United States Court of Appeals,
Fifth Circuit.
No. 94-20592.
Sam FELDT, Plaintiff-Appellant,
v.
MENTOR CORPORATION, Defendant-Appellee.
Aug. 21, 1995.
Appeal from the United States District Court for the Southern District of Texas.
Before WISDOM, GARWOOD and DAVIS, Circuit Judges.
GARWOOD, Circuit Judge:
In this products liability suit, plaintiff-appellant Sam Feldt
(Feldt) appeals the district court's award of summary judgment, on
the basis of preemption, for defendant-appellee Mentor Corporation
(Mentor). We affirm in part, reverse in part, and remand.
Facts and Proceedings Below
On October 19, 1988, in an effort to cure erectile impotency,
Feldt, then 68 years old, had implanted a pump-activated, Mentor
GFS inflatable penile prosthesis (the prosthesis or the GFS), which
had been approved by the Food and Drug Administration (the FDA) for
marketing because of its substantial equivalence to prior devices.
Feldt's prosthesis worked until June 1991 when, because of a flaw
in the connection between the penile cylinders and the scrotal pump
reservoir, it would no longer inflate and had to be removed and
replaced. Feldt claims that, as a result of this defect, he
suffered from embarrassment, trauma, and decreased sexual desire.
He also claims that the defect contributed to the end of his
1 relationship with his fiancee.
Seeking recovery for these and other injuries, Feldt filed
suit against Mentor, the product manufacturer, in Texas state court
on June 17, 1993, alleging negligence, strict products liability,
breach of express and implied warranties, and violations of the
Texas Deceptive Trade Practices Act (DTPA). In its answer, Mentor
raised eighteen affirmative defenses, among them the complete
preemption of Feldt's state law claims. Asserting diversity and
federal question jurisdiction, Mentor removed the suit to federal
court, where on May 20, 1994, it filed a motion for summary
judgment based only on the preemption defense. Feldt opposed the
motion but dropped his negligence and strict liability claims with
regard to the GFS's manufacture. On July 11, 1994, the district
court awarded Mentor summary judgment, from which Feldt now
appeals.
Discussion
The only issue in this appeal is whether 21 U.S.C. § 360k(a),
part of the Medical Device Amendments of 1976 (MDA) to the Federal
Food, Drug and Cosmetic Act, expressly preempts Feldt's remaining
state law claims.1 When the field alleged to be preempted by
federal law has been traditionally occupied by the states, there is
a presumption against preemption that can be rebutted only by a
"clear and manifest" congressional purpose, be it express or
1 Although Feldt dropped his negligence and strict liability claims based on defective manufacture, he preserved his failure-to-warn and defective-design claims, which are also grounded on theories of negligence and strict liability.
2 implied. Jones v. Rath Packing Co., 430 U.S. 519, 525, 97 S.Ct.
1305, 1309, 51 L.Ed.2d 604 (1977). When Congress explicitly
displaces state law, however, as it has here, congressional intent
is determined with reference only to the express language of the
statute; preemption will not be implied. Cipollone v. Liggett
Group, Inc., --- U.S. ----, ----, 112 S.Ct. 2608, 2618, 120 L.Ed.2d
407 (1992); Stamps v. Collagen Corp., 984 F.2d 1416, 1420 (5th
Cir.) (rejecting the argument that the language of the MDA permits
a finding of implied preemption), cert. denied, --- U.S. ----, 114
S.Ct. 86, 126 L.Ed.2d 54 (1993). The federal statute at issue,
section 360k(a) of the MDA, provides as follows:
"[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter." 21 U.S.C. § 360k(a).
The parties dispute whether Texas law establishes, with respect to
the GFS, "any requirement different from, or in addition to, any
requirement applicable under this chapter to the device."2 Id.
Since the enactment of the MDA in 1976, the FDA has had
authority to regulate the entry of medical devices into the market.
2 We have held that state requirements subject to preemption by the MDA may be positive enactments or common law duties. Stamps, 984 F.2d at 1420; see also Cipollone, --- U.S. at ----, 112 S.Ct. at 2620. Feldt thus draws no distinction between his statutory and common law claims.
3 Pursuant to this authority, the FDA groups medical devices into
three classes (Classes I-III) according to the amount of regulation
necessary to ensure their safety and effectiveness. Although all
classes of medical devices are subject to general controls,
including labeling requirements and so-called good manufacturing
practices (GMPs), Class II and Class III devices are subject to
additional regulations. Moreover, because Class III devices are
deemed to pose the greatest threat of illness or injury, they are
subject to the most stringent regulation of the three classes. The
GFS is a Class III device. 21 C.F.R. § 876.3350(b).
Before being marketed and sold, Class III devices must undergo
the rigors of Pre-Market Approval (PMA), a lengthy, comprehensive
process, at the end of which the FDA determines whether there is
"reasonable assurance" that the device under consideration is safe
and effective. See 21 U.S.C. § 360d(c)(1), (d); see also Reeves
v. AcroMed Corp., 44 F.3d 300, 303 (5th Cir.), cert. denied, ---
U.S. ----, 115 S.Ct. 2251, 132 L.Ed.2d 258 (1995). As this Court
recently summarized,
"The FDA's [PMA] application requires manufacturers to submit extensive animal and human data to establish their devices' safety and effectiveness. 21 C.F.R. § 814.20.... FDA regulations also require [PMA] applicants to submit "[c]opies of all proposed labeling for the device.' 21 C.F.R. § 814.20(b)(10). The FDA approves a [PMA] application only after extensive review by the agency and an advisory committee composed of outside experts." Id.
Although as a general rule a Class III device must obtain PMA
before it can be marketed to the public, 21 U.S.C. § 360e(c)(2),
there are two exceptions. First, Class III devices found by the
FDA to be "substantially equivalent" to devices on the market
4 before May 28, 1976, the MDA's effective date, are entitled to
bypass the PMA process. Id. § 360e(b)(1). Second, Class III
devices that obtain an investigational device exemption (IDE) from
the FDA, id. § 360j(g), may be clinically tested on humans without
first obtaining PMA. Id. § 360e(a). At any time, however, the FDA
may issue a regulation requiring an exempted device to undergo the
formal PMA process, see id. § 351(f)(2), but to date has not done
so for inflatable penile prostheses.
It is undisputed that Mentor never obtained PMA for the GFS.
The prosthesis was instead found by the FDA to be substantially
equivalent to devices marketed before the MDA's effective date. A
finding of substantial equivalence is based on a section 510(k)
statement submitted as part of a pre-market notification
application, a process significantly more abbreviated and less
involved than PMA.3 Reeves, 44 F.3d at 303. Applicants for
pre-market notification must submit device descriptions and other
information sufficient for the FDA to determine whether the device
in question is substantially equivalent to pre-MDA marketed
devices. As with the application for PMA, applicants must also
submit their proposed labeling, 21 C.F.R. § 807.87, for the FDA to
determine compliance with general labeling regulations. See 21
C.F.R. § 801 et seq.; Reeves, 44 F.3d at 305. In this case,
3 Mentor was also granted an IDE, pursuant to which it conducted clinical trials of the prosthesis. Approval for the implant of Feldt's GFS, however, was not connected to this clinical program, but was instead based only on Mentor's pre-market notification and the subsequent FDA determination of substantial equivalence.
5 Mentor filed a 510k notification for the GFS on June 9, 1987, and
included a variety of information relating to the design of the
product as well as a summary of a nine-month clinical evaluation
performed pursuant to a previously approved IDE. See English v.
Mentor Corp., 1994 WL 263353 at 4-5 (E.D.Pa. June 13, 1994)
(unpublished) (describing the content of Mentor's 510k statement).
The FDA approved the pre-market notification application on August
26, 1987, thereby allowing the GFS to enter the market subject only
to general controls, at least until the FDA requires by regulation
that the prosthesis undergo PMA.
Whether the pre-market notification procedures and general
controls, like the PMA process, constitute "any requirement[s]
applicable ... to the device" so as to displace any additional or
different state requirements (relating to the product's safety or
effectiveness), 21 U.S.C. § 360k(a), is the central question in
this case. The test for section 360k preemption in this Circuit
tracks the statutory language:
"A state tort cause of action will be preempted if, in the context of the particular case, it (1) constitutes a requirement different from, or in addition to, any requirement the MDA makes applicable to the device at issue and (2) relates either to (a) the safety or effectiveness of the device or (b) any other matter included in a requirement made applicable to the device by the MDA." Stamps, 984 F.2d at 1421.
There is no question that the state law duties in question are
requirements relating to safety and effectiveness. The only issue,
then, is whether there is "any requirement the MDA makes applicable
to the device at issue."
Below and on appeal, Feldt has argued that, although state law
6 imposes duties on manufacturers of medical devices, these duties
are not "in addition to" any federal requirements because no such
requirements exist until the FDA requires PMA for penile
prostheses. Rejecting this contention, the district court
determined that the FDA's regulations relating to pre-market
notification were requirements to which all Mentor's state law
duties were "in addition" and therefore preempted. On appeal,
Feldt argues mainly that the regulations now applicable to the GFS
are for identification and classification only and therefore should
not, in light of the MDA's purpose of consumer protection, be
construed as federal requirements within the meaning of section
360k. Instead, Feldt contends, consumers should be allowed to
pursue state law claims until the FDA promulgates requirements
specifically applicable to the GFS.
This Court has considered the preemptive scope of the MDA in
a trio of opinions, beginning with Moore v. Kimberly-Clark Corp.,
867 F.2d 243, 246-47 (5th Cir.1989). In Moore, we held that
section 360k(a) preempted a claim that the manufacturer of a Class
II device, a tampon, had failed to adequately warn plaintiff of the
dangers of toxic shock syndrome. We reasoned that because FDA
regulations specifically prescribe the form and content of toxic
shock warnings on tampons, the recognition of a state law tort duty
would in effect impose labeling requirements on the manufacturer
beyond those required by the FDA. The plaintiff, however, also
brought a strict liability claim premised on the manufacturer's
allegedly defective construction and design of the tampon. Because
7 "[t]here are no federal regulations on tampon design, composition,
or construction," we held that plaintiff's defective design claims
were not preempted. Id. at 246.
In Stamps v. Collagen Corp., 984 F.2d 1416 (5th Cir.), cert.
denied, --- U.S. ----, 114 S.Ct. 86, 126 L.Ed.2d 54 (1993), we held
that section 360k(a) preempted a plaintiff's failure-to-warn claim
against a manufacturer of a Class III device (anti-wrinkle cream)
even though the FDA had not promulgated device-specific regulations
prescribing the form and content of the product's labels and
warnings. Id. at 1423-24. According to the Court, the "Class III
regulatory structure, no less than that of Class II," imposed
general requirements on the proposed labeling and warnings of the
device that were "different from, or in addition to" those under
Texas tort law. Id. at 1422. We also determined that the
plaintiff's defective design and manufacturing claims were
preempted because of the PMA process and the generally applicable
GMPs. Id. at 1422 & n. 5. Together, these regulations left us
"with little doubt as to whether the MDA tolerates different or
additional state requirements, respecting design or
manufacture...." Id. at 1422 n. 5.
Finally, in Reeves, we held that section 360k(a) preempted the
plaintiff's failure-to-warn claim against a manufacturer of a Class
III device (metal bone implant) marketed without PMA. 44 F.3d at
305. Because the plaintiff's failure-to-warn claim would impose
"labeling requirements beyond those required by the FDA," we
concluded, the claim "runs afoul of § 360k(a) of the MDAs." Id.
8 We rejected the plaintiff's basis for distinguishing Stamps: that
the device at issue had not undergone the rigors of PMA but was
instead marketed on the basis of substantial equivalence, an FDA
finding that does not brand the product with official approval. We
focused instead on the fact that pre-market notification, like PMA,
imposes some requirements on labeling and warning, and held that it
is the existence of any federal requirement that triggers the
preemption analysis.4 Id. Although the plaintiff in Reeves also
brought claims relating to design and manufacturing defects, the
defendant did not contend that these were preempted; the Court
therefore did not address this issue.
Reeves forecloses Feldt's principal basis for distinguishing
Stamps: that the pre-market notification process, unlike PMA, does
not invoke the preemption provision of section 360k. Preemption
does not depend on the route the product takes to the market, but
on whether there are any specific federal requirements applicable
to the device. See Reeves, 44 F.3d at 305 (holding that, "despite
the differences between" PMA and pre-market notification, "our
preemption analysis remains the same"). Furthermore, since Moore,
it has become clear that these regulations need not be
device-specific; they need only apply generally to the device at
issue. In Stamps, this Court ruled that the test is whether there
4 In so holding, we agreed with an earlier decision of the First Circuit, Mendes v. Medtronic, Inc., 18 F.3d 13 (1st Cir.1994). Under facts virtually identical to these here, the court in Mendes concluded that section 360k(a) preempted the plaintiff's claims of implied warranty and failure to warn. The Court did not consider preemption of plaintiff's defective design claims because the plaintiff had abandoned them. Id. at 17-18.
9 is "any requirement the MDA makes applicable to the device at
issue." 984 F.2d at 1421.5 Both Reeves and Stamps, moreover,
identified as federal requirements certain general controls
applicable to the Class III device, including the GMPs. See
Reeves, 44 F.3d at 305; Stamps, 984 F.2d at 1422 n. 5 (describing
the GMPs of section 360j(f) as "further requirements").
In his reply brief, filed after this Court's decision in
Reeves, Feldt appears to concede, as he must, that his
failure-to-warn claims are preempted by regulations, both general
and specific, on labels and warnings applicable to the GFS. See 21
C.F.R. § 801.1 et seq.; id. § 895.25; see also id. § 801.109
(relating only to prescription devices). In Reeves, this Court
relied on the same non-PMA provisions relating to labels and
warnings that apply to the prosthesis in this case. Reeves, 44
F.3d at 305. We therefore hold that Feldt's claims are preempted
5 Citing the following provision, Feldt suggests, and amicus Public Citizen Inc. argues, that the FDA's own gloss on section 360k(a) requires device-specific regulation:
"State or local requirements are preempted only when the [FDA] has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific [FDA] requirements." 21 C.F.R. § 808.1(d).
Although the requirements must be "specific" and applicable to a "particular" device, there is no language mandating that such requirements be specifically applicable to the device. In Stamps, this Court labelled the FDA's test "essentially the same" as the one set forth in that opinion. 984 F.2d at 1421 n. 2. Moreover, this Court in Reeves based preemption on labeling regulations generally applicable to all Class III devices. 44 F.3d at 305.
10 to the extent they are grounded on allegations of inadequate
warnings or labeling. See also Mendes, 18 F.3d at 18. The
district court did not err in finding preempted Feldt's
failure-to-warn claim.6
That there are some specific requirements applicable to the
GFS, however, does not necessarily mean that all Feldt's claims are
thereby preempted. As Moore and even Reeves make plain, there must
be some nexus between the state and federal requirements to trigger
section 360k preemption. See also Cipollone, --- U.S. at ---- - --
--, 112 S.Ct. at 2621-23. In Reeves, for instance, the plaintiff's
inadequate warning claims were preempted not because of the FDA's
GMPs, but only because of its specific regulations on labels and
warnings. Furthermore, in Moore, we determined that there was no
preemption of the plaintiff's defective construction and design
claims because there were "no federal regulations on [the device's]
design, composition, or construction." 867 F.2d at 246. The
district court thus erred in relying on the labeling regulations
and GMPs as adequate grounds to automatically preempt all Feldt's
claims. We therefore consider Feldt's remaining claims, those
based on implied warranty, defective design, and the DTPA.
With regard to his implied warranty claim, Feldt alleges that
Mentor impliedly represented that the GFS was merchantable and fit
6 Although Feldt does not discuss his claim of negligent marketing, the claim is essentially based on a failure to warn and is likewise preempted. See Lujan v. Tampo Mfg. Co., Inc., 825 S.W.2d 505, 510 (Tex.App.—El Paso 1992, no writ) (a claim of negligent marketing "involves a failure to warn, or warn adequately, of dangers or risks of harm or the failure to provide instructions for safe use of the particular product").
11 for its intended purpose. See Tex.Bus. & Com.Code §§ 2.314, 2.315.
In Texas, these warranties arise by operation of law for any sale
of goods in Texas.7 Dennis v. T.H. Allison, 698 S.W.2d 94, 94-95
(Tex.1985). Liability under these provisions depends on a finding
that the goods are defective, meaning that they are "unfit for the
ordinary purposes for which they are used because of a lack of
something necessary for adequacy." Plas-Tex, Inc. v. U.S. Steel
Corp., 772 S.W.2d 442, 444 (Tex.1989). The defect, moreover, may
be one of "design, material, or manufacture." Clark v. DeLaval
Separator Corp., 639 F.2d 1320, 1326 (5th Cir.1981). At oral
argument, Feldt maintained that he is not pursuing a warranty claim
based on defective manufacture, but only on defective design.8
With respect to the design of the GFS, Mentor has not cited,
nor can we find, any specific, applicable FDA regulations.
Pre-market notification, as mentioned earlier, does not necessarily
7 Although Feldt also alleged a breach of an express warranty based on advertising and product literature, he does not specifically discuss any express warranty claim, as such, in his brief. We therefore deem abandoned any contentions on appeal regarding the preemption of this particular claim, L & A Contracting v. Southern Concrete Services, 17 F.3d 106 (5th Cir.1994) (issues not adequately briefed deemed abandoned on appeal), and as a result do not decide whether express warranties are preempted by section 360k, given that they arise not by operation of law but by agreement. See American Airlines, Inc. v. Wolens, --- U.S. ----, ----, 115 S.Ct. 817, 824, 130 L.Ed.2d 715 (1995) (distinguishing state-imposed from contractually imposed obligations); Cipollone, --- U.S. at ----, 112 S.Ct. at 2622 (same). See also Michael, 46 F.3d at 1325-28 (holding that section 360k(a) does not preempt claims relating to the breach of express warranties). 8 The First Circuit has explicitly held that the GMPs preempt implied warranty claims based on defective manufacture. Mendes, 18 F.3d at 19.
12 entail an assessment, and certainly not an affirmation, of the
adequacy or quality of the product's design. Although the
generally applicable GMPs regulate the manufacture of the GFS, and
although PMA devices are deemed "safe and effective," Mentor has
identified no comparable regulations relating specifically to the
design quality of non-PMA Class III devices generally or of the GFS
in particular. Because the design of the device is not
specifically addressed by regulation, we hold that Feldt may
proceed with so much of his implied warranty claim as relates to
the allegedly defective design of the prosthesis.9
The same conclusion holds for Feldt's tort-based claims of
defective design.10 In Moore, this Court specifically held that,
because there were no regulations concerning the tampon's "design,
composition, or construction," the plaintiff could proceed with a
9 We acknowledge that our holding in this respect is perhaps in tension with a recent decision from the Third Circuit, Michael v. Shiley, Inc., 46 F.3d 1316 (3d Cir.1995). In Michael, the court relied in part on the GMPs to conclude that the plaintiff's design-related implied warranty claim was preempted. Id. at 1325. Michael is distinguishable, however, because the decision was clearly grounded on the fact that the device had undergone PMA; indeed, it is not certain that the Third Circuit would have found the GMPs to be an independently adequate basis for the preemption of claims relating to design. The same can be said of our decision in Stamps, where we mentioned in passing the GMPs in reference to claims relating to both design and manufacturing. See Stamps, 984 F.2d at 1422 n. 4. It is clear that Stamps, especially when viewed in light of Moore, premised the preemption of the plaintiff's defective-design claims on the fact that the device had undergone PMA. 10 In contrast, the term "defect" under Texas tort law "means a condition of the product that renders it unreasonably dangerous." Plas-Tex, 772 S.W.2d at 444. Whether a product is unreasonably dangerous or inadequately fit for its intended purpose may be, in either case, a question of the product's design.
13 defective design claim. Although Moore concerned a Class II device
that apparently did not have to comply with the procedures for
pre-market notification, there is no indication here of any general
Class III regulations specifically concerning the safety or
adequacy of the GFS's design. We recognize that at least two
district courts, on virtually identical facts, have held that the
plaintiffs' defective design claims were preempted, in part because
of the pre-market notification process. See Bokis v. American
Medical Systems, Inc., 875 F.Supp. 748, 755 (W.D.Ok.1995); English
v. Mentor Corp., 1994 WL 263353 (E.D.Pa. June 13, 1994)
(unpublished). Neither court, however, explained how pre-market
notification imposes requirements regarding the device's design.
Indeed, the most the manufacturer is required to do in its 510k
statement is describe the device in a way that establishes that the
device "has the same technological characteristics" or, if not,
that it is "as safe and effective" as a predicate device, 21 U.S.C.
§ 360c(i)(1)(A);11 there are, in short, no requirements or
11 At oral argument, Mentor contended that a finding of substantial equivalence necessarily means that an approved device is no less safe than the predicate device. Consequently, the question arises whether Feldt's design claims should be preempted at least to the extent they rely on allegations that the device is defective because of differences between it and the predicate device. Although 21 U.S.C. § 360c(i) is the law today and has been since 1990, it is unclear what necessarily went into a finding of substantial equivalence at the time the GFS was approved for marketing in 1987. At that time, what determined substantial equivalence was not controlled by statute, and Mentor has not cited, nor can we find, any regulations or case law to support its position that the GFS has necessarily been found to be as safe and effective as predicate devices. With regard to design, the FDA regulations applicable in 1987 appear to have required only "[a] statement indicating the device is similar to and/or different from other products of comparable type, ...
14 prohibitions specifically regarding the design of non-PMA Class III
devices. Indeed, in the letter approving Mentor's 510k statement,
the FDA stated that its finding of substantial equivalence did not
necessarily indicate approval of the GFS's design. At the very
least, then, the nexus between the state and federal requirements
is much weaker with respect to design defects than it is with
respect to manufacturing and labeling, and we find this nexus
inadequate to justify the displacement of state law regarding
defective design.12
Finally, Feldt has alleged violations of the DTPA. With
regard to this claim, Feldt's complaint focuses on representations
regarding the GFS's design quality. To the extent Feldt's DTPA
claims relate to general marketing or advertising of the device,
they are preempted by the FDA's explicit regulations on labels and
accompanied by data to support the statement." 21 C.F.R. § 807.87(f). Safety information was required only if the new device "has undergone a significant change or modification that could significantly affect the safety or effectiveness of the device." Id. § 807.87(g). There is nothing in the record that clearly indicates whether the GFS is technologically different from the predicate devices to which it was found to be substantially equivalent. In any event, it does not appear that Feldt has grounded his defective design claims on any differences in design between the GFS and its predicates. 12 According to one district court, a jury finding that the GFS is unreasonably dangerous "would be contrary to the determinations necessarily made by the FDA" under its procedures for pre-market notification. Bokis, 875 F.Supp. at 755. The FDA, however, may approve an unreasonably dangerous device so long as the device has the same technological characteristics or, if the device has different technological characteristics, is as safe and effective as the predicate device. 21 U.S.C. § 360c(i). To say that a new device is as safe as its predicate thus indicates nothing, absolutely, about how safe either product is; a new device may be as safe as a predicate device that itself is unreasonably dangerous.
15 warnings. To the extent the DTPA claims are based on the breach of
an implied warranty, however, the preemptive effect is the same as
for Feldt's implied warranty claim under the Texas Business and
Commerce Code, discussed above.
Conclusion
For the foregoing reasons, we reverse the district court's
judgment insofar as it holds that Feldt's state law claims of
design defect are preempted; we affirm the remainder of the
judgment and remand the cause for further proceedings consistent
with this opinion.
AFFIRMED in part, REVERSED in part, and REMANDED.