Carol Jean Brooks v. Howmedica, Inc.

United States Court of Appeals
FOR THE EIGHTH CIRCUIT
___________
No. 00-1188
___________
Carol Jean Brooks, *
*
Plaintiff - Appellant; *
*
St. Luke's Hospital, *
*
Intervenor Below, *
* Appeal from the United States
v. * District Court for the
* District of Minnesota.
Howmedica, Inc., a Delaware *
Corporation, Division of Pfizer *
Hospital Products Group, Inc.; *
Pfizer, Inc.; Howmedica *
International, Ltd., *
*
Defendants - Appellees. *
______________________ *
*
Product Liability Advisory *
Council, Inc., *
*
Amicus on Behalf *
of Appellees. *
___________
Submitted: July 10, 2001
Filed: December 11, 2001
___________
Before WOLLMAN, Chief Judge, HEANEY, McMILLIAN, BOWMAN, LOKEN,
HANSEN, MORRIS SHEPPARD ARNOLD, MURPHY, and BYE, Circuit
Judges.
___________
MURPHY, Circuit Judge.
Carol Jean Brooks brought this action against the manufacturer of Simplex
bone cement claiming damages for injury resulting from its failure to give adequate
warnings about product dangers. The case was dismissed on summary judgment after
the district court1 concluded that her claim was preempted by federal law, § 360k of
the 1976 Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act,
21 U.S.C. §§ 301 et. seq. A panel of this court reversed with one judge dissenting,
Brooks v. Howmedica, Inc., 236 F.3d 956 (8th Cir. 2001), a petition for rehearing en
banc was granted, and the panel opinion was vacated. After examining the record and
considering Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), we affirm the judgment of
the district court.
I.
Carol Jean Brooks is a licensed practical nurse whose work as a surgical
technician included mixing bone cement. Bone cement is used to bond with a bone
or prosthesis in replacements. Brooks began
mixing bone cement during 1978 while she worked at St. Mary's Hospital in Duluth,
Minnesota, but her principal exposure occurred after she moved to St. Luke's Hospital
in Duluth in 1982. At St. Luke's she
mixing bone
cement or being present during its preparation approximately four times a week. By
1
The Honorable Michael J. Davis, United States District Judge for the District
of Minnesota.
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1992 she was mixing bone cement or was close to the mixing process during
approximately ten surgeries a week. Although Brooks is unable to identify the brand
of bone cement used at St. Mary's, it is undisputed that St. Luke's used Simplex P
Radiopaque bone cement (Simplex), which was manufactured and marketed by
appellees (collectively Howmedica).2
Brooks began to cough at some time in 1989 or 1990. She went to see a doctor
about it in 1991 when she was told she had asthma. An occupational health physician
at St. Luke's Hospital also investigated possible causes for her cough, reviewed
Howmedica's Material Safety Data Sheet, and talked with a Howmedica chemist, but
that investigation did not link her cough to Simplex. St. Luke's restricted her
exposure to a number of chemicals after an acute asthma attack in 1992; the
restriction included methyl methacrylate which is an ingredient in Simplex. Brooks
was later diagnosed to have occupational asthma caused by exposure to methyl
methacrylate. Brooks has been unable to work since 1995.
Brooks brought a failure to warn claim against Howmedica, alleging that it had
not provided "adequate warnings and instructions" for Simplex use and that as a
result, she had contracted "severe asthma and associated respiratory complications."
Howmedica asserted federal preemption and also denied that the Simplex label
contained inadequate warnings and instructions or that it proximately caused Brooks'
injury. St. Luke's Hospital intervened, seeking compensation from Howmedica for
what it had paid Brooks in workers compensation benefits, costs, interest,
disbursements, and attorney fees, but it is not involved in this appeal.
2
At the time this action was commenced, defendants Howmedica Inc. and
Howmedica International, Ltd. were wholly owned subsidiaries of defendant Pfizer,
Inc. which corporate entity was responsible for
manufacturing or selling Simplex during the time Brooks was injured, but none of the
appellees has challenged its status as a defendant.
-3-
II.
Starting in the early 1970's Howmedica began to market bone cement in the
United States under the trade mark Simplex. Bone cement is sold in two separately
packaged components: methyl methacrylate monomer which is a colorless liquid and
a powder mixture containing polymethyl methacrylate, methyl methacrylate styrene
copolymer, and barium sulfate. The liquid and powder are mixed together in the
operating room to form a pliable mass that later hardens into a cement like
consistency. The mixing process releases vapors containing methyl methacrylate,
which is classified as a hazardous chemical by the Occupational Safety and Health
Administration.
It is undisputed that Simplex has been heavily regulated by the FDA since it
entered the market when it was treated as a drug subject to the Federal Food, Drug,
and Cosmetic Act of 1938 (1938 Act). The 1938 Act required Howmedica to submit
a New Drug Application (NDA) before it could sell Simplex,3 see 21 U.S.C. § 355,
and the NDA is a rigorous process. The NDA process required Howmedica to
disclose details of animal studies, manufacturing and quality control procedures, the
identification of possible side effects, results of clinical trials, summaries of surgical
cases and post operative complications, long term toxicity, and carcinogenicity
studies. The process also produced reports from the investigational use of Simplex
by sixty seven physicians in 1,408 hip replacements which involved 2,800
preparations of the product. All these submissions were then studied and reviewed
by a panel of FDA experts. Under the 1938 Act, Simplex could not be marketed
without approval by the Secretary of Health and Human Services. See 21 U.S.C. §
360(c) (premarket approval process).
3
Howmedica developed and submitted NDAs for two types of Simplex. The
only difference between the two is that one type was detectable on x-ray and the other
was not. The approval process was identical for both types, and neither side in this
case differentiates between the two.
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The NDA included review by the FDA of the proposed design and content for
all Simplex labels, including labels for a vial, a pouch, two internal boxes, an outer
box, and a package insert. Howmedica employees met with members of the FDA on
several occasions to discuss its application, including the product labels. The FDA
reviewed every word that appeared on Simplex labels, and the FDA drafted the
language that was used in the package insert. That package insert included the
following warning:
As the liquid monomer is highly volatile and flammable, the operative
room should be provided with adequate air circulation. Caution should
be exercised during the mixing of the two components to prevent
excessive exposure to the concentrated vapors of the monomer which
may produce irritation of the respiratory tract, eyes, and possibly the
liver.
The vial containing the liquid component and the box with the powder both referred
the user to the package insert for information regarding dosage and administration.
Simplex was approved by the FDA for use in total hip replacement surgeries
in 1971. The FDA wrote "[w]e have completed the review of this application and
have concluded that the drug is safe and effective for use as recommended in the
submitted labeling. Accordingly, the application is approved."
These review requirements were affected by the 1976 Medical Device
Amendments (MDA) to the 1938 Act. The MDA created three classes of medical
devices, categorized by the risk to the public and the degree of regulation required.
Class I devices present no unreasonable risk of illness or injury and are subject only
to "general controls." 21 U.S.C. § 360c(a)(1)(A). Class II devices present greater
risk than those in Class I, and they must comply with federal performance regulations
called "special controls" but may be marketed without advance approval. Id. at §
360c(a)(1)(B). Class III devices carry "a potential unreasonable risk of illness or
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injury," or are used for "supporting or sustaining human life," or are seen to be "of
substantial importance in preventing impairment of human health." Id. at §
360c(a)(1)(C). Class III devices are highly regulated and must receive premarket
approval (PMA) from the FDA before they may be sold. Id. at § 360e(a).4
Devices such as Simplex, which had been treated as drugs prior to the
amendments to the 1938 Act, were automatically reclassified by the MDA as Class
III medical devices.5 21 U.S.C. § 360j(l)(1). The statute provided that these
devices were deemed to have PMA approval if they had gone through the NDA
approval process. Id. at § 360j(l)(3)(A). Beginning in 1976 Simplex was accordingly
treated as a Class III medical device with PMA approval.
Under both the 1938 Act and the MDA, the FDA has continuing authority and
responsibility to control the content of any information or warnings Howmedica
provides Simplex users. Howmedica was required to provide the FDA with regular
reports of any new information learned about Simplex. See 21 U.S.C. § 355(k); 21
C.F.R. §§ 314.80, 314.81, 814.84 (2000). The company was not permitted to make
any changes to the product label affecting the safety or effectiveness of the device
without submitting a supplemental PMA, but it could temporarily "add or strengthen"
warnings during the time the FDA had any supplement under consideration. 21
C.F.R. § 814.39(a), (d) (2000).
Howmedica learned that some individuals exposed to Simplex had developed
contact dermatitis, and in 1973 it requested permission from the FDA to insert the
4
There are certain exemptions to the PMA requirement which do not apply to
Simplex but are discussed in Kemp v. Medtronic, 231 F.3d 216, 221-22 (6th Cir.
2000).
5
The FDA later reclassified bone cement from a Class III device to Class II, but
that was at a time after the period during which Brooks was exposed to Simplex.
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following language into its warnings: "The liquid component is a powerful lipid
solvent, and may also act as a sensitizer in certain individuals." After its
consideration of the request, the FDA decided to direct Howmedica to revise its
package insert to include this additional language:
The liquid component is a powerful lipid solvent. It has caused contact
dermatitis in susceptible individuals. Wearing of a second pair of
surgical gloves and strict adherence to the mixing instructions may
diminish the possibility of hypersensitivity reactions. The compound
should not be allowed to come into direct contact with sensitive tissues
or be absorbed by the body.
In 1975, the FDA required bone cement manufacturers to participate in a
review of the inhalation toxicity of methyl methacrylate vapors, and the Simplex
warnings were reexamined. After a number of discussions, the FDA required
Simplex to modify the package insert warnings concerning vapor inhalation as
follows:
As the liquid monomer is highly volatile and flammable, the operating
room should be provided with adequate ventilation so as to eliminate the
maximum amount of monomer vapor. Caution should be exercised
during the mixing of the two components to prevent excessive exposure
to the concentrated vapors of the monomer which may produce irritation
of the respiratory tract, eyes, and possibly the liver.
The FDA also directed Howmedica to send a "Dear Doctor" letter to Simplex
users to warn about inhalation hazards associated with methyl methacrylate.
Howmedica told the FDA it believed the letter was unnecessary because studies had
shown that the concentration of methyl methacrylate vapors in operating rooms was
within accepted limits, but the FDA insisted on compliance with its directive.
Howmedica and the FDA then worked together to draft the letter, which directed
attention to methyl methacrylate vapor inhalation studies and to the package insert
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warning. It also recommended that hospital facilities be inspected for adequate
ventilation. The final paragraph of the letter warned:
In some sensitive individuals, exposure to MMA can cause dermatitis
and other allergenic responses. If any of your operating room personnel
develop such responses when using Simplex®, both prudence and good
medical practice would suggest that they avoid all procedures involving
use of Simplex®.
Howmedica sought to expand the uses of Simplex, and in March 1976 the FDA
approved its request from the previous year to use the product in fixing pathological
fractures. The FDA approved the request with the condition that Howmedica send
the "Dear Doctor" letter to members of the American Academy of Orthopaedic
Surgeons and to all hospital administrators and operating room supervisors at
hospitals and clinics which had recently purchased Simplex. In July, Howmedica
submitted a supplemental NDA to seek approval of Simplex use in elbow, wrist,
ankle, shoulder, and finger joint replacement surgery. During this application
process, the FDA again reviewed Simplex labels and required specific changes be
made to reflect these uses. After Howmedica had made the required labeling changes,
the FDA approved the application.
In 1986, Howmedica received information that soft contact lenses could be
damaged by methyl methacrylate vapors and requested that additional warnings be
added to Simplex labels. The FDA approved the addition of the following warning:
It has been recommended by manufacturers of soft contact lenses that
such lenses should be removed 'in the presence of noxious and irritating
vapors.' Since soft contact lenses are quite permeable, they should not
be worn in an operating room where methyl methacrylate is being
mixed.
-8-
This addition was the final adjustment made to the Simplex warning related to
occupational use during the period when Carol Brooks was exposed to the product.
III.
After discovery was complete in the district court, Howmedica moved for
summary judgment. It argued that Brooks' failure to warn claim was preempted by
the MDA because she sought to impose a requirement on Simplex that was different
from, or in addition to, federal requirements developed through the NDA process. It
also argued that any inadequacy in Simplex warnings was not the proximate cause of
Brooks' injury because she admitted she had never read the product labels or package
insert. Brooks argued that her claim was not preempted because the duty to warn is
a general obligation applicable to all devices, and approval by the PMA or NDA does
not impose specific federal requirements with preemptive effect. She also asserted
at this time that Howmedica had failed to comply with general FDA labeling
regulations although she had not pled such a claim in her complaint.
The district court granted Howmedica's motion and dismissed the case. After
a comprehensive discussion of the relevant case law, the court concluded that even
if Brooks could show that her injury had been caused by Howmedica's failure to
provide her with adequate warnings and directions for use, her failure to warn claim
was preempted by federal law and that she had not submitted sufficient support for
any claim that Howmedica failed to comply with FDA rules or regulations.
Brooks appealed, arguing that her general common law duty to warn claim was
not preempted and that the NDA and PMA are not specific federal requirements with
preemptive force. She also argued that Howmedica's alleged breach of its duty under
common law amounted to a violation of general FDA labeling requirements.
Howmedica responded that Simplex is deemed under the MDA to have PMA
approval and that the PMA has been recognized by this court to be a federal
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requirement with preemptive effect, citing Martello v. Ciba Vision Corp., 42 F.3d
1167 (8th Cir. 1994). It argued that Brooks' claim was a state requirement different
from, or in addition to, the federal requirement and therefore preempted under § 360k
of the MDA. Howmedica also argued that Brooks had provided no evidence that it
had violated any FDA rules or regulations. Both sides contended that the Supreme
Court's decision in Medtronic v. Lohr, 518 U.S. 470 (1996), favored their respective
positions.
A panel of this court reversed the dismissal of the failure to warn claim, with
one judge dissenting. Brooks v. Howmedica, Inc., 236 F.3d 956 (8th Cir. 2001). The
majority interpreted Lohr to permit the claim to go forward, holding that the claim
would not result in any actual conflict between state common law and federal
requirements and was therefore not preempted. Id. at 964-66. The dissent pointed
out that the device at issue in Lohr had been approved through a much less rigorous
process than the PMA and the NDA review of Simplex, and that during the regulatory
process for Simplex the FDA had considered a particular federal requirement, had
concluded how competing considerations regarding that requirement should be
resolved, and had imposed a specific mandate on Howmedica to that end. Id. at 967.
The panel treated Brooks' allegation that Howmedica had not complied with FDA
regulations as a common law negligence per se claim and affirmed its dismissal. Id.
at 966-67.
Howmedica's petition for rehearing en banc was granted, and the panel opinion
was vacated. The parties submitted additional briefs, and the Product Liability
Advisory Council, Inc. was given permission to submit an amicus brief.6 At oral
6
In its brief the Product Liability Advisory Council asserts that Brooks' claim
is preempted under the MDA. It argues that neither state nor federal requirements
need to be "device-specific" in order to warrant federal preemption and that
permitting claims such as the one alleged by Brooks would cause "over-warning"
injurious to the FDA's regulatory goals and to the public health.
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argument, the parties advanced substantially the same points they had made earlier,
but Brooks put increased emphasis on her contention that the link between methyl
methacrylate and occupational asthma had not been made until 1985. She asserts that
the product warning was not changed in response to the publication in 1985 of two
articles linking methyl methacrylate and occupational asthma and that it is not clear
that the FDA ever considered such a risk. Howmedica responds that the FDA decided
on the wording of the warnings for the Simplex package insert with full awareness
of the respiratory risks.
IV.
A grant of summary judgment is reviewed de novo. United States v.
Scherping, 187 F.3d 796, 800 (8th Cir. 1999). Summary judgment is proper when
there is no genuine issue of material fact and the moving party would be entitled to
judgment as a matter of law. Fed. R. Civ. P. 56(c); Celotex Corp. v. Catrett, 477 U.S.
317, 322-23 (1986). Brooks contends that her state claim for failure to warn is not
preempted under the MDA, and she also advances an argument that she has a state
claim of inadequate labeling which "parallels" federal labeling requirements.
Howmedica responds that the district court correctly dismissed the claims on
summary judgment.
A.
State law which conflicts with federal law is preempted under the Supremacy
Clause of the Constitution. U.S. Const., Art. VI, cl. 2. Congressional intent to
preempt state law can either be expressed in statutory language or implied in the
structure and purpose of federal law. Cipollone v. Liggett Group, Inc., 505 U.S. 504,
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516 (1992).7 At the time Carol Brooks was exposed to Simplex, the product was
regulated as a Class III device under the MDA, which contains an express preemption
provision, codified at 21 U.S.C. § 360k:
(a) [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
requirements applicable under this [Act] 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 [Act].
21 U.S.C. § 360k.
At first glance the preemption issue presented here under § 360k might seem
quite simple since the state law result sought by Brooks relates to safety and would
impose different or additional requirements on the product warning for Simplex. That
the issue is not so simple is evidenced by Medtronic, Inc. v. Lohr. 518 U.S. 470(1996), a case in which a sharply divided Supreme Court interpreted § 360k.
Lohr involved claims relating to the design, manufacture, and labeling of a
pacemaker, including claims for common law failure to warn and violation of FDA
7
Howmedica asserts that Brooks' failure to warn claim is expressly preempted
by § 360k, but on appeal it has also argued in the alternative that her claim is
impliedly preempted under federal law. Because we find express preemption, we do
not address any potential issue of implied preemption. We notice parenthetically,
however, that the Supreme Court recently held that state law claims of fraud on the
FDA are impliedly preempted under federal law,"express[ing] no view" on whether
such claims are subject to express preemption under § 360k. Buckman Co. v.
Plaintiffs' Legal Comm., 531 U.S. 348 n.2 (2001).
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regulations. Id. at 481, 495. The manufacturer unsuccessfully attempted to persuade
a majority of the Court that Lohr's failure to warn claim was barred by the MDA
preemption provision. The Court split, with Justice Breyer the swing vote as he
joined first one group of justices, then the other. Justice Stevens, writing for a four
justice plurality, stated that § 360k would rarely, if ever, preempt state common law
claims. Id. at 502. Justice O'Connor on behalf of four dissenting justices disagreed,
believing that § 360k preempts any state requirement - including a common law duty
- that is "different from, or in addition to" a federal requirement. Id. at 514. Justice
Breyer agreed with Justice O'Connor that state common law claims can be subject to
preemption under § 360k, id. at 503, but he joined Justice Stevens and the plurality
in ruling on Lohr's claim for failure to warn.
In a part of the opinion written by Justice Stevens and joined by Justice Breyer,
the Lohr Court examined the regulations promulgated by the FDA which contain the
agency's interpretation of § 360k:
(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. . . .
(1) [§360k] does not preempt 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.
....
(6)(ii) Generally, [§360k] does not preempt a State or local requirement
prohibiting the manufacture of . . . misbranded devices [unless] such a
prohibition has the effect of establishing a substantive requirement for
a specific device, e.g., a specific labeling requirement, [that is] different
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from, or in addition to, a Federal requirement established under the act.
...
21 C.F.R. § 808.1(d) (2000). These regulations attempt to clarify the intended
meaning of the statutory language, and the Lohr Court said it was "substantially
informed" by them. 518 U.S. at 495.
Drawing on the statute and the regulations, the Stevens majority in Lohr
described a series of requirements necessary for a finding of preemption under the
MDA. State requirements are preempted only if they relate to "the safety or
effectiveness of the device" or to another matter included in a requirement applicable
to the device. Id. at 500. State requirements must be "with respect to" medical
devices, and state requirements of "general applicability" are subject to preemption
only if they have the effect of establishing a substantive requirement for a specific
device. Id. Federal requirements must also be "applicable to the device" at issue;
that is, they must be "specific counterpart regulations" or specific to the particular
device. Id. State law will be preempted under the MDA when "a particular state
requirement threatens to interfere with a specific federal interest." Id.The Court concluded that Lohr's failure to warn claim was too general to
require preemption. Id. at 502. Although the duty to inform users of potential
product dangers applies to all manufacturers, this general duty was "not specifically
developed 'with respect to' medical devices." Id. at 501. Medtronic's duty to warn
in respect to the pacemaker was not the kind of "requirement[] that Congress and the
FDA feared would impede the ability of federal regulators to implement and enforce
specific federal requirements." Id.If some of the language in Lohr were read without careful consideration of the
separate opinions, it might imply that no state tort claim could ever be preempted
since each is based on broadly applicable common law duties. Such a reading would
directly contradict the view of a separate majority of the Court, however, for five
justices concurred in Justice O'Connor's statement that § 360k "clearly preempts any
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state common-law action that would impose a requirement different from, or in
addition to" a specific federal requirement. Id. at 511. See also id. at 503 (Breyer,
J., concurring).
The crux of the disagreement in Lohr between the Stevens majority and the
dissenters is the meaning to be given to the statutory phrase "a requirement different
from, or in addition to." Lohr instructs that state requirements - including common
law duties - are preempted to the extent that they interfere with specific federal
requirements. The state and federal restrictions must be "carefully compar[ed]" to
ascertain whether there is interference between them – that being the "overarching
concern" of the test articulated by Justice Stevens and joined in by Justice Breyer. Id.
at 500. A state claim will be preempted in circumstances where "a particular state
requirement threatens to interfere with a specific federal interest." Id. In his
concurring opinion Justice Breyer phrased the issue as whether an "actual conflict"
exists between the state and federal requirements, id. at 508,8 and that opinion
deserves close attention since his vote created the majority. The key question before
the court is whether the specific state requirement Brooks wishes to impose on
Simplex would interfere with a specific federal requirement, but the question may
also be phrased as whether the specific state and federal requirements conflict.
In Lohr, the plaintiff's failure to warn claim did not conflict with the federal
requirements imposed on the Medtronic pacemaker. The product had received FDA
approval through a system intended to allow rapid introduction of improvements to
8
In his opinion Justice Breyer cited earlier Supreme Court cases describing
"conflict" preemption. 518 U.S. at 507. Among the cases he cited was Gade v. Nat'l
Solid Wastes Mgmt. Ass'n., 505 U.S. 88 (1992), which explained that a state
requirement is preempted if it actually conflicts with a federal requirement, either
because compliance with both is impossible or because the state requirement "stands
as an obstacle to the accomplishment and execution of the full purposes and
objectives of Congress." Id. at 98 (1992) (quoting Hines v. Davidowitz, 312 U.S. 52,
67 (1941)).
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existing devices. Id. at 478. Under the § 510(k) process9 involved in Lohr, a device
can be sold without PMA approval if it is "substantially equivalent" to one already
on the market. See 21 U.S.C. § 360e(b)(1)(B); 21 C.F.R. 814.1(c)(1) (2000). A
substantially equivalent device is examined in the § 510(k) process only for
similarities with existing devices; safety and effectiveness are not the focus. Lohr,
518 U.S. at 493. Section 510(k) approval is a mere grant to market; it imposes no
"requirements" of its own. Id. at 493-94. The pacemaker there was subject to a
federal regulation requiring Medtronic to provide a label indicating "any relevant
hazards, contraindications, side effects, and precautions." 21 C.F.R. § 801.109(c)
(2000). This requirement applied to all manufacturers in the industry and reflected
generic concerns about device regulation. It did not require the FDA to be involved
in the drafting or approval of the pacemaker's product label. The requirement was not
specific, and a common law claim would not "impede the ability of federal regulators
to implement and enforce" it. 518 U.S. at 501.
The facts in the case before the court are very different from those in Lohr.
The FDA drafted or approved every word of the Simplex label, and any changes were
subject to close FDA scrutiny. PMA review typically requires 1,200 hours of
rigorous testing for device safety. In contrast, § 510(k) review focuses on
"substantial equivalence" and is completed in an average of twenty hours. Id. at 479.
The two processes are "by no means comparable." Lohr, 518 U.S. at 478.
B.
Our court considered the preemptive effect of the MDA in a decision predating
Lohr, Martello v. Ciba Vision Corp., 42 F.3d 1167 (8th Cir. 1994). In Martello, we
held that the PMA is a specific federal requirement within the meaning of § 360k
which preempts state court claims involving safety "when the claims would impose
9
The type of process established under § 510(k) of the MDA as enacted in
1976.
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additional requirements in areas [it has] regulated." Id. at 1169. Under Lohr this
holding requires some modification because common law claims are only preempted
to the extent that they threaten to interfere with specific federal requirements. 518
U.S. at 501-02.
Most courts of appeal have interpreted Lohr to mean that the MDA preempts
common law claims to the extent that they interfere or conflict with specific federal
requirements. See, e.g., Martin v. Medtronic Inc., 254 F.3d 573, 582 (5th Cir. 2001);
Kemp v. Medtronic, Inc., 231 F.3d 216, 230 (6th Cir. 2000); Mitchell v. Collagen
Corp., 126 F.3d 902, 913-14 (7th Cir. 1997); Papike v. Tambrands, Inc., 107 F.3d
737, 742 (9th Cir. 1997). But see Oja v. Howmedica, Inc., 111 F.3d 782, 789 (10th
Cir. 1997) (common law failure to warn claim is not subject to preemption under the
MDA). Martin, Kemp, and Mitchell all considered failure to warn claims involving
products which had had a full PMA like that undergone by Simplex. The Fifth
Circuit in Martin concluded that a general duty of care under state law is preempted
if "the elements needed to prove [its] violation" are specific and "therefore threaten
specific federal requirements." 254 F.3d at 582. Because the design of the Martin
product label had been approved by the FDA through the PMA process, a failure to
warn claim would impose state requirements that would conflict with specific federal
requirements and it was therefore preempted. Id. at 584-85. Similarly, the Sixth
Circuit in Kemp held that a common law claim is preempted if it would add
"different" or "additional" elements to specific federal requirements approved through
the PMA. 231 F.3d at 236. The Seventh Circuit also concluded in Mitchell that
when a manufacturer has adhered to the PMA process, a common law claim of
mislabeling is preempted because it would impose "different" or "additional"
requirements. 126 F.3d at 913-14. Cf. Papike, 107 F.3d at 742 (failure to warn claim
preempted by FDA labeling regulations regarding toxic shock syndrome).
Those circuit court decisions since Lohr which have not found preemption in
failure to warn cases were faced with circumstances different from those in this case.
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In Oja, the Tenth Circuit held that a common law duty to warn is not a "substantive
requirement" subject to preemption, but that case involved approval through an
investigational device exemption, a considerably less rigorous process than the full
PMA. 111 F.3d at 786-87, 789. In Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th
Cir. 1999), a case in which the FDA had issued no statement or order of requirements
beyond review and approval of the initial PMA, the Eleventh Circuit ruled that simple
approval of the PMA application imposes no federal "requirements." Id. at 1375.
The Goodlin court implied, however, that it would find preemption in a case
involving an "ascertainable requirement in an express FDA" order or regulation. Id.(citing Papike, 107 F.3d at 740-41). That is what we have here, where the FDA has
issued a series of specific mandates regarding the label for Simplex. Simplex has
been subject to continuing and specific FDA regulation, beyond its initial approval
through the PMA process.
C.
The failure to warn claim asserted by Brooks would interfere or conflict with
the specific federal requirements imposed during the regulation of Simplex. A jury
finding of negligent failure to warn would be premised on the fact that the label for
Simplex was not written in a particular way or did not contain certain information.
This would be equivalent to a state regulation imposing specific label requirements.
Justice Breyer illustrated this principle in his concurring opinion in Lohr when he
pointed out that if a jury were to find negligence in the use of a wire longer than one
inch in the manufacture of a hearing aid when the FDA had required a two inch wire,
there would be federal preemption as surely as if a state regulation were to impose
such a limitation. Id. at 504 (Breyer, J., concurring).10
10
See also Martin, 254 F.3d at 582-83; Kemp, 231 F.3d at 237 (Moore, J.,
concurring). Also illustrative is the report of one of Brooks' experts (Frank
Junghans), which proposed revisions to the label, safety sheet, and package insert for
Simplex, including additional language and colorful pictographs. A jury might adopt
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The effect of a jury finding of negligent failure to warn would be that state law
would require Howmedica to change the label and package insert for Simplex, but
Howmedica may not unilaterally make such changes under federal law. A device
may not be labeled in a manner inconsistent with any conditions specified in its PMA.
21 C.F.R. § 814.80 (2000). A manufacturer must submit a Supplemental PMA for
any proposed labeling changes that affect the safety of the device. Id. at § 814.39(a).
Brooks points out that the regulations permit manufacturers to make temporary
changes in the interest of safety, see id. at § 814.39(d), but such changes are valid
only after the manufacturer has submitted a Supplemental PMA and only during the
pendency of that application. Id. at § 814.39(a)(2), (d)(1). Once the Supplemental
PMA has been approved, modified, or denied, the manufacturer must comply with the
FDA's decision. Id. at § 814.80.
Brooks argues that limiting the warnings on a label would not seem to advance
the FDA's purpose to ensure device safety. There are, however, a number of sound
reasons why the FDA may prefer to limit warnings on product labels. Warnings
about dangers with less basis in science or fewer hazards could take attention away
from those that present confirmed, higher risks. A label with many varied warnings
may not deliver the desired information to users. Space on product labeling material
is also a factor, and the most effective labels are those with large, bold warnings and
a simple design. See generally Ctr. for Devices & Radiological Health, U.S. Dep't of
Health & Human Servs., Guidance on Medical Device Patient Labeling: Final
Guidance for Industry and FDA Reviewers 42 (2001), available at
. See also Richard M. Cooper, Drug
Labeling and Products Liability: The Role of the Food & Drug Administration, 41
Food, Drug & Cosm. L.J. 233, 237-38 (1986). The FDA's enabling statute also
reflects these concerns: warnings must be "prominent[]" and "conspicuous[]," as
compared with other material on the label. 21 U.S.C. § 352(c).
any of his suggestions as a state requirement after a trial on a common law claim.
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The arguments advanced by Brooks ignore the need for national uniformity in
product regulation, one of the explicit goals of the MDA. The legislative history
indicates that this was the reason the preemption provision was included within the
MDA. H.R. Rep. No. 853, 45 (1976) ("[I]f 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."). The state
requirement in this case would come from a common law duty as applied by an
individual jury. Trials of tort claims pose incentives to overwarn: "the visible
monetary costs of additional warnings are typically quite low - a few pennies for a bit
more paper and a little more ink." James A. Henderson & Aaron D. Twerski,
Doctrinal Collapse in Products Liability: The Empty Shell of Failure to Warn, 65
N.Y.U. L. Rev. 265, 297 (1990). It would be difficult for a jury focused on a single
case to take into account "the cumulative, systemic effects" of a series of verdicts.
Richard B. Stewart, Regulatory Compliance Preclusion of Tort Liability: Limiting
the Dual-Track System, 88 Geo. L. J. 2167, 2175 (2000). In contrast, the FDA
possesses a broader perspective. Regulation by the FDA allows the agency to craft
labels that maximize safety and effectiveness.
Brooks also claims that an alleged link between methyl methacrylate and
occupational asthma first became known in 1985, well after the original FDA
approval of Simplex in 1971. She suggests that the FDA did not consider such a
danger nor impose any warning requirement with respect to it. She bases this
argument on the fact that two articles appeared in 1985 which describe case studies
linking methyl methacrylate and occupational asthma and one claimed there had been
no previous published report of the chemical's association with asthma. S. Lozewicz
et al., Occupational asthma due to methyl methacrylate and cyanoacrylates, 40 Thorax
836, 836 (1985). Neither of the two experts put forward by Brooks nor the cited
articles claimed, however, that the risk of respiratory irritation from methyl
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methacrylate had not been previously appreciated, and the product labeling for
Simplex and the "Dear Doctor" letter are evidence to the contrary.11
The record demonstrates that the FDA was aware of a possible link between
methyl methacrylate and respiratory damage for several decades, and the agency
required Howmedica to take specific steps in response. The label for Simplex
incorporated the danger of sensitivity to vapors from the very beginning. When
Simplex was introduced in 1971, the FDA drafted a package insert which warned that
the liquid methyl methacrylate used in mixing is "highly volatile" and that the mixing
process required both "adequate air circulation" and caution "to prevent excessive
exposure to the concentrated vapors" which could produce "irritation of the
respiratory tract." In 1973 Howmedica requested permission to add to the warning
to indicate that the ingredients of the product could "act as a sensitizer," but the FDA
decided on different wording, requiring a warning about "strict adherence to the
mixing instructions" to "diminish the possibility of hypersensitivity reactions" and to
prevent absorption of the product.
The FDA conducted an official review of the inhalation toxicity of methyl
methacrylate vapors by operating room personnel in 1975, and it subsequently
directed Howmedica to send a "Dear Doctor" letter to Simplex users drafted by both
Howmedica and the FDA. The letter directed user attention to methyl methacrylate
vapor inhalation studies and to the package insert warning and recommended that
user facilities be inspected for adequate ventilation. The FDA also mandated changes
in the package label. The new version read:
11
There is evidence that even by 1998 a specific connection between methyl
methacrylate and occupational asthma had not been conclusively established. See
World Health Organization, et al., Concise International Chemical Assessment
Document No. 4, Methyl Methacrylate 5 (1998) ("Although occupational asthma
associated with methyl methacrylate has . . . been reported, there is no conclusive
evidence that methyl methacrylate is a respiratory sensitizer.")
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As the liquid monomer is highly volatile and flammable, the operating
room should be provided with adequate ventilation so as to eliminate the
maximum amount of monomer vapor. Caution should be exercised
during the mixing of the two components to prevent excessive exposure
to the concentrated vapors of the monomer which may produce
irritation of the respiratory tract, eyes, and possibly the liver.
(emphasis added)
In 1986, after receiving reports of damage to soft contact lenses, Howmedica
requested, and the FDA approved, an additional warning for the Simplex package
insert referring to the vapors created during the mixing process as "noxious and
irritating."
The FDA was deeply involved in drafting and editing the warnings on the
Simplex label and package label, beginning with the product's approval in 1971 and
continuing on through the period in which Brooks was exposed to it. Through its
approval of the PMA application for Simplex and its continuing series of directives,
the agency imposed specific federal requirements on Howmedica. The failure to warn
claim Brooks seeks to assert could impose state requirements which conflict or
interfere with these federal directives. Because these "particular state requirement[s]
threaten[] to interfere with . . . specific federal interest[s]," Lohr, 518 U.S. at 500,
Brooks' claim is preempted by the MDA.
D.
Brooks also argued in the district court that Simplex instructions were
inadequate under federal law because FDA regulations require package labeling for
prescription products to contain information about "any relevant hazards,
contraindications, side effects, and precautions." 21 C.F.R. § 801.109(c) (2000).
Brooks claims that her common law claim contains requirements identical to those
imposed under federal law and is therefore not preempted. Brooks is correct in her
assertion that a claim of failure to comply with FDA regulations is not preempted by
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the MDA, Lohr, 518 U.S. at 495, since such a state claim imposes no requirement
"different from, or in addition to" any federal requirement. Id. at 496-97. See also
id. at 513 (O'Connor, J., concurring in part and dissenting in part). Her assertion that
she has put forward such a cause of action is a separate issue, however. The district
court dismissed "any claim that Howmedica failed to comply with FDA rules or
regulations" because it found no showing of noncompliance. The panel treated this
claim as one for negligence per se unsupported in the record. Brooks asserts that her
argument has been misunderstood and that she alleges a violation of state law that
"parallels" similar requirements under federal law.
This unpled claim lacks both clarity and support, and we find no error in its
dismissal. To the extent that Brooks attempts to distance herself from the
categorization of this claim as one for negligence per se, the claim begins to sound
very similar to the preempted failure to warn claim just discussed. Cf. Papike, 107
F.3d at 742-43 (denying a claim that general labeling regulations require warnings
beyond those contained in specific FDA requirements). Under the type of theory
Brooks advances the general duty of C.F.R. 801.109(c) could trump even the most
specific FDA labeling directive and § 360k of the MDA could be completely
circumvented. Moreover, Brooks has presented no evidence that Howmedica
violated federal regulations or refused to add warnings drafted by the FDA, changed
FDA-approved labels failed to meet regular reporting requirements, failed to report
a known hazard to the FDA, or failed to comply with federal law in any other respect.
We conclude that this claim was properly dismissed on summary judgment.
V.
Simplex package labeling was subject to meticulous and ongoing federal
regulation from the product's approval in 1971 through the time of Brooks' exposure
to it. The FDA imposed specific federal requirements on Simplex through the PMA
and NDA process. The specific state requirement Brooks seeks to establish by her
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common law claim would interfere with the specific federal requirements set for
Simplex. Her claim is therefore preempted under § 360k of the MDA because it
would impose a specific state requirement "different from, or in addition to" specific
federal requirements. There is also no showing that Howmedica violated federal
regulations. For these reasons, we affirm the judgment of the district court.
BYE, Circuit Judge, with whom HEANEY, Circuit Judge, joins, dissenting in part.
The majority stitches together a coherent, scholarly explication of § 360k
preemption from the complicated opinions of the Supreme Court in Medtronic, Inc.
v. Lohr, 518 U.S. 495 (1996). I admire the majority’s efforts. I also agree with its
development of a three-step test, in which courts must discern the federal requirement
imposed on a medical device manufacturer, then the state requirement imposed on
that manufacturer, and finally compare the two to determine whether they present
conflicting obligations. Though I agree with the standard expressed by the majority,
I strongly disagree with its application of that standard to the facts of Carol Brooks’s
case and I respectfully dissent in that respect.
Following Lohr, we search for incompatibility between state laws (or putative
state court judgments) and federal requirements imposed on manufacturers.
Howmedica claims that the FDA’s labeling requirements for Simplex conflict with
a hypothetical adverse judgment on Brooks’s state-law failure-to-warn claim.
Howmedica raises two distinct arguments in support of this claim, but neither
survives careful scrutiny. The majority adds two considerations in favor of
preemption that I find unpersuasive. I address these four arguments in turn.
I
Howmedica professes that it is powerless to alter Simplex’s packaging or
warning insert, and hence it could not comply both with a state-law judgment and the
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federal labeling regulations. In effect, while a 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 misstates a critical premise. FDA labeling regulations
do not mandate that Simplex’s label and package insert remain freeze-framed in their
1971-approved state. The FDA’s regulations authorize Howmedica to initiate
changes to Simplex’s labeling. 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”). Section 814.39(d)(2) is not a moth-eaten relic of past
regulatory efforts to which we attach little or no importance. The provision is a vital
component of the FDA’s larger regulatory mission of ensuring that manufacturers
amend their warnings and their products in response to safety concerns and scientific
advancements. The Supreme Court explicitly acknowledged the provision’s
importance in Lohr: “We also note that the agency permits manufacturers of devices
that have received PMA to make certain labeling . . . changes which would enhance
the safety of the device or the safety in the use of the device without prior FDA
approval. See 21 CFR §§ 814.39(d)(1) and (2) (1995).” Lohr, 518 U.S. at 497 n.16
(punctuation removed).
If, for example, Howmedica learns that Simplex poses an unforeseen risk to
consumers’ health, Howmedica may immediately alter Simplex’s labeling and
package inserts to warn users of the newly-discovered risk. Howmedica does not
have the final say, of course; Howmedica has only the power to initiate review before
the FDA concerning the merits of additional warnings. Interim warnings added by
a manufacturer must be simultaneously submitted for FDA approval, and the
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proposed additions will be vetted by FDA doctors. If the FDA approves the
additional warnings, the manufacturer may continue to display them. If the FDA
rejects the additional warnings, however, the manufacturer must then remove the
warnings to maintain compliance with the FDA’s specific mandate. In sum, while
FDA approval is pending, a manufacturer may include additional warnings on
labeling and package inserts.
Section 814.39(d)(2) relieves any tension between Brooks’s failure-to-warn
claim and the FDA’s ongoing oversight of Simplex labeling. Simplex’s label and
package insert have never contained warnings or information about the risk of
contracting asthma. Brooks asserts that the scientific community began to learn of
the asthma-inducing propensity of methyl methacrylate vapors in 1985 and 1986,
more than a decade after the FDA approved Simplex for use in the United States.
Brooks claims that Howmedica negligently failed to warn Simplex users that repeated
exposure to vapors released in the mixing process could cause occupational asthma.
Though the FDA approved Simplex’s labeling without the type of asthma warnings
suggested by Brooks, Howmedica could have sought FDA approval to add such
warnings in the mid-1980s. Under § 814.39(d)(2), Howmedica could have altered its
label or package insert—unilaterally—to alert users to the dangers of contracting
asthma, pending permanent FDA approval of those warnings.
Had the FDA refused permission to add asthma warnings, Brooks’s failure-to-
warn claim would almost certainly be preempted. In that hypothetical instance,
Howmedica would face the dilemma it so fears: a state law judgment would
effectively require it to add an asthma warning that the FDA mandated must not be
included. That hypothetical example is not the present case, however. In this case,
Howmedica made no effort to warn Simplex users about asthma, though it had the
power to do so initially, and could have done so permanently with the FDA’s
approval. Brooks’s attempt to hold Howmedica liable for this alleged shortcoming
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in no way conflicts with FDA oversight of medical device labeling generally, or with
Simplex’s federal labeling requirements specifically.
My understanding of § 814.39(d)(2)’s role in the preemption analysis is
identical to that of the former Chief Counsel of the FDA, Richard Cooper. “In some
situations, FDA has not, at the relevant time, considered the precise question of
whether the insert it had previously approved should be changed in light of
subsequent information. Where that is the case, there would seem to be no relevant
federal decision entitled to supremacy.” Richard Cooper, Drug Labeling and
Products Liability: The Role of the Food and Drug Administration, 41 Food Drug
Cosm. L.J. 233, 234-35 (1986) (discussing the regulatory predecessor to
§ 814.39(d)(2)). Cooper cautions courts not to “over-read” FDA regulations as
permitting drug manufacturers carte blanche authority to change labeling or package
inserts, id. at 235-36, a point with which I fully agree. But Cooper ultimately ascribes
to the fundamental point we raise above: manufacturers possess the authority,
consistent with § 814.39(d)(2), to initiate the process of changing a medical device
label to warn users of a newly-discovered risk. Manufacturers who negligently fail
to seek FDA approval for such additional warnings (and to supplement their warnings
pending FDA approval) cannot benefit from § 360k’s preemption defense because
they encounter no conflict between their respective state and federal obligations.
In the present case, Brooks’s state law failure-to-warn claim and the FDA’s
scheme of regulatory oversight may coexist without impediment, and thus preemption
is inappropriate.
II
Howmedica also argues there is actual conflict between state and federal
requirements—even accepting my interpretation of § 814.39(d)(2) for argument’s
sake. Howmedica contends the FDA rejected the type of asthma warning that Brooks
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advocates when it approved Simplex’s initial warnings in 1971, and when it oversaw
Simplex labeling changes in 1975 and 1976. Howmedica asserts it presented possible
warnings to the FDA that encompassed asthma-type risks. The FDA incorporated
some of those warnings into the package insert, but rejected others. In either event,
Howmedica posits, the FDA’s decision to accept or reject such warnings constitutes
specific federal regulations inconsistent with Brooks’s effort to obtain a state-law
judgment requiring an asthma warning.
The record does not substantiate Howmedica’s assertions. In the first place,
Howmedica has not directed the court to any evidence that warnings specifically
pertaining to asthma were discussed by the FDA or presented for its consideration.
Howmedica is therefore left to contend that the warnings it did propose, and those
considered by the FDA, encompass the same territory as an asthma warning.
Howmedica argues, in effect, that some of the warnings it proposed would have
“done the work” of an asthma warning, and thus the FDA’s rejection of those
warnings implies a specific federal prohibition. This contention also lacks any basis
for support in the record presented to the district court.
The package insert warnings drafted by the FDA in 1971 during the PMA
process mention the following:
Caution should be exercised during the mixing of [Simplex’s] two
components to prevent excessive exposure to the concentrated vapors of
the monomer which may produce irritation of the respiratory tract, eyes,
and possibly the liver.
Brooks App. 202 (Aff. of Christopher Lawler, Exh. K) (Dec. 15, 1998).
It is obvious this warning does not encompass asthma in the manner
Howmedica suggests. Warning a Simplex user of possible “irritation of the
respiratory tract” is not equivalent to warning the user about contracting asthma
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through repeated exposure. The warning does not adequately reflect the medical
reality of an asthmatic condition. Asthma is a chronic disease that derives from
repeated exposure to irritants or allergens, see 1 Gale Encyclopedia of Medicine 347
(1999); Brooks App. 409 (Depo. of Dr. Kaye) (Dec. 16, 1998), yet the Simplex
warning bears no mention of duration or long-term exposure. To the contrary, the
warning implies to the reader that possible irritation will be only temporary.
Moreover, the label does not even hint that such exposure might cause disease.
Howmedica’s argument fares no better if the warning in fact connotes
permanent harm. Viewed most charitably to Howmedica, the warning’s reference to
“irritation of the respiratory tract” might incorporate the possibility of long-term
suffering. Brooks strongly disagrees any such inference may be drawn, and thus a
dispute of material fact (perhaps a dispute of medical fact) would prevent the entry
of summary judgment. Because we are presently reviewing the propriety of summary
judgment entered against Brooks, we are in no position to draw factual inferences in
favor of Howmedica. If such a factual dispute exists, its resolution—and thus the
overarching preemption question presented in this case—would require some initial
fact-finding. Cf. Brown v. Hotel & Rest. Employees & Bartenders Int’l Union, 468
U.S. 491, 511 (1984) (expressing an inability to resolve a preemption question until
appropriate findings of fact had been made to permit review of the legal question).
Howmedica’s assertion that the FDA considered and rejected warnings
encompassing asthma in 1975 and 1976 is even less believable. In early 1975, the
FDA commenced review of the inhalation toxicity of methyl methacrylate vapors.
Howmedica and other manufacturers were required to participate in committee
meetings and other proceedings with the FDA. As a result of these discussions, the
FDA required Howmedica to alter the Simplex package insert to state Simplex’s
liquid component was highly flammable and operating rooms should be adequately
ventilated. See Brooks App. 126 (Lawler Aff. ¶ 40). The FDA also required
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Howmedica to send a “Dear Doctor” letter pertaining to concerns of inhalation
toxicity. See id. at 325-26 (Lawler Aff., Exh. Z).
It cannot fairly be contended that the warnings the FDA required in the mid-
1970s were germane to asthma. The FDA was then concerned with the inhalation
toxicity of methyl methacrylate vapors. Toxins are essentially poisons. See supra,
Gale Encyclopedia at 2878. But Brooks does not claim she was poisoned by
exposure to Simplex. She claims she contracted asthma from repeated exposure to
the vaporous byproducts of the Simplex mixing process. Howmedica has not directed
our attention to any evidence that suggests the FDA considered and rejected warnings
that would have notified Simplex users of the risk of contracting asthma. The FDA’s
consideration of inhalation toxicity studies simply does not indicate the FDA
considered warnings related to asthma.
And even if the FDA had considered and rejected asthma warnings in the
1970s, Howmedica’s counter-argument would still fail. Brooks’s failure-to-warn
claim is predicated upon scientific discoveries of the mid-1980s. See, e.g., Brooks
App. 78 (Plaintiff’s Memo. Opp. Summ. J. 21) (Jan. 8, 1998) (“In 1985, scientific
literature established a causal relationship between the induction of occupational
asthma and exposure to methyl methacrylate, a component of Defendants’ bone
cement.”); id. at 465 n.4 (Expert report of Environmental Health & Safety, Inc.) (July
15, 1998) (citing S. Lozewicz et al., Occupational Asthma Due to Methyl
Methacrylate and Cyanoacrylates, 40 Thorax 836 (1985)); id. at 480. FDA
regulations require manufacturers to apprize themselves and the agency of new
product risks that come to light subsequent to market approval. Howmedica could
have sought FDA approval (under § 814.39(d)(2)) to add asthma warnings when
scientists began to notice (or at least thought they began to notice) a causal link
between methyl methacrylate vapor exposure and occupational asthma in the mid-
1980s. Howmedica could have added such warnings to its package insert
immediately, pending final FDA approval or rejection. Howmedica’s reference to
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FDA actions in the 1970s is not responsive to Brooks’s assertion that Howmedica
failed to warn Simplex users of the risk of contracting asthma when such risks
became known in 1985.
Howmedica’s argument therefore fails. No evidence in the record demonstrates
that current Simplex labeling warns users of the possibility of contracting asthma.
Nor does any evidence suggest the FDA considered and rejected other warnings that
might have encompassed asthma within their scope. The FDA has not issued
Howmedica any specific federal directive pertinent to asthma, and consequently,
Howmedica’s claim of preemption based upon conflicting state and federal
requirements melts away. The majority therefore errs in holding that Brooks’s
failure-to-warn claim is preempted by federal law.
III
In places, the majority seems to suggest that even if Howmedica’s state and
federal requirements do not conflict, Brooks’s hypothetical state-law judgment
nevertheless “threatens to interfere with a specific federal interest,” ante at 14
(quoting Lohr, 518 U.S. at 500), and thus her state-law claim should be preempted.
See ante at 19 (“Such ‘threaten[ed] interfere[nce]’ between specific requirements of
state and federal law requires preemption under the MDA.”) (quoting Lohr, 518 U.S.
at 500). I find this suggestion contrary to Lohr and legally untenable in any event.
While predicting that § 360k and its concomitant regulations will occasionally
preempt state tort claims, Lohr states “it is impossible to ignore [the regime’s]
overarching concern that preemption occur only where a particular state requirement
threatens to interfere with a specific federal interest.” 518 U.S. at 500. After uttering
this broad platitude, the Court got down to the business of deciding when a specific
federal interest might be threatened. The ensuing paragraph considers the sort of state
and federal requirements imposed on medical device manufacturers. And then, to
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sum up, the Court concludes “[t]he statute and regulations, therefore, require a careful
comparison between the allegedly preempting 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.The Court’s language, and the structure of its discussion, emphasize that while
the overarching concern of § 360k preemption is to prevent “threatened interference”
with “federal interests,” the standard by which to determine such a threat is actual
conflict between state and federal requirements. In this case, there is no actual
conflict between Howmedica’s federal labeling requirements and the requirements
imposed by a hypothetical state-law judgment for Brooks—as I have demonstrated
above. It would be odd, to say the least, to discard the Court’s analytical framework
of conflict-motivated preemption in favor of the generic concern present in any
preemption case that federal interests persevere.
It is critical to distinguish between the threat to federal interests, to which Lohr
alludes, and the threat to a particular manufacturer, which Lohr does not similarly
discuss. The federal interest in MDA cases will rarely if ever be threatened. The
FDA always has the last word in labeling decisions. If a manufacturer presents a §
841.39 request to the FDA to add a warning, the FDA’s ruling on that request will
have preemptive effect. If the FDA refuses permission to add the warning, a
subsequent state-law tort claim based on the failure to include that warning will be
preempted. The federal interest—the FDA’s regulatory mission—is never
compromised by a competing state-law judgment because the FDA’s decision
supplants state tort law.
I acknowledge that manufacturers who are sued in tort before they request
additional warnings from the FDA may be threatened. But the federal interest—the
subject of discussion in Lohr—will not be threatened. Suppose a plaintiff prevails
on a state-law failure-to-warn claim against a medical device manufacturer. After
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judgment is entered, the manufacturer seeks FDA approval to add the warning
compelled by the state-law judgment. If the FDA refuses to approve that warning, the
manufacturer need not place the warning on its labels because the FDA’s requirement
preempts the effect of the state-law judgment. In this scenario, the manufacturer may
have lost considerable time and money defending the suit, and thus its interests have
in some sense been threatened. But the federal interest has not been threatened.
When the FDA was presented with a label modification request, the FDA rejected it,
and the FDA’s judgment carries the day and supplants the state-law judgment for the
future based upon § 360k preemption. Section 360k preemption, as envisioned by the
Supreme Court, could hardly protect the federal interest more capably.
I therefore resist the majority’s apparent attempt to resolve this case based on
generic concerns that federal interests might be “threatened.”
IV
Finally, spurred on by amicus curiae, the majority makes passing reference to
certain policy considerations that militate against a preemption holding in this case.
The majority argues that Brooks’s effort to add another warning to Simplex’s label
could result in “over-warning” consumers. The majority also posits that Brooks’s
lawsuit should not establish medical device labeling policy because she lacks the
FDA’s capacity to appreciate and balance all the risks presented.
These arguments suggest the FDA’s regulations and directives should always
supplant state tort suits. Yet the Supreme Court implicitly rejected these policy
arguments in Lohr by holding at least one plaintiff’s state-law failure-to-warn claim
was not preempted under § 360k.
Moreover, the majority’s considerations form an inappropriate basis for
resolving an express preemption case. When Congress has declared its preemptive
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intent in statutory form, we are limited to interpreting its language in discerning the
scope of federal preemption. See Cipollone v. Liggett Group, Inc., 505 U.S. 504, 517
(1992) (declaring that the preemptive scope of the Federal Cigarette Labeling and
Advertising Act is “governed entirely” by the language in its express preemption
provision, 15 U.S.C. § 1334(b)). In the MDA, Congress set forth its intention to
preempt some state regulations and requirements placed on medical device
manufacturers. Reasonable jurists may debate the meaning of § 360k’s words as they
apply to particular cases. But we may not rely on broader considerations of public
policy, for then we overstep our duty faithfully to interpret the language upon which
Congress has agreed.
I respectfully dissent in part, though I do join in Part IV.D of the majority
opinion, which concludes that the district court properly granted summary judgment
as to Brooks’s seeming negligence per se claim.
A true copy.
ATTEST:
CLERK, U.S. COURT OF APPEALS, EIGHTH CIRCUIT.
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