Feldt v. Mentor Corp.

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.

16