     17-2059-cv
     Tomaselli, et al. v. Zimmer, et al.
                           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 for the Second Circuit,
 2   held at the Thurgood Marshall United States Courthouse, 40 Foley Square, in the
 3   City of New York, on the 4th day of April, two thousand and eighteen.
 4
 5   Present:
 6                ROBERT D. SACK,
 7                PETER W. HALL,
 8                CHRISTOPHER F. DRONEY
 9                     Circuit Judges.
10
11
12   Mary Tomaselli, Eugene Tomaselli,
13
14                Plaintiffs-Appellants,
15
16   v.                                                                   17-2059-cv
17
18   The New York and Presbyterian Hospital,
19   Columbia University College of Physicians and
20   Surgeons, The Trustees of Columbia University in
21   the City of New York, John Doe #1, John Doe #9,
22   The University Hospital of Columbia and Cornell,
23   Columbia University Medical Center,
24
25                Defendants,
26
27   Zimmer, Inc., Zimmer Holdings, Inc., Pioneer
28   Surgical Technology, Inc.
29
30                Defendants-Appellees.
31
1
2    For Plaintiffs-Appellants:       JAMES K. RILEY, O’Connell & Riley, Pearl River, NY
3
4    For Defendants-Appellees:        VICTORIA A. GRAFFEO (Judi Abbott Curry, Marina
5                                     Plotkin, on the brief), Harris Beach PLLC, New
6                                     York, NY
7
8          Appeal from a final judgment and decision entered March 16, 2017, in the

9    Southern District of New York (Abrams, J.).

10         UPON      DUE     CONSIDERATION,           IT    IS   HEREBY       ORDERED,

11   ADJUDGED, AND DECREED that the district court’s decision and judgment are

12   AFFIRMED.

13         In 2011, Mary Tomaselli underwent hip surgery that included implantation of

14   a Greater Trochanter Reattachment ("GTR") device, which had two cables designed

15   to hold the bone together while it heals. Over a year later, Tomaselli discovered that

16   one of the cables in the device had broken. She and her husband sued, among others,

17   the GTR device's manufacturer, Pioneer Surgical Technology, Inc., and its

18   distributor, Zimmer, Inc. and Zimmer Holdings, Inc. (collectively "Zimmer"),

19   asserting, inter alia, product liability and failure-to-warn claims. The district court

20   granted summary judgment to the defendants, and plaintiffs appealed the failure-to-

21   warn determination. We assume the parties' familiarity with the underlying facts,

22   the procedural history, the arguments presented on appeal, and the district court’s

23   rulings, which we reference only to explain our decision.

24         We review de novo the district court’s grant of summary judgment, which is

25   appropriate "if the movant shows that there is no genuine dispute as to any material




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1    fact and the movant is entitled to judgment as a matter of law." Walsh v. N.Y.C.

2    Hous. Auth., 828 F.3d 70, 74 (2d Cir. 2016) (internal quotation marks omitted).

3          Under New York law, a failure-to-warn claim requires a showing of both

4    proximate cause and the warning's inadequacy. See Bravman v. Baxter Healthcare

5    Corp., 984 F.2d 71, 74-75 (2d Cir. 1993); Figueroa v. Bos. Sci. Corp., 254 F. Supp. 2d

6    361, 369-70 (S.D.N.Y. 2003); Glucksman v. Halsey Drug Co., 553 N.Y.S.2d 724, 726,

7    160 A.D.2d 305, 307 (1st Dep't 1990). New York uses an informed intermediary

8    doctrine, whereby warnings must be given to "the physician, whose duty it is to

9    balance the risks against the benefits of various drugs and treatments and to

10   prescribe them and supervise their effects." Martin v. Hacker, 83 N.Y.2d 1, 9, 628

11   N.E.2d 1308 (1993). "[T]he manufacturer’s duty to caution against a drug’s side

12   effects is fulfilled by giving adequate warning through the prescribing physician, not

13   directly to the patient." Id. This standard also applies to devices, such as the GTR

14   device, that are available only by prescription. See Fane v. Zimmer, Inc., 927 F.2d

15   124, 129 (2d Cir. 1991). Insofar as adequate warnings are concerned, under New

16   York law, "[i]f the doctor is sufficiently warned, the product is not defective." Id.

17         The district court concluded that Tomaselli failed to meet her burden in

18   demonstrating proximate cause.       We agree for two reasons.       First, there is no

19   competent evidence that the broken cable – the risk of which Tomaselli was not

20   warned – caused her injury. The plaintiffs did not engage an expert witness, and the

21   two testifying doctors concluded that Tomaselli's pain was caused either from the




                                                3
1    device's plate, which had not malfunctioned, or her underlying bone fracture, which

2    the device was inserted to fix. Medical records corroborate these conclusions.

3             A plaintiff cannot prove proximate cause "[a]bsent competent medical expert

4    testimony on the issue of causation" when "the question [is] beyond the purview of

5    the ordinary person." Fane, 927 F.2d at 132; see also Barnes v. Anderson, 202 F.3d

6    150, 159 (2d Cir. 1999) (collecting cases in the tort law context); In re Mirena IUD

7    Prods. Liab. Litig., 202 F. Supp. 3d 304, 311-12 (S.D.N.Y. 2016) ("[C]ases involving

8    pharmaceuticals, toxins or medical devices involve complex questions of medical

9    causation beyond the understanding of a lay person" and thus "summary judgment

10   is appropriate where required expert testimony is absent from the record."), aff'd,

11   713 F. App'x 11, 2017 WL 4785947 (2d Cir. Oct. 24, 2017) (summary order). Here,

12   the only evidence in the record to support the notion that Tomaselli's pain was caused

13   by the GTR's broken cable was her own, uninformed speculation, which, standing

14   alone, cannot constitute sufficient evidence on which to base a finding of proximate

15   cause.

16            Second, the evidence demonstrates that while Tomaselli's doctor never saw the

17   specific prepackaged warning indicating that the cables could break, he nevertheless

18   knew that cables in implant devices could break after implantation. For example, he

19   testified that “every orthopedic surgeon knows” about cable fatigue strength and that

20   “any cable could break with enough stress.” J.A. 346-47. Because Zimmer provided

21   warnings describing that the GTR device's cables could break, and because

22   Tomaselli's physician was aware that cables used in implant devices can break, the



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1    plaintiffs' strict liability claims against the defendants fail under the informed

2    intermediary doctrine. See Fane, 927 F.2d at 130 ("Because the warnings provided

3    specific information on the risks associated with use of the . . . device and Dr. Elting

4    was fully aware of these risks, we hold as a matter of law that the warnings were

5    adequate."). For the same reasons, the plaintiffs' negligence claims fail as well. See

6    id. ("Regardless of the descriptive terminology used to denominate the cause of

7    action . . . where the theory of liability is failure to warn, negligence and strict

8    liability are equivalent." (alteration in original)).

9           We have considered the plaintiffs' remaining arguments and find them to be

10   without merit.    We reiterate that we resolve this appeal by summary order on

11   alternative grounds one or both of which would justify our conclusion. Accordingly,

12   the district court's judgment and decision and order are AFFIRMED.

13                                                    FOR THE COURT:
14                                                    Catherine O’Hagan Wolfe, Clerk




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