Court Opinion

ID: 183528
Source: CourtListenerOpinion
Date Created: 2011-01-25 18:20:22+00
Date Added: 2024-06-11T17:26:03.838519
License: Public Domain

Case: 10-20022 Document: 00511360334 Page: 1 Date Filed: 01/25/2011

        IN THE UNITED STATES COURT OF APPEALS
                 FOR THE FIFTH CIRCUIT  United States Court of Appeals
                                                 Fifth Circuit

                                              FILED
                                                                January 25, 2011

                                  No. 10-20022                      Lyle W. Cayce
                                                                         Clerk

RONALD FUNK,

                                            Plaintiff - Appellant
v.

STRYKER CORPORATION; STRYKER SALES CORPORATION;
HOWMEDICA OSTEONICS CORP., doing business as Stryker Orthopaedics,

                                            Defendants - Appellees

                 Appeal from the United States District Court
                      for the Southern District of Texas

Before JOLLY, DeMOSS, and DENNIS, Circuit Judges.
E. GRADY JOLLY, Circuit Judge:
      In this medical device products liability case, Ronald Funk appeals the
district court’s judgment granting Stryker Corporation’s (“Stryker”) Rule 12(b)(6)
motion to dismiss for failure to state a claim that overcomes a preemption
defense. Before us on appeal, the relevant pleadings asserted are Funk’s first
amended complaint and a proposed second amended complaint, which the court
denied leave to file. He did not appeal that order. Thus the only complaint
before us is Funk’s first amended complaint. Based upon the issues over which
we have appellate jurisdiction, we hold that the district court committed no error
     Case: 10-20022 Document: 00511360334 Page: 2 Date Filed: 01/25/2011

                                      No. 10-20022

in assessing Funk’s pleadings, nor in its application of judicial notice.
Accordingly, we affirm the district court’s dismissal of the case.
                                             I.
       On March 26, 2007, Ronald Funk underwent a total hip replacement
during which his surgeon implanted a Trident System artificial hip replacement
(“Trident”). Stryker produces Trident, which is comprised of several component
parts, including an: acetabular cup, ceramic liner, ceramic femoral ball, and
femoral stem. Following surgery, Funk experienced ongoing pain in his right
hip. His surgeon attributed Funk’s pain to loosening of the acetabular cup,
caused by a lack of boney ingrowth that would ordinarily secure the device to his
hip. Funk underwent another surgery to remove and replace the loose cup,
apparently successfully as far as this record shows.
       Trident is a Class III device under the Federal Food, Drug, and Cosmetic
Act (the “FFDCA”). Section 360 of the Medical Device Amendments of 1976
prohibits states from establishing “safety or effectiveness” standards that are
“different from, or in addition to” the requirements under the FFDCA. 21 U.S.C.
§ 360.     Section 360 preemption only applies to Class III devices approved
through the Food and Drug Administration’s (the “FDA”) pre-market approval
(“PMA”) process, rather than the less-rigorous § 510(k) approval process. Still,
however, § 360 allows “parallel” state actions – state law claims that are based
on federal regulations. Trident received PMA on February 3, 2003; a question
Funk attempts to present here, however, is whether the PMA process applied to
one of the Trident’s component parts, the acetabular cup.1

       1
          This opinion does not address whether the independent components of Trident -
including the acetabular cup - underwent PMA. For jurisdictional reasons outlined below, that
issue is not properly before the court.

                                             2
     Case: 10-20022 Document: 00511360334 Page: 3 Date Filed: 01/25/2011

                                       No. 10-20022

                                             II.
      On December 13, 2009, the district court granted Stryker’s Rule 12(b)(6)
motion to dismiss, finding that Funk failed to state a claim upon which relief
could be granted (the “December Judgment”). Based upon the first amended
complaint and the responsive pleadings, the district court held that Trident
underwent PMA, and that Funk’s design defect claims were therefore preempted
by § 360. To reach this holding, the court took judicial notice of a letter from the
FDA to Stryker indicating that Trident underwent the PMA process, noting that
the approval process was a matter of public record. The district court held that
finding that Trident received PMA was consistent with both parties’ pleadings.
Finally, the court noted that many district court cases addressing preemption
claims indicated that Trident underwent the PMA process.2 On these bases, the
court held that Trident underwent PMA approval, that Funk’s claims were
preempted, and that the complaint failed to state a claim upon which relief could
be granted. The court therefore dismissed Funk’s complaint.
      After the district court entered its judgment, Funk appealed to this court.
Almost simultaneously with his appeal of the December Judgment, he also filed
a motion for reconsideration with the district court, along with a motion for leave
to file a proposed second amended complaint. The district court denied both of
these motions on January 13, 2010 (“the January Order”). Funk did not file a
notice of appeal with respect to the January Order; nor did he amend his earlier
notice to include the January Order, as is required by Federal Rule of Appellate
Procedure Rule 4(a)(4)(B)(ii).3

      2
          We do not evaluate this finding.
      3
          After oral arguments, we asked the parties to provide letter briefs addressing
appellate jurisdiction over claims pled after the December Judgment.

                                             3
    Case: 10-20022 Document: 00511360334 Page: 4 Date Filed: 01/25/2011

                                  No. 10-20022

                                       III.
                                        A.
      At the outset, we will summarize our holding today, which affirms the
district court’s dismissal of Funk’s complaint for failure to state a claim: (1) We
do not have appellate jurisdiction to consider whether the district court erred in
denying Funk’s motion for leave to file a second amended complaint and motion
for reconsideration, because he did not appeal the January Order; (2) Funk’s
allegation of his component theory under the PMA approval process is not before
us, as it was not pleaded in district court prior to the only appealed judgment;
(3) the district court correctly dismissed Funk’s claim because neither his
original complaint nor first amended complaint satisfies required pleading
standards to set forth a cognizable claim; and (4) the district court’s application
of judicial notice did not transform the motion to dismiss into a motion for
summary judgment. For these reasons, the district court order is affirmed.
                                        B.
      First we must begin with the jurisdictional questions—which were briefed
only after oral argument—because two of Funk’s major arguments presented in
his appellate brief concern the January Order. First, he contends that the
district court erred in denying his motion for reconsideration and motion for
leave to file a second amended complaint; these rulings were contained only in
the January Order. Second, Funk draws extensively upon the allegations he
presented in his proposed second amended complaint as support for why he
believed the district court erred in dismissing his complaint under Rule 12(b)(6).
In this respect, Funk’s primary contention is that the district court’s reasoning
was erroneous because the acetabular cup received § 510(k) approval, not PMA.
This “component theory” suggests that the acetabular cup underwent a different
approval process than the rest of Trident, and was thus subject to different
preemption standards. However, as noted by Stryker, this court is foreclosed

                                        4
     Case: 10-20022 Document: 00511360334 Page: 5 Date Filed: 01/25/2011

                                     No. 10-20022

from considering this argument on appeal because it was not raised until after
the entry of the December Judgment; these issues were presented to the district
court only in the motion for reconsideration and in the proposed second amended
complaint addressed in the January Order, which Funk did not appeal. Thus,
Funk is foreclosed from presenting in this appeal the arguments based on
allegations asserted in the proposed second amendment.
       Although the Fifth Circuit liberally construes issues on appeal, we are
bound by specific jurisdictional requirements. The Supreme Court has held that
the timely notice of appeal in a civil case is a jurisdictional requirement, to
which courts cannot create equitable exceptions. Bowles v. Russell, 551 U.S.
205, 214 (2007). An appellant must amend his notice of appeal to challenge
orders subsequent to the final judgment. Taylor v. Johnson, 257 F.3d 470, 474
(5th Cir. 2001). Although “a brief may serve as the ‘functional equivalent’ of an
appeal” if it is filed within the time specified by Federal Rule of Appellate
Procedure Rule 4, it may only do so if it gives the notice provided under Federal
Rule of Appellate Procedure Rule 3, which requires, in relevant part,
“designating the judgment, order, or part thereof being appealed.” Id. at 475;
F ED. R. A PP. P. 3(c)(1)(B). Funk did not appeal the January Order, nor amend
his earlier appeal, nor specifically designate that he was appealing the order in
his appellate brief.
       Moreover, neither exhaustive review of the record nor the letter brief
submitted by Funk identifies a single concrete instance in which Funk pled the
component theory before the entry of the December Judgment. Funk’s first
amended complaint noted that Stryker obtained approval to market the Trident
“under either a 510(k) procedure or a pre-market approval.”4 (emphasis added).

      4
        Funk’s original complaint alleges that “Plaintiff believes that Defendant obtained
approval from the [FDA] to market the hip prostheses under a 510(k) procedure and not under
a [PMA] procedure.” This allegation was amended in the first amended complaint, which
instead read: “Defendant obtained approval from the [FDA] to market the hip prostheses

                                            5
     Case: 10-20022 Document: 00511360334 Page: 6 Date Filed: 01/25/2011

                                     No. 10-20022

In its ruling, the district court held that it was consistent with both parties’
pleadings to find that Trident received PMA. We repeat ourselves to conclude
that the arguments Funk raises in the appellate brief concerning the component
theory cannot be considered, as they were not presented to the district court
until after it entered the December Judgment, the only judgment before us
today.
      Because Funk did not file a notice of appeal for the January Order, we
have appellate jurisdiction to consider neither the argument that the district
court erred in denying his motions for reconsideration and leave to amend nor
the arguments presented in his proposed second amended complaint on appeal.
                                           C.
      Funk has two claims stemming from the December Judgment, over which
the court has jurisdiction: (1) whether the court erred in finding that Funk did
not adequately plead manufacturing defect claims parallel to the requirements
of federal regulations; and (2) whether the 12(b)(6) motion was converted to a
motion for summary judgment because the district court considered extrinsic
evidence through the use of judicial notice to recognize a publically-available
letter. We consider each of these claims below.
                                           1.
      In Funk’s first amended complaint (the complaint before the district court
at the time it issued its December Order) he alleged that even if Trident was
approved via PMA, Funk’s claims survive preemption because his complaint
alleges that Stryker failed to meet the manufacturing requirements of the FDA.
Although Funk correctly understands the law regarding parallel state claims,
his claim that Stryker violated FDA manufacturing requirements when

under either a 510(k) procedure or a [PMA] procedure. Pursuant to this approval, Defendant
was required to comply with the FDA’s standards and requirements established through the
PMA process.” The district court correctly considered the first amended complaint.

                                            6
     Case: 10-20022 Document: 00511360334 Page: 7 Date Filed: 01/25/2011

                                   No. 10-20022

producing Trident was not legally cognizable as set out in his pleadings before
the district court. The district court held that “Funk provides no facts in support
of his conclusory allegations, instead relying on the doctrine of res ipsa loquitur -
a doctrine that would seem to be soundly refuted by Riegel.” R. at 289. The
district court’s holding is borne out by our review of the pleading. In the first
amended complaint, Funk offered the following allegations:
      Manufacturing Defect.

            [3.]   The hip prostheses contained a manufacturing defect
      in that it was manufactured in such a manner that impurities,
      residues and bacteria remained on the prosthesis in violation of the
      FDA standards and requirements and in violation of the
      manufacturing processes and design approved by the FDA.

            [4.]     The hip prostheses deviated, in its construction or
      quality, from the specifications or planned output. As more
      particularly set forth below, Plaintiff invokes the doctrine of res ipsa
      loquitur as to the manufacturing defect contained in the hip
      prosthesis.

R. at 260. This complaint is impermissibly conclusory and vague; it does not
specify the manufacturing defect; nor does it specify a causal connection between
the failure of the specific manufacturing process and the specific defect in the
process that caused the personal injury. Nor does the complaint tell us how the
manufacturing process failed, or how it deviated from the FDA approved
manufacturing process. It instead relies on res ipsa loquitur to suggest only that
the “that the thing speaks for itself.” See Ashcroft v. Iqbal, 129 S. Ct. 1937, 1949
(2009) (noting that in order to survive a 12(b)(6) motion to dismiss, the plaintiff
must plead enough facts to “state a claim that is plausible on its face.”) (citation
and quotation omitted); Delaney v. Stryker Orthopedics, 2009 WL 564243, at *6
(D. N.J. March 5, 2009) (dismissing a manufacturing claim because plaintiff did
not point “to a defect or deviation from the FDA-reviewed Trident manufacturing

                                         7
    Case: 10-20022 Document: 00511360334 Page: 8 Date Filed: 01/25/2011

                                  No. 10-20022

specifications regarding the Trident implanted in him” or “allege that ‘something
was wrong’ with the product”).
      Comparing the first amended complaint with the proposed second
amended complaint shows how the first is lacking:          The second amended
complaint specifies with particularity what went wrong in the manufacturing
process and cites the relevant FDA manufacturing standards Stryker allegedly
violated. But, alas for Funk, the second amended complaint is not part of this
appeal and is not before us. Left to consider only the conclusory pleading of the
first amended complaint, we hold that the district court did not err in finding
that Funk’s claim of manufacturing defects failed to state a manufacturing
defect in Trident.
                                        2.
      Funk finally contends that the court erred when it failed to convert
Stryker’s motion to dismiss into a motion for summary judgment because, he
argues, the district court considered extrinsic evidence. The district court took
judicial notice of public records indicating that the Trident received PMA to
reach the holding that Funk’s claims were preempted by § 360k. Although the
district court did not identify the specific record(s) upon which it based its
findings, the parties appear to agree that the court referenced Record P000013,
which includes a letter from the FDA dated February 3, 2003, granting PMA to
the Trident.
      When reviewing a motion to dismiss, a district court “must consider the
complaint in its entirety, as well as other sources courts ordinarily examine
when ruling on Rule 12(b)(6) motions to dismiss, in particular, documents
incorporated into the complaint by reference, and matters of which a court may
take judicial notice.” Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308,
322 (2007) (citations omitted). A district court’s use of judicial notice under
Federal Rule of Evidence 201 is reviewed for abuse of discretion. See Taylor v.

                                        8
     Case: 10-20022 Document: 00511360334 Page: 9 Date Filed: 01/25/2011

                                   No. 10-20022

Charter, 162 F.3d 827, 829 (5th Cir. 1998).         The district court abuses its
discretion when its ruling is based on an erroneous view of the law or a clearly
erroneous assessment of the evidence. Nunez v. Allstate Ins. Co., 604 F.3d 840,
844 (5th Cir. 2010).     “A judicially noticed fact must be one not subject to
reasonable dispute in that it is either (1) generally known within the territorial
jurisdiction of the trial court or (2) capable of accurate and ready determination
by resort to sources whose accuracy cannot reasonably be questioned.” F ED. R.
E VID. 201(b).
      The district court appropriately used judicial notice in accordance with
these standards. In the pleadings before the December Judgment, there was no
actual asserted factual dispute (Funk’s complaint specified the hip prosthesis
was approved “under either a 510(k) procedure or a pre-market approval (PMA)
procedure.”). See R. at 229. Further, the district court took appropriate judicial
notice of publically-available documents and transcripts produced by the FDA,
which were matters of public record directly relevant to the issue at hand.
Norris v. Hearst Trust, 500 F.3d 454, 461 n.9 (5th Cir. 2007) (“it is clearly proper
in deciding a 12(b)(6) motion to take judicial notice of matters of public record.”).
Accordingly, we hold that it was appropriate for the court to take judicial notice,
under Rule 12(b)(6), of the PMA the FDA granted to Stryker for marketing its
Trident System.
                                         IV.
      We conclude by summarizing our holding today: We have held that we
lack appellate jurisdiction over the January Order of the district court denying
Funk’s motion to reconsider its December Judgment and denying his motion to
file a second amended complaint because he failed to file a notice of appeal from
that order; the only judgment over which we have appellate jurisdiction is the
December Judgment, dismissing the complaint for failure to state a claim; that
the district court did not err in taking judicial notice of the PMA; and finally that

                                          9
    Case: 10-20022 Document: 00511360334 Page: 10 Date Filed: 01/25/2011

                                 No. 10-20022

the district court did not err in dismissing the complaint on the grounds that it
failed to plead a legally cognizable claim. Accordingly, the judgment of the
district court is
                                                                    AFFIRMED.

                                       10