Coolidge v. United States of America

Filing 176

DECISION AND ORDER DENYING Plaintiff's 171 Motion in Limine. Signed by William M. Skretny, United States District Judge on 11/13/2018. (MEAL)

UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF NEW YORK
WILMA COOLIDGE
as Executor of the Estate of Howard Southard,
deceased,
Plaintiff,
v.

DECISION & ORDER
10-CV-363S

UNITED STATES OF AMERICA,
Defendant.

I. INTRODUCTION
Plaintiff moves to preclude the testimony of Defendant’s expert, Dr. David
Gillespie, on the grounds that his opinions are uncertain, speculative, and lacking in
foundation. (Docket Nos. 171 (Motion), 170 (Rimmler Decl.), 170-1 (Mem.)) She also
moves to preclude documents relied on by Dr. Gillespie in forming his opinion, including
journal articles and adverse incident reports, also called “MAUDE Reports.” (Id.) The
Government opposes the motion. (Docket No. 173) Before the commencement of this
bench trial, Plaintiff moved for the same relief. The Court denied the motion, but allowed
the parties to revisit the issue during trial.

Counsel are familiar with the facts and

arguments, which the Court will recite only to the extent necessary to explain its ruling.
For the reasons set forth below, the Court will deny Plaintiff’s motion.

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II. DISCUSSION
A.

Standard
The admissibility of expert testimony is governed by Rule 702 of the Federal Rules

of Evidence, which provides in relevant part that “[a] witness who is qualified as an expert
by knowledge, skill, experience, training, or education may testify” to his opinion if:
(a) the expert's scientific, technical, or other specialized knowledge will help
the trier of fact to understand the evidence or to determine a fact in issue;
(b) the testimony is based on sufficient facts or data;
(c) the testimony is the product of reliable principles and methods; and
(d) the expert has reliably applied the principles and methods to the facts of
the case.
Fed. R. Evid. 702; Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 596 (1993). The
Rule 702 inquiry is a “flexible” one that “depends upon the particular circumstances of the
particular case at issue.” Floyd v. City of N.Y., 861 F. Supp. 2d 274, 286 (S.D.N.Y. 2012)
(internal

quotation

marks

omitted).

Although

a

district

court

should

“admit expert testimony only where it is offered by a qualified expert and is relevant and
reliable,” Cohalan v. Genie Indus., Inc., No. 10-CV-2415 (JMF), 2013 WL 829150, at *3
(S.D.N.Y. Mar. 1, 2013), exclusion remains “the exception rather than the rule,” Floyd,
861 F. Supp. 2d at 287 (internal quotation marks omitted).
“Although expert testimony should be excluded if it is speculative or conjectural, or
if it is based on assumptions that are so unrealistic and contradictory as to suggest bad
faith, or to be in essence an apples and oranges comparison, other contentions that the
assumptions

are

unfounded

go

to

the

weight,

not

the

admissibility,

of

the testimony.” Cohalan, 2013 WL 829150, at *5 (quoting Bacardi & Co. v. N.Y. Lighter
Co., No. 97-CV-7140 (JS) (VVP), 2000 WL 298915, at *2 (E.D.N.Y. Mar. 15, 2000)); see
also McCullock v. H.B. Fuller Co., 61 F.3d 1038, 1044 (2d Cir. 1995) (“Disputes as to the
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strength of [an expert’s] credentials, faults in his use of differential etiology as a
methodology, or lack of textual authority for his opinion, go to the weight, not the
admissibility, of his testimony.”). As the Daubert Court itself stressed, “the traditional and
appropriate means of attacking shaky but admissible evidence” are not exclusion, but
rather “[v]igorous cross-examination, presentation of contrary evidence, and careful
instruction on the burden of proof.” Daubert, 509 U.S. at 596.
B.

Analysis
1. Motion to Preclude Dr. Gillespie’s Testimony
Plaintiff again moves to preclude the testimony of Dr. Gillespie on the grounds that

his opinions are uncertain, speculative, and lacking in foundation. Plaintiff contends, as
she did in her previous motion in limine, that Dr. Gillespie should not be allowed to testify
because he does not have a definitive opinion as to the cause of Howard Southard’s
renal-artery blockage, and that now that “plaintiff has offered extensive evidence at trial
that there was a deviation from the standard of care,” Dr. Gillespie’s “speculative”
testimony “should not be permitted to contradict such uncontested facts.” (Rimmler Decl.
¶¶ 5, 12, 26, 32).
The Court will deny Plaintiff’s motion. Plaintiff’s argument primarily goes to the
reliability and relevance of Dr. Gillespie’s opinion, as well as the information that he relied
on in forming that opinion. Having reviewed the parties’ submissions, including Dr.
Gillespie’s expert report and his deposition testimony, as well having the benefit of 15
days of trial testimony, including from the performing surgeons and from Plaintiff’s expert,
Dr. Muhs, the Court finds that Dr. Gillespie’s opinion and the information he relied on are
relevant and, under Rule 702, his specialized knowledge would help the Court further

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understand the facts in issue. More specifically, the issue of whether the coverage of
Howard Southard’s renal arteries occurred due to operator error or another possible
reason (such as the intraoperative migration of the Cook Zenith stent graft, as Dr.
Gillespie will purportedly testify) is critical in determining whether there was a breach of
the standard of care.
Plaintiff further argues that any testimony that Dr. Gillespie will offer concerning
the possibility of stent grafts to intraoperatively migrate on their own “is not supported by
the medical journal articles and the MAUDE adverse event report upon which Dr. Gillespie
initially relied” and therefore must be precluded. (Rimmler Decl. ¶ 32). This argument
goes to the weight to be accorded the opinions, not to their admissibility. Plaintiff will be
entitled to vigorously cross-examine Dr. Gillespie at trial. See Daubert, 509 U.S. at 596;
cf. McElroy v. Albany Mem'l Hosp., 332 F. Supp. 2d 502, 508 (N.D.N.Y. 2004) (“However,
even if Dr. McGoldrick could point to no textual authority for her opinion, the Second
Circuit has stated that disputes regarding such matters as the lack of textual authority for
an expert's opinion, or faults in the methodology used by an expert in reaching an
opinion, ‘go to the weight, not the admissibility,’ of the expert's testimony.” (emphasis in
original) (quoting McCullock, 61 F.3d at 1044)). Accordingly, Plaintiff’s motion to exclude
Dr. Gillespie’s testimony is denied.
2. Motion to Preclude MAUDE Reports
Plaintiff primarily argues that the MAUDE reports should be precluded because
they are statutorily inadmissible under 21 U.S.C. § 360i(b)(3), and are irrelevant “because
they are not substantially similar to the instant case in their relevant details.” (Mem. at 15; Rimmler Decl. ¶¶ 47-48)

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Plaintiff’s first argument regarding the statutory inadmissibility of the MAUDE
reports is misplaced for two reasons. First, the statute concerns the inadmissibility of
reports made by “a device user facility,” which the statute defines as “a hospital,
ambulatory surgical facility, nursing home, or outpatient treatment facility which is not a
physician’s office.”

21 U.S.C. § 360i(b)(6)(A); see also id. § 360i(b)(3) (“No report

made . . . by a device user facility . . . shall be admissible into evidence or otherwise used
in any civil action involving private parties[.]”). None of the MAUDE reports (Docket Nos.
170-14, 170-15, 170-16, 170-17, 170-18, 170-19, 170-20, 170-21, 170-22, 170-23) relied
on by Dr. Gillespie were made by a device user facility, but rather by the device
manufacturer. Accordingly, this provision of the statute does not apply to the case at bar.
See Smith v. I-Flow Corp., No. 09 C 3908, 2011 WL 12627554, at *1 (N.D. Ill. June 19,
2011) (denying motion in limine to preclude adverse incident reports on the same
grounds); Chism v. Ethicon Endo-Surgery, Inc., No. 4:08CV00341-WRW, 2009 WL
3066679, at *1 (E.D. Ark. Sept. 23, 2009) (“Although device user facilities report to
manufacturers, who then base their reports to the FDA on the user reports, § 360i does
not prohibit the admissibility of manufacturer reports into evidence, or other uses of the
reports in civil actions.” (emphasis added)).1
Second, the statute explicitly prohibits such reports only “in any civil action
involving private parties”; the United States of America, the Defendant in this case, is not
a private party, and therefore the statute is inapplicable. Cf. Butler v. Aaron Med. Indus.,

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Plaintiff cites a number of cases that purportedly stand for the proposition that, in products liability cases
“even mandatory Adverse Event Reports are held to be inadmissible in evidence (Mem. at 5).” In re
Medtronic, Inc., 184 F.3d 807 (8th Cir. 1999); SCOX V. Medtronic, Inc., 131 F. Supp. 2d 1070 (E.D. Ark.
1999). These cases discuss the discoverability of adverse event reports, not their admissibility, and in
any event, are distinguishable on the basis that they are products liability actions (not medical malpractice
actions) involving private parties (not the Government).

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Inc., No. C03-00896 HRL, 2004 WL 7330072, at *4 (N.D. Cal. Oct. 21, 2004) (“The reports
may not be admitted into evidence or otherwise used in any civil actions involving private
parties.” (emphasis added) (citing H.R. Rep. No. 101-808, 1990 WL 200530)).
Plaintiff also argues that the MAUDE reports should be precluded “because they
are not substantially similar to the instant case in their relevant details,” relying on three
products liability cases to support that proposition. See Jackson v. Firestone Tire &
Rubber Co., 788 F.2d 1070, 1082 (5th Cir. 1986) (“Evidence of similar accidents occurring
under substantially similar circumstances and involving substantially similar components
may be probative of defective design.”); Bellinger v. Deere & Co., 881 F. Supp. 813, 818
(N.D.N.Y. 1995) (“In product liability actions, it is appropriate to define the similarity of the
accidents based upon the product or defect at issue.”); Hyde v. Rensselaer Cty., 51
N.Y.2d 927, 929, 415 N.E.2d 972, 973 (1980) (“It is well settled that proof of a prior
accident, whether offered as proof of the existence of a dangerous condition or as proof
of notice thereof, is admissible only upon a showing that the relevant conditions of the
subject accident and the previous one were substantially the same.”).
Plaintiff does not demonstrate how these cases undermine Dr. Gillespie’s reliance
on MAUDE reports, which address situations where stent grafts have migrated outside of
operator error—one of the key issues bearing on liability in this case. See Fed. R. Evid.
R. 401; Amorgianos, 303 F.3d at 265 (evidence is relevant if it has “any tendency to make
the existence of any fact that is of consequence to the determination of the action more
probable or less probable than it would be without the evidence” (internal citations and
quotation marks omitted)). Regardless, the Northern District of New York in Bellinger—
upon which Plaintiff relies—concluded even that where there is a dispute as to whether

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circumstances

are

substantially

similar,

“[d]ifferences

in

[such]

surrounding

circumstances go to the weight to be given the evidence, rather than to its admissibility.”
Bellinger, 881 F. Supp. at 818. Plaintiff will have the opportunity to vigorously crossexamine Dr. Gillespie with respect to his reliance on the MAUDE reports in forming his
conclusions regarding the intraoperative migration of stent grafts.
IV. CONCLUSION
For the reasons stated above, Plaintiff’s motion in limine (Docket No. 171) is
denied.

SO ORDERED.

Dated:

November 13, 2018
Buffalo, New York
/s/William M. Skretny
WILLIAM M. SKRETNY
United States District Judge

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