[DO NOT PUBLISH]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., 

, 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, 

, 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,

, 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.” 

. “We review the denial of a motion for reconsideration for an abuse

of discretion.” Richardson v. Johnson, 

, 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., 

, 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., 

, 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.” 

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.” 

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.” 

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, 

, 1573 n.6 (11th Cir. 1989) (holding that issues not argued on appeal
are deemed abandoned).

                                                4
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 & 

. 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,” 

nothing about the circumstances of this case would permit such an inference. As

the district court explained:

                                           6
       [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., 

, 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, 

,

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.” 

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, 

n.6.

                                                8
from a products liability claim under the AEMLD. See Vesta Fire Ins. Corp. v.

Milam & Co. Constr., Inc., 

, 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., 

,

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

                                           9
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 

. 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., 

, 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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