                                                            NOT PRECEDENTIAL

                    UNITED STATES COURT OF APPEALS
                         FOR THE THIRD CIRCUIT
                              _____________

                                    No. 15-2854
                                   _____________

          GREGORY KLINE, and CHERRIE KLINE, husband and wife,
                                                     Appellants

                                          v.

       ZIMMER HOLDINGS, INC.; ZIMMER, INC.; ZIMMER U.S., INC.
                          _____________


                 On Appeal from the United States District Court
                     for the Western District of Pennsylvania
                          District Court No. 2-13-cv-00513
                 District Judge: The Honorable Joy Flowers Conti

                Submitted Pursuant to Third Circuit L.A.R. 34.1(a)
                              September 29, 2016

             Before: AMBRO, SMITH, and FISHER, Circuit Judges

                              (Filed: October 7, 2016)
                             _____________________

                                   OPINION**
                             _____________________

SMITH, Circuit Judge.

 Honorable D. Brooks Smith, United States Circuit Judge for the Third Circuit,
assumed Chief Judge status on October 1, 2016.
**
   This disposition is not an opinion of the full court and pursuant to I.O.P. 5.7 does
not constitute binding precedent.
      On January 13, 2010, Gregory Kline underwent a total hip replacement. His

surgeon implanted a Femoral Stem with Kinectiv Technology. On April 6, 2011,

Kline’s hip replacement broke; the stem fractured at the neck. Kline sued Zimmer

Holdings Inc., Zimmer Inc., and Zimmer United States Inc. (collectively,

“Zimmer”), alleging several state-law product liability claims. By the time the

case reached summary judgment, Kline’s only remaining claims were negligent

design defect and negligent failure to warn.1 The District Court granted summary

judgment to Zimmer on all counts. Because Kline failed to show that a reasonable

jury could find that any unreasonable act or omission by Zimmer caused him harm,

we will affirm the judgment of the District Court.

      The District Court had jurisdiction under 28 U.S.C. § 1332, and we have

jurisdiction pursuant to 28 U.S.C. § 1291.

      We review the District Court’s disposition of a summary judgment motion

de novo, applying the same standard as the District Court. Doe v. Luzerne County,

660 F.3d 169, 174 (3d Cir. 2011). “[W]hen the nonmoving party is the plaintiff, he

1
  Kline’s wife, Cherrie Kline, also sued for lack of consortium. Because Cherrie
Kline’s claims are entirely derivative of Kline’s claims and because we will affirm
the grant of summary judgment as to Kline’s claims, we need not perform any
separate analysis relating to Cherrie Kline or her loss of consortium claim. See,
e.g., Darr Const. Co. v. Workers’ Compensation Appeal Bd., 715 A.2d 1075, 1080
(Pa. 1998) (“It is well-settled that the [loss of consortium] claim is
derivative . . . .”); Banks v. Int’l Rental & Leasing Corp., 680 F.3d 296, 300 n.6 (3d
Cir. 2012) (“The District Court dismissed his claim for loss of consortium because
that claim was derivative and therefore must rise or fall with his wife’s claims.”).
                                          2
must produce sufficient evidence to establish every element that he will be

required to prove at trial.” J.S. ex rel. Snyder v. Blue Mountain Sch. Dist., 650

F.3d 915, 925 (3d Cir. 2011) (en banc).

      Under Pennsylvania law, a plaintiff must show four elements to establish a

negligence claim: duty, breach, causation, and damages. See Phillips v. Cricket

Lighters, 841 A.2d 1000, 1008 (Pa. 2003); Morena v. S. Hills Health Sys., 462

A.2d 680, 684 n.5 (Pa. 1983). Demonstrating breach requires showing that the

defendant acted unreasonably. See, e.g., Phillips, 841 A.2d at 1008 (holding that

negligence claims require an inquiry “into the reasonableness of the

manufacturer’s conduct in creating and distributing such a product”).

Reasonableness requires comparing the risk and the utility of the alleged acts or

omissions. See, e.g., Benson v. Penn Cent. Transp. Co., 342 A.2d 393, 397 (Pa.

1975) (“A risk is unreasonable if it is of such magnitude as to outweigh what the

law regards as the utility of the act or of the particular manner in which it is done.”

(citing Restatement (Second) of Torts § 291)); see also Metzgar v. Playskool, Inc.,

30 F.3d 459, 462 (3d Cir. 1994) (conducting risk-utility analysis in a negligent

design case). Then, a plaintiff “must demonstrate ‘the causal connection between

the breach of a duty of care and the harm alleged: that the increased risk was a

substantial factor in bringing about the resultant harm.’” Green v. Pa. Hosp., 123


                                          3
A.3d 310, 316 (Pa. 2015) (quoting Scampone v. Highland Park Care Ctr., LLC, 57

A.3d 582, 596 (Pa. 2012)).

      Thus, to survive summary judgment, Kline has to show that there is a

genuine issue of material fact that Zimmer acted unreasonably in designing the

stem or failing to warn about the stem and that any unreasonable act was the cause

of the harm to Kline. Kline failed to do so.2

      On appeal, Kline primarily contends the District Court erred because the

District Court did not fully consider two affidavits filed after the Magistrate Judge

first recommended granting Zimmer’s summary judgment motion. Because these

affidavits do not advance Kline’s reasonableness or design causation arguments,

they do not affect summary judgment. Therefore, this Court need not address

Kline’s arguments that the sham affidavit doctrine was improperly applied3 or that

certain portions of the affidavit of Klein’s surgeon were admissible.



2
  Because the parties primarily addressed whether the District Court should or
should not have considered certain evidence, there was little briefing on
reasonableness. However, Zimmer briefed the causation issue, and the record is
clear. See Disability Rights N.J., Inc. v. Comm’r, N.J. Dep’t of Human Servs., 796
F.3d 293, 300–01 (3d Cir. 2015) (“We may affirm a district court for any reason
supported by the record.” (quoting Brightwell v. Lehman, 637 F.3d 187, 191 (3d
Cir. 2011))).
3
  For the same reason, this Court does not need to determine whether the standard
of review with regard to the sham affidavit doctrine is de novo or abuse of
discretion. See Galvin v. Eli Lilly & Co., 488 F.3d 1026, 1030 n.* (D.C. Cir. 2007)
(identifying national confusion over this issue).
                                          4
      Kline argues that the failure of the Zimmer device in another patient treated

by Kline’s doctor—an issue raised in both affidavits—is important here. Evidence

about the other patient’s device failure is not admissible, however, because it did

not “involv[e] the same product under similar circumstances,” nor did it (1) “show

notice to the defendant of the danger,” (2) “show [the] existence of the danger,” or

(3) “show the cause of the accident.” Gumbs v. Int’l Harvester, Inc., 718 F.2d 88,

97 (3d Cir. 1983). Here, the other patient’s device failure could not show notice of

the danger because the allegedly related device failure occurred after the Zimmer

device already had been implanted in Kline. The other patient’s device failure also

does not prove the “existence of the danger” or “cause of the accident” because

Kline fails to offer any sort of causation theory regarding the prior accident—let

alone one related to any unreasonable act that affected his own device. There is no

reason to believe that whatever latent danger allegedly harmed the other patient

had any relationship to Kline. Kline’s lack of a causation theory for the other

patient’s device failure means Kline failed to show that there were relevant

“similar circumstances.” Gumbs, 718 F.2d at 97.

      With regard to the negligent design defect claim, the District Court held that

Plaintiffs’ experts, Mari Truman and Dr. Donald Koss, had waived Kline’s design

defect claims in their depositions.


                                         5
      In fact, Truman and Koss did raise design defect theories in their expert

reports. Although these theories were not waived, they fail at summary judgment.

Truman and Koss’s design defect theories were that: Zimmer should have

conducted more stringent tests; Zimmer could have used a different surface

treatment; Zimmer should not have used the particular type of titanium it used; the

device should not have been multimodular; the offset or size of the device was

dangerous; or the device is inherently flawed.

      Kline failed to produce record evidence showing any of these design choices

were unreasonable, thus causing his device to fail.               With regard to

unreasonableness, Kline failed to provide record evidence from which a jury could

find that the allegedly faulty design changes increased risk more than they

increased utility. See Metzgar, 30 F.3d at 462 (conducting risk-utility analysis in a

negligent design case). See generally Tincher v. Omega Flex, Inc., 104 A.3d 328,

389–91 (Pa. 2014) (discussing risk-utility analysis). Instead, for instance, Truman

refers to a “NEW and foreseeable risk.” Whether a new risk is unreasonable can

only be determined based on a comparison with alternative risks and benefits, cf.

Peter Huber, Safety and the Second Best: The Hazards of Public Risk Management

in the Courts, 85 Colum. L. Rev. 277, 309 (1985) (“[T]he rejection of one risk is

always the acceptance of another.”), or proof that the new risk was of such

magnitude and likelihood that it was facially unreasonable, see Lance v. Wyeth, 85
                                         6
A.3d 434, 458–59, 458 n.36 (Pa. 2014) (discussing the common use of an

alternative design and approving plaintiff’s theory that defendant “tender[ed] into

the market a drug which it knows or should know is so dangerous that it should not

be taken by anyone”). Here, there is neither sufficient record evidence about the

relative risks of an alternative design nor sufficient record evidence that the stem is

so dangerous that a jury could find Zimmer’s design choices were unreasonable.

      Moreover, to the extent Kline presented admissible causation evidence, that

evidence does not support any of Kline’s theories of unreasonable design. For

example, Truman failed to show how increased testing would have resulted in a

design change; Truman admitted that she did not have “information” to conclude

that different surface treatment would have prevented the stem fracture; and

Kline’s metallurgy expert admitted he was not aware of a better material to use for

the stem.

      Summary judgment also must be granted to Zimmer on Kline’s failure to

warn claim. Kline’s theory, supported by Zimmer’s experts, was that an individual

of Kline’s weight or body mass index who engaged in vigorous activity was at a

higher risk of device failure.     As Kline acknowledged, a package insert for

Zimmer’s device warned about those risks, at least in general terms.4 Truman


4
             “Complication or failure of any total hip prosthesis are more likely to
             occur in heavy patients.”
                                          7
opined that there were two defects with these warnings: (1) Zimmer should have

contraindicated the device and (2) done so for use at specific weights, body mass

indexes, and/or activity levels. Truman based her opinion on the fact that one of

Zimmer’s competitors contraindicated specific combinations of weights and

activity levels on the competitor’s device. However, to the extent Truman opined

that the weaker warning was unreasonable, that opinion is unsubstantiated and

therefore fails to create a genuine issue of material fact. See Advo, Inc. v. Phila.

Newspapers, Inc., 51 F.3d 1191, 1198 (3d Cir. 1995) (“[E]xpert testimony

without . . . a factual foundation cannot defeat a motion for summary judgment.”);

see also Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 815 (5th Cir. 1992)

(describing contraindication). Truman did not indicate, among other things, that

the competitor’s device was sufficiently analogous to Zimmer’s device, that the

competitor’s warning was reasonable, that there were any particular weights or



            “Complications and/or failure of total hip prostheses. [sic]
            are more likely to occur in patients with unrealistic
            functional expectations, heavy patients, physically active
            patients, and/or with patients who fail to follow through with
            the required rehabilitation program. Physical activity can
            result in loosening, wear, and/or fracture of the hip implant.
            The prospective implant patient must be counseled about the
            capabilities of the implant and the impact it will have on his
            or her lifestyle. The patient must be instructed about all
            postoperative restrictions, particularly those related to
            occupational and sports activities . . . .”
                                         8
activity levels at which excessive risk existed, or that the likelihood of fracture was

high enough to warrant the contraindication. Accordingly, there is no evidence in

the record that the risk was of a magnitude to require a contraindication at any

specific weight, body mass index, or activity level, except that the device broke in

Kline. For the reasons set forth above, we will affirm the judgment of the District

Court.




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