[DO NOT PUBLISH]
IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT FILED
________________________ U.S. COURT OF APPEALS
ELEVENTH CIRCUIT
No. 10-13529 APR 14, 2011
JOHN LEY
Non-Argument Calendar CLERK
________________________
D.C. Docket No. 1:08-cv-00655-WS-N
JUDITH HUGHES,
lllllllllllllllllllllPlaintiff - Appellant,
versus
STRYKER CORPORATION,
lllllllllllllllllllllDefendant,
STRYKER SALES CORPORATION,
HOWMEDICA OSTEONICS CORP.,
d.b.a. Stryker Orthopaedics,
lllllllllllllllllllllDefendants - Appellees.
________________________
Appeal from the United States District Court
for the Southern District of Alabama
________________________
(April 14, 2011)
Before MARCUS, MARTIN and KRAVITCH, Circuit Judges.
PER CURIAM:
Judith Hughes appeals the district court’s denial of her motion for
reconsideration of its order granting summary judgment in favor of Stryker Sales
Corporation (“Stryker Sales”) and Howmedica Osteonics Corp (“Howmedica”) on
Hughes’s products liability and negligence claims relating to the failure of a hip
prosthesis designed, manufactured, and marketed by the defendants.1 After
thorough review of the record and the parties’ briefs, we affirm.
I.
Hughes first argues that the district court erred in granting summary
judgment on her products liability claims under the Alabama Extended
Manufacturer Liability Doctrine (“AEMLD”). Although the notice of appeal only
indicates that Hughes seeks review of the district court’s denial of her motion for
reconsideration, we construe such notices as an appeal from the underlying order
or judgment regarding which reconsideration is sought. See Kicklighter v. Nails
by Jannee, Inc., 616 F.2d 734, 738–39 n.1 (5th Cir. 1980).2 “This Court reviews
1
Hughes’s complaint originally named a third defendant, Stryker Corporation, who is not
a party to this appeal because the district court entered an earlier order granting Hughes’s request
to voluntarily dismiss without prejudice her claims against Stryker Corporation under Federal
Rule of Civil Procedure 41(a)(1).
2
In Bonner v. City of Prichard, 661 F.2d 1206, 1209 (11th Cir. 1981) (en banc), we
adopted as binding precedent all decisions of the former Fifth Circuit handed down before the
close of business on September 30, 1981.
2
de novo summary judgment rulings and draws all inferences and reviews all
evidence in the light most favorable to the non-moving party.” Moton v. Cowart,
631 F.3d 1337, 1341 (11th Cir. 2011). Summary judgment is appropriate only if
“the movant shows that there is no genuine dispute as to any material fact and the
movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). “The
moving party may meet its burden to show that there are no genuine issues of
material fact by demonstrating that there is a lack of evidence to support the
essential elements that the non-moving party must prove at trial.” Moton, 631
F.3d at 1341. “We review the denial of a motion for reconsideration for an abuse
of discretion.” Richardson v. Johnson, 598 F.3d 734, 740 (11th Cir. 2010).
Hughes argues that the “evidence raised genuine issues of material fact that
the Trident acetabular cup implanted in her hip was unreasonably dangerous as
manufactured because it contained residues that impeded biologic fixation.”
To establish a prima facie case against a manufacturer under the
AEMLD, a plaintiff must show that (1) the defendant manufacturer sold
a defective product, (2) the defect was the cause in fact of the plaintiff’s
injury and is traceable to the defendant, and (3) the product reached the
plaintiff without substantial modification to the condition in which it
was sold.
Goree v. Winnebago Indus., Inc., 958 F.2d 1537, 1541 (11th Cir. 1992). Under
Alabama law, “[t]he fact of an injury . . . does not establish the presence of a
3
defect.” Sears, Roebuck & Co. v. Haven Hills Farm, Inc., 395 So. 2d 991, 995
(Ala. 1981) (quotation marks omitted). Instead, a plaintiff must show “that the
product’s failure of performance is causally related in fact to the product’s
defective condition at the time of its sale.” Id. “[O]rdinarily, expert testimony is
required [to prove that the product was defective and that the defect caused the
injury] because of the complex and technical nature of the commodity.” Id. But
expert testimony is not required if the inference “that the defective condition of the
product is the cause of the product’s failure and the plaintiff’s resultant injury . . . .
may be reasonably made from the product’s failure of performance under all the
attendant circumstances.” Id.
Because Hughes failed to disclose any expert testimony as required by
Federal Rule of Civil Procedure 26(a)(2), the district court considered whether the
non-expert evidence Hughes offered was sufficient to allow a jury to infer from
the failure of the Trident acetabular cup to achieve biological fixation that the
product was defective and that the defect caused the product’s failure and
Hughes’s injury.3 As the district court observed, Hughes pointed to four pieces of
3
In Hughes’s response to the defendant’s motion for summary judgment, she requested
leave to belatedly designate expert witnesses. On appeal, she does not challenge the district
court’s denial of this request, so we consider this issue abandoned. See Greenbriar, Ltd. v. City
of Alabaster, 881 F.2d 1570, 1573 n.6 (11th Cir. 1989) (holding that issues not argued on appeal
are deemed abandoned).
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evidence: (1) medical records showing that she received a total right hip
replacement on September 14, 2007, at which time a prosthetic hip device
manufactured by the defendants was implanted in her body; (2) a hospital record
stating that on or about July 1, 2008, her treating physician determined that she
“had suffered a hardware failure involving the acetabular cup with migration of
the cup,” such that she would need a second surgical procedure called a “[r]evision
of right total hip arthroplasty;” (3) a March 15, 2007 “Warning Letter” sent from
the United States Department of Health and Human Services to a company called
Stryker Ireland, Ltd., Orthopaedics in Cork, Ireland, which states that an
inspection of the manufacturing facility in the fall of 2006 had revealed several
violations of regulations promulgated under the Federal Food, Drug, and Cosmetic
Act; and (4) a January 24, 2008 letter from Stryker Orthopaedics recalling all
Trident Hemispherical and PSL Shells manufactured at the company’s Cork,
Ireland facility between January 2000 and December 2007 because “the average
level of manufacturing residuals in some cases exceeded Stryker Orthopaedics self
imposed conservative acceptance criteria,” creating “[t]he potential hazard . . . that
the device may not achieve biological fixation,” but noting that “failure to achieve
biological fixation may result from many factors unrelated to the device.”
5
The district court correctly rejected Hughes’s arguments premised on the
recall letter because that letter, which states only that “in some cases” the level of
manufacturing residuals exceeded the company’s “self imposed conservative
acceptance criteria,” did not amount to an admission by the defendants that the
Trident acetabular cup was defective, and in any event the recall letter was
inadmissible as evidence of subsequent remedial measures used to show product
defect. See Fed. R. Evid. 407 (“[E]vidence of . . . subsequent measures is not
admissible to prove . . . a defect in a product . . . .”). Turning to the remaining
evidence, the Warning Letter is insufficient to prove the existence of a defect
because, while it describes the company’s failure to establish and maintain certain
general quality control procedures, it says nothing about the presence of residuals
in any Trident acetabular cups. Nor is the medical record indicating a “hardware
failure” enough to permit a jury to conclude that the product was defective
because, under Alabama law, the “mere failure of a product does not presuppose
the existence of a defect.” Sears, Roebuck & Co., 395 So. 2d at 996. While a
defect, and its causal relation to a plaintiff’s injury, may be inferred “from the
product’s failure of performance under all the attendant circumstances,” id. at 995,
nothing about the circumstances of this case would permit such an inference. As
the district court explained:
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[t]he interaction between a complex and technical medical device and
the unique physiological and medical circumstances of the patient in
which it is implanted is a subject on which no ordinary juror could
rationally be expected to have knowledge. The net result is that, without
the benefit of expert testimony, a reasonable jury could not possibly
make a determination on this summary judgment record that Hughes’[s]
injuries were caused by a maufacturing or design defect in the prosthetic
hip.4
We decline to consider Hughes’s argument that the evidence in the record
demonstrates a genuine dispute as to causation because the medical records negate
the possibility of alternate causes. Hughes failed to make this argument before the
district court in her response to the defendants’ motion for summary judgment, and
that court did not abuse its discretion in refusing to consider the argument when
Hughes presented it belatedly in her motion for reconsideration, which the district
court properly treated as a motion to alter or amend the judgment under Federal
4
We need not decide whether the defendants are correct that expert testimony is always
necessary to prove product defect and breach of duty in products liability cases involving
complicated medical devices because even if such testimony is not required, Hughes cannot
survive summary judgment under the circumstances of this case.
7
Rule of Civil Procedure 59. See Green v. Drug Enforcement Admin., 606 F.3d
1296, 1299 (11th Cir. 2010) (noting that district courts have “almost without
exception” treated motions for reconsideration as Rule 59 motions “regardless of
their label” (quotation marks omitted)). We have explained that such “[m]otions
to amend should not be used to raise arguments which could, and should, have
been made before the judgment was issued.” Case v. Eslinger, 555 F.3d 1317,
1329 (11th Cir. 2009) (quotation marks omitted). Hughes “cannot readily
complain about the entry of a summary judgment order that did not consider an
argument [she] chose not to develop for the district court at the time of the
summary judgment motions.” Id. (quotation marks omitted).
For all these reasons, we conclude that the district court did not err in
granting summary judgment in favor of Stryker Sales and Howmedica on
Hughes’s products liability claims.
II.
Hughes next argues that the district court erred in granting summary
judgment on her negligence claims.5 A plaintiff’s negligence claim is distinct
5
Before the district court, Hughes pursued claims for both negligence and wantonness,
but on appeal she argues only that the district court erred in granting summary judgment on her
negligence claims. We conclude that she has therefore abandoned her wantonness claims. See
Greenbriar, Ltd., 881 F.2d at 1573 n.6.
8
from a products liability claim under the AEMLD. See Vesta Fire Ins. Corp. v.
Milam & Co. Constr., Inc., 901 So. 2d 84, 102 (Ala. 2004). “In a negligence
action the plaintiff must prove (1) that the defendant owed the plaintiff a duty; (2)
that the defendant breached that duty; (3) that the plaintiff suffered a loss or
injury; and (4) that the defendant’s breach was the actual and proximate cause of
the plaintiff’s loss or injury.” QORE, Inc. v. Bradford Bldg. Co., 25 So. 3d 1116,
1123 (Ala. 2009) (quotation marks omitted). The district court concluded that
Hughes failed to establish a genuine dispute as to causation.
Hughes argues that there is sufficient circumstantial evidence to permit a
jury to find that the defendants’ negligent manufacture of the Trident acetabular
cup proximately caused the failure of the prosthesis in her hip replacement. We
disagree. As the district court stated: “No evidence links the failure of that
complex, technical medical device to any negligent or wanton conduct by
defendants; to the contrary, it could have failed for myriad reasons totally
unrelated to any negligent acts or omissions by defendants.” Hughes argues that
records from her treating physician negate alternative causes because the physician
stated that the failure of the prosthesis was the result of “aseptic loosening.” As
explained above, we decline to consider this argument because it was not
presented to the district court in response to the defendant’s motion for summary
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judgment, and the district court did not abuse its discretion in refusing to consider
the argument when Hughes belatedly presented it in her motion to reconsider.
See Case, 555 F.3d at 1329. Hughes also points again to the recall letter, but this
would be inadmissible as evidence of negligence under Rule 407. See Fed. R.
Evid. 407 (“[E]vidence of . . . subsequent measures is not admissible to prove
negligence . . . .”).
On this summary judgment record, a jury could only speculate as to why the
prosthesis failed in this case, but “[s]peculation does not create a genuine issue of
fact.” Cordoba v. Dillard’s, Inc., 419 F.3d 1169, 1181 (11th Cir. 2005). We
therefore conclude that the district court did not err in granting summary judgment
in favor of Stryker Sales and Howmedica on Hughes’s negligence claims.
For all of these reasons, we affirm the district court’s entry of summary
judgment in favor of Stryker Sales and Howmedica.
AFFIRMED.
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