1 10-1769-cv Donovan v. Centerpulse Spine Tech Inc.



### UNITED STATES COURT OF APPEALS **FOR THE SECOND CIRCUIT**



## SUMMARY ORDER

**R ULINGS BY SUMMARY ORDER DO NOT HAVE PRECEDENTIAL EFFECT**  **. C**  **ITATION TO A SUMMARY ORDER FILED**
**ON OR AFTER J** **ANUARY 1,**  **2007, IS PERMITTED AND IS GOVERNED BY**  **F EDERAL**  **R ULE OF**  **A PPELLATE**  **P ROCEDURE**  **32.1 AND THIS COURT**  **’ S**  **L OCAL**  **R ULE**  **32.1.1. W** **HEN CITING A SUMMARY ORDER IN A**
**DOCUMENT FILED WITH THIS COURT ,**  **A PARTY MUST CITE EITHER THE F**  **EDERAL A** **PPENDIX 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** 1 **for the Second Circuit, held at the Daniel Patrick Moynihan** 2 **United States Courthouse, 500 Pearl Street, in the City of** 3 **New York, on the 25 th** **day of March, two thousand eleven.** 4 5 **PRESENT: DENNIS JACOBS,** 6 **Chief Judge ,**  7 **ROSEMARY S. POOLER,** 8 **PETER W. HALL,** 9 **Circuit Judges**

**.** 10 11 12 - - - - - - - - - - - - - - - - - - - -X 13 **EILEEN F. DONOVAN and TIMOTHY D.** 14 **DONOVAN** , 15 16 **Plaintiffs-Appellants ,**  17 18 **-v.- 10-1769-cv** 19 20 **CENTERPULSE SPINE TECH INC.,** 21 22 **Defendant-Appellee ,**  23 24 **CENTERPULSE USA, INC.,** 25 26 **Defendant**

**.** 27 - - - - - - - - - - - - - - - - - - - -X 28* The potential failure-to-warn claim is discussed separately below.

2 1 **FOR APPELLANTS:** HUGH M. RUSS, III (Ryan K. Cummings, on 2 the brief ), Hodgson Russ LLP, Buffalo, 3 NY. 4 5 **FOR APPELLEE:** HARRY F. MOONEY (Jody E. Briandi, Tasha 6 T. Dandridge, Hurwitz & Fine, P.C., 7 Buffalo, NY, and Thomas G. Stayton, Baker 8 & Daniels LLP, Indianapolis, IN, on the 9 brief ), Hurwitz & Fine, P.C., Buffalo, 10 NY. 11 12 Appeal from a judgment of the United States District 13 Court for the Western District of New York (Curtin, J. ). 14 15 **UPON DUE CONSIDERATION, IT IS HEREBY ORDERED, ADJUDGED** 16 **AND DECREED**that the judgment of the district court be 17
**AFFIRMED**

. 18 19 Appellants Eileen and Timothy Donovanappeal from the 20 judgment entered on March 31, 2010 by the United States 21 District Court for the Western District of New York (Curtin, 22 J. ) , which, inter alia , granted appellee’s motion for 23 summary judgment on the Donovans’ strict products liability 24 and negligence claims under New York law relating to 25 appellee’s product, the Silhouette Spinal Fixation System 26 (“Spinal System”) . We assume the parties’ familiarity with 27 the underlying facts, the procedural history, and the issues 28 presented for review. 29 30 A grant of summary judgment is reviewed de novo

, 31 “resolv[ing] all ambiguities and draw[ing] all permissible 32 factual inferences in favor of the party against whom 33 summary judgment is sought.” Terry v. Ashcroft , 336 F.3d 34 128, 137 (2d Cir. 2003) (internal quotation marks omitted). 35 36 **[1]** The amended complaint alleges that Ms. Donovan was 37 harmed by the “defective design and/or manufacture of the 38 [fractured] screw” from the Spinal System. (Am. Compl. 39 ¶ 11.) The parties dispute which legal claims are raised by 40 the allegation, but any such claim * is subject to the same 41 causation analysis: Under New York law, “whether the action 42 is pleaded in strict products liability, breach of warranty 433 or negligence, it is a consumer’s burden to show that a 1 defect in the product was a substantial factor in causing 2 the injury.” Tardella v. RJR Nabisco, Inc. , 576 N.Y.S.2d 3 965, 966 (3d Dep’t 1991). 4 5 Although expert medical evidence of causation is not 6 required in all products liability cases under New York law, 7 Voss v. Black & Decker Mfg. Co. , 59 N.Y.2d 102, 110-11 8 (1983), “[o]rdinarily, expert medical opinion evidence . . . 9 is required, when the subject-matter to be inquired about is 10 presumed not to be within common knowledge and experience.” 11 Fane v. Zimmer, Inc. , 927 F.2d 124, 131 (2d Cir. 1991) 12 (quoting Meiselman v. Crown Heights Hosp. , 285 N.Y. 389, 396 13 (1941)). Here, the Spinal System was installed to help 14 remedy a pain condition that arose from an accident that 15 preceded installation and continued unabated after removal. 16 Normally, when “an injury has multiple potential etiologies, 17 expert [medical] testimony is necessary to establish 18 causation.” Wills v. Amerada Hess Corp. , 379 F.3d 32, 46 19 (2d Cir. 2004) (requiring expert medical testimony even for 20 Jones Act claim, which has a reduced burden for causation). 21 22 The plaintiffs have not supported their claims with 23 expert medical opinion evidence. Their metallurgical expert 24 considered causation only in respect of the failure of the 25 device itself; he was not qualified to opine on medical 26 causation, and did not so do. Plaintiffs’ causation 27 argument therefore rests on one statement from Dr. Suddaby’s 28 deposition, indicating that Ms. Donovan’s pain was caused in 29 part by the loose hardware. At the threshold, it is unclear 30 whether Dr. Suddaby was referring to pain experienced after 31 the removal surgery or while the Spinal System remained 32 implanted. If the latter (which seems more likely), the 33 comment is not probative of the “severe and permanent 34 disabilities” alleged in the complaint. 35 36 In any event, this remark taken in context provides 37 insufficient support of causation. “[T]he mere existence of 38 a scintilla of evidence in support of the plaintiff’s 39 position will be insufficient [to defeat summary judgment]; 40 there must be evidence on which the jury could reasonably 41 find for the plaintiff.” Jeffreys v. City of New York , 426 42 F.3d 549, 554 (2d Cir. 2005) (internal quotation marks 43 omitted). Furthermore, an expert opinion “requires some 44 explanation as to how the expert came to his conclusion and 45 what methodologies or evidence substantiate that 46 conclusion,” Riegel v. Medtronic, Inc. , 451 F.3d 104, 127 474 (2d Cir. 2006); taking one statement from a deposition out 1 of context, without more, provides insufficient explanation. 2 3 In context, Dr. Suddaby clearly (and repeatedly) opined 4 that the “significant component” of Ms. Donovan’s pain 5 following removal was the residual spinal instability that 6 pre-dated the surgeries and that the embedded screw fragment 7 would not have adverse effects. Joint Appendix at 1697, 8 1725. 9 10 On this record, a reasonable jury could not find that 11 the Spinal System was a substantial factor in causing Ms. 12 Donovan’s lasting injuries. 13 14 **[2]** Plaintiffs argue here that they pled a failure-to-warn 15 claim; but the plain language of the amended complaint 16 alleged only “defective design and/or manufacture of the 17 [fractured] screw.” (Am. Compl. ¶ 11.) And plaintiffs have 18 not moved to further amend the complaint. “[A] district 19 court does not abuse its discretion when it fails to grant 20 leave to amend a complaint without being asked to do so.” 21 See Greenidge v. Allstate Ins. Co. , 446 F.3d 356, 361 (2d 22 Cir. 2006). We therefore need not consider plaintiffs’ 23 failure-to-warn argument, because it was untimely raised. 24 See Id. 25 26 In any event, a failure-to-warn claim would be futile. 27 Under New York law, “[t]he physician acts as an ‘informed 28 intermediary’ between the manufacturer and the patient; and, 29 thus, the manufacturer’s duty to caution against a 30 [device’s] side effects is fulfilled by giving adequate 31 warning through the [treating] physician, not directly to 32 the patient.” Martin v. Hacker , 83 N.Y.2d 1, 9 (1993) 33 (internal citations omitted); Banker v. Hoehn , 718 N.Y.S.2d 34 438, 440 (3d Dep’t 2000) (applying informed intermediary 35 doctrine to medical devices). 36 37 The record reflects that Dr. Suddaby was supplied 38 product information, including specific warnings about 39 nonunion and device component fracture, which he had read 40 prior to the surgery; he attended courses about the device 41 on a routine basis, which included hands-on practice on 42 cadavers; he traveled several times to appellee’s teaching 43 facility; he reviewed workbooks that described the device 44 and its use; and he was aware that obesity was 45 contraindicated for the device. The plaintiffs do not 465 identify any particular information that Dr. Suddaby lacked 1 that would have affected the course of treatment. 2 3 We have considered all of appellants’ contentions on 4 this appeal and have found them to be without merit. 5 Accordingly, the judgment of the district court is hereby 6
**AFFIRMED**

. 7 8 9 FOR THE COURT: 10 CATHERINE O’HAGAN WOLFE, CLERK 11 12 13 14 15 16