Feldt v. Mentor Corp. ( 1995 )


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  •                   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.
    
    
    
    
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