Stamps v. Collagen Corp. ( 1993 )


Menu:
  •               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
    

Document Info

DocketNumber: 92-2084

Filed Date: 2/19/1993

Precedential Status: Precedential

Modified Date: 3/3/2016

Authorities (21)

Rice v. Santa Fe Elevator Corp. , 331 U.S. 218 ( 1947 )

Florida Lime & Avocado Growers, Inc. v. Paul , 373 U.S. 132 ( 1963 )

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

Jones v. Rath Packing Co. , 430 U.S. 519 ( 1977 )

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

Chicago & North Western Transp. Co. v. Kalo Brick & Tile Co. , 450 U.S. 311 ( 1981 )

Fidelity Fed. Sav. & Loan Assn. v. De La Cuesta , 458 U.S. 141 ( 1982 )

Pacific Gas & Elec. Co. v. State Energy Resources ... , 461 U.S. 190 ( 1983 )

Silkwood v. Kerr-McGee Corp. , 464 U.S. 238 ( 1984 )

Eligaah Ardalle Jacobs v. Louie L. Wainwright, Secretary, ... , 469 U.S. 1062 ( 1984 )

Hillsborough County v. Automated Medical Laboratories, Inc. , 471 U.S. 707 ( 1985 )

Morales v. Trans World Airlines, Inc. , 504 U.S. 374 ( 1992 )

Cipollone v. Liggett Group, Inc. , 505 U.S. 504 ( 1992 )

Richard Leander Ferebee, Jr. v. Chevron Chemical Company , 736 F.2d 1529 ( 1984 )

Clois Osburn and Anita Osburn v. Anchor Laboratories, Inc., ... , 825 F.2d 908 ( 1987 )

tracy-isabel-abbot-a-minor-who-sues-by-her-mother-and-next-friend-deborah , 844 F.2d 1108 ( 1988 )

Joyce A. Moore v. Kimberly-Clark Corporation , 867 F.2d 243 ( 1989 )

Grover Lee v. E.I. Dupont De Nemours and Company , 894 F.2d 755 ( 1990 )

Albert Slater v. Optical Radiation Corporation , 961 F.2d 1330 ( 1992 )

Bowles v. Seminole Rock & Sand Co. , 325 U.S. 410 ( 1945 )

View All Authorities »