Stamps v. Collagen Corp.

IN THE UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

_______________

No. 92-2084

_______________

JENNIFER STAMPS,

Plaintiff-Appellant,

VERSUS

COLLAGEN CORPORATION,

Defendant-Appellee.

_________________________

Appeals from the United States District Court

for the Southern District of Texas

_________________________

(February 19, 1993)

Before GOLDBERG, SMITH, and EMILIO M. GARZA, Circuit Judges.

JERRY E. SMITH, Circuit Judge:

Contending that she contracted a rare autoimmune disease

from being injected with defendant Collagen Corporation's ("Colla-

gen") products, Jennifer Stamps filed suit to recover damages in

state court, alleging causes of action based upon defective design,

inadequate warnings, and negligent failure to warn. Collagen

timely removed and thereafter moved for summary judgment. The

district court found all of Stamps's state law claims to be

preempted by federal law and granted summary judgment. We affirm.

I.

A.

Zyderm and Zyplast are so-called Class III medical devices

regulated under the Medical Device Amendments of 1976 ("MDA"), 21

U.S.C. §§ 360c-360l, pursuant to which the Food and Drug Adminis-

tration ("FDA") classifies all medical devices in one of three

categories. See 21 U.S.C. § 360c. Class I devices generally pose

little or no threat to public health and safety; tongue depressors

are an example. Accordingly, Class I devices are subject only to

general controls on manufacturing processes.

Class II items are more complex than Class I and include such

devices as oxygen masks used in anesthesiology and tampons. These

may be subject to recommendations, guidelines, post-marketing

surveillance, the development of patient registries, and even the

promulgation of specific performance standards, should the FDA deem

them a sufficient health hazard as to require strict product

specifications or warnings. See 21 U.S.C. § 360c(a)(B).

Class III devices, such as Zyderm, require premarket approval

("PMA"), which process permits the FDA to determine whether a

proposed product provides "reasonable assurance of its safety and

effectiveness." 21 U.S.C. § 360c(a)(C). Such devices are subject

to the more stringent PMA process because they "present[] a

potential unreasonable risk of illness or injury." 21 U.S.C.

§ 360c(a)(1)(C)(ii)(II).

The PMA process requires a manufacturer to submit a detailed

application to the FDA, including information pertaining to product

2

specifications, intended use, manufacturing methods, and proposed

labeling. See 21 U.S.C. § 360e(c). The FDA refers each applica-

tion to a panel of qualified experts that prepares a report and

recommendation. Within six months, the FDA must either accept or

reject the application. 21 U.S.C. § 360e(d).

B.

In March and April 1988, Stamps was injected with Zyderm and

Zyplast, which contain processed bovine collagen that Collagen

markets as an anti-wrinkle treatment for middle-aged women. A

typical treatment consists of a series of injections directly under

the skin, the collagen then remaining to smooth out any wrinkles or

deformities on the skin's surface.

Shortly after receiving her injections, Stamps began complain-

ing of muscle and joint pains that subsequently were diagnosed as

dermatomyositis/polymyositis ("DM/PM"). DM/PM is a relatively rare

autoimmune disease in which an individual's immune system identi-

fies one's own skin and muscle tissue as foreign and attacks them.

Stamps claims that Collagen's products attached to her tissues and

provoked an immune response that destroyed her body tissue.

II.

In granting summary judgment, the district court likened the

instant case to Moore v. Kimberly-Clark Corp., 867 F.2d 243 (5th

Cir. 1989), in which we found a plaintiff's state-law-based

failure-to-warn and labeling claims regarding a Class II medical

3

device (tampons) to be preempted, although her defective construc-

tion and design claims survived. Reasoning that collagen implants

are regulated under Class III, which requires FDA pre-market

approval of not just labeling and packaging, but manufacturing

methods as well, see, e.g., 21 C.F.R. §§ 814.20, 814.80, the court

concluded that Stamps's claims are completely preempted.

Appellant Stamps disputes the district court's interpretation

of the MDA and its application of Moore, contending that the MDA

neither expressly nor impliedly preempts general state tort law and

that Moore must be limited to the Class II regulatory context it

describes. As a final matter, Stamps argues that even if we find

Moore compelling precedent in the Class III context as well, the

most it can be said to require is the preemption of her defective

labeling and negligent failure-to-warn claims; her products

liability, fraud, and negligence per se causes of action, as in

Moore, should be reinstated.

III.

The question is whether the MDA preempts Stamps's state law

claims. The Supremacy Clause of the Constitution invalidates state

laws that "interfere with, or are contrary to" federal law. U.S.

CONST. art. VI, cl. 2. When "the field which Congress is said to

have pre-empted has been traditionally occupied by the States . . .

`we start with the assumption that the historic police powers of

the States [are] not to be superseded by the Federal Act unless

that [is] the clear and manifest purpose of Congress.'" Jones v.

4

Rath Packing Co., 430 U.S. 519, 525 (1977) (quoting Rice v. Santa

Fe Elevator Corp., 331 U.S. 218, 230 (1947)) (citations omitted);

see also Hillsborough County v. Automated Medical Lab., 471 U.S.

707, 715 (1985) (recognizing a "presumption that state or local

regulation of matters related to health and safety is not invali-

dated under the Supremacy Clause"). Accordingly, "`[t]he purpose

of Congress is the ultimate touchstone'" of preemption analysis.

Malone v. White Motor Corp., 435 U.S. 497, 504 (1978) (quoting

Retail Clerks v. Schermerhorn, 375 U.S. 96, 103 (1963)).

Congress's intention to preempt may be either express or

implied from the statutory text. Absent an express declaration,

Congressional intent to preempt state law may be inferred only if

state law actually conflicts with federal law, see Pacific Gas &

Elec. Co. v. Energy Resources Conservation & Dev. Comm'n, 461 U.S.

190, 204 (1983), or where the scheme of federal legislation is so

comprehensive "`as to make reasonable the inference that Congress

left no room for the States to supplement it.'" Fidelity Fed. Sav.

& Loan Ass'n v. de la Cuesta, 458 U.S. 141, 153 (1982) (quoting

Rice, 331 U.S. at 230).

IV.

A.

The Supreme Court's most recent and authoritative treatment of

preemption doctrine is Cipollone v. Liggett Group, Inc., 112 S. Ct.

2608 (1992). In Cipollone, a plurality held that a lung cancer

victim's suit against cigarette manufacturers alleging breach of

5

warranty, failure to warn, fraudulent misrepresentation, and

conspiracy to deprive the public of medical information regarding

smoking was not preempted by the 1965 Federal Cigarette Labeling

and Advertising Act; certain of her failure to warn and fraudulent

misrepresentation claims were, however, preempted by the language

added by Congress to the Public Health Cigarette Smoking Act of

1969. Id. at 2625.

In Cipollone, the Court relied exclusively upon the express

language of the statutory provision regarding preemption.

Reasoning that "Congress' enactment of a provision defining the

pre-emptive reach of a statute implies that matters beyond that

reach are not pre-empted," the Court concluded,

When Congress has considered the issue of pre-emption and

has included in the enacted legislation a provision

explicitly addressing that issue, and when that provision

provides a "reliable indicium of congressional intent

with respect to state authority," "there is no need to

infer congressional intent to pre-empt state laws from

the substantive provisions" of the legislation . . . .

Therefore, we need only identify the domain expressly

pre-empted by [the statute].

112 S. Ct. at 2618 (citations omitted). See also id. at 2625

(Blackmun, J., concurring) (same).

The MDA was enacted in 1976 as an amendment to the Federal

Food, Drug and Cosmetic Act of 1938. Like the Public Health

Cigarette Smoking Act addressed in Cipollone, it contains a

provision expressly addressing its intended preemptive scope:

[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

6

chapter to the device, and

(2) which relates to the safety or effec-

tiveness 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) (Supp. 1992).

B.

Applying Cipollone, we reject, at the outset, Collagen's

contention that we may resort to the doctrine of implied preemption

to uphold the district court. The existence in the MDA of an

express preemption provision precludes any such reliance.

C.

We likewise must reject Stamps's argument that Congress did

not intend to preempt state tort law remedies when it enacted the

MDA. Section 360k(a) speaks broadly: Any state requirement

"different from, or in addition to," federal law is preempted.

Moreover, Stamps's contention that the MDA does not preempt

common law tort actions is necessarily foreclosed by Moore.

Implicit in our holding that certain of Moore's state law claims

were preempted by the applicable FDA Class II regulations is the

conclusion that Congress intended the preemption of state tort

liability where such liability effectively creates a requirement

"different from, or in addition to" specific federal requirements.

Congress, of course, has the power so to displace state tort law

remedies. See, e.g., Chicago & N.W. Transp. Co. v. Kalo Brick &

Tile Co., 450 U.S. 311, 331 (1981) (state common law may be

7

preempted by federal law).

This result is fortified not merely by Moore's compatibility

with the analysis pursued in Cipollone but also by the Court's

determination that the language of the statute at issue there,

preempting any state "requirement or prohibition," "sweeps broadly

and suggests no distinction between positive enactments and common

law . . . ." Cipollone, 112 S. Ct. at 2620. It would be anomalous

to interpret the MDA differently from the Public Health Cigarette

Smoking Act solely on the basis that while they both employ

"requirement," the MDA omits "prohibition."1 Thus, Moore correctly

decided this issue; section 360k(a) also "sweeps broadly" and

encompasses common law tort actions within its preemptive scope.

See also Morales v. Trans World Airlines, Inc., 112 S. Ct. 2031,

2037 (1992) (finding state common law actions "relating to" airline

advertising preempted by Airline Deregulation Act of 1978).

D.

Returning to Cipollone's admonition that our inquiry be guided

solely by the express language of the statute's preemption

provision, we glean from section 360k(a) the following analysis:

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

1

Indeed, the FDA regulation that parallels § 360k(a), 21 C.F.R.

§ 808.1(b), extends the "any requirement" language of that section to any

medical device standard "having the force and effect of law (whether estab-

lished by statute, ordinance, regulation, or court decision) . . . ." (Empha-

sis added.)

8

effectiveness of the device or (b) any other matter included in a

requirement made applicable to the device by the MDA.2 See also

King v. Collagen Corp., 1993 U.S. App. LEXIS 432, at *12-*13 (1st

Cir. Jan. 15, 1993) (applying similar test to identical product).

By this test, we find that our decision in Moore logically

extends to the FDA Class III regulatory context and that Stamps's

claims may be preempted under the MDA. Simply put, Texas tort

liability, following Cipollone, would constitute a requirement

either different from, or in addition to, a requirement )) the

Class III PMA process )) that the MDA has made applicable to Zyderm

and Zyplast. The second part of the analysis, involving as it does

the "relates to" language of section 360k(a)(2) recently given a

sweeping interpretation by the Supreme Court in Morales, 112 S. Ct.

at 2037-38, is even simpler than the first. In the context of this

case, Stamps's state law claims undoubtedly "relate to" either the

safety or effectiveness of Zyderm and Zyplast, or to some other

matter included in the PMA requirements applicable to the

2

The FDA's gloss on § 360k(a) poses essentially the same test:

(d) 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. There are other

State or local requirements that affect devices that are not

preempted by section [360k(a)] of the act because they are not

"requirements applicable to a device" within the meaning of

section [360k(a)] of the act.

21 C.F.R. § 808.1(d). As with administrative agencies generally, the FDA's

construction of the statute is entitled to "controlling weight unless it is

plainly erroneous or inconsistent with the regulation." Bowles v. Seminole

Rock & Sand Co., 325 U.S. 410, 414 (1945). Neither party contests the

validity of the FDA's regulations pursuant to the MDA.

9

products.3

V.

Because the MDA, like the statute at issue in Cipollone, fails

to "indicate that any familiar subdivision of common law claims is

or is not pre-empted," Cipollone, 112 S. Ct. at 2621, we must

pursue the "straightforward" inquiry commended to us by the Supreme

Court: "[W]e ask whether the legal duty that is the predicate of

the common law damages action constitutes" a requirement relating

to the safety or effectiveness of Zyderm and Zyplast or to any

other matter included in a requirement made applicable to it by the

MDA. Id.

A.

We need not conduct a categorical inquiry into each cause of

action pursued by the plaintiff, as did the Court in Cipollone, as

Moore tells us that Stamps's inadequate labeling (paragraph IV of

the original petition) and failure to warn (paragraph V) allega-

tions are preempted by the MDA. The Class III regulatory struc-

ture, no less than that of Class II, involves the FDA in consider-

able oversight regarding proposed package labeling of a device.4

3

Applying the language of § 808.1(d), see supra note 2, yields the

same result: The PMA process constitutes a "specific requirement[] 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."

4

See 21 U.S.C. § 360e(c)(1)(F) (requiring PMA application to contain

samples of device's proposed labeling); 21 C.F.R. § 814.20(b)(10), (e) (same);

(continued...)

10

Nor can Stamps's third cause of action (paragraph VI), based upon

the defective design and manufacture of Collagen's products,

survive preemption, as the Class III PMA process includes FDA

scrutiny and approval of these particular aspects of a device.5

B.

Stamps's claim that even if preemption applies to the Class

4

(...continued)

see also 21 U.S.C. § 360e(d)(2)(A)-(B),(D) (requiring denial of PMA applica-

tion for insufficient showing that the device is safe and effective "under the

conditions of use prescribed, recommended, or suggested in the proposed

labeling thereof," or if the proposed labeling is false or misleading in any

particular).

5

See 21 U.S.C. § 360e(c)(1)(B)-(C) (requiring, in PMA application,

statements and descriptions of the ingredients, components, methods, controls,

and facilities used in the manufacture and processing of the device); id.

§ 360e(d)(2)(C) (requiring denial of application where "the methods used in,

or the facilities or controls used for, the manufacture, processing, packing,

or installation of such device do not conform to the requirements of section

360j(f) of this title . . ."). See also 21 C.F.R. § 814.80 ("A device may not

be manufactured, packaged, stored, labeled, distributed, or advertised in a

manner that is inconsistent with any conditions to approval specified in the

PMA approval order for the device.").

Moreover, § 360j(f)'s "[g]ood manufacturing practice requirements"

impose further requirements upon the manufacture of Class III devices, leaving

us with little doubt as to whether the MDA tolerates different or additional

state requirements, respecting design or manufacture, in the form of common

law products liability duties.

Lastly, we note that we have not analyzed Stamps's fraud-based cause of

action in accordance with Cipollone because we are convinced that her original

petition contains no adequate averment of fraud. Although the petition does

state in paragraph V that "Defendant engaged in an active campaign to suppress

the facts, blame the adverse reactions on some other cause, and prevent

discovery of the risks associated with its products," this sentence comes

sandwiched between allegations of negligence in a paragraph that concludes

only that "Defendant's conduct was negligent and was the proximate cause of

Plaintiff's damages." Such an allegation of fraud would not suffice under

Fed. R. Civ. P. 9(b); and while Stamps is technically correct that the burden

lies with the defendant to request a more definite statement under Fed. R.

Civ. P. 12(e) when a pleading or allegation is too vague or ambiguous to admit

of a response, we do not believe such was the case here. Paragraph V is not

vague or ambiguous; it reads quite plainly as an allegation of negligence.

Albeit liberal with respect to the formalities, notice pleading is yet to be

distinguished from reading tea leaves. To require Collagen to move for a more

definite statement in order to determine whether, when Stamps pled negligence,

she in fact meant fraud, would go far towards erasing that distinction.

11

III context, the MDA preempts state law only to the extent that the

state mandates a similar PMA process, presents a close question.

In Larsen v. Pacesetter Sys., 837 P.2d 1273, 1282 (Haw. 1992), for

example, the court has found that an implant patient's claims

arising from the recall of a "substantially equivalent" Class III

pacemaker were not preempted by the MDA, noting that "the statutes

and regulations governing premarket approval set forth general

procedural requirements and, therefore, do not trigger a preemption

analysis under [21 C.F.R.] § 808.1(b)."6 On this subject, the FDA

has stated,

Like all other medical device requirements, differ-

ent or additional State and local [PMA] requirements are

preempted when FDA establishes specific counterpart

regulations or there are other specific requirements

applicable to the device under the act.

43 Fed. Reg. 13,664 (1978) (emphasis added).

This passage might be construed exclusively )) to the effect

that only different or additional state PMA processes are preempted

6

Larsen is distinguishable from the instant case in that it involved a

device that passed through a less stringent Class III review process by virtue

of its being "substantially equivalent" to devices already allowed to be

marketed. As the court stated, "Although a determination of substantial

equivalence involves a review by FDA of what is known of the safety and

effectiveness of the devices, and may even include some additional clinical

testing, it is not equivalent to an approval by the FDA of the device's safety

and effectiveness." Larsen, 837 P.2d at 1282 (citing H.R. Rep. No. 8081,

101st Cong., 2d Sess. 14, reprinted in 1990 U.S.C.C.A.N. 6305, 6307; 21 C.F.R.

§ 807.97 (FDA's acceptance of claim of substantial equivalence does not denote

official approval of the device)).

The instant devices are not "substantially equivalent" to marketable

devices; rather, they have been subjected to the full rigor of the PMA

process. While we do not rely upon this ground, one could argue that 21

C.F.R. § 807.97's explicit statement that the FDA does not officially approve

"substantially equivalent" devices creates at least the presumption )) by way

of the doctrine expressio unius est exclusio alterius )) that the FDA does

officially approve those products it scrutinizes through the regular Class III

PMA process. Such official approval, of course, strongly would imply that

federal preemption is present.

12

when the FDA has classified a device under Class III. We believe,

instead, that the emphasized language above )) added to the fact

that the passage was written in response to public comments seeking

clarification from the FDA as to "whether or when State and local

[PMA] requirements are preempted," id. )) demonstrates that the

better reading is that PMA processes are preempted in addition to

any other state requirements relating to safety or effectiveness or

any other MDA requirement established for the device.7

We believe the literal language of the statute compels this

result: State requirements pertaining to the safety or effective-

ness of a device, or to any other matter included in a requirement

made applicable to the device by the MDA, are preempted whenever

they are different from, or in addition to, any requirement imposed

upon the device under the MDA. Zyderm and Zyplast, it is undis-

puted, are required by the MDA to undergo the FDA's stringent PMA

7

See Slater v. Optical Radiation Corp., 961 F.2d 1330, 1333 (7th

Cir.), cert. denied, 113 S. Ct. 327 (1992) (finding that MDA Class III devices

developed under the FDA "Investigational Device Exemption" ("IDE") regulations

are preempted from state tort law liability; although IDE regulations "do not

specify the safe and effective design [,] they specify the procedures for

determining whether the experimental design is safe and effective" and thus

"are requirements relating to safety and effectiveness and they can therefore

have preemptive effect"). To our knowledge, Slater and King are the only

decisions by federal courts of appeals to have reached the preemptive scope of

the MDA's Class III regulations, and both have reached conclusions consistent

with our analysis herein. Inasmuch as we have previously determined in Moore

that preemption applies in the MDA Class II sphere, extension of that holding

to Class III regulations comports with logic and our understanding of the MDA

regulatory scheme. Moreover, although we do not need to consult legislative

history to decide this issue, we note that Senator Kennedy stated, when he

introduced the MDA, that "[t]he most hazardous devices . . . would require

full premarket testing and clearance before they are allowed on the market.

Premarket clearance represents the highest degree of regulatory control . . .

." 121 CONG. REC. 10,688 (1975) (emphasis added); see also King, 1993 U.S.

App. LEXIS 432, at *22-*28 (Aldrich and Campbell, JJ., concurring) (finding

intent of Congress in enacting MDA was to provide maximum of protection

available to medical device users).

13

process. State tort causes of action )) to the extent they relate

to safety, effectiveness, or other MDA requirements )) constitute

requirements "different from, or in addition to" the Class III

process; they are, therefore, preempted.8

C.

Stamps also argues that Collagen's ability to strengthen the

contraindications in its packaging and labeling proves that it

could comply with both state tort law and the federal statute. In

essence, Stamps argues that the MDA forms only the floor of

regulation; the states are free to construct a regulatory ceiling.

We agree with Stamps that, under the Class III regulatory

framework, Collagen could have strengthened its warning labels

without first obtaining prior FDA approval. The "Conditions of

Approval" issued with respect to Zyderm, for example, provide,

Changes in labeling, manufacturing, sterilization,

packaging, or performance of design specification which

enhance safety of the device or safety in the use of the

device may be placed into effect by the sponsor prior to

the receipt of a written FDA approval of the supplemental

PMA . . . .

Specific examples of changes permitted are:

8

Nor does the seemingly more restrictive language of § 808.1(d) compel

a different result. That section provides that state and local requirements

are preempted "only when the [FDA] has established specific counterpart

regulations or there are other specific requirements applicable to a particu-

lar device under the act . . . " (emphasis added).

Stamps apparently reads out the latter half of this clause and points to

the fact that the FDA premarket approval process is not a "specific counter-

part regulation" to state tort law. We disagree with this interpretation and

need look no further than the second half of the quoted clause. It is plain

that § 808.1(d) poses the same test as the statute: When there exists a

specific requirement applicable to a particular device under the act )) such

as the MDA's PMA requirement for Zyderm and Zyplast )) additional or different

state laws are preempted.

14

(1) addition of warnings, contraindications,

or side effects . . . .

See also 21 C.F.R. § 814.39(d)(2)(i) (permitting without prior FDA

approval "[l]abeling changes that add or strengthen a contraindica-

tion, warning, precaution or information about an adverse reac-

tion.").

We cannot agree, however, with the conclusion Stamps draws

from this )) that the lack of direct conflict between the state and

federal regulations compels a finding of no preemption. While we

are aware that the court in Ferebee v. Chevron Chem. Co., 736 F.2d

1529, 1540-43 (D.C. Cir.), cert. denied, 469 U.S. 1062 (1984),

interpreting the Federal Insecticide, Fungicide, and Rodenticide

Act's ("FIFRA") similar express preemption provision, found no

preemption where there was no direct conflict between the state and

federal regulation, we do not believe the analysis therein applied

can be said to have survived Cipollone, and was directly refuted in

Morales. See Morales, 112 S. Ct. at 2038 (rejecting contention

that express preemption is inappropriate where state and federal

law are consistent).

In Ferebee, the court rejected Chevron's contention that

FIFRA's express preemption provision, 7 U.S.C. § 136v(b), which

said that states "shall not impose or continue in effect any

requirements for labeling . . . in addition to or different from

those required under this subchapter," required a holding of

preemption of state tort liability. Instead, the court noted that

Congress, although explicitly preempting state labeling "require-

ments," had not stated its intention to preempt state damages

15

actions. 736 F.2d at 1542. Yet in the statute at issue in

Cipollone, Congress had not expressly declared its intent to

preempt state damages actions, and the Court nevertheless found

them preempted, at least in part. Thus, no such "plain statement"

of congressional intent as Ferebee contemplated is required.

Moreover, we reiterate our belief that no sound distinction can be

drawn between the "no requirement or prohibition" language found

dispositive in Cipollone and the express preemption of "any

requirement" contained in the FIFRA and the MDA.9

D.

Finally, we acknowledge that our reading of the MDA effec-

tively denies Stamps access to state law damages actions as a

9

Lastly, to the extent Ferebee can be read to import a direct conflict

requirement into express preemption analysis, it runs afoul of Cipollone,

where the Court stated, 112 S. Ct. at 2618, that the language of the express

preemption provision alone must guide the preemption inquiry. Direct con-

flict, moreover, is more appropriately considered as an aspect of implied

preemption analysis, particularly of that version that applies where "compli-

ance with both federal and state regulations is a physical impossibility."

See Florida Lime & Avocado Growers v. Paul, 373 U.S. 132, 142-43 (1963);

Osburn v. Anchor Lab., 825 F.2d 908, 912-13 (5th Cir. 1987), cert. denied, 485

U.S. 1009 (1989) (finding no implied preemption in FDA label PMA process for

new animal drugs where FDA regulations permitted manufacturer to strengthen

label warnings without prior approval).

As Cipollone has clarified, resort to implied preemption analysis is

inappropriate where the statute specifies the scope of its intended preemptive

effect. Lastly, the MDA is different from FIFRA, although it incorporates a

similar express preemption provision. And as regards the preemptive scope of

the MDA, the FDA has stated,

Congress has expressly declared that the Federal Food, Drug &

Cosmetic Act preempts any State or local requirement with respect

to the safety or effectiveness of a medical device that is differ-

ent from or in addition to a requirement under the act applicable

to the device. The test of implied Federal preemption, therefore,

does not apply . . . . Under Section [360k(a)] of the act,

preemption is not restricted to State requirements that directly

conflict with Federal law . . . .

45 Fed. Reg. 67326, 67328 (1980).

16

remedy for her injuries. Stamps cites Silkwood v. Kerr-McGee

Corp., 464 U.S. 238, 251 (1984), for the proposition that there is

a strong presumption against preemption of state law remedies where

no federal remedy exists. Like Stamps's direct conflict argument,

however, this too is more appropriately addressed in the context of

implied preemption.10 That is to say, where Congress has expressly

preempted state common law damages actions, as in Cipollone and the

MDA, its failure to provide a federal remedy will not defeat its

intent to preempt state law.11

VI.

In conclusion, the district court did not err in finding

Stamps's state law claims completely preempted by section 360k(a).

The summary judgment is AFFIRMED.

10

See Silkwood, 464 U.S. at 256 (rejecting suggestion that "there could

never be an instance in which the federal law would pre-empt the recovery of

damages based on state law," but refusing to recognize any such preemption in

that case based upon implied "conflict" or "frustration" preemption); Abbott

by Abbott v. American Cyanamid Co., 844 F.2d 1108, 1112 (4th Cir.), cert.

denied, 488 U.S. 908 (1988) (applying unavailability of federal remedy

presumption in impled preemption context).

11

See Lee v. E.I. DuPont de Nemours & Co., 894 F.2d 755, 757 (5th Cir.

1990) (ERISA's express preemption provision preempts state tort law despite

unavailability of federal remedy); see also Slater, 961 F.2d at 1333 "(It

would be a mistake to conclude that preemption in these circumstances leaves

the consuming public remediless, at least if we have concern for economic

substance rather than legal formality and do not suppose that the only

`remedies'. . . are those that the law provides.").

17