O'Shea v. Zimmer Biomet Holdings, Inc. et al
Filing
66
OPINION AND ORDER granting in part and denying in part 48 Motion for Summary Judgment; denying as moot 55 Motion to Amend. Signed by Judge Michael L. Brown on 9/27/18. (jpa)
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF GEORGIA
ATLANTA DIVISION
Patrick O’Shea,
Plaintiff,
Case No. 1:16-cv-02813
v.
Michael L. Brown
United States District Judge
Zimmer Biomet Holdings, Inc., et
al.,
Defendants.
________________________________/
OPINION AND ORDER
This products-liability case arises from the failure of a replacement
knee manufactured by Defendants Zimmer Biomet Holdings, Inc.,
Zimmer, Inc., and Zimmer U.S., Inc., and implanted in Plaintiff Patrick
O’Shea’s left leg. For the reasons below, the Court grants Defendants’
Motion for Summary Judgment (Dkt. 48) in part and denies it in part.
The Court also denies Plaintiff’s Motion to Amend Complaint as moot.
(Dkt. 55).
1
I. Background
Plaintiff suffered from chronic knee pain in his left knee. Dkt. 482 at ¶ 1-2; Dkt. 51 at ¶¶ 3-4. His left leg was deformed, the result of a
gunshot wound sustained in 1978. Dkt. 48-2 at ¶ 3; Dkt. 51 at ¶ 1. His
femur bowed forward and to the outside. Dkt. 48-2 at ¶ 4. His left leg
was also 1.5 centimeters shorter than his right leg and rotated twenty
degrees externally. Id. He walked with a gait. Id.
In 2007, he decided to have his knee replaced. Dkt. 48-2 at ¶ 6; Dkt.
51 at ¶ 8. He was obese. Dkt. 48-2 at 2. Plaintiff’s surgeon, Dr. Diehl,
chose to implant a Zimmer Biomet NexGen Complete Knee Solution LPSFlex Prolong System replacement knee. Id. at ¶ 7. Dr. Diehl performed
the knee-replacement surgery in June 2007.
Id. at ¶ 6.
Plaintiff
recovered well and regained movement. Id. at ¶ 10.
Seven years later, Plaintiff’s pain returned. Dkt. 48-2 at ¶ 11; Dkt.
51 at ¶ 10-13.
Dr. Diehl examined him and recommended another
surgery to diagnose the problem. Dkt. 48-2 at ¶ 13; Dkt. 51 at ¶ 14.
During that surgery, Dr. Diehl found that the polyethene tibial post of
the replacement knee – that is, the portion of the artificial knee attached
to the tibia – had broken. Dkt. 48-2 at ¶ 11; Dkt. 51 ¶ 14. Dr. Diehl
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replaced the polyethylene liner, still using the Zimmer product. Dkt. 482 at ¶ 14. No one kept the broken component after surgery. Dkt. 51 at ¶
15.
Plaintiff filed this action asserting design defect, manufacturing
defect, and failure-to-warn claims arising from the broken tibial post.
After discovery, Defendants moved for summary judgment on all of
Plaintiff’s claims. (Dkt. 48).
II. Legal Standard
Summary judgment is appropriate where “the movant shows that
there is no genuine dispute as to any material fact and that the movant
is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). “No
genuine issue of material facts exists if a party has failed to ‘make a
showing sufficient to establish the existence of an element . . . on which
that party will bear the burden of proof at trial.’” Am. Fed’n of Labor &
Cong. Of Indus. Orgs. v. City of Miami, 637 F.3d 1178, 1186 (11th Cir.
2011) (quoting Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986)). An
issue is genuine when the evidence is such that a reasonable jury could
return a verdict for the nonmovant. Anderson v. Liberty Lobby, Inc., 477
U.S. 242, 249-50 (1986).
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The moving party bears the initial responsibility of asserting the
basis for its motion. Id. at 323. The movant is not, however, required to
negate the non-movant’s claim. Instead, the moving party may meet its
burden by showing that there is “an absence of evidence to support the
non-moving party’s case.” Id. at 324. After the moving party has carried
its burden, the non-moving party must present competent evidence of a
genuine issue for trial. Id.
The Court views all evidence and factual inferences in a light most
favorable to the non-moving party. Samples v. City of Atlanta, 846 F.2d
1328, 1330 (11th Cir. 1988). But the existence of some alleged factual
disputes will not defeat an otherwise proper motion for summary
judgment. “The requirement is there be no genuine issue of material
fact.” Anderson, 477 U.S. 247-48.
III. Analysis
Plaintiff brings claims of manufacturing defect, design defect, and
failure-to-warn arising out of the failure of his Zimmer knee-replacement
device.
Plaintiff asserts these claims as both strict-liability and
negligence claims.
Although Georgia recognizes causes of action for
products liability sounding in both strict-liability and negligence,
4
“[b]ecause of the inherent similarity between a negligence and a strict
liability action under Georgia law, the analysis of plaintiff’s strict liability
claims largely applies to an examination of the negligence claim.” Jones
v. Amazing Prods., Inc., 231 F. Supp. 2d 1228, 1251 (N.D. Ga. 2002).
A. Manufacturing Defect
To establish a manufacturing defect under Georgia law, a plaintiff
“must prove that defendant is the manufacturer of the property, that the
property when sold by the manufacturer was not merchantable and
reasonably suited to the use intended (i.e. defective), and that its
condition when sold was the proximate cause of the injury sustained.”
Williams v. Mast Biosurgery USA, Inc., 644 F.3d 1312, 1319 (11th Cir.
2011) (quoting Chicago Hardware & Fixture Co. v. Letterman, 610 S.E.2d
875, 877-78 (Ga. App. 1999)). “A manufacturing defect is one where there
was a flaw from the manufacturing process not in the design or
specifications of the product.” Brazil v. Janssen Research & Dev., 196 F.
Supp. 3d 1351, 1358 (N.D. Ga. 2016). The flaw must render the product
unsuitable for its intended use.
A manufacturing defect is “measurable against a built-in objective
standard or norm of proper manufacture.” Banks v. ICI Americas Inc.,
5
450 S.E.2d 671, 673 n.2 (Ga. 1994).
The “product’s defectiveness is
determined by measuring the product in question against the benchmark
of the manufacturer’s designs.”
In re Mentor Corp. ObTape
Transobturator Sling Prods. Liability Litig., 711 F. Supp. 2d 1348, 1365
(M.D. Ga. 2010) (quoting ACE Fire Underwriters Ins. Co. v. ALC
Controls, Inc., No. 1:07-cv-606, 2008 WL 2229121, at *2 (N.D. Ga. May
28, 2008)). So to succeed on a manufacturing-defect claim, a plaintiff
must show that the defendants’ product “was not manufactured in
accordance with its design.” Jones v. Amazing Prods. Inc., 231 F. Supp.
2d 1228, 1239 (N.D. Ga. 2002). But “[i]t is not necessary for the plaintiff
to specify precisely the manner of the defect.” Williams v. American Med.
Sys., 548 S.E.2d 371, 374 (Ga. App. 2001).
To survive summary
judgment, the plaintiff must show that the product did not “operate as
intended” from which a jury could infer that the product deviated from
the manufacturer’s design. Id.1
Defendants contend they are entitled to summary judgment on
Plaintiff’s manufacturing-defect claim because Plaintiff failed to produce
Of course, the plaintiff must also show that the manufacturing defect
proximately caused the injury. Williams, 248 S.E.2d at 374.
1
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expert testimony that the replacement knee was defective.
Plaintiff
contends that he need not provide expert testimony and that his other
evidence is enough.
Georgia law does not always require a plaintiff in a manufacturing
defect case to present expert testimony. Mast Biosurgery, 644 F.3d at
1319. Georgia courts have held that “the existence of a manufacturing
defect in a products liability case may be inferred from circumstantial
evidence.” Firestone Tire and Rubber Co. v. King, 244 S.E.2d 905, 909
(Ga. App. 1978). Reliance on circumstantial evidence is particularly
appropriate when – as here – the product is destroyed or otherwise
unavailable for testing. Graff v. Baja Marine Corp., 310 F. App’x 298,
306 (11th Cir. 2009) (citing Rose v. Figgie Int’l, Inc., 495 S.E.2d 77, 81
(Ga. App. 1997)).
The Eleventh Circuit has explained that expert testimony is
necessary to show a manufacturing defect when an evaluation of the
alleged defect lies outside the “common experience of a jury” – that is,
when a juror would not otherwise understand how the product was
intended to perform.
Mast Biosurgery, 644 F.3d at 1320.
In Mast
Biosurgery, the plaintiff claimed surgical wrap implanted in her abdomen
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was defective. Id. at 1318-19. She presented testimony from her doctor
showing that the wrap broke down into hard plastic pieces, migrated into
her colon, and caused severe injuries. Id. at 1319. She did not, however,
present expert testimony about how the wrap was intended to operate or
that it failed to operate appropriately. Id.
The Eleventh Circuit affirmed the district court’s order granting
summary judgment for the defendant, finding that – while Georgia law
may not require expert testimony in all manufacturing-defect cases – the
proper functioning of the surgical mesh was beyond the ken of the
average juror. Id. at 1320-1321. Expert testimony was necessary to
provide information “about the nature of the product and how it was
expected to function when implanted in the human body.” Id. at 1321.
Without this expert testimony, the court found the plaintiff failed to raise
an issue of material fact about whether the mesh was defective. Id.
In reaching this decision, the Eleventh Circuit distinguished two
cases in which Georgia courts ruled that expert testimony was
unnecessary.
First, the Eleventh Circuit distinguished McDonald v.
Mazda Motors of America, Inc., 603 S.E.2d 456 (Ga. App. 2004). In that
case, the plaintiff alleged that a new car was defective because it began
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making a loud rattling noise right after delivery and the dealership could
not fix it.
Second, the Eleventh Circuit distinguished Williams v.
American Med. Sys., 548 S.E.2d 371, 374 (Ga. App. 2001). In that case,
the plaintiff alleged that an inflatable penile implant was defective after
it ruptured just one month after implantation.
The Eleventh Circuit held that both cases involved alleged defects
“within the common experience of a jury.” Mast Biosurgery, 644 F.3d at
1320. Expert testimony was unnecessary because the average person
would know a new car is not supposed to make loud rattling noises. Id.
And while an inflatable penile implant may be more complicated, any
juror would know the device should not have ruptured within the first
month. Id. Evidence, therefore, that the engine ran loudly or that the
implant broke into pieces was sufficient for the jury to determine that the
product did not operate as intended. Id.
Like Williams, this case involves an implant that simply broke.
But, in this case, it did not break within the first month.
Plaintiff
underwent knee-replacement surgery in 2007. Dkt. 48-2 at ¶ 6; Dkt. 51
at ¶ 8. The Zimmer implant operated perfectly for seven years. Dkt. 482 at ¶¶ 6-11; Dkt. 51 at ¶ 8. Plaintiff claims that it was defective for not
9
lasting eight years or more. A typical juror, however, would not know
how long it should last. Also, Plaintiff was obese at the time of his initial
surgery and had a pronounced gait because of a previous gunshot wound.
The average juror certainly would not know whether the implant failed
to function as intended when it wore out and broke after seven years
under these circumstances. This is not a case in which an inference of
defective manufacturing is “particularly obvious.” Mast Biosurgery, 644
F.3d at 1320. Put differently, the failure of Plaintiff’s replacement knee
is not like finding a trout in the milk bottle. Graff v. Baja Marine Corp.,
2007 WL 6900363 (N.D. Ga. Dec. 21, 2007) (noting some defects are so
obvious that expert testimony is unnecessary as when you “find a trout
in the milk bottle”).
Because Plaintiff presented no expert testimony, it may seem that
Defendants are entitled to summary judgment. But, in Mast Biosurgery,
the Eleventh Circuit (after finding expert testimony necessary) still
considered whether plaintiff’s circumstantial evidence was somehow
enough to avoid summary judgment. See id. at 1321. The court noted
that the plaintiff presented testimony from her doctor about his use of
the surgical wrap, the fact that he later found pieces of it in her colon,
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and that those pieces injured the plaintiff. Id. The Eleventh Circuit
found this circumstantial evidence insufficient because it did not show
that the wrap “performed other than as expected.”
Id.
The court
explained that the evidence did not “strengthen the inference that it was
a manufacturing defect” that caused the injury rather than some other
potential cause such as the product being mishandled, having been
inserted in a negligent manner, or having been unsuitable for use in this
plaintiff. Id. The court held that, while a plaintiff need not present
circumstantial
evidence
to
disprove
all
causes
other
than
a
manufacturing defect, a plaintiff relying on circumstantial evidence must
“provide evidence that would permit a jury to select [his or her]
explanation, that of a manufacturing defect, as the most likely cause.”
Id.
The Eleventh Circuit reached a similar conclusion in Graff v. Baja
Marine Corp., 310 F. App’x 298 (11th Cir. 2009). In that case, the driver
of a speed boat died in a boating accident. His family sued claiming the
engine gimble had a manufacturing defect that caused it to break and
eject the decedent. Id. at 301. The defendant argued that there was no
defect and that the decedent hit a wave at an excessively high speed,
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causing the gimble to break and leading to the accident. Id. The district
court excluded the plaintiff’s expert witness, and the Eleventh Circuit
affirmed. Id. at 301-305. As a result, the Eleventh Circuit recognized
that the plaintiff was essentially making a circumstantial argument that
the gimble housing – a complicated device – would not suddenly fail
during operation unless it contained a manufacturing defect. Id. at 305.
The court found this insufficient, holding that “it would simply be
speculation to conclude that plaintiff’s theory is the only plausible
explanation for the accident.” Id. at 306. The court held that, without
expert testimony, a plaintiff must present circumstantial evidence
sufficient to allow the jury to infer that the “plaintiff’s theory [of a defect]
is the only plausible explanation for the [injury].” Id. at 306.2
Georgia courts have held that a plaintiff may circumstantially establish
a manufacturing defect through evidence that goods manufactured at the
same plant at around the same time as the product at issue suffered the
same failure. See Rose, 495 S.E.2d at 82 (“Circumstantial evidence
relevant to prove a manufacturing defect may include evidence of the
existence of the defect in goods produced at the same plant at around the
same time”). In this case, there is no evidence of problems with other
replacement knees manufactured in the same plant and at the same time
as the knee implanted in Plaintiff’s leg. To the contrary, the undisputed
evidence shows that Zimmer’s product has an impeccable record for
reliability. Dkt. 48-2 at ¶ 20. That theory of liability is thus unavailable
here.
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As the Eleventh Circuit has done, this Court must consider whether
Plaintiff has presented enough circumstantial evidence to avoid
summary judgment without expert testimony. Plaintiff argues that an
affidavit executed by Dr. Mark Diehl – his surgeon – is sufficient. See
Dkt. 51-8. Dr. Diehl provided the affidavit before litigation began. In it,
he stated that he implanted the knee in the condition he received it from
Defendants “without any modification” and that the surgery “went as
planned.” Id. at ¶ 5. Dr. Diehl also stated that “in all [his] years as an
orthopedic surgeon performing hundreds of knee surgeries, [he] had not
seen such a fracture or failure of this polyethylene insert in this manner,
and the insert is not supposed to fail as it did.” Id. at ¶ 9. He stated that
it was his opinion “to a reasonable degree of medical certainty” that
Plaintiff’s weight and femoral deformity did not cause the fracture. Dkt.
51-8 at ¶¶ 10-11. Finally, he said the implant should have lasted more
than fifteen years and “did not perform as [he] would have expected.” Id.3
Although immaterial to this motion, Dr. Diehl testified at his deposition
that he believed that Plaintiff’s deformities “put some abnormal forces
across . . . the post, [which] led to failure.” Dkt. 48-3 at 17. Perhaps Dr.
Diehl’s testimony can be reconciled with his pretrial affidavit, but that is
a question for the jury.
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Dr. Diehl is not an expert on the design and performance of
polyethylene components in replacement knees and was not offered as an
expert. As the Eleventh Circuit held in Mast Biosurgery, the testimony
of a treating physician cannot be enough to show how a manufacturer
intended a complicated device to operate when that treating physician is
not qualified as an expert in the design and production of the product.
Mast Biosurgery, 644 F.3d at 1320. So Dr. Diehl’s affidavit is insufficient
circumstantial evidence to raise a genuine issue of material fact.
But this case involves something else. In support of his claim,
Plaintiff points to an internal document, called a complaint-handling
form, that Defendants used to gather information about the failure of
Plaintiff’s replacement knee.
See Dkt. 51-16.
One of Defendants’
employees completed the form. Dkt. 51-19 at 2. A question on the form
asked: “Does the available information suggest that the device/product
has malfunctioned or failed to perform as intended?” Dkt. 51-16 at 26.
The employee checked the box for the answer “Yes.” Id. The form then
stated: “If yes, explain circumstance below.” The employee wrote: “The
articular surface post broke while implanted.” Id. In a deposition, a
Zimmer employee was asked about the question. He explained that “[t]he
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articular surface post was not designed to fracture under normal loading
and conditions; therefore, a post fracture would be checked off as a yes.”
Dkt. 51-19 at 2.
The complaint-handling form then asked “Were there any
contributing conditions related to the event? (Ex: trauma, illness,
previous injury, related non-compliance, patient anatomy).”
The
employee checked the box for the answer “No.” Dkt. 51-16 at 26.
Plaintiff contends that the complaint-handling form creates a
genuine issue of material fact about whether the device suffered from a
manufacturing defect that caused it to break. The Court agrees. Put
together, the answer to these questions establish an admission by
Defendants that the knee “malfunctioned or failed to perform as
intended” and that there were no other “contributing conditions” like
Plaintiff’s weight or gait. Id. The admission provides both evidence of a
defect and evidence that the defect was the most likely cause of the
failure.
During oral argument, counsel for Defendants argued that the
employee who completed the form had no knowledge of the facts at issue
and thus the form has little evidentiary value. That may be true. But no
15
evidence in the record supports this contention. Indeed, each of these two
critical answers allowed Defendants’ employee four possible choices:
“Yes”, “No”, “No Information”, or “N/A” (not applicable). The employee
chose to answer the questions with “Yes” and “No” answers rather than
stating that he or she did not have the necessary information. When
asked if the device malfunctioned or failed to perform as intended, for
example, the employee could have answered “No Information” but said
“Yes.”
Likewise, when asked whether there were any contributing
factors (like Plaintiff’s anatomy), the employee could have said “No
Information” but said “No.”
The very next section of the complaint-handling form also includes
the following supplemental information: “it was noted that the patient
had a verus flexion femoral deformity, but this was corrected by the distal
femoral cut.”
Id. at 27.
This seems like a reference to Plaintiff’s
preexisting condition that caused his uneven gait, an indication
Defendants’ employee was aware of these issues when he or she wrote
there were no contributing factors.4
It is unclear whether Defendants received the supplemental information
after completing the initial answers. But, even so, the employee could
have revised the initial answers after receiving the additional
4
16
With this one form Plaintiff has accomplished what the plaintiffs in
Mast Biosurgery and Graff failed to do: produce evidence that at once
shows that the device did not operate as intended and that – if believed
by the jury – would eliminate other plausible explanations for the
product’s failure. The Court recognizes that Plaintiff’s evidence is thin.
Defendants may well present evidence to prevent the complaint-handling
form from being considered a knowing admission. So Defendants may
ultimately obtain judgment as a matter of law. Even so, on this record,
Plaintiff has “provide[d] evidence that would permit a jury to select her
explanation, that of a manufacturing defect, as the most likely.” Mast
Biosurgery, 644 F.3d at 1321.5
For these reasons, the Court denies Defendants’ motion for
summary judgment on Plaintiff’s manufacturing-defect claim.
information. At any rate, those are also questions for a jury to consider
in assessing the strength of the alleged admissions.
5 If Plaintiff asserts a negligent-manufacturing claim separate from his
strict-liability claim, the record lacks any evidence from which a jury
could infer that Defendants were negligent in manufacturing the
product. See Williams, 548 S.E.2d at 374 (granting summary judgment
on negligent-manufacturing claim where the plaintiff failed to
“demonstrate[] that the defect was the result of any negligence by [the
defendants].”).
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B. Failure to Warn
Under Georgia law, the learned-intermediary doctrine governs
failure-to-warn claims involving medical devices. Lance v. American
Edwards Labs., 452 S.E.2d 185 (Ga. App. 1994). Under this doctrine, the
duty to warn runs not from the manufacturer to the patient, but from the
manufacturer to the physician. See Ellis v. C.R. Bard, Inc., 311 F.3d 1272
(11th Cir. 2002) (recognizing that the learned intermediary doctrine
applies to failure-to-warn claims involving medical devices).
The
rationale for the doctrine is that the treating physician is in a better
position than the manufacturer to warn the patient. “The decision to
employ [a medical device] involves professional assessment of medical
risks in light of the physician’s knowledge of a patient’s particular needs
and susceptibilities.” McCombs v. Synthes, 587 S.E.2d 594, 595 (Ga.
2003) (internal quotation omitted).
So “the manufacturer of a medical device does not have a duty to
warn the patient of the dangers involved with the product, but instead
has a duty to warn the patient’s doctor.” Id. “In most cases, a court
begins its inquiry under this doctrine by determining whether the
manufacturer provided the learned intermediary with an adequate
18
warning. . . . If the warning was adequate, the inquiry ends, and the
plaintiff cannot recover.” Dietz v. Smithkline Beecham Corp., 598 F.3d
812, 816 (11th Cir. 2010).
Plaintiff argues that Defendants did not sufficiently warn Dr. Diehl
about the risks of breakage or the severity of any injury. The undisputed
facts show otherwise. The Instructions for Use included with the Zimmer
implant state that a possible adverse effect of the knee implantation is
“[l]oosening or fracture/damage of the prosthetic knee components or
surrounding tissues.” Dkt. 48-8 at 5. And Dr. Diehl testified that he
knew of – and explained to Plaintiff – that “the components [of the device]
sometimes can fail. They’re mechanical parts, just like bearings for your
car or tires for your car, and sometimes they don’t last like you anticipate
they would.” Dkt. 51-4 at 16.
Thus, the undisputed facts show that Defendants warned Dr. Diehl
about the risk of hardware breakage and Dr. Diehl understood the risk.
Because Defendants warned Plaintiff’s physician of the exact harm about
which Plaintiff complains, its warnings were “adequate and reasonable
under the circumstances.” McCombs v. Synthes, 596 S.E.2d 780, 780 (Ga.
App. 2004) (affirming summary judgment on failure-to-warn claim where
19
medical device’s package warned of harm that “occurred in [the
plaintiff’s] situation.”).
The Court grants Defendants’ motion for summary judgment on the
failure-to-warn claim.6
C. Design Defect
“While a ‘manufacturing defect’ is a fairly straightforward concept,
a ‘design defect’ is a far more diffuse proposition under Georgia Supreme
Court precedent, as the latter calls for a finder of fact to employ a loose
balancing test to determine whether the manufacturer properly designed
the product.” Amazing Prods., 231 F. Supp. 2d at 1236. “[A] product
design is defective if the risks inherent in a product design outweigh the
utility or benefit derived from the product.” In re Mentor Corp, 711 F.
Supp 2d at 1364 (internal quotations omitted). Plaintiff thus must show
a genuine issue of material fact that the Zimmer knee was defectively
designed. To do this, “[he] must produce evidence from an expert who is
qualified to conduct the risk-utility analysis and to opine that the risk
If Plaintiff asserts a negligent failure-to-warn claim, it fails for the same
reason.
6
20
inherent in the [Zimmer knee’s] design outweigh the utility or benefit
derived from the product.” Id. at 1365.
Plaintiff presented no such evidence. He does not even defend his
design-defect claim in his response to Zimmer’s motion for summary
judgment. See Dkt. 49. Instead, he asks to amend his complaint and
drop the claim. (Dkt. 55). In the light of Plaintiff’s failure to present any
evidence to show that design of the knee suffered from a defect, summary
judgment is appropriate on Plaintiff’s design-defect claim. And because
the Court grants summary judgment against this claim, the motion to
amend the complaint to drop the claim is denied as moot. (Dkt. 55).7
IV. Conclusion
The Court GRANTS IN PART AND DENIES IN PART
Defendants’ Motion for Summary Judgment. (Dkt. 48). The Court also
DENIES AS MOOT Plaintiff’s Motion to Amend. (Dkt. 55).
IT IS SO ORDERED.
Dated: September 27, 2018
Atlanta, Georgia
If Plaintiff asserts a negligent design defect claim, it fails for the same
reason.
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