     Case: 11-10076       Document: 00511743125          Page: 1     Date Filed: 01/31/2012




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

                                                                                FILED
                                                                             January 31, 2012

                                          No. 11-10076                         Lyle W. Cayce
                                                                                    Clerk

ALTON BASS,

                                                     Plaintiff - Appellant
v.

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

                                                     Defendants - Appellees



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


Before JONES, Chief Judge, HAYNES, Circuit Judge, and CRONE, District
Judge.*
HAYNES, Circuit Judge:
        Plaintiff Alton Bass (“Bass”) appeals from the district court’s dismissal of
his state-law tort claims against Stryker Corporation, Stryker Sales Corporation,
and Howmedica Osteonics Corporation, doing business as Stryker Orthopaedics
(collectively, “Stryker”) pursuant to Federal Rule of Civil Procedure 12(b)(6). In
his complaint, Bass alleged that a hip replacement product manufactured by
Stryker malfunctioned and caused him injury. Bass argues that the district


       *
           United States District Judge for the Eastern District of Texas, sitting by designation.
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                                  No. 11-10076

court erred in concluding that Riegel v. Medtronic, Inc., 552 U.S. 312 (2008),
forecloses his state-law claims because: (1) the Trident PSL Acetabular Shell (or
“Shell”) manufactured by Stryker was not subject to pre-market approval
(“PMA”) testing and therefore Riegel is inapplicable; and (2) even if Riegel is
applicable, his state-law claims merely “parallel” the federal requirements and
therefore are expressly allowed under Riegel. Bass also challenges the district
court’s holding that his claims, even if parallel, are impliedly preempted by 21
U.S.C. § 337(a). For the reasons that follow, we AFFIRM the dismissal of Bass’s
strict liability, design defect, negligence, and Texas Deceptive Trade Practices
Act (“DTPA”) claims to the extent they are premised on a failure to warn or a
marketing defect; AFFIRM as to Bass’s breach of express warranty claims; and
REVERSE and REMAND the following: (1) Bass’s strict liability and negligence
claims, to the extent they are based on manufacturing defects that violate the
Food and Drug Administration’s (“FDA”) Current Good Manufacturing Practices
(“CGMPs”) or are inconsistent with Stryker’s manufacturing processes or
procedures that were approved by the FDA; (2) his claim for breach of an implied
warranty to the extent it relies on the failure to comply with the FDA’s
requirements; and (3) his DTPA claim, to the extent that it relies on a breach of
an implied warranty.
                 I. FACTS AND PROCEDURAL HISTORY
      Alton Bass underwent left hip replacement surgery in August 2007. As a
part of the surgery, the surgeon implanted a hip replacement consisting of four
components, each manufactured by Stryker: (1) a Shell; (2) an Accolade TMZ
Plus Hip Stem #4.5; (3) a V40 Alumina Femoral Head; and (4) a Trident 0
Alumina Insert.     Following the hip replacement, Bass allegedly began to
experience pain in his left hip, despite following all of his surgeon’s instructions


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                                    No. 11-10076

after surgery. For the next two years, Bass complained to his surgeon about
increasing pain in his left hip. Bass then underwent a revision of his hip
replacement. The surgeon determined that the Shell was too loose and revised
it. Bass alleges that the looseness was caused by manufacturing residuals on
the Shell which prevented bony ingrowth to the Shell.
        On October 23, 2009, Bass filed suit against Stryker in the Northern
District of Texas, asserting diversity jurisdiction. Bass raised a number of state-
law claims, including strict liability, negligence, breach of warranty, and
violation of the DTPA. Stryker filed a motion to dismiss, claiming that Bass’s
state-law claims were preempted by the Medical Device Amendments of 1976
(“MDA”) to the Food, Drug, and Cosmetics Act (“FDCA”), see 21 U.S.C. § 360c et
seq., and by 21 U.S.C. § 337(a). The district court granted Stryker’s motion to
dismiss on preemption grounds. Bass filed a timely notice of appeal.
                          II. STANDARD OF REVIEW
        This court reviews the district court’s grant of a motion to dismiss de novo.
Wampler v. Sw. Bell Tel. Co., 597 F.3d 741, 744 (5th Cir. 2010). All well-pleaded
facts in the complaint are accepted as true and viewed in the light most
favorable to the nonmovant. Jebaco Inc. v. Harrah’s Operating Co., 587 F.3d
314, 318 (5th Cir. 2009). Dismissal is appropriate when the plaintiff has not
alleged enough facts to state a claim to relief that is plausible on its face or has
failed to raise his right to relief above the speculative level. Wampler, 597 F.3d
at 744.
                                III. DISCUSSION
A.      Whether the district court erred in finding that the Shell was subject to
        PMA testing.
        Before addressing Bass’s first argument, we provide a brief overview of the
statutory scheme applicable to medical devices. In response to the concern that
state-law governance of medical devices was inadequate, Congress passed the

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MDA, giving the FDA authority to regulate medical devices and expressly
preempting certain state regulations. See Riegel, 552 U.S. at 315-16; see also 21
U.S.C. § 360k.
         The devices at issue in this litigation are Class III devices, which receive
the most federal oversight. Riegel, 552 U.S. at 317; see also Funk v. Stryker
Corp., 631 F.3d 777, 779 (5th Cir. 2011) (“Trident is a Class III device under the
[FDCA].”). Most Class III devices are approved by a review determining that the
device is “substantially equivalent” to another device exempt from the PMA
process. See Riegel, 552 U.S. at 317. This is referred to as a § 510(k) approval.
Id. The remaining devices are approved through the “rigorous” PMA process.
Id.
         A state-law tort claim to recover for injuries allegedly caused by a medical
device is preempted if: (1) “the Federal Government has established
requirements applicable to [the device]”; and (2) the claims are based on state-
law requirements that are “‘different from, or in addition to’ the federal ones,
and that relate to safety and effectiveness.” Id. at 321-22 (quoting 21 U.S.C.
§ 360k(a)(1)). Devices that are approved through PMA procedures automatically
satisfy the “federal requirements” prong. Id. at 322 (“Premarket approval . . .
imposes ‘requirements’ under the MDA as we interpreted it in [Medtronic, Inc.
v. Lohr, 518 U.S. 470 (1996)].”). In contrast, the § 510(k) approval process does
not impose federal requirements on a device. See Lohr, 518 U.S. at 493-94
(“[E]ven though the FDA may well examine § 510(k) applications for Class III
devices . . . with a concern for the safety and effectiveness of the device, . . . it did
not ‘require’ Medtronics’ pacemaker to take any particular form for any
particular reason.” (internal citation omitted)).
         Bass argues that the district court wrongfully concluded that the Shell,
which malfunctioned, was subject to PMA testing. He argues that: (1) the


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                                  No. 11-10076

district court was required to credit his allegation that the FDA had not granted
PMA approval to the Shell as true; and (2) even if the district court was not
required to accept the truth of his pleading, the district court nonetheless erred
in determining that the FDA documents indicate that the FDA considered the
Shell to be a part of the Trident hip replacement system. We address both
arguments in turn.
      1.    Whether the district court erred by failing to accept Bass’s allegation
            that the Shell was not subject to PMA testing.
      The district court’s decision that the Shell was subject to PMA testing was
based upon publicly available documents from the FDA. Although a district
court ruling on a motion to dismiss is required to accept all well-pleaded facts as
true, “courts ‘are not bound to accept as true a legal conclusion couched as a
factual allegation.’” See Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007)
(quoting Papasan v. Allain, 478 U.S. 265, 286 (1986)).
      We conclude that the determination of whether the Shell was subject to
the PMA process is a question of law. We have held that where underlying facts
are not disputed, the significance of those facts becomes a question of law. See,
e.g., House v. Am. United Life Ins. Co., 499 F.3d 443, 448 (5th Cir. 2007) (“We
have frequently stated that the existence of an ERISA plan within the statutory
definition is a question of fact. . . . However, where the factual circumstances
are established as a matter of law or undisputed, we have treated the question
as one of law to be reviewed de novo.”); AT&T Corp. v. PUC, 373 F.3d 641, 645
(5th Cir. 2004) (“The material facts in this case are not in dispute, therefore we
review de novo the district court’s preemption decision and the interpretation of
the TA96.”). Bass does not dispute that testing was done or that the documents
describing the FDA’s approval process are subject to judicial notice; rather,
Bass’s allegation asks the court to make a conclusion as to the legal significance
of these tests and the FDA’s subsequent approval of the Trident system.

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Therefore, we treat Bass’s allegations that the Shell did not receive PMA testing
as a legal conclusion that the district court was not required to accept as true.
       2.     Whether the district court erred in concluding that the FDA
              documents showed that the Shell was approved through the PMA
              process.
       Bass alleges that the district court erroneously concluded that the Shell
was subject to PMA testing. Bass points to statements made at the FDA public
hearing in which a Stryker employee indicated that “only the ceramic inserts are
under investigation in these systems.” See Medical Devices Advisory Committee,
Summary Minutes of the Orthopedic and Rehabilitation Devices Panel, at 12
(July 20, 2000), available at http://www.fda.gov/ohrms/dockets/ac/00/minu
tes/3633m1.pdf. However, as Stryker points out, at the same meeting, the FDA
Director of General and Restorative Devices “clarified for the panel that they
would be voting on an entire system and not just the ceramic on ceramic
interface.” Id. at 16.1
       Additionally, there are numerous indications that the FDA considered the
Shell to be a part of the Trident system. Perhaps most significantly, the PMA
supplements included in the record indicate that changes to the labeling and
design of the Shell were approved through the PMA process. Supplemental
approval of changes is required for any device which has received PMA approval.


       1
           Other courts have also concluded at the motion to dismiss stage that the Shells were
subject to the PMA process. See Lewkut v. Stryker Corp., 724 F. Supp. 2d 648, 657 (S.D. Tex.
2010) (“[T]hat the acetabular shell was previously approved through only the § 510(k) process
. . . does not change the fact that it was later subject to the more rigorous scrutiny of the PMA
process as a component of the Trident System.”); see also Cornwell v. Stryker Corp., No. 1:10-
cv-00066, 2010 U.S. Dist. LEXIS 116824, at *8 (D. Idaho Nov. 1, 2010); Phillips v. Stryker
Corp., No. 3:09-CV-488, 2010 U.S. Dist. LEXIS 55117, at *14-15 (E.D. Tenn. June 3, 2010);
Delaney v. Stryker Orthopaedics, No. 08-03210, 2009 U.S. Dist. LEXIS 16865, at *10 (D.N.J.
Mar. 5, 2009) (“[Plaintiff] further argues that discovery is needed to determine if all or only
part of the Trident TM was subject to the PMA process. Discovery is not required in this
instance because [Stryker] has sufficiently demonstrated that the Trident TM underwent the
PMA process.”).

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                                        No. 11-10076

See Lewkut, 724 F. Supp. 2d at 655 (“[S]everal supplements approved by the
FDA through the PMA process after the Trident System’s initial approval refer
to the acetabular shell component in a manner that strongly suggests that it had
already been approved.”); Purcel v. Advanced Bionics Corp., No. 3:07-cv-1777,
2010 U.S. Dist. LEXIS 67109, at *8-9 (N.D. Tex. June 30, 2010) (“Supplemental
premarket approval is evaluated largely by the same procedures, criteria, and
extensive scrutiny as the original PMA process.”). Furthermore, the record also
indicates that the safety and effectiveness data for the PMA testing refers to the
Shell as a component of the system. For these reasons, we hold that the district
court did not err in determining that the Shell in its entirety was subject to PMA
approval and therefore satisfied the “federal requirement” prong of Riegel.
B.      Whether the district court erred in determining that Bass’s complaint
        failed to plead parallel claims.
        We now turn to the preemption question. Although “common-law causes
of action for negligence and strict liability do impose ‘requirement[s],’” Riegel,
552 U.S. at 323-24; see also id. at 324 (“Absent other indication, reference to a
State’s ‘requirements’ includes its common-law duties.”), that is not the end of
our inquiry. “[Section] 360k does not prevent a State from providing a damages
remedy for claims premised on a violation of FDA regulations; the state duties
in such a case ‘parallel,’ rather than add to, federal requirements.” Id. at 330.
        The district court determined that Bass’s claims do not parallel FDA
requirements.2 Two subsequent opinions from our court—Funk, 631 F.3d 777,



       2
         Although neither party discusses this in its brief, parts of the district court’s order
dismissing the suit appear to be premised upon Bass’s original complaint rather than the
amended complaint. To the extent that the district court relied on the original complaint, such
reliance was error. The amendment was filed before Stryker filed a responsive motion, and
therefore no leave of the district court was required. See FED. R. CIV. P. 15; see also Santee v.
Quinlan, 115 F.3d 355, 357 (5th Cir. 1997). Because the complaint was amended as of right,
our analysis proceeds as to the Amended Complaint.

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and Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011)—compel an
opposite conclusion as to some of his claims.
      In Funk, we dealt with a nearly identical claim that the Shell failed to
attach correctly due to impurities in the manufacturing process. 631 F.3d at
782. In that case, we recognized that such an injury could lead to a parallel
claim but held that the plaintiff’s pleadings were too conclusory to state a claim.
See id. (“[Funk’s] claim that Stryker violated FDA manufacturing requirements
when producing Trident was not legally cognizable as set out in his pleadings
before the district court. . . . This complaint is impermissibly conclusory and
vague.”). Specifically, Funk’s complaint did
      not specify the manufacturing defect; nor d[id] 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 d[id] the complaint tell us how the manufacturing
      process failed, or how it deviated from the FDA approved
      manufacturing process.
Id. This conclusion was consistent with a number of other courts holding that
to plead a parallel claim successfully, a plaintiff’s allegations that the
manufacturer violated FDA regulations must meet the Twombly plausibility
standard. See, e.g., In re Medtronic Inc., 623 F.3d 1200, 1203 (8th Cir. 2010);
Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 280 (E.D.N.Y. 2009); Parker v.
Stryker Corp., 584 F. Supp. 2d 1298, 1301 (D. Colo. 2008); cf. Bausch v. Stryker
Corp., 630 F.3d 546, 558, 560 (7th Cir. 2010) (acknowledging that Twombly
applies, but rejecting the notion that Twombly requires the plaintiff to allege
which specific regulation was violated).
      In Hughes, we noted that any claim asserting a state-law tort action
despite compliance with FDA regulations was preempted by the MDA. 631 F.3d
at 768. However, state common law claims “are not preempted, provided that
such claims are premised entirely on violation of the applicable federal

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requirements.” Id. at 770. Importantly, a formal finding of a violation by the
FDA was not required to plead a parallel action. See id. at 772 (“We are
persuaded that any additional ‘formal’ finding or enforcement action by the FDA
is not an ‘implicit precondition’ to suit under the facts of this case.”). We
ultimately held that the cause of action survived where the plaintiff provided
expert testimony showing that the medical device manufacturer had “violated
the plain text of the [Medical Device Reporting] regulations.” Id. at 773.
      Under Funk and Hughes, Bass has sufficiently pleaded parallel claims in
his first amended complaint, to the extent that the claims are based upon
manufacturing defects resulting from violations of federal regulations. Bass
alleges that his injury was caused by the Shell’s failure to attach to the bone.
The complaint further alleges that the Shell was adulterated due to violations
of 21 C.F.R. §§ 820.20(a), 820.20(b)(2), and 820.70(e).          In support of the
allegations that the Shell was adulterated, Bass pleaded that Stryker initiated
a recall on its Shell, and that the recall “included Plaintiff’s specific hip device.”
Bass also alleged that the FDA sent a warning letter to Stryker five months
before his surgery, which included a notice that Stryker failed to verify and
implement changes to reduce the Final Rinse Tank bioburden. See Letter from
Timothy A. Ulatowski, Director, FDA Office of Compliance to Michael McGrath,
General    Manager/Vice      President,    Stryker    Ireland   (Mar.    15,   2007),
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2007/ucm076
326.htm [hereinafter Warning Letter]. According to Bass, the recall followed an
investigation in which the FDA noted that manufacturing residuals in excess of
those permitted by the FDA were found on the Shells and that the Shells were
“adulterated within the meaning of section . . . 21 U.S.C. § 351(h).” Warning
Letter at 1. Bass also pleaded that excess bioburden (microbial contaminant)
and manufacturing residuals on the Shells are known to prevent bony ingrowth,


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resulting in a loose cup, which is the injury that Bass pleads. In summary, Bass
pleaded: (1) he received a Shell implant; (2) the FDA had previously warned
Stryker of bioburden in excess of FDA regulations in its final rinse of the Shells;
(3) after Bass’s surgery, Stryker ultimately voluntarily recalled those Shells,
including the Shell specifically used in Bass’s implant; (4) Bass suffered from a
loose Shell due to a lack of bony ingrowth; and (5) the lack of bony ingrowth is
a known effect of an excess of bioburden and manufacturing residuals on Shells.
Bass has thus pleaded sufficient facts to find that his injury plausibly resulted
from a violation of FDA standards in connection with his manufacturing defect
claims, as more fully explained below, and, therefore, has pleaded a non-
conclusory parallel claim under our precedents in Funk and Hughes.
      Stryker argues that Bass “does not plead that his doctor saw any signs of
contamination on the device when it was removed or that the Plaintiff had an
infection at the sight of the hip replacement.” Stryker argues that Bass’s claim
is essentially one of res ipsa loquitur, which we rejected in Funk. See 631 F.3d
at 782. However, Bass’s pleadings are more detailed than those in Funk. See
id. Unlike the Funk complaint, Bass “specifies with particularity what went
wrong in the manufacturing process and cites the relevant FDA manufacturing
standards Stryker allegedly violated.” Id. Evidence that the doctor noticed
contamination on the Shell would provide evidentiary support for a finding of
contamination, but Stryker does not point to any case stating that such
allegations are required at the motion to dismiss stage. We conclude that these
pleadings are sufficient as to Bass’s specific injury.
      Similarly, we conclude that Bass has pleaded sufficient facts as to
Stryker’s failure to conform with FDA regulations in manufacturing the Shell.
As noted above, Bass pleads that the FDA warned Stryker of excess contaminant
in the manufacture of its Shells; that the Shells, including the Shell implanted


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                                 No. 11-10076

into Bass’s hip, were ultimately recalled because of contamination issues; and
that Bass’s Shell caused the type of injury that is consistent with excess
contamination.      These   allegations     plausibly   contend   that   Stryker’s
manufacturing of the Shells failed to conform to FDA regulations and rendered
them defective.
      Stryker also argues that even if Bass’s allegations are not conclusory, they
nonetheless fail to allege adequately that Stryker did not comply with FDA
regulations. In support of this argument, Stryker notes that the recall of the
Shells was voluntary, that the pleadings regarding the Warning Letter are
conclusory, and that the Warning Letter “is not a final determination of an FDA
decision.” Stryker also notes that at all times the Trident system maintained its
PMA approval.
      However, this claim is undermined by our decision in Hughes. The
manufacturer in Hughes similarly argued that “the FDA never made a ‘formal’
finding that [the manufacturer] failed to comply with the MDR regulations or
initiated an enforcement action against [it.]” 631 F.3d at 772. We rejected the
argument that a formal finding of a violation or an enforcement action was a
necessary precursor of a parallel claim. Id. at 772-73. The device in that case
similarly had PMA approval, id. at 764, and nothing in the opinion suggests that
the approval was revoked; rather, the fact that we acknowledged that the FDA
had not taken any enforcement action likely precludes the possibility that the
PMA approval had been revoked.
      Additionally, although the Warning Letter itself is somewhat unclear, it
does identify that the Trident Acetabular System was determined by the FDA
to be “adulterated within the meaning of section 501(h) of the [FDCA].” Warning
Letter at 1. The letter also mentions that the FDA had found “Final Rinse Tank
bioburden nonconformances” and notes that Stryker’s response to some of these


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                                   No. 11-10076

“nonconformances” was inadequate. Id. at 3. Therefore, the letter appears to
provide further support for Bass’s allegations. Furthermore, as the Seventh
Circuit noted, and as the redactions in the Warning Letter illustrate, “courts
must keep in mind that much of the product-specific information about
manufacturing needed to investigate [a medical device claim] fully is kept
confidential by federal law.” Bausch, 630 F.3d at 558. Therefore, asking the
plaintiff to make more specific allegations than those found in Bass’s complaint
may make pleading a parallel claim regarding defective manufacturing nearly
impossible. See In re Medtronic, 623 F.3d at 1209 (Melloy, J., dissenting)
(stating that Twombly only requires a degree of specificity that may be achieved
without the use of confidential documents). At this early stage, Bass has
successfully alleged that Stryker’s manufacturing was conducted in violation of
the applicable federally mandated standards and resulted in the contamination
of some of the Shells, including the Shells at issue.
      Finally, Stryker argues that we should affirm the district court’s opinion
because the regulations upon which Bass relies are CGMPs, which are “not
specific enough to constitute parallel claims.” This contention is not that the
allegations are not specific enough to plead a claim, but rather that the
regulations are not specific enough to support a claim.
      Although the circuits are not in complete agreement as to what constitutes
a sufficient pleading with regard to a CGMP, the pleadings here would satisfy
any of the courts relied upon by Stryker.           The key distinction between
complaints that are sufficient to withstand a motion to dismiss and those that
are not is not reliance on CGMPs, but rather the existence of a manufacturing
defect caused by a violation of federal regulations and allegations connecting a
defect in the manufacture of the specific device to that plaintiff’s specific injury.
See Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1301-02 (11th Cir. 2011)


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(affirming summary judgment but stating that a complaint is adequate if it
“set[s] forth any specific problem, or failure to comply with any FDA regulation
that can be linked to the injury alleged” (internal quotation marks omitted)); In
re Medtronic, 623 F.3d at 1207 (noting that a plaintiff must plead that the
manufacturer “violated a federal requirement specific to the FDA’s PMA
approval of th[e] Class III device” and concluding that classwide claims of
generic manufacturing defects do not survive a motion to dismiss); Bausch, 630
F.3d at 555-56 (concluding that violations of CGMPs are not too general to be
applied by a jury). This is perhaps best summed up in In re Medtronic, in which
the Eighth Circuit noted that reliance on CGMPs may be appropriate where, as
here, “a specific defective Class III device injured a consumer, and the plaintiff
did not have access to the specific federal requirements in the PMA prior to
commencing the lawsuit.” In re Medtronic, 623 F.3d at 1206.
      Here, Stryker alleges that permitting Bass to proceed would allow a jury
to set bioburden or residual standards that are not in the regulations. Bass
responds that the FDA approves the manufacturing process in the PMA
application, see Riegel, 552 U.S. at 317-18, such that the jury could measure
Stryker’s performance against this specific FDA-approved PMA process.
      In Riegel, the Supreme Court noted that “the FDA requires a device that
has received premarket approval to be made with almost no deviations from the
specifications in its approval application, for the reason that the FDA has
determined that the approved form provides a reasonable assurance of safety
and effectiveness.” Id. at 323. The PMA application that is approved by the
FDA is more specific than the regulations. Cf. id. at 318 (noting that PMA
application “includes, among other things, full reports of all studies and
investigations of the device’s safety and effectiveness that have been published
or should reasonably be known to the applicant; a ‘full statement’ of the device’s


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                                  No. 11-10076

‘components, ingredients, and properties and of the principle or principles of
operation’; ‘a full description of the methods used in, and the facilities and
controls used for, the manufacture, processing, and, when relevant, packing and
installation of, such device’; samples or device components required by the FDA;
and a specimen of the proposed labeling” (quoting 21 U.S.C. § 360e(c)(1)).
      Thus, we cannot agree that the regulations are too vague to be enforced by
a jury, because by the time the case is tried, the jury will have before it the PMA
application that was approved by the FDA. To the extent a plaintiff can show
that the FDA-approved processes and procedures were not followed, and that the
injury was caused by this deviation, the plaintiff’s claim will be parallel.
However, if the plaintiff challenges the suitability of the precise processes or
procedures chosen by the maker, and approved by the FDA, to achieve the
broader regulatory goals, such a claim could not proceed.
      We therefore hold that if a plaintiff pleads that a manufacturer of a Class
III medical device failed to comply with either the specific processes and
procedures that were approved by the FDA or the CGMPs themselves and that
this failure caused the injury, the plaintiff will have pleaded a parallel claim.
To illustrate, suppose a manufacturer had represented to the FDA in its
pre-approval documentation that each hip implant component would be
sterilized for ten minutes at 800 degrees. We would accept a parallel claim that
pleaded that the manufacturer instead sterilized the component at only 200
degrees for five minutes, as that would “violate” what it told the FDA. However,
if the plaintiff’s claim was that proper sterilization required twenty minutes at
1000 degrees or some other method of sterilization altogether, this claim would
not be allowed, as it would “add to” the regulatory requirements. Thus, we reject
Stryker’s argument that the regulations are too vague to be enforced because




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Bass will have to prove violations of the more specific, FDA-approved PMA
process for this device.
      Furthermore, we have already rejected a similar argument in Hughes. In
that case, the manufacturer argued that “permitting [a] jury to determine
whether [it] violated the FDA’s reporting requirements would lead to the
possible imposition of different or additional state requirements.” 631 F.3d at
772. We noted that “any danger that the jury in th[at] case may apply the plain
terms of the MDR regulations in a different or more stringent manner than the
FDA intended is considerably mitigated by the summary judgment evidence
indicating that the FDA disapproved of [the manufacturer’s] reporting
practices.” Id. at 773; see also id. at 774 (“This evidence strongly suggests that
the FDA concluded that [the manufacturer’s] algorithm failed to satisfy the MDR
regulations requiring reports of ‘serious injuries.’”).
      Under these standards, Bass sufficiently alleged a concrete injury and a
connection between a defect in Stryker’s manufacture of the Shells and Bass’s
injury. Notably, unlike the plaintiffs in In re Medtronic and Wolicki-Gables,
Bass does not allege that his injury simply arises from Stryker’s failure to abide
by the CGMPs, but rather alleges that the failure to abide by its own
manufacturing standards required to satisfy the CGMPs and the PMA approval
process resulted in an unacceptable level of bioburden on his Shell. See Warning
Letter at 3 (noting Final Rinse Tank nonconformances). Furthermore, the FDA
itself determined that Stryker was in violation of the CGMPs. See Warning
Letter at 1 (“[The FDA’s] inspection revealed that . . . the methods used in, or the
facilities or controls used for, [the] manufacture, packing, storage, or installation
[of the Shells] are not in conformity with the [CGMP] requirements of the
Quality System (QS) regulation found at [21 C.F.R. 820].”). The fact that the
FDA was able to determine, even preliminarily, that Stryker violated the
manufacturing (or sterilization) procedures that it adopted to fulfill the CGMPs


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                                   No. 11-10076

suggests that the federal regulations are not so vague that they “[do] not spell
out standards that the court could enforce.” Therefore, we hold that Bass’s
reliance, in part, on CGMPs does not preclude him from having effectively
alleged a parallel claim.
C.      Whether the district court erred in holding that Bass’s claims are
        preempted under § 337(a).
        The district court held that even if Bass’s claims are not preempted by
§ 360k, they are preempted by 21 U.S.C. § 337(a), which provides that “all such
proceedings for the enforcement, or to restrain violations, of this Act . . . shall be
by and in the name of the United States.” 21 U.S.C. § 337(a). The district court
then held that under the workings of § 360k and § 337(a), a state-law claim for
injuries sustained from a PMA-tested medical device will only be valid in the
face of a statute creating causes of action for violations of the FDCA.
        We considered and rejected this interpretation of Buckman Co. v.
Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), in Hughes. There, we noted
that there is a difference between the “freestanding federal cause of action based
on violation of the FDA’s regulations” presented by the plaintiffs in Buckman
and a state-law tort claim. See 631 F.3d at 775; see also Bausch, 630 F.3d at 558
(distinguishing between a “breach of a recognized state-law duty” and “an
implied right of action under federal law”). “Riegel, decided long after Buckman
. . . unequivocally held that parallel state claims survive a defendant’s
preemption defense under the MDA . . . .” Hughes, 631 F.3d at 775. This case
is premised on state-law tort claims rather than any duties independently
created by FDA regulations.
        Stryker argues that Hughes is distinguishable because it is based on
Mississippi law, which could allow a plaintiff to show that a defendant violated
its duty of care by proving a federal regulatory violation. Stryker asserts that
under Texas law, “statutory and regulatory violations do not establish a violation


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                                  No. 11-10076

of the state standard of care unless negligence per se applies.” It contends that
even if Bass pleaded negligence per se, Texas would not permit a showing of
negligence per se based on FDCA violations.
      We reject Stryker’s attempt to distinguish Hughes on this basis; even if
Stryker is correct that Bass may not rely on the theory of negligence per se, he
may still have a negligence cause of action. Indeed, as noted by the Texas
Supreme Court, “[n]egligence per se is a tort concept whereby a legislatively
imposed standard of conduct is adopted by the civil courts as defining the
conduct of a reasonably prudent person.” Carter v. William Sommerville & Son,
Inc., 584 S.W.2d 274, 278 (Tex. 1979). “In such a case the jury is not asked to
judge whether or not the defendant acted as a reasonably prudent person would
have acted under the same or similar circumstances; the statute itself states
what a reasonably prudent person would have done.” Id. Even though Bass
may not be able to rely on the theory of negligence per se to establish a violation
of the standard of care, Bass has sufficiently alleged facts, which, if true, would
support a claim that Stryker was negligent.
      Indeed, it is evident from the Texas Supreme Court’s discussion in Worthy
v. Collagen Corp., 967 S.W.2d 360 (Tex. 1998), that it would not disallow tort
claims predicated on violations of FDA regulations. Id. at 372-77. Purcel also
indicated that 21 U.S.C. § 337(a) did not preempt negligence and products
liability causes of action under Texas law. See 2010 U.S. Dist. LEXIS 67109, at
*20-21. Yet another court concluded that “claims based on a manufacturer’s
failure to follow the FDA’s regulations and procedures in manufacturing and
marketing a device are not preempted.” Baker v. St. Jude Med., S.C., Inc., 178
S.W.3d 127, 138 (Tex. App.—Houston [1st Dist.] 2005, pet. denied).             We
therefore conclude that Bass’s parallel state claims are not preempted by 21
U.S.C. § 337(a).


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                                   No. 11-10076

D.      Which claims survive?
        Based on the above analysis, we conclude that the only claims that survive
preemption are manufacturing defect claims premised on Stryker’s alleged
violations of the FDA regulations and requirements.
        1.    Strict Liability
        To plead a cause of action for strict liability under Texas law, Bass must
plead that: (1) Stryker placed the Shells in the stream of commerce; (2) the
Shells were in a defective or unreasonably dangerous condition; (3) there was a
causal connection between the defect and his injury; and (4) the Shell was
expected to and did reach him without substantial change in the condition in
which it is sold. See Hous. Lighting & Power Co. v. Reynolds, 765 S.W.2d 784,
785 (Tex. 1988).      Bass pleads two kinds of claims for strict liability: a
manufacturing defect and a “marketing defect.” Bass’s manufacturing defect
claims may proceed, because, as discussed above, to the extent they are premised
on violations of FDA regulations, they are parallel claims that are not
preempted. See Purcel, 2010 U.S. Dist. LEXIS 67109, at *34. However, to the
extent that Bass’s claims are premised on a “marketing defect,” Bass has not
pleaded specific facts as to how the marketing of the Trident system violated
FDA regulations; therefore, we affirm the district court’s dismissal of those
claims. See In re Medtronic, 623 F.3d at 1205 (“The FDA’s PMA approval
includes specific language for Class III device labels and warnings. Plaintiffs did
not allege that Medtronic modified or failed to include FDA-approved
warnings.”); Purcel, 2010 U.S. Dist. LEXIS 67109, at *20 (“Plaintiffs cite no
federal requirement obligating [the manufacturer] to warn them that the devices
were adulterated. These claims of . . . failure to warn impose a requirement in
addition to those approved by the FDA—the duty to warn consumers if devices
are adulterated—and are therefore preempted by § 360k(a).”).


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                                  No. 11-10076

       2.    Negligence
       For the same reasons that the strict liability “marketing defect” claim is
dismissed, we affirm the district court’s dismissal of Bass’s claims for negligence
to the extent that they are premised on a failure to warn or improper marketing.
Bass did not plead that Stryker failed to include FDA-approved warnings, and
any claim that Stryker had a duty to warn consumers that the Shell was
adulterated is preempted by § 360k(a). Purcel, 2010 U.S. Dist. LEXIS 67109, at
*20.
       However, as discussed in detail above, Bass’s negligent manufacturing
claims survive, as they are parallel claims that do not impose different or
additional requirements than the FDA regulations because Bass pleaded that
Stryker failed to abide by the FDA regulations in the manufacture of the Shell.
Hughes, 631 F.3d at 775-76; Purcel, 2010 U.S. Dist. LEXIS 67109, at *12. Even
if Bass cannot rely on the theory of negligence per se to prove his case, Texas law
does allow “parallel” negligent manufacturing claims to proceed. E.g., Schronk
v. City of Burleson, No. 10-07-00399-CV, 2009 Tex. App. LEXIS 5654, at *68
(Tex. App.—Waco July 22, 2009, pet. filed) (allowing a claim that a medical
device was “defectively manufactured, designed, supplied, sold, or marketed to
the City” to go forward); Purcel, 2010 U.S. Dist. LEXIS 67109, at *34 (allowing
plaintiff’s negligent manufacturing claims to proceed under Texas law).
Therefore, we hold that the district court erred in dismissing Bass’s negligent
manufacturing claims.
       3.    Express Warranty
       We agree with Medtronic that the express warranty claims cannot be used
to impose requirements greater than that provided by the FDA regulations.
Medtronic, 623 F.3d at 1207. To the extent that Bass is claiming that Stryker
made some affirmative representation of compliance with FDA manufacturing


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                                  No. 11-10076

processes, he has done so only in a wholly conclusory fashion. Therefore, we
affirm the dismissal of Bass’s express warranty claim. See, e.g., Purcel, 2010
U.S. Dist. LEXIS 67109, at *37; Delaney, 2009 U.S. Dist. LEXIS 16865, at *16.
      4.    Implied Warranties
      To prevail on a breach of the implied warranty of merchantability, a
plaintiff must prove that: (1) “the defendant sold or leased the product to the
plaintiff; (2) the product was unmerchantable; (3) the plaintiff notified the
defendant of the breach; and (4) the plaintiff suffered injury.” Purcel, 2010 U.S.
Dist. LEXIS 67109, at *23; see also TEX. BUS. & COM. CODE ANN. § 2.314 (West
2009). A product is unmerchantable if it is “unfit for its ordinary purpose.”
Purcel, 2010 U.S. Dist. LEXIS 37109, at *23.
      “To establish a breach of the implied warranty of fitness for a particular
purpose, the plaintiff must establish that (1) the seller had reason to know any
particular purpose for which the goods were required at the time of contracting
and (2) the buyer was relying on the seller’s skill or judgment to select or furnish
suitable goods.” Hartford v. Lyndon-DFS Warranty Servs., Inc., No. 01-08-
00398-CV, 2010 Tex. App. LEXIS 4241, at *28-29 (Tex. App.—Houston [1st
Dist.] May 28, 2010, no pet.); see also TEX. BUS. & COM. CODE ANN. § 2.315 (West
2009).
      Some courts that have considered this issue have concluded that implied
warranty claims are preempted because a finding that a product is
unmerchantable or unfit for the purpose for which it is intended conflicts with
the PMA process, through which the FDA has explicitly approved the device.
See Michael v. Shiley, 46 F.3d 1316, 1325 (3d Cir. 1995); King v. Collagen Corp.,
983 F.2d 1130, 1135-36 (1st Cir. 1993). However, both Michael and King were
decided before the Supreme Court’s decisions in Lohr and Riegel. In Riegel, the
Supreme Court affirmed the dismissal of the plaintiff’s negligence, strict


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                                       No. 11-10076

liability, and implied warranty claims, but noted that this was because the
district court “interpreted the claims [in that case] to assert that Medtronic’s
device violated state tort law notwithstanding compliance with the relevant
federal requirements . . . .” 552 U.S. at 330. The Court explicitly stated that
“§ 360k does not prevent a State from providing a damages remedy for claims
premised on a violation of FDA regulations; the state duties in such a case
‘parallel,’ rather than add to, federal requirements.” Id.
       Several courts that have addressed whether implied warranty claims are
preempted after Riegel have determined that, to the extent the plaintiff relies
on the failure to comply with the FDA’s requirements in asserting its breach of
implied warranty claim, such claims may proceed. E.g., Hofts v. Howmedica
Osteonics Corp., 597 F. Supp. 2d 830, 839-40 (S.D. Ind. 2009) (concluding that
an implied warranty claim could proceed unless it “rested on allegations about
standards other than those permitted by the FDA . . .”)3; Gelber v. Stryker Corp.,
No. 09-Civ-1322, 2011 U.S. Dist. LEXIS 41758, at *22 (S.D.N.Y. Apr. 18, 2011)
(concluding that “Plaintiffs’ implied warranty claims are not preempted to the
extent they allege a defective manufacturing claim . . .”); Purcel, 2010 U.S. Dist.
LEXIS 67109, at *38-39; Kallal v. Ciba Vision Corp., No. 09-CV-3346, 2010 U.S.
Dist. LEXIS 56838, at *8 (N.D. Ill. June 9, 2010) (concluding that the plaintiff’s
claims related to violation of a federal standard could proceed). Most post-Riegel



       3
         The court in Hofts relied in part on 21 C.F.R. § 808.1(d)(1), to conclude that the
implied warranty claims were not preempted. 597 F. Supp. 2d at 839. Section 808.1(d)(1)
states that “Section 521(a) [of the FDCA, or 21 U.S.C. § 360k] does not preempt State or local
requirements of general applicability where the purpose of the requirement relates either to
other products in addition to devices (e.g., requirements such as general electrical codes, and
the Uniform Commercial Code (warranty of fitness)), or to unfair trade practices in which the
requirements are not limited to devices.” 21 C.F.R. § 808.1(d)(1). The Supreme Court rejected
a similar argument in Riegel. 552 U.S. at 328-29. We do not address this issue, as we do not
rely on this regulation in holding that Bass’s implied warranty claims may proceed.


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                                  No. 11-10076

cases that have found implied warranty claims preempted either concluded that
the claims failed to rely on violations of the FDA’s requirements, or the plaintiff
pleaded that the defendants complied with the FDA’s requirements. E.g., Horn
v. Boston Sci. Neuromodulation Corp., No. CV409-074, 2011 U.S. Dist. LEXIS
102164, at *16-19 (S.D. Ga. Aug. 26, 2011) (dismissing an implied warranty
claim but stating that the claim would have survived if the plaintiff had properly
pleaded a failure to comply with FDA requirements); Walker v. Medtronic, Inc.,
No. 2:07-00317, 2010 U.S. Dist. LEXIS 125103, at *21 (S.D. W. Va. Nov. 24,
2010) (finding that the implied warranty claim was preempted because there
was no allegation of non-compliance with FDA standards); Yost v. Stryker Corp.,
No. 2:09-Cv-28-FtM-29DNF, 2010 U.S. Dist. LEXIS 27079, at *12-13 (M.D. Fla.
Mar. 23, 2010) (same). But see In re Medtronic, Inc. Sprint Fidelis Leads Prods.
Liab. Litig., 592 F. Supp. 2d 1147, 1163-64 (D. Minn. 2009) (concluding that the
plaintiff’s implied warranty claim was preempted despite the plaintiff’s
allegation that the device was not manufactured in accordance with CGMPs),
aff’d, 623 F.3d 1200 (8th Cir. 2010).
      We agree with the courts that hold that an implied warranty claim is not
preempted if the plaintiff alleges that the defendant violated federal
requirements and can ultimately show a causal link between the violation and
the breach of the implied warranty. If, however, the plaintiff claims that the
defendant breached the implied warranty despite its compliance with FDA
requirements, that claim is clearly preempted, as it would be “‘different from, or
in addition to,’ the requirements imposed by federal law.” See Riegel, 552 U.S.
at 330 (quoting 21 U.S.C. § 360k(a)(1)).
      Here, the issue is whether Bass sufficiently pleaded that his breach of
implied warranty claims are causally related to Stryker’s alleged violations of
the FDA’s requirements. Bass incorporated all of his factual allegations into his


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                                  No. 11-10076


claim that Stryker breached the implied warranties of merchantability and
fitness for a particular purpose, and he sets out that Stryker manufactured the
Shell in violation of the FDA requirements and received the Warning Letter
from the FDA because the Shell was “adulterated.” Therefore, although this
portion of the complaint is not a model of clarity, to the extent that he bases his
breach of implied warranty claims on violations of federal requirements, those
claims survive. To the extent he alleges that Stryker complied with the FDA
requirements, his implied warranty claims are preempted.
      5.    DTPA
      Finally, Bass asserts a violation of the DTPA. Stryker’s briefing before the
district court noted that the Texas Supreme Court found that DTPA claims are
preempted by the PMA in Worthy. 967 S.W.2d at 376-77.                  Worthy is
distinguishable because the plaintiff in that case did not “contend that [the drug]
was manufactured, marketed, or injected in her in any way other than that
approved by the FDA.” Id. at 376. Here, of course, Bass does allege that the
Shell was manufactured in violation of FDA regulations.
      It appears that Bass alleges two theories of violation of the DTPA:
misrepresentation and breach of implied warranty. To the extent that Bass’s
claim relies on a misrepresentation, it is essentially asserting a failure to warn
claim that is preempted for the reasons discussed above. To the extent that
Bass’s DTPA claim relies upon a breach of implied warranty, we allow it to go
forward, subject to the limitations discussed in the implied warranty section
above.
                              IV. CONCLUSION
      For the foregoing reasons, we AFFIRM the dismissal of Bass’s strict
liability, negligence, and DTPA claims inasmuch as they are premised on a


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                                No. 11-10076


failure to warn or a marketing defect; AFFIRM as to Bass’s breach of express
warranty claims; and REVERSE and REMAND the following: (1) Bass’s strict
liability claim, to the extent it is based on a manufacturing defect; (2) his
negligent manufacturing claim; (3) his claim for breach of an implied warranty;
and (4) his DTPA claim, to the extent that it relies on a breach of an implied
warranty.




                                      24
