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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

New York, on the 25th 4 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

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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.

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* The potential failure-to-warn claim is discussed

separately below.

2

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, 336 F.3d

35 128, 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

the allegation, but any such claim* 41 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
3

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., 576 N.Y.S.2d

4 965, 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., 59 N.Y.2d 102, 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., 927 F.2d 124, 131 (2d Cir. 1991)

13 (quoting Meiselman v. Crown Heights Hosp., 285 N.Y. 389, 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., 379 F.3d 32, 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

43 F.3d 549, 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., 451 F.3d 104, 127
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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., 446 F.3d 356, 361 (2d

23 Cir. 2006). We therefore need not consider plaintiffs’

24 failure-to-warn argument, because it was untimely raised. 

25 See Id.

26

27 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, 83 N.Y.2d 1, 9 (1993)

34 (internal citations omitted); Banker v. Hoehn, 718 N.Y.S.2d

35 438, 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
5

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. 

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10 FOR THE COURT:

11 CATHERINE O’HAGAN WOLFE, CLERK

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