Court Opinion

ID: 3025903
Source: CourtListenerOpinion
Date Created: 2015-10-13 22:34:37.70766+00
Date Added: 2024-06-11T11:40:32.345865
License: Public Domain

United States Court of Appeals
                          FOR THE EIGHTH CIRCUIT
                                 ___________

                                 No. 00-1188
                                 ___________

Carol Jean Brooks,                       *
                                         *
             Appellant,                  *
                                         * Appeal from the United States
St. Luke’s Hospital,                     * District Court for the
                                         * District of Minnesota
             Intervenor below,           *
                                         *
      v.                                 *
                                         *
Howmedica, Inc., a Delaware              * [PUBLISHED]
Corporation, Division of Pfizer Hospital *
Products Group, Inc.; Pfizer, Inc.;      *
Howmedica International, Ltd.,           *
                                         *
             Appellees.                  *
                                    ___________

                           Submitted: October 18, 2000

                                Filed: January 10, 2001
                                 ___________

Before MURPHY, HEANEY, and BYE, Circuit Judges.
                           ___________

BYE, Circuit Judge.

    This appeal requires us to assess the preemptive power of the Medical Device
Amendments of 1976 (MDA), Pub. L. No. 94-295, 90 Stat. 539 (codified in various
sections of 21 U.S.C. and 26 U.S.C.), in view of the Supreme Court’s recent decision
in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).

                                  BACKGROUND

       In the late 1960s, defendants Howmedica, Inc., Pfizer, Inc. and Howmedica
International, Ltd. (together, “Howmedica”) developed a product called “surgical
Simplex® P Radiopaque bone cement” (“Simplex”). Surgeons employ Simplex in a
variety of orthopedic procedures, including joint, hip, knee, shoulder and elbow
replacement surgeries, and the repair of bone fractures.

      Simplex consists of two components: a colorless liquid and a powder. Prior to
surgery, the liquid and powder ingredients are mixed together, forming an amorphous
mass. That mass quickly hardens into a cement-like substance that bonds tissues and
bones. The mixing process releases a potentially harmful chemical byproduct, methyl
methacrylate vapors. Nurses and surgical technicians who mix the Simplex
components often inhale those methyl methacrylate vapors.

        Howmedica submitted Simplex to the Food and Drug Administration (FDA) for
marketing approval on February 8, 1971. Howmedica provided the FDA with a wealth
of safety information concerning Simplex: details of animal studies; manufacturing and
quality control procedures; identification of possible side effects; results of clinical
trials; summaries of surgical cases and post-operative complications; long-term
carcinogenicity and toxicity studies; and the results of investigational use by 67
physicians in 1508 hip replacements involving 2800 preparations of the bone-cement.

       The FDA subjected Simplex to the New Drug Application (NDA) process. As
part of the NDA process, the FDA scrutinized Howmedica’s proposed labeling and
packaging for Simplex. The FDA reviewed, and in many instances rewrote, language
to be included on Simplex’s package (and its insert) explaining how to use the bone

                                          -2-
cement. FDA doctors met with Howmedica representatives on several occasions to
discuss the content of Simplex’s label and inserts. The FDA also informed Howmedica
that Simplex would not be approved until the FDA had seen the actual printed labels
and the final Simplex package insert. Each Simplex label, and every word included in
the package insert, was scrutinized by FDA doctors and representatives.

        The FDA formally approved Simplex for marketing on October 7, 1971. In
subsequent years, the FDA required modifications to Simplex’s labels and package
inserts. In 1973, in response to a rat-study, the FDA recommended revising the
warning section of the label; Howmedica revised the label accordingly. In 1976,
doctors released a study observing operating room personnel’s response to Simplex.
In response to that study, the FDA required Howmedica to send out a “Dear Doctor”
letter, cautioning physicians to use Simplex carefully, and referring doctors to the
package insert warnings.

      In 1965, Carol Brooks began work as a licensed practical nurse in Duluth,
Minnesota. Between 1978 and 1981, she worked at St. Mary’s Hospital in Duluth. At
St. Mary’s, Brooks regularly mixed bone cement for use in surgical procedures. In late
1983, Brooks left St. Mary’s and joined the staff at St. Luke’s Hospital in Duluth.

       Brooks worked almost exclusively in the orthopedic surgery department at St.
Luke’s. During her first year on the job, she mixed bone cement for an average of four
cases per week. Brooks’s bone cement mixing duties increased steadily thereafter. In
1992, she assisted surgeons in approximately 10 operations per week requiring the use
of bone cement. In virtually all such operations, Brooks mixed the bone cement
herself, or she was positioned nearby as another nurse mixed the cement.

       In 1989, Brooks began to cough frequently at work. Her persistent cough
worsened and, in 1991, she was diagnosed with asthma. Brooks’s doctor attempted
to find the cause of her asthma, but he could not pin down its precise etiology.

                                         -3-
Brooks’s doctor even phoned Howmedica to inquire about Simplex’s components.
Though the doctor was unable to conclude that Simplex was the cause of Brooks’s
asthma, he restricted her exposure to Simplex at work. In 1992, Brooks suffered an
acute asthma attack at work, and was thereafter restricted from exposure to Simplex.
Brooks left work in 1995, unable to do her job. She has been diagnosed with
occupational asthma. Her doctors now attribute its cause to her repeated exposure to
methyl methacrylate vapors, a Simplex byproduct.

       On March 19, 1997, after her illness prevented her from working, Brooks
commenced a products liability action against Howmedica. In particular, Brooks
contended that Howmedica had negligently failed to warn her of the danger of
contracting occupational asthma by inhaling methyl methacrylate vapors during the
process of mixing the liquid and powder components of Simplex. In addition, Brooks
claimed that Howmedica failed to comply with FDA labeling regulations. After more
than a year of discovery, Howmedica moved for summary judgment. Both sides filed
affidavits, many of which explained the medical and technical issues in the case. The
district court ultimately granted Howmedica’s motion, and entered judgment adverse
to Brooks. Brooks now appeals from that judgment.

                                   DISCUSSION

       We review de novo a district court’s grant of summary judgment by applying the
same standard as the district court. See Treanor v. MCI Telecomm. Corp., 200 F.3d
570, 573 (8th Cir. 2000). Summary judgment is appropriate when the evidence —
viewed in the light most favorable to the nonmoving party — demonstrates that there
are no disputed issues of material fact and the moving party is entitled to judgment as
a matter of law. See Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986).

                                          -4-
A.    Brooks’s Failure-to-Warn Claim

       Brooks alleged that Howmedica failed to warn her of the risk of contracting
asthma through repeated exposure to methyl methacrylate vapors. The district court
ruled that Howmedica was entitled to summary judgment because Brooks’s state-law
failure-to-warn claim was preempted by federal law. We reverse.

     The MDA contains an express preemption provision that governs federal
preemption of state law with respect to medical devices:

      [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 Supreme Court recently analyzed the meaning and scope of § 360k
preemption in Lohr. The plaintiff in Lohr suffered a complete heart block that required
emergency surgery after her Medtronic pacemaker failed. She filed suit against
Medtronic alleging products liability causes of action stemming from the failure of the
company’s Model 4011 pacemaker lead. After considering the nature and scope of §
360k preemption, the Supreme Court held that none of Lohr’s Florida law causes of
action were preempted.

      Lohr clarified several aspects of § 360k preemption, but the Court’s fractured
holding has troubled the lower federal courts. See, e.g., Kemp v. Medtronic, Inc., 231

                                          -5-
F.3d 216, 224 (6th Cir. Nov. 1, 2000) (“The various courts of appeals that have
confronted issues of preemption arising under the MDA have struggled mightily with
Lohr’s language in the effort to discern its holding.”). Justice Stevens favored very
narrow preemption; he wrote a plurality opinion for four Justices. See Lohr, 518 U.S.
at 474-503 (Stevens, J., joined by Kennedy, Souter and Ginsburg, JJ.). Justice
O’Connor favored far broader federal preemption, and wrote a partial concurrence and
partial dissent for four Justices. See id. at 509-14 (O’Connor, J., joined by the Chief
Justice, and Scalia and Thomas, JJ.). Justice Breyer agreed with portions of both
opinions, and with Justice Stevens’s overall result, but wrote a separate opinion. See
id. at 503-508 (Breyer, J.). From this, then, we must divine the Supreme Court’s
intentions.

        All nine Justices agreed that § 360k’s reference to state “requirements” included
common law tort actions. See Lohr, 518 U.S. at 486-91 (Stevens, J.), 504-505 (Breyer,
J.), 510 (O’Connor, J.). Justices Stevens and Breyer then parted company from Justice
O’Connor’s foursome. Justices Stevens and Breyer argued that courts’ interpretation
of § 360k should be “informed by” the FDA’s own regulations explaining § 360k. See
id. at 495-97 (Stevens, J.), 505-507 (Breyer, J.). Justice O’Connor bitterly dissented
from the Court’s decision to look to the FDA’s preemption regulations for guidance.
See id. at 509 (O’Connor, J.) (decrying the decision as “bewildering and seemingly
without guiding principle”). Notwithstanding Justice O’Connor’s opinion for four
Justices, however, a majority1 of the Court sought assistance from FDA regulations in
interpreting § 360k’s preemptive force.

         The FDA preemption regulation provides that “state requirements are
pre-empted ‘only’ when the FDA has established ‘specific counterpart regulations or
. . . other specific requirements applicable to a particular device.’” Id. at 498 (quoting

      1
      Cf. Vasquez v. Hillery, 474 U.S. 254, 261 n.4 (1986) (explaining that the
amalgamated view of five Justices forms the holding of the Court).

                                           -6-
21 C.F.R. § 808.1(d)). The FDA regulation also states that § 360k “is not intended to
pre-empt ‘State or local requirements of general applicability where the purpose of the
requirement relates either to other products in addition to devices . . . or to unfair trade
practices in which the requirements are not limited to devices.’” Id. at 499 (quoting 21
C.F.R. § 808.1(d)).

       Justice Stevens — joined by Justice Breyer in this portion of the plurality opinion
— proceeded to interpret § 360k in view of that FDA preemption regulation. Justice
Stevens’s analysis divided the overarching preemption question into three distinct steps.
Each step focused on a separate aspect of the preemption analysis: the state
requirement, the federal requirement, and a thoroughgoing comparison of the two
requirements. See Lohr, 518 U.S. at 500.

       Preemption analysis begins with an examination of the putative state
“requirement” described in § 360k(a). Only state laws specific to the medical device
in question, or general state laws that have “the effect of establishing a substantive
requirement for a specific device,” Lohr, 518 U.S. at 500, may be preempted. Whether
the state law is specific or general, the state law must relate to the safety or
effectiveness of the device. See 21 U.S.C. § 360k(a)(2).

        Second, a specific federal requirement must govern the medical device at issue.
“[F]ederal requirements must be ‘applicable to the device’ in question, and, according
to the regulations, pre-empt state law only if they are ‘specific counterpart regulations’
or ‘specific’ to a ‘particular device.’” Lohr, 518 U.S. at 500.

       Third, if both such state and federal requirements exist, they must be compared
using traditional principles of conflict2 preemption. This comparison is the heart of the

       2
      Although conflict preemption principles loom large in the Court’s analysis, field
preemption does not animate § 360k preemption analysis. Five Justices concluded that

                                            -7-
analytical framework. If state and federal laws render a medical device manufacturer’s
compliance with both impossible, then federal law preempts state law. See id. at 501
(Stevens, J.) (explaining that § 360k “protects” specific federal regulations from
interference by potentially contradictory state requirements), 507-508 (Breyer, J.). In
addition, if state law necessarily impedes the fulfillment of Congressional objectives,
federal law preempts state law. See id. at 501 (Stevens, J.) (explaining that most
general common law claims would not “impede the ability of federal regulators to
implement and enforce specific federal requirements”), 507-508 (Breyer, J.).

      The statute and regulations, therefore, require a careful comparison
      between the allegedly pre-empting federal requirement and the allegedly
      pre-empted state requirement to determine whether they fall within the
      intended pre-emptive scope of the statute and regulations.

Id. at 500 (Stevens, J.).

Congress did not create an exhaustive or pervasive scheme of federal regulation that
would supplant state tort law altogether. See Lohr, 518 U.S. at 491 (Stevens, J.)
(“There is, to the best of our knowledge, nothing in the hearings, the Committee
Reports, or the debates suggesting that any proponent of the [MDA] legislation
intended a sweeping pre-emption of traditional common-law remedies against
manufacturers and distributors of defective devices.”), 508 (Breyer, J.) (“I can find no
. . . indication that either Congress or the FDA intended the relevant FDA regulations
to occupy entirely any relevant field.”). Justice O’Connor’s opinion, in contrast, would
have held that the FDA’s extensive labeling requirements occupied the field, thereby
preempting failure-to-warn claims and other common law claims, but Justice O’Connor
failed to command the vote of five Justices on this point. See id. at 514 (O’Connor, J.).

                                          -8-
      With this tripartite scheme in mind, we turn our attention to the respective state
and federal laws, and their compatibility.

      1.     State Requirement

       Brooks claimed that Howmedica failed to warn her of the dangers of exposure
to methyl methacrylate vapors while mixing Simplex. Brooks argues that a common
law failure-to-warn claim is generic, and therefore cannot constitute a “specific” state
requirement subject to federal preemption.

      We agree with Brooks that Minnesota failure-to-warn claims are generic in the
sense that such claims apply to a wide range of products. Cf., e.g., Kallio v. Ford
Motor Co., 407 N.W.2d 92, 99-100 (Minn. 1987) (motor vehicle); Germann v. F.L.
Smithe Machine Co., 395 N.W.2d 922, 924-25 (Minn. 1986) (hydraulic press); Frey
v. Montgomery Ward & Co., Inc., 258 N.W.2d 782, 787-88 (Minn. 1977) (space
heater); Marcon v. Kmart Corp., 573 N.W.2d 728, 730-32 (Minn. Ct. App. 1998)
(plastic snow sled). But this conclusion doesn’t resolve the more difficult question
framed in Lohr: may an otherwise generic common law claim act as a device-specific
requirement by virtue of the claim’s application to a particular product?

      Five Justices in Lohr indicated that generic common law claims could be
preempted, though such claims aren’t device-specific in the abstract. Those Justices
(through the opinions of Breyer and O’Connor, JJ.) concluded that, in application, a
common law judgment adverse to a medical device manufacturer would force
compliance in much the same fashion as a state’s enactment of regulations or other
positive law specific to the medical device at issue. Justice Breyer stated that “insofar
as the MDA pre-empts a state requirement embodied in a state statute, rule, regulation,
or other administrative action, it would also pre-empt a similar requirement that takes
the form of a standard of care or behavior imposed by a state-law tort action.” Lohr,
518 U.S. at 504-505 (Breyer, J.). Justice O’Connor’s partial concurrence echoed

                                          -9-
Justice Breyer’s sentiment that common law tort actions frequently act as state
“requirements,” as described in § 360k. See id. at 510-11 (O’Connor, J.); see also id.
at 500 (Stevens, J.) (allowing for the remote possibility that general state requirements
could sometimes be preempted).

       A judgment favoring Brooks would provide precisely the sort of specific state-
law mandate, or requirement, envisioned by Justices Breyer and O’Connor. If a jury
found Howmedica liable for failing to warn Brooks and others of Simplex’s asthma-
inducing propensity, then the resulting judgment against Howmedica would effectively
require Simplex to bear more expansive labeling detailing the risk of contracting asthma
from exposure to chemical byproducts in the mixing process. Thus we find that
Brooks’s state law failure-to-warn claim would have the effect of a specific state law
requirement, the first step in the preemption triad.

      2.     Federal Requirement

      We turn now to the second stage of the analysis, the specific federal requirement.
We have previously held that the premarket approval (PMA) process to which new
medical devices are subjected “is a specific [federal] requirement for a device within
the meaning of 21 U.S.C. § 360k(a) and 21 C.F.R. § 808.1(d).” Martello v. Ciba
Vision Corp., 42 F.3d 1167, 1169 (8th Cir. 1994) (citations omitted). Although
Martello was decided before Lohr, we are confident that Martello’s holding survives
Lohr, at least in this respect. Lohr did not address the preemptive power of the PMA
process; instead, Lohr focused on a different (and far less stringent) approval process,
the substantial equivalence, or § 510(k) process. See Lohr, 518 U.S. at 480. Lohr’s
conclusion that less rigorous federal review doesn’t preempt state common law claims
fails to resolve whether more rigorous federal review would preempt a state common
law claim — the question we face.

                                          -10-
      The Supreme Court of Rhode Island, facing the same situation, answered the
question in terms that apply equally well in this case.

      We think rather than expressing entirely generic concerns of safety, the
      FDA has expressed explicit concerns toward [Simplex]. We conclude
      that the premarket approval process constitutes a specific federal interest
      as contemplated in Medtronic [v. Lohr] and that, therefore, the FDA
      approval served to impose strict FDA [warning and labeling] requirements
      upon the defendant.

Fry v. Allergan Medical Optics, 695 A.2d 511, 516 (R.I. 1997).

        Our conclusion is buttressed by the considered views of the Sixth and Seventh
Circuits, both of whom have recently explained that the PMA process may be
considered specific federal regulation. See Kemp, 231 F.3d at 225-28 (dictum);
Mitchell v. Collagen Corp., 126 F.3d 902, 911 (7th Cir. 1997) (“[T]he PMA process
. . . can constitute the sort of specific federal regulation of a product that can have
preemptive effect.”); but see Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1374-77 (11th
Cir. 1999) (concluding that the PMA process is “conceptually distinct” from specific
federal regulation of medical devices).

      Of course, Simplex was not actually reviewed under the PMA process. When
Howmedica developed Simplex in the late 1960s, and submitted Simplex to the FDA
in 1971, PMA review had not yet been fashioned by the FDA. But the FDA did test
and review Simplex under the older New Drug Application (NDA) process, the
precursor to the FDA’s post-1976 PMA process.

       As part of the NDA process, the FDA scrutinized Howmedica’s proposed
labeling and packaging for Simplex. The FDA reviewed and recrafted language that
appeared on Simplex’s package and package insert. FDA doctors also met with
Howmedica representatives to discuss the content of Simplex’s labels and warning

                                         -11-
inserts. Prior to Simplex’s release into the market, the FDA reviewed each label, and
every word, included in Simplex’s package label and package insert. This federal
review process constitutes “specific” regulation; the full might of the FDA’s regulatory
power was brought to bear upon a single product, Howmedica’s Simplex.

      Although the PMA process is arguably more rigorous than the older NDA
process, the purpose of both processes is identical: to ensure that medical devices are
reviewed for safety in advance of their release into the marketplace. As Howmedica
points out, PMA is the functional equivalent of the old NDA approval process.
Consequently, a medical device subject to NDA review ought to receive the same
protection afforded a PMA-reviewed device.

       Brooks disputes the fact that the PMA and NDA processes are functional
equivalents. But even if we assumed the truth of Brooks’s contention — something we
are disinclined to do — Simplex is deemed to have been PMA-approved by operation
of law. See 21 U.S.C. §§ 360e(b)(1)(A), 360j(l)(3)(A); 21 C.F.R. § 888.3027
(establishing, in combination, that drugs reclassified as devices in 1976 — such as
Simplex — are considered PMA-compliant). As a result, we are not persuaded by
Brooks’s argument.

       As we explained above, Martello holds that a PMA-compliant medical device
has been subjected to specific federal regulation. Because Simplex was subjected to
a PMA-equivalent approval process (NDA), and because Simplex is deemed “PMA-
compliant” by virtue of federal regulations, Martello applies. Simplex was subject to
specific federal regulation.

      3.     Comparing Federal and State Requirements

      Having established the existence of pertinent state and federal requirements, we
must now compare those requirements. Following the Supreme Court’s lead, we

                                         -12-
search for (1) outright incompatibility between the state and federal requirements, or
for (2) state laws that defeat the purpose of federal law or Congressional intent. Justice
Stevens’s comparison between the Lohr plaintiff’s common law claims and applicable
federal requirements focused on both these paths to preemption. See Lohr, 518 U.S.
at 501.

      Justice Stevens suggested that state regulations that complement federal
regulations, i.e., those that peacefully coexist without imposing conflicting duties upon
manufacturers, would not yield to § 360k’s preemptive reach. Justice Stevens
analogized complementary state requirements to “local fire prevention regulations” and
to “zoning codes,” neither of which requires manufacturers to avoid compliance with
federal health requirements enunciated in the MDA. See id. at 501-502.

        In addition, state requirements that duplicate federal requirements pose no threat
to federal law, and thus will not be preempted. Only state requirements that differ from
federal law, see 21 U.S.C. § 360k(a)(1), and those that are divergent from federal law,
see 21 C.F.R. § 808.1(d), require preemption. See Lohr, 518 U.S. at 496-97 (Stevens,
J., joined by Breyer, J.) (“The regulations promulgated by the FDA expressly support
the conclusion that § 360k ‘does not preempt State or local requirements that are equal
to, or substantially identical to, requirements imposed by or under the act.’”) (quoting
21 C.F.R. § 808.1(d)(2)); id. at 513 (O’Connor, J.) (“Section 360k does not preclude
States from imposing different or additional remedies, but only different or additional
requirements.”) (italics in original). Thus a state law that provides a remedy for
violation of FDA regulations, for example, doesn’t impose a burden on manufacturers
that is “different from” federal law. See Lohr, 518 U.S. at 495.

      Howmedica argues that the FDA’s labeling requirements for Simplex are
inconsistent with a hypothetical adverse judgment on Brooks’s state-law failure-to-
warn claim. Howmedica professes that it is powerless to alter Simplex’s packaging or
warning insert, and hence it couldn’t comply with both a state-law judgment and the

                                          -13-
federal labeling regulations. In effect, while the state-law judgment would require
Howmedica to add to its labeling and package insert, it asserts, federal regulations
would require Howmedica not to add to its labeling and package insert. Howmedica
submits that this Catch-22 epitomizes the need for, and importance of, § 360k
preemption.

       Howmedica’s argument suffers from a fatal defect: the argument misstates a
critical premise. FDA regulations do not in fact mandate that Simplex’s labeling and
package inserts remain frozen in their 1971-approved state. The regulations require
only that Howmedica provide no less information and warning than the 1971-approved
labeling. Howmedica is free to provide more information, and more detailed warnings,
to consumers. See 21 C.F.R. §§ 814.39(d)(2)(i) (authorizing medical device
manufacturers to change labels to “add or strengthen a contraindication, warning,
precaution, or information about an adverse reaction”), (d)(2)(ii) (permitting “[l]abeling
changes that add or strengthen an instruction that is intended to enhance the safe use
of the device”).

        Howmedica’s assertion that the 1971 labeling on Simplex is set in stone by virtue
of FDA regulations is wrong. See Lohr, 518 U.S. at 497 n.16; Connelly v. Iolab Corp.,
927 S.W.2d 848, 854 (Mo. 1996) (“Nothing in [the FDA] regulations prohibits Iolab
from adding a warning to the label regarding unreasonably high complication rates.”).
An adverse judgment on Brooks’s failure-to-warn claim would not, as Howmedica
posits, force Howmedica to choose between complying with FDA regulations and the
state law judgment. Nothing prohibits Howmedica from increasing the warnings and
information it provides to consumers and health practitioners on Simplex’s package and
package insert.

        Likewise, a judgment adverse to Howmedica on Brooks’s failure-to-warn claim
wouldn’t interfere with Congressional intent or FDA policy. The FDA’s raison d’etre
is to review new medical devices to ensure that the devices are moderately safe before

                                          -14-
they are released into the marketplace. We struggle to imagine how a common law
judgment requiring greater warnings would interfere with that purpose. Brooks’s
counsel captured the essence of this point when he remarked at oral argument that
“FDA regulations create floors, not ceilings.” A common law judgment against a
manufacturer such as Howmedica would raise the floor, not puncture the ceiling.

       Because Howmedica could have added language warning consumers of asthma
risks associated with exposure to Simplex without running afoul of federal
requirements, Howmedica doesn’t face a Catch-22. Howmedica could comply with
both an adverse state-law judgment and FDA regulations. Accordingly, preemption is
inappropriate in this instance. The district court erred in granting Howmedica’s motion
for summary judgment on Brooks’s failure-to-warn claim.

       At first blush, there appears to be tension between our holding and the language
of § 360k. We hold that § 360k does not preempt a failure-to-warn action that might,
if successful, require Howmedica to add to Simplex’s warnings. Section 360k forbids
state requirements that are “different from, or in addition to” federal law. 21 U.S.C.
§ 360k(a)(1) (emphasis added). The apparent tension is illusory, however, because (as
the Supreme Court explained in Lohr) § 360k doesn’t really mean what it says.

       Justice Breyer demonstrated the folly of reading § 360k’s “different from, or in
addition to” language literally: every state requirement would then be preempted
because, in some small or obscure way, every such state requirement could be deemed
different or additive. See Lohr, 518 U.S. at 505 (Breyer, J.) (“Congress must have
intended that courts look elsewhere for help [i.e., beyond the words in § 360k] as to
just which federal requirements pre-empt just which state requirements, as well as just
how they might do so.”). Justice Breyer sought refuge in “basic pre-emption
principles,” id. at 508, the twin notions of conflict and field preemption, see id. at 508-
509. Justice Stevens likewise acknowledged the importance of conflict preemption
analysis as a reprieve from § 360k’s ambiguity. See id. at 503 (Stevens. J.).

                                           -15-
       The best illustration of Justices Stevens and Breyer’s reliance upon conflict
preemption to the exclusion of § 360k’s very language comes from Justice O’Connor’s
separate opinion. Justice O’Connor dissented precisely on this point; she would have
interpreted § 360k literally, as preempting each and every state law “different from, or
in addition to” federal law.

      If § 360k’s language is given its ordinary meaning, it clearly pre-empts
      any state common-law action that would impose a requirement different
      from, or in addition to, that applicable under the FDCA — just as it would
      pre-empt a state statute or regulation that had that effect. . . .
             The plurality’s reasons for departing from this reading are neither
      clear nor persuasive. . . . The Court holds that an FDCA “requirement”
      triggers pre-emption only when a conflict exists between a specific state
      requirement and a specific FDCA requirement applicable to the particular
      device.

Lohr, 518 U.S. at 511.

       Under Justice O’Connor’s view, Brooks’s failure-to-warn claim would certainly
be preempted as an “additional” state requirement. But Justice O’Connor failed to
garner four additional votes for her position. Thus her opinion demonstrates, by
negative implication, that five other Justices interpreted § 360k’s ambiguous language
to require conflict preemption analysis. The conflict preemption analysis we undertook
with respect to Brooks’s case reveals no tension between her failure-to-warn claim and
FDA labeling requirements.

                                         -16-
B.    Failure to comply with FDA regulations claim

       Sometime after the pleadings were filed, Brooks began to assert that Howmedica
had violated, or had failed to comply with, FDA regulations. We are mindful of our
liberal pleading rules, see, e.g., Fed. R. Civ. P. 8(a)(2), (e)(1), as well as the Supreme
Court’s acknowledgment in Lohr that such claims often arise late in the life of a
products liability action, see Lohr, 518 U.S. at 494-95. As a result, we construe
Brooks’s complaint to raise a “negligence per se” claim based upon Howmedica’s
alleged violation of FDA regulations. Lohr makes clear that this type of state-law claim
against a medical device manufacturer would not be preempted. See id. at 495-96.
Howmedica concedes as much.

       Minnesota law recognizes a common law action for negligence per se stemming
from a defendant’s violation of FDA regulations. See Femrite v. Abbott Northwestern
Hosp., 568 N.W.2d 535, 539 & n.4 (Minn. Ct. App. 1997). Femrite requires a
plaintiff, such as Brooks, to prove both that she “belongs to the class of persons that
the regulation is intended to protect,” id. at 539, and that the defendant in fact violated
the applicable FDA regulations, see id. at 542. The latter question is one of law,
appropriate for disposition on summary judgment. See id. (“Considering these FDA
documents, and the record as a whole, we conclude as a matter of law that the
physicians’ implantation of the screw devices in appellants’ surgeries was a permissible
“off-label” use not in violation of FDA regulations.”); cf. Bammerlin v. Navistar Int’l
Transp. Corp., 30 F.3d 898, 900 (7th Cir. 1994) (“The meaning of federal regulations
is not a question of fact, to be resolved by the jury after a battle of experts. It is a
question of law, to be resolved by the court.”) (citations omitted).

      We have no doubt that Brooks belongs to the class of persons whom the FDA
intends to protect by promulgating labeling regulations. Brooks, like many nurses and
surgical technicians, was regularly exposed to Simplex and its concomitant chemical

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byproducts. FDA labeling regulations are designed to promote safe and effective use
of medical devices such as bone-cement. Howmedica cannot seriously contest
Brooks’s membership in the protected class.

       Despite proving membership in the protected class, however, Brooks’s claim
founders on the second element — violation of FDA regulations. As we explained
above, Howmedica fully complied with the FDA’s labeling requirements at the time
that Simplex was approved for use in 1971. In the intervening years, Howmedica
altered Simplex’s package and package insert to accommodate changes recommended
by the FDA. As Howmedica indicated in its briefs, every word on the Simplex package
and package insert has been formally approved by the FDA. It is folly to suggest,
therefore, that Howmedica violated FDA regulations in labeling Simplex. As the
district court pointed out, Brooks neglected to develop any support in the record (or in
her argument) that Howmedica violated FDA regulations.3 We have scoured the record
and the pertinent case law independently and located no additional support for
Brooks’s claim.

       Because Brooks has not demonstrated any violation of FDA labeling
requirements, her Minnesota-law negligence per se claim fails as a matter of law. We
therefore affirm the district court’s summary judgment in favor of Howmedica as to this
aspect of Brooks’s complaint.

      3
        Brooks points to two affidavits and reports from expert witnesses trained in
toxicology and safety engineering to support her claim that Howmedica violated FDA
regulations. These reports are insufficient to entitle Brooks to prevail. Assuming for
argument’s sake that Brooks’s experts would be qualified to opine that Howmedica
violated FDA regulations, cf. Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 147-
49 (1999) (holding that all forms of expert testimony must be subjected to Daubert’s
relevance-and-reliability inquiry), the fact remains that Brooks’s experts did not opine
to this effect. These experts’ affidavits and reports fail even to mention the pertinent
FDA regulations.

                                         -18-
                                   DISPOSITION

      We reverse the district court’s judgment that Brooks’s state-law failure-to-warn
claim is preempted by federal law. We affirm the court’s judgment in favor of
Howmedica as to Brooks’s claim that Howmedica neglected to comply with federal
regulations. We remand the matter for further proceedings consistent with our opinion.

MURPHY, Circuit Judge, dissenting.

      I agree with part of the court's opinion, but I respectfully dissent from the
discussion in section A.3. and the conclusion that Brooks' failure to warn claim is not
preempted by federal law.

        Simplex, the product on which Brooks' lawsuit is based, is regulated by a
comprehensive set of federal requirements. It is thus unlike the pacemaker in Lohr
which had no federal requirement specific to the product. See Lohr at 493-94. The
Lohr pacemaker passed through a substantial equivalency process instead of the NDA
process which Simplex underwent. See id. at 480. During the NDA process the FDA
reviewed, and in some instances drafted, every word of the product labeling for
Simplex. This labeling cannot be changed without FDA approval. In the case of
Simplex, unlike for the Lohr pacemaker, "the Federal Government [] weighed the
competing interests relevant to the particular requirement in question, reached an
unambiguous conclusion about how those competing considerations should be resolved
. . . , and implemented that conclusion via a specific mandate on manufacturers or
producers." Id. at 501.

        A state requirement of general applicability will be preempted under the MDA
if there is a federal requirement specific to the device and if the state requirement has
the effect of imposing a substantive requirement on the device different from, or in
addition to, the federal requirement. See id. at 500. The failure to warn claim brought

                                          -19-
by Brooks seeks to impose a substantive requirement on Simplex because if it were to
prevail, Howmedica would need to add warnings about the effects of inhaling methyl
methacrylate vapors during the mixing process in order to escape tort liability in
Minnesota. This would be in addition to federal requirements since the labels reviewed
and drafted by the FDA do not include these warnings. Thus, the substantive
requirement sought by the failure to warn claim would be in addition to the federal
requirement specific to Simplex, and the claim is preempted. This conclusion is
consistent with results in other federal circuit courts which have concluded that
common law failure to warn claims are preempted by the MDA when the device has
been approved after a PMA or NDA review. See Kemp v. Medtronic, Inc., 231 F.3d
216, 236-37 (6th Cir. 2000); Mitchell v. Collagen Corp., 126 F.3d 902, 907, 913 (7th
Cir. 1997), cert. denied, 523 U.S. 1020 (1998); cf. Papike v. Tambrands, Inc., 107 F.3d
737, 741-42 (9th Cir. 1997) (failure to warn claim preempted by FDA labeling
regulations regarding toxic shock syndrome), cert. denied, 522 U.S. 862 (1997). But
see Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1377 (11th Cir. 1999) (failure to warn
claim did not impose a substantive requirement).

       In spite of the clear language of the statute which provides for preemption of any
state requirement "different from, or in addition to, any requirement applicable under
this chapter to the device," 21 U.S.C. § 360k(a), the court says that Congress did not
"really mean" the language be taken literally because it was concerned about safety.
The legislative history shows, however, that the preemption provision was included
within the MDA because of congressional concern that "if a substantial number of
differing requirements applicable to a medical device are imposed by jurisdictions other
than the Federal government, interstate commerce would be unduly burdened." H.R.
Rep. No. 853, 45 (1976). In respect to Simplex, the FDA worked closely with
Howmedica and thoroughly reviewed and approved the warning labels. To permit state
requirements to be added to those imposed by the federal government would frustrate
congressional intent because it could result in conflicting labeling requirements in

                                          -20-
various states, confusion, and unwarranted expense to manufacturers and developers
of medical devices.

     Since the failure to warn claim in this case falls within the scope of the
preemption provision of the MDA, I would affirm the judgment of the district court.

      A true copy.

            Attest:

               CLERK, U.S. COURT OF APPEALS, EIGHTH CIRCUIT.

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