10-1769-cv
     Donovan v. Centerpulse Spine Tech Inc.


                          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.

 1            At a stated term of the United States Court of Appeals
 2       for the Second Circuit, held at the Daniel Patrick Moynihan
 3       United States Courthouse, 500 Pearl Street, in the City of
 4       New York, on the 25th day of March, two thousand eleven.
 5
 6       PRESENT: DENNIS JACOBS,
 7                         Chief Judge,
 8                ROSEMARY S. POOLER,
 9                PETER W. HALL,
10                         Circuit Judges.
11
12
13       - - - - - - - - - - - - - - - - - - - -X
14       EILEEN F. DONOVAN and TIMOTHY D.
15       DONOVAN,
16
17                    Plaintiffs-Appellants,
18
19                    -v.-                                        10-1769-cv
20
21       CENTERPULSE SPINE TECH INC.,
22
23                    Defendant-Appellee,
24
25       CENTERPULSE USA, INC.,
26
27                 Defendant.
28       - - - - - - - - - - - - - - - - - - - -X

                                                  1
 1
 2   FOR APPELLANTS:   HUGH M. RUSS, III (Ryan K. Cummings, on
 3                     the brief), Hodgson Russ LLP, Buffalo,
 4                     NY.
 5
 6   FOR APPELLEE:     HARRY F. MOONEY (Jody E. Briandi, Tasha
 7                     T. Dandridge, Hurwitz & Fine, P.C.,
 8                     Buffalo, NY, and Thomas G. Stayton, Baker
 9                     & Daniels LLP, Indianapolis, IN, on the
10                     brief), Hurwitz & Fine, P.C., Buffalo,
11                     NY.
12
13        Appeal from a judgment of the United States District
14   Court for the Western District of New York (Curtin, J.).
15
16        UPON DUE CONSIDERATION, IT IS HEREBY ORDERED, ADJUDGED
17   AND DECREED that the judgment of the district court be
18   AFFIRMED.
19
20        Appellants Eileen and Timothy Donovan appeal from the
21   judgment entered on March 31, 2010 by the United States
22   District Court for the Western District of New York (Curtin,
23   J.), which, inter alia, granted appellee’s motion for
24   summary judgment on the Donovans’ strict products liability
25   and negligence claims under New York law relating to
26   appellee’s product, the Silhouette Spinal Fixation System
27   (“Spinal System”). We assume the parties’ familiarity with
28   the underlying facts, the procedural history, and the issues
29   presented for review.
30
31        A grant of summary judgment is reviewed de novo,
32   “resolv[ing] all ambiguities and draw[ing] all permissible
33   factual inferences in favor of the party against whom
34   summary judgment is sought.” Terry v. Ashcroft, 

  128, 137 (2d Cir. 2003) (internal quotation marks omitted).
36
37   [1] The amended complaint alleges that Ms. Donovan was
38   harmed by the “defective design and/or manufacture of the
39   [fractured] screw” from the Spinal System. (Am. Compl.
40   ¶ 11.) The parties dispute which legal claims are raised by
41   the allegation, but any such claim* is subject to the same
42   causation analysis: Under New York law, “whether the action
43   is pleaded in strict products liability, breach of warranty

         *
           The potential failure-to-warn claim is discussed
     separately below.
                                  2
 1   or negligence, it is a consumer’s burden to show that a
 2   defect in the product was a substantial factor in causing
 3   the injury.” Tardella v. RJR Nabisco, Inc., 

  965, 966 (3d Dep’t 1991).
 5
 6        Although expert medical evidence of causation is not
 7   required in all products liability cases under New York law,
 8   Voss v. Black & Decker Mfg. Co., 

, 110-11
 9   (1983), “[o]rdinarily, expert medical opinion evidence . . .
10   is required, when the subject-matter to be inquired about is
11   presumed not to be within common knowledge and experience.”
12   Fane v. Zimmer, Inc., 

, 131 (2d Cir. 1991)
13   (quoting Meiselman v. Crown Heights Hosp., 

, 396
14   (1941)). Here, the Spinal System was installed to help
15   remedy a pain condition that arose from an accident that
16   preceded installation and continued unabated after removal.
17   Normally, when “an injury has multiple potential etiologies,
18   expert [medical] testimony is necessary to establish
19   causation.” Wills v. Amerada Hess Corp., 

, 46
20   (2d Cir. 2004) (requiring expert medical testimony even for
21   Jones Act claim, which has a reduced burden for causation).
22
23        The plaintiffs have not supported their claims with
24   expert medical opinion evidence. Their metallurgical expert
25   considered causation only in respect of the failure of the
26   device itself; he was not qualified to opine on medical
27   causation, and did not so do. Plaintiffs’ causation
28   argument therefore rests on one statement from Dr. Suddaby’s
29   deposition, indicating that Ms. Donovan’s pain was caused in
30   part by the loose hardware. At the threshold, it is unclear
31   whether Dr. Suddaby was referring to pain experienced after
32   the removal surgery or while the Spinal System remained
33   implanted. If the latter (which seems more likely), the
34   comment is not probative of the “severe and permanent
35   disabilities” alleged in the complaint.
36
37        In any event, this remark taken in context provides
38   insufficient support of causation. “[T]he mere existence of
39   a scintilla of evidence in support of the plaintiff’s
40   position will be insufficient [to defeat summary judgment];
41   there must be evidence on which the jury could reasonably
42   find for the plaintiff.” Jeffreys v. City of New York, 426

, 554 (2d Cir. 2005) (internal quotation marks
44   omitted). Furthermore, an expert opinion “requires some
45   explanation as to how the expert came to his conclusion and
46   what methodologies or evidence substantiate that
47   conclusion,” Riegel v. Medtronic, Inc., 

, 127

                                  3
 1   (2d Cir. 2006); taking one statement from a deposition out
 2   of context, without more, provides insufficient explanation.
 3
 4        In context, Dr. Suddaby clearly (and repeatedly) opined
 5   that the “significant component” of Ms. Donovan’s pain
 6   following removal was the residual spinal instability that
 7   pre-dated the surgeries and that the embedded screw fragment
 8   would not have adverse effects. Joint Appendix at 1697,
 9   1725.
10
11        On this record, a reasonable jury could not find that
12   the Spinal System was a substantial factor in causing Ms.
13   Donovan’s lasting injuries.
14
15   [2] Plaintiffs argue here that they pled a failure-to-warn
16   claim; but the plain language of the amended complaint
17   alleged only “defective design and/or manufacture of the
18   [fractured] screw.” (Am. Compl. ¶ 11.) And plaintiffs have
19   not moved to further amend the complaint. “[A] district
20   court does not abuse its discretion when it fails to grant
21   leave to amend a complaint without being asked to do so.”
22   See Greenidge v. Allstate Ins. Co., 

, 361 (2d
23   Cir. 2006). We therefore need not consider plaintiffs’
24   failure-to-warn argument, because it was untimely raised.
25   See 

       In any event, a failure-to-warn claim would be futile.
28   Under New York law, “[t]he physician acts as an ‘informed
29   intermediary’ between the manufacturer and the patient; and,
30   thus, the manufacturer’s duty to caution against a
31   [device’s] side effects is fulfilled by giving adequate
32   warning through the [treating] physician, not directly to
33   the patient.” Martin v. Hacker, 

, 9 (1993)
34   (internal citations omitted); Banker v. Hoehn, 

  438, 440 (3d Dep’t 2000) (applying informed intermediary
36   doctrine to medical devices).
37
38         The record reflects that Dr. Suddaby was supplied
39   product information, including specific warnings about
40   nonunion and device component fracture, which he had read
41   prior to the surgery; he attended courses about the device
42   on a routine basis, which included hands-on practice on
43   cadavers; he traveled several times to appellee’s teaching
44   facility; he reviewed workbooks that described the device
45   and its use; and he was aware that obesity was
46   contraindicated for the device. The plaintiffs do not


                                  4
 1   identify any particular information that Dr. Suddaby lacked
 2   that would have affected the course of treatment.
 3
 4        We have considered all of appellants’ contentions on
 5   this appeal and have found them to be without merit.
 6   Accordingly, the judgment of the district court is hereby
 7   AFFIRMED.
 8
 9
10                              FOR THE COURT:
11                              CATHERINE O’HAGAN WOLFE, CLERK
12
13
14
15
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