Gregory Kline v. Zimmer Holdings Inc ( 2016 )

NOT PRECEDENTIAL
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
_____________
No. 15-2854
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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)
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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
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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.”).
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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
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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.
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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
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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.”
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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 . . . .”
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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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