Case: 14-40183 Document: 00512886600 Page: 1 Date Filed: 12/31/2014
IN THE UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT
No. 14-40183 United States Court of Appeals
Summary Calendar Fifth Circuit
FILED
December 31, 2014
RICARDO A. RODRIGUEZ, Lyle W. Cayce
Clerk
Plaintiff - Appellant
v.
AMERICAN MEDICAL SYSTEMS, INCORPORATED,
Defendant - Appellee
Appeal from the United States District Court
for the Southern District of Texas
USDC No. 7:12-CV-330
Before PRADO, OWEN, and GRAVES, Circuit Judges.
PER CURIAM:*
Plaintiff Ricardo Rodriguez appeals from the district court’s dismissal of
his state law products liability, deceptive trade practices and breach of contract
claims against American Medical Systems, Inc. (“AMS”), the manufacturer of
medical devices. We affirm.
* Pursuant to 5TH CIR. R. 47.5, the court has determined that this opinion should not
be published and is not precedent except under the limited circumstances set forth in 5TH
CIR. R. 47.5.4.
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I. Factual and Procedural Background
In February 2012, Rodriguez filed suit in Texas state court against
defendants AMS and Dr. Henry E. Ruiz. According to Rodriguez’s pleadings,
Dr. Ruiz implanted Rodriguez with a penile inflatable prosthesis called the
“AMS 700 MS.” AMS designed and manufactured the AMS 700 MS. Rodriguez
alleges that the implant has not functioned properly and is causing him pain
and disfiguration. The claims against Dr. Ruiz were dismissed in Texas state
court. Subsequently, AMS removed the case to the Southern District of Texas
on the basis of diversity jurisdiction.
Rodriguez asserts three claims against AMS: (1) products liability claims
based on defective design and manufacturing; (2) violations of the Texas
Deceptive Trade Practices Act (“DTPA”); and (3) breach of contract. AMS
moved to dismiss under Federal Rule of Civil Procedure 12(b)(6), arguing that
the claims against AMS are preempted by the Medical Device Amendments
(“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 360k(a),
and that Rodriguez failed to state a claim upon which relief can be granted. In
support of its preemption arguments, AMS provided documentary evidence
that the FDA had approved the AMS 700. Because it looked beyond the
pleadings to this evidence, the district court converted the part of the motion
regarding the claims subject to preemption, specifically the products liability
and DTPA claims, into a motion for summary judgment and gave Rodriguez
an opportunity to respond. The court considered the breach of contract claim
under Rule 12(b)(6). The district court granted summary judgment to AMS on
the products liability claims and DTPA claims under Rule 56, and dismissed
the breach of contract claim under Rule 12(b)(6). Rodriguez appeals.
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II. Discussion
We review both the district court’s grant of summary judgment and the
dismissal under Rule 12(b)(b)(6) de novo. See Bass v. Stryker Corp., 669 F.3d
501, 506 (5th Cir. 2012) (motion to dismiss); Lofton v. McNeil Consumer &
Specialty Pharm., 672 F.3d 372, 375 (5th Cir. 2012) (summary judgment).
Questions of law regarding preemption are also reviewed de novo. See Lofton,
672 F.3d at 375.
A. Preemption
“In response to the concern that state-law governance of medical devices
was inadequate, Congress passed the MDA, giving the FDA authority to
regulate medical devices and expressly preempting certain state regulations.”
Bass, 669 F.3d at 506; see Riegel v. Medtronic, Inc., 552 U.S. 312, 315-16 (2008);
21 U.S.C. § 360k(a). A state law tort claim to recover for injuries allegedly
caused by a medical device is preempted if two requirements are met: (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.”
Bass, 669 F.3d at 507 (internal quotation marks omitted) (quoting Riegel, 552
U.S. at 321-22); see also 21 U.S.C. § 360k(a)(1). However, “§ 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.” Riegel, 552 U.S. at 330; see Bass, 669 F.3d
at 509.
The implant at issue in this case is a Class III medical device under
federal law. Class III devices receive the most federal oversight. See Riegel,
552 U.S. at 317; Bass, 669 F.3d at 506. Class III devices that are approved
through the FDA’s rigorous pre-market approval process (“PMA”)
automatically satisfy the “federal requirements” prong of the preemption
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analysis. Riegel, 552 U.S. at 322-23; Bass, 669 F.3d at 507. “[T]he FDA may
grant premarket approval only after it determines that a device offers a
reasonable assurance of safety and effectiveness.” Riegel, 552 U.S. at 323
(citing 21 U.S.C § 360e(d)). After PMA review and approval, the device “must
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. Here,
AMS provided a letter from the FDA and a supporting affidavit from one of its
employees indicating that the AMS 700 MS pump received FDA approval
through the product development protocol (“PDP”) provided by 21 U.S.C.
§ 360e(f), rather than through the most rigorous PMA process. Rodriguez
makes no argument that the PDP and PMA procedures should be treated
differently under the preemption analysis. See Betterton v. Evans, 351 F. Supp.
2d 529, 534-35 (N.D. Miss. 2004) (describing the PDP and PMA processes and
concluding that the preemption analysis for each is the same). Further, the
MDA provides that a device which has been approved through the PDP process
“shall be considered as having [PMA] approval.” 21 U.S.C. § 360e(f)(1); see also
21 C.F.R. § 814.19 (“A class III device for which a product development protocol
has been declared completed by the FDA under this chapter will be considered
to have an approved PMA.”). Thus, we assume that a device which has been
approved through the PDP process meets the federal requirements prong of
the preemption analysis.
Rodriguez argues that summary judgment was inappropriate because a
genuine issue of material exists as to whether the implant used in his surgery
was in fact approved by the FDA. We agree with the district court that there
is no genuine dispute of fact whether the AMS 700 MS received FDA approval
through the PDP process. The 2006 letter provided by AMS is printed on FDA
letterhead, is supported by the affidavit of an AMS employee, and clearly states
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that the AMS 700 MS had received PDP approval. Rodriguez argues that the
letter reflecting FDA approval is a supplemental letter, rather than an initial
approval letter, and mentions the specific AMS 700 MS only in parentheses.
He argues that the reference to the AMS 700 MS model could have been a
mistake or that the letter could have been falsified, and that a jury could find
that this particular model was never approved by the FDA. However,
Rodriguez provides no evidence contradicting the FDA letter. His arguments
to the contrary are purely speculative and raise no genuine dispute of fact.
Because the PDP approval establishes that there are federal
requirements applicable to the implant, Rodriguez’s claims survive preemption
only if his state claims parallel the federal requirements. See Riegel, 552 U.S.
at 300; Bass, 669 F.3d at 509. The district court granted summary judgment
to AMS on Rodriguez’s products liability and DTPA claims because it
concluded that Rodriguez’s complaint was too vague and conclusory to state
parallel claims under the applicable law. We agree.
Rodriguez’s complaint fails to meet the standards for pleading parallel
design or manufacturing defect claims. In Bass, we held 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 [FDA’s Current Good Manufacturing Practices] and that this failure
caused the injury, the plaintiff will have pleaded a parallel claim.” Bass, 669
F.3d at 512; see also Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1301-
02 (11th Cir. 2011) (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 1200, 1207 (8th Cir. 2010) (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
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concluding that classwide claims of generic manufacturing defects could not
survive a motion to dismiss). Bass addressed a claim that an FDA-approved
Class III hip implant malfunctioned because of impurities in the
manufacturing process. 669 F.3d at 509. We held that the plaintiff did state
parallel claims where the complaint specified which FDA regulations were
violated in the manufacturing process, alleged that the manufacturer had
received a warning letter from the FDA regarding the manufacturing defect,
and eventually recalled the implant due to the defect. Bass, 669 F.3d at 510.
By contrast, in Funk we addressed a similar claim regarding the same hip
implant but held that the plaintiff’s pleadings were too conclusory to state a
parallel claim. See Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011).
Specifically, we noted that Funk’s complaint did not specify the manufacturing
defect, did not specify a causal connection between a failure of the
manufacturing process and a specific defect in the process that caused the
personal injury, and did not specify how the process deviated from the FDA
approved manufacturing process. Id.
Applying this case law, it is clear that Rodriguez fails to state parallel
manufacturing or design defect claims. Rodriguez’s complaint does not plead
a violation of any federal requirement relating to design or manufacturing of
the implant, either those specific to the AMS 700 MS or those generally
applicable to the manufacturing of medical devices, and he cites no facts
supporting a finding of any such violation. He fails to allege a specific defect
in the manufacturing process or design, any deviation from the FDA-approved
design or manufacturing processes, or any causal connection between a
violation of federal requirements and his injuries. Thus, he has failed to plead
a parallel claim. See Funk, 631 F.3d at 782.
Rodriguez likewise fails to plead a parallel DTPA claim. Construed
liberally, Rodriguez’s DTPA claim alleges that representations in AMS
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“brochures and literature” promised a certain performance that did not occur,
and constitute a “false, misleading, or deceptive act or practice” and an
“unconscionable action or course of action” under the DTPA. See Tex. Bus. &
Com. Code §§ 17.50(a), 17.46(b), 17.45(5). However, Rodriguez fails to allege
whether or how AMS’s marketing materials deviated from FDA-approved
requirements. Therefore, he fails to plead a parallel DTPA claim. See Bass,
669 F.3d at 515 (holding that DTPA claim premised on a “marketing defect”
was preempted where the plaintiff did not plead specific facts as to how the
marketing violated FDA requirements).
B. Breach of Contract
Rodriguez also argues that the district court incorrectly dismissed his
breach of contract claim under Rule 12(b)(6). Rodriguez primarily argues that
AMS’s motion to dismiss the claim should have been converted to a motion for
judgment on the pleadings under Rule 12(c), because it was filed after AMS
filed an answer to the petition and a response to a motion for remand.
However, a “motion for judgment on the pleadings under Rule 12(c) is subject
to the same standard as a motion to dismiss under Rule 12(b)(6).” Doe v.
MySpace Inc., 528 F.3d 413, 418 (5th Cir. 2008). Thus, even if there was error,
there is no cause to reverse on this basis.
Rodriguez next argues that the district court erred by dismissing his
breach of contract claim for failure to state a claim. In his briefing, Rodriguez
fails to cite a single case regarding breach of contract claims in Texas.
However, even if we consider the claim despite this inadequate briefing, we
conclude that it was correctly dismissed. In Texas, the first essential element
of a breach of contract action is the existence of a valid contract. See Valero
Mktg. & Supply Co. v. Kalama Int’l, L.L.C., 51 S.W.3d 345, 351 (Tex. App.
2001); Smith Int’l, Inc. v. Egle Grp., LLC, 490 F.3d 380, 387 (5th Cir. 2007).
Rodriguez’s complaint does not identify any contract between AMS and
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Rodriguez. He merely alleges that the implant did not perform as provided in
AMS’s “brochures and literature” and as stated by Dr. Ruiz. However,
Rodriguez does not allege how the advertising or promotional materials
created a valid and enforceable contract, does not describe the terms of any
such contract, and does not explain how any statements made by Dr. Ruiz
could have given rise to a contract between AMS and Rodriguez. This claim
was thus properly dismissed.
III. Conclusion
For the foregoing reasons, the judgment of the district court is
AFFIRMED.
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