, JR., 

 Circuit Judges, 

RICHARD M. BERMAN, 

District Judge.*

 

N.K., an infant by his mother and natural guardian, 

TANJA BRUESTLE-KUMRA, 

Plaintiffs-Appellants, 17-1777-cv 

v. 

ABBOTT LABORATORIES, 

Defendant-Appellee.

 

FOR PLAINTIFFS-APPELLANTS: STUART L. FINZ (Ameer Benno, on the 

brief), Finz & Finz, P.C., Mineola, NY. 

 

*

 Judge Richard M. Berman, of the United States District Court for the Southern District of New 

York, sitting by designation. 
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FOR DEFENDANT-APPELLEE: JOHN A. MCCAULEY (Matthew T. 

McLaughlin and Adam Possidente, 

Venable LLP, New York, NY; Paul F. 

Strain, Christina L. Gaarder, and Stephen 

E. Marshall, Venable LLP, Baltimore, 

MD, on the brief), Venable LLP, Baltimore, 

MD. 

Appeal from a judgment of the United States District Court for the Eastern District of New 

York (Ramon E. Reyes, Jr., Magistrate Judge).†

UPON DUE CONSIDERATION WHEREOF, IT IS HEREBY ORDERED, 

ADJUDGED, AND DECREED that the September 1, 2017 judgment of the District Court be 

and hereby is AFFIRMED. 

Plaintiffs-appellants Tanja Bruestle-Kumra and her infant child N.K. (jointly, “Plaintiffs”) 

appeal from a September 1, 2017 judgment of the District Court granting defendant-appellee Abbott 

Laboratories’ (“Abbott Labs”) motion to strike the specific causation testimony of two of Plaintiffs’ 

witnesses, and granting summary judgment in favor of Abbott Labs. On appeal, Plaintiffs argue that 

the District Court erred when it (1) applied the Federal Rule of Evidence 702 standard to the 

testimony of N.K.’s treating physician; (2) excluded the testimony of Plaintiffs’ two expert witnesses 

on specific causation; (3) granted summary judgment in favor of Abbott Labs; and (4) denied 

Plaintiffs’ motion to amend their pleadings. Upon review, we affirm the District Court’s judgment. 

We assume the parties’ familiarity with the underlying facts, the procedural history of the 

case, and the issues on appeal. 

STANDARD OF REVIEW 

This Court “review[s] the district court’s decision to admit or exclude expert testimony 

under a highly deferential abuse of discretion standard.” Zuchowicz v. United States, 140 F.3d 381, 386 

(2d Cir. 1998). A district court’s Rule 702 ruling “will be reversed only for manifest error.” United 

States v. Tin Yat Chin, 371 F.3d 31, 40 (2d Cir. 2004). “That standard applies as much to the trial 

court’s decisions about how to determine reliability as to its ultimate conclusion.” Kumho Tire Co. v. 

Carmichael, 526 U.S. 137, 152 (1999). 

This Court reviews de novo a district court’s award of summary judgment, “constru[ing] the 

evidence in the light most favorable to the [losing party]” and “drawing all reasonable inferences and 

 

†

 The parties consented to the referral of the case to a United States magistrate judge to conduct 

all proceedings and order the entry of a final judgment in accordance with 28 U.S.C. § 636(c) and 

Federal Rule of Civil Procedure 73. 
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resolving all ambiguities in [its] favor.” Darnell v. Pineiro, 849 F.3d 17, 22 (2d Cir. 2017) (internal 

quotation marks omitted). We “will affirm only when ‘there is no genuine dispute as to any material 

fact and the movant is entitled to judgment as a matter of law.’” In re 650 Fifth Ave. & Related Props., 

830 F.3d 66, 86 (2d Cir. 2016) (quoting Fed. R. Civ. P. 56(a)). 

“We ordinarily review a district court’s denial of a motion to amend the pleadings for abuse 

of discretion.” AEP Energy Servs. Gas Holding Co. v. Bank of Am., N.A., 626 F.3d 699, 725 (2d Cir. 

2010). 

DISCUSSION

I. 

Plaintiffs first argue that the District Court erred when it applied Rule 702 to determine 

whether Dr. Lewis, N.K.’s treating physician, was qualified to offer testimony on causation. 

Specifically, Plaintiffs contend that the District Court should have considered Dr. Lewis as a factual

witness—as opposed to an expert witness—because she developed her opinions in the course of 

treating N.K. And fact witnesses, Plaintiffs note, are not subject to Rule 702 scrutiny. 

Plaintiffs’ attempt to circumvent Rule 702 by proffering Dr. Lewis as a non-expert factual 

witness is self-defeating. Under New York law,1 “expert medical opinion evidence . . . is required, 

when the subject-matter to be inquired about is presumed not to be within common knowledge and 

experience.” Meiselman v. Crown Heights Hosp., 34 N.E.2d 367, 370 (N.Y. 1941); see also Fiore v. Galang, 

478 N.E.2d 188, 189 (N.Y. 1985). Plaintiffs wisely do not suggest that identifying the etiology of 

N.K.’s constellation of congenital anomalies is within common knowledge and experience. Expert 

medical opinion evidence is thus required to establish causation. See Amorgianos v. Nat’l R.R. Passenger 

Corp., 303 F.3d 256, 268 (2d Cir. 2002) (“[T]o establish causation, [Plaintiffs] must offer admissible 

expert testimony regarding both general causation . . . and specific causation.” (emphasis added)). 

The Federal Rules of Evidence provide that only Rule 702 expert witnesses may provide 

expert medical opinions. See Fed. R. Evid. 701(c) (“If a witness is not testifying as an expert, 

testimony in the form of an opinion is limited to one that is . . . not based on scientific, technical, or 

other specialized knowledge within the scope of Rule 702.”). Accordingly, if Plaintiffs proffered Dr. 

Lewis as a non-expert factual witness, she could not provide the expert testimony required to 

establish causation.

 

1 See 29 Charles Alan Wright & Victor James Gold, Federal Practice & Procedure: 

Evidence § 6263 (2d ed.) (“[S]tate law controls where it makes a precondition to recovery . . . the 

proffer of expert testimony to prove an element of the substantive-law claim, such as standard of 

care or causation.”); see also Amorgianos v. Nat’l R.R. Passenger Corp., 303 F.3d 256, 268 (2d Cir. 2002).
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In short, the District Court correctly determined that Dr. Lewis had to be admitted as a Rule 

702 expert witness to provide expert testimony on specific causation. 

II. 

Plaintiffs next argue that the District Court abused its discretion when it determined that Dr. 

Lewis, N.K.’s treating physician, and Dr. Stodgell, a teratologist and toxicologist, were not qualified 

to testify as Rule 702 expert witnesses. We disagree. 

When parties seek to introduce expert testimony under Rule 702, the district court must play 

a “gatekeeping role,” Amorgianos, 303 F.3d at 265, “ensuring that an expert’s testimony both rests on 

a reliable foundation and is relevant to the task at hand,” Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 

579, 597 (1993). As gatekeeper, the district court has significant discretion to consider numerous 

factors, including “[1] the theory’s testability, [2] the extent to which it has been subjected to peer 

review and publication, [3] the extent to which a technique is subject to standards controlling the 

technique’s operation, [4] the known or potential rate of error, and [5] the degree of acceptance 

within the relevant scientific community.” United States v. Romano, 794 F.3d 317, 330 (2d Cir. 2015) 

(internal quotation marks omitted). We recognize that a district court’s application of these factors 

“will necessarily vary from case to case.” Amorgianos, 303 F.3d at 266. 

The District Court here determined that, to lay a reliable foundation for their specific 

causation testimony, Plaintiffs’ witnesses had to perform an adequate “differential diagnosis.” That 

is, the witnesses had to “assess the patient’s symptoms, create a list of possible causes, and then seek 

to eliminate possible causes to identify the most likely cause.” Special App’x at 14 (internal quotation 

marks and alterations omitted). The District Court found particularly wanting the method that the 

witnesses employed to eliminate the possibility that genetic defects caused N.K.’s injuries. 

In 2005, when N.K. was twelve days old, Dr. Lewis determined that N.K.’s injuries were 

likely caused by either exposure to Depakote or genetic defects. In an attempt to rule out genetic 

defects, Dr. Lewis referred N.K. for genetic testing. While the initial tests for genetic abnormalities 

came back negative, the geneticist recommended that N.K. “be re-evaluated in Genetics in six 

months or earlier if his tests are positive.” App’x at 1397. We do not know from the record whether 

Dr. Lewis followed the geneticist’s 2005 recommendation to have N.K. re-evaluated. Id. at 1366, 

94:4–96:6 (Dr. Lewis’s deposition testimony in which she is unable to find record of re-evaluation). 

But we do know that since 2005 at least four other physicians recommended or suggested additional 

genetic testing, and no additional genetic tests were ever conducted. See, e.g., id. at 1371 (Dr. Morel); 

id. at 1373 (Dr. Engel); id. at 1288 (Dr. Wells); id. at 1295 (Dr. Mandel). 

Based in part on the absence of additional genetic testing, the District Court determined that 

Dr. Lewis could not reliably eliminate the possibility that N.K.’s injuries were caused by genetic 

defects. We agree with the District Court. The District Court had more than adequate reason to 
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find, under the circumstances of this case, that a reliable differential diagnosis required the 

performance of additional genetic tests. 

Dr. Stodgell did not conduct an independent differential diagnosis on N.K., but relied upon 

the same medical records as Dr. Lewis. Accordingly, the District Court also had adequate reason to 

exclude Dr. Stodgell’s testimony on specific causation. 

In short, we conclude that the District Court did not abuse its discretion when it excluded 

the testimony of Drs. Lewis and Stodgell on specific causation. 

III. 

New York law requires expert witnesses to establish specific causation. Meiselman, 34 N.E.2d 

at 370; see also Fiore, 478 N.E.2d at 189. With the testimony of Drs. Lewis and Stodgell excluded, 

Plaintiffs could not proffer any expert witness testimony on specific causation. We therefore 

conclude that the District Court properly granted summary judgment in favor of Abbott Labs. 

IV. 

Finally, Plaintiffs appeal the District Court’s denial of their motion to amend their pleadings. 

Plaintiffs filed their motion over two years after their initial complaint and after the close of 

discovery. We affirm the District Court’s denial principally for the reasons set forth in its February 

28, 2017 Memorandum and Order. 

CONCLUSION 

We have reviewed all of the arguments raised by Plaintiffs on appeal and find them to be 

without merit. For the foregoing reasons, we AFFIRM the September 1, 2017 judgment of the 

District Court. 

 FOR THE COURT: 

 Catherine O’Hagan Wolfe, Clerk