McFadden v. 3M Company, et al.
MEMORANDUM AND ORDER re: IT IS HEREBY ORDERED that defendant's motion to dismiss [Doc. # 11 ] is denied.. Signed by District Judge Carol E. Jackson on 3/3/15. (KKS)
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MISSOURI
3M COMPANY and MINE SAFETY
No. 4:14-CV-803 (CEJ)
MEMORANDUM AND ORDER
This matter is before the Court on the motion of defendant Mine Safety
Appliances to dismiss for failure to state a claim, pursuant to Fed.R.Civ.P. 12(b)(6).
Plaintiff has filed a response in opposition and the issues are fully briefed.
Between August 29, 1973 and June 7, 1985, plaintiff Stanley McFadden was
continuously exposed to silica dust in the course of his employment. In order to
protect him from inhaling silica dust, his employer provided him with respirators
designed and manufactured by defendants 3M Company (3M) and Mine Safety
Appliances (MSA). He alleges that the respirators failed to work properly and, as a
result, he developed pneumoconiosis and/or silicosis.
Plaintiff asserts claims
against MSA for product liability (Count II), breach of warranty (Count IV),
negligence (Count VII) and negligence per se (Count VIII).
Defendant MSA moves to dismiss, arguing that plaintiff’s tort claims are
completely preempted by the Occupational Safety and Health Act of 1970 (OSH
Act), 29 U.S.C. §§ 651 et al., and regulations implemented by the Bureau of Mines
and the National Institute for Occupational Safety (NIOSH). Alternatively, defendant
argues that the complaint fails to state a claim for relief under Missouri law.
The doctrine of preemption, which is derived from the Supremacy Clause,
provides that “any state law, however clearly within a State’s acknowledged power,
which interferes with or is contrary to federal law must yield.” Gade v. National
Solid Wastes Mgmt. Ass’n, 505 U.S. 88, 108 (1992) (internal quotations and
citations omitted). Consideration of issues arising under the Supremacy Clause
“start[s] with the assumption that the historic police powers of the States [are] not
to be superseded by . . . Federal Act unless that [is] the clear and manifest purpose
of Congress.” Cipollone v. Liggett Grp., Inc., 505 U.S. 504, 516 (1992) (citation
omitted; alterations in original).
“Preemption may arise in one of three ways.” Lindsey v. Caterpillar, Inc., 480
F.3d 202, 205 (3rd Cir. 2007).
First, courts will find express preemption if Congress has defined
explicitly the extent to which a statute preempts state law. Second, in
the absence of explicit statutory language, state law is subject to field
preemption if it regulates conduct in a field that Congress intended the
federal government to occupy exclusively. Finally, state law is
preempted to the extent it actually conflicts with federal law. English v.
Gen. Elec. Co., 496 U.S. 72, 78-79 (1990). Actual conflict arises when
it is impossible to comply with both the federal and state laws or when
the state law stands as an obstacle to the accomplishment and
execution of the full purposes and objectives of Congress. Id. at 79.
Id. at 205-06. A federal agency may preempt state law through its regulations so
long as the agency acts within its congressionally-delegated authority. Id. (citing
Fid. Fed. Sav. & Loan Ass’n v. De la Cuesta, 458 U.S. 141, 153-54 (1982)).
Defendant relies on the third type of preemption, arguing that plaintiff’s tort
claims “actually conflict” with federal law.
The “touchstone” of preemption is congressional purpose. Lindsey, 480 F.3d
at 206 (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 485-86 (1996)). Congress
enacted the OSH Act in 1970, with the purpose “to assure so far as possible every
working man and woman in the Nation safe and healthful working conditions and to
preserve our human resources.” 29 U.S.C. § 651(b). Congress also authorized the
Secretary of Labor “to set mandatory occupational safety and health standards
applicable to business affecting interstate commerce.” § 651(b)(3). In doing so,
Congress “thereby brought the Federal Government into a field that traditionally
has been occupied by the States.” In re Welding Fume Products Liability Litigation,
364 F. Supp. 2d 669, 674 (N.D. Ohio 2005) (quoting Gade v. National Solid Wastes
Mgmt. Ass’n, 505 U.S. 88, 96 (1992)).
The federal entry was not uniform or comprehensive, however. Lindsey, 480
F.3d at 206. First, Congress permitted states to assume responsibility for
occupational safety and health by obtaining approval from the Secretary of Labor.
§ 667(b). This provision is not at issue in this case. Second, the Act preserves to
the states the power to “assert jurisdiction . . . over any occupational safety or
health issue with respect to which no standard is in effect under [the Act].” §
667(a).1 Finally, the Act includes a “clearly articulated savings clause.” Lindsey, 480
F.3d at 206.
Although this section does not use the term “preemption,” it is considered to have
preemptive effect. See Welding Fume Products, 364 F. Supp. 2d at 674 (referring to
§ 667(a) as OSH Act’s “preemption provision”); see also Nat’l Solid Wastes Mgmt.
Nothing in this chapter shall be construed to supersede or in any
manner affect any workmen’s compensation law or to enlarge or
diminish or affect in any other manner the common law or statutory
rights, duties, or liabilities of employers and employees under any law
with respect to injuries, diseases, or death of employees arising out of,
or in the course of, employment.
“[N]o other enactment contains a saving clause more broad.” Welding Fume
Products, 364 F. Supp. 2d at 687. Despite its breadth, “[t]he savings clause does
not save tort claims that actually conflict with federal regulations.” Santos v. Crown
Equipment Corp., No. 08-80161-CIV, 2009 WL 1066946, at * 4 (S.D. Fla. Apr. 21,
2009). In assessing whether tort claims “actually conflict” with federal regulations,
courts have held that no such conflict is created when the federal regulations
“neither require nor forbid particular safety features.” Id.
“There is a solid consensus that section  (b)(4) operates to save state
tort rules from preemption.” Pedraza v. Shell Oil Co., 942 F.2d 48, 53 (1st Cir.
1991) (listing cases and finding that OSH Act did not preempt claims brought by
worker exposed to chemical); Lindsey, 480 F.3d at 209 (OSHA’s rollover-protection
regulation did not preempt tort claims brought by estate of worker killed when
tractor flipped over); Welding Fume Products, 364 F. Supp. 2d at 690 (OSH Act and
Hazard Communication Standard did not preempt claims brought by workers
injured by inhaling manganese given off during welding); Santos, 2009 WL
1066946, at *4 (regulation regarding operator enclosures for industrial trucks did
not preempt claims brought by worker injured while operating a forklift); Fullen v.
Ass’n v. Killian, 918 F.2d 671, 675 (7th Cir. 1990) aff’d sub nom. Gade v. Nat’l
Solid Wastes Mgmt. Ass’n, 505 U.S. 88 (1992) (quoting § 667(a) and (b) as general
Philips Electronics N. Am. Corp., 266 F. Supp. 2d 471, 478-79 (N.D.W. Va. 2002)
(OSH Act did not preempt claims brought by workers exposed to multiple hazards);
Sakellaridis v. Polar Air Cargo, Inc., 104 F. Supp. 2d 160, 164 (E.D.N.Y. 2000)
(“The savings clause plainly states that workers’ statutory remedies for personal
injuries are preserved. It is not consequential that the standard of care is
prescribed by the common law, a separate statutory scheme, or an administrative
scheme.”); cf. Solis v. Summit Contractors, Inc., 558 F.3d 815, 829 (8th Cir. 2009)
(“The federal courts have held that [OSH Act’s savings] provision does not create a
private cause of action and prevents federal preemption of state tort law and
worker’s compensation schemes.”).
Defendant cites a case in which a court held that a state tort claim actually
conflicted with the OSH Act and regulations. In Gonzalez v. Ideal Tile Importing
Co., 877 A.2d 1247, 1252 (2005), the New Jersey Supreme Court considered
whether the Act preempted tort claims against a forklift manufacturer whose
product was in compliance with federal agency standards for warning devices. The
plaintiff, who was injured when he was struck by a forklift operated by a coworker,
argued that the manufacturer was negligent in failing to include an additional
warning device. In determining that the plaintiff’s claims were preempted by federal
law, the court relied on an agency determination that additional devices should not
be used if they would create more dangers than they prevented. Id. at 1252-53.
Based on this interpretation, the court found that the federal standards regulated
the universe of warning devices. Id.
Defendant argues that plaintiff’s state law claims actually conflict with federal
regulations governing respirators. In 1971, the Secretary of Labor published
regulations concerning respiratory protection. 29 U.S.C. § 1910.134. The regulation
specifies that where atmospheric contamination cannot be prevented through
engineering controls, “appropriate respirators” will be used. § 1910.134(a).
Employers are required to provide respirators to employees “when such equipment
is necessary to protect the health of such employee[s]”. § 1910.134(b).2 During the
course of plaintiff’s employment, the Bureau of Mines and NIOSH promulgated
regulations governing the design, manufacture, testing, and certification of
respirators. See 30 C.F.R. Parts 11 and 14. In relevant part, manufacturers were
required to submit an application for certification, accompanied by engineering
drawings, testing results, and details regarding quality control and manufacturing
processes. See Def. Memo at 7. Once a respirator was approved, it could not be
modified without agency approval.3
Defendant asserts that, in order to undertake a proper conflict-preemption
analysis, the court must examine the specific standards governing respirators.
Despite this assertion, defendant has not undertaken that analysis itself. Rather,
defendant draws an analogy between the regulatory scheme here and the Medical
Device Amendments (MDA) to the Food, Drug and Cosmetic Act. Under the MDA,
manufacturers of medical devices are required to submit their products to the U.S.
Until 1972, the Bureau of Mines was solely responsible for testing and approving
respirators. In 1972, the Bureau of Mines and NIOSH jointly published regulations,
30 C.F.R. Part 11 pursuant to which the Bureau of Mines evaluated respirator
performance, and NIOSH administered the quality control provisions. In 1972,
NIOSH undertook primary responsibility for performance testing of respirators.
Respiratory Protective Devices, 59 Fed. Reg. 26892, 26892 (May 24, 1994).
The Dustfoe 66 received regulatory approvals effective through June 30, 1975.
Def. Memo. at 8-9. It was not approved for use in hazardous atmospheres after
that date. Id.
Food and Drug Administration (FDA) for pre-market approval. Riegel v. Medtronic,
Inc., 552 U.S. 312, 317-18 (2008). Once approval is given, the medical device may
not be altered in any fashion without FDA approval. Id. at 319 (citing §
360e(d)(6)(A)(i)). Under the Supreme Court’s interpretation of the MDA, state law
claims escape preemption only if the state requirements are equivalent to the
federal requirements. McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir.
2005). A state law claim that depends upon a finding that the manufacturer should
have varied from those “requirements” is preempted. See, e.g., Caplinger v.
Medtronic, Inc., 921 F. Supp. 2d 1206, 1219 (W.D. Okla. 2013) (plaintiff’s
fraudulent misrepresentation claims preempted by § 360k(a) because they required
a finding that the manufacturer should have provided additional warnings above
and beyond those on the FDA-approved label).
Defendant argues that, like an approved medical device, its respirator was
subjected to regulatory approval and that it could not make alterations without
further regulatory approval. Thus, it argues, plaintiff’s claims are actually in conflict
with the federal standards to the extent that they depend upon a finding that its
design was defective. Defendant cites no authority for the proposition that the
agency process in and of itself preempts tort claims under the OSH Act. Indeed,
work-place safety regulations are so pervasive that, under defendant’s argument,
the Act would preempt nearly every state law claim.
A regulatory process in and of itself does not create a preemptive effect;
rather, preemption arises from the statutory language. The MDA’s preemption and
savings provisions are much more restrictive than those in the OSH Act. The MDA
expressly preempts state law claims that impose a “requirement” that is different
from or in addition to a federal “requirement.”4 21 U.S.C. § 360k(a). The savings
provision, found at § 360h(d),5 does not apply to devices subject to the premarket
approval process. Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1378-79 (11th Cir.
1999) (reading 21 U.S.C. 360h(d) to refer “only to compliance with FDA orders
regarding notification, repair, replacement, refund, or reimbursement—and not to
include compliance with the PMA process, which arises under a different section of
the MDA.”); see also Talbott v. C.R. Bard, Inc., 865 F. Supp. 37, 48 (D. Mass.
1994) (§360h(d)applies only to those Class III devices for which a state exemption
was obtained). By contrast, here, the pertinent language directs that the Act cannot
diminish the common law or statutory rights of employees under any law with
respect to employment-related injuries or death. Lindsey, 480 F.3d at 210
(contrasting preemption provision and savings clause in the National Traffic and
Motor Vehicle Safety Act of 1964).
The court finds that plaintiff’s claims fall within the scope of the OSH Act
savings clause and are not preempted.
Failure to State a Claim for Relief
Defendant also seeks dismissal pursuant to Fed.R.Civ.P. 12(b)(6).
support of its motion, defendant asserts that its respirator was not unreasonably
dangerous as a matter of law, that the plaintiff’s breach of warranty claim is barred
by the statute of limitations, and that plaintiff cannot establish a claim of negligence
The Supreme Court has held that the FDA pre-market approval process imposes
device-specific “requirements” under the MDA. Riegel v. Medtronic, Inc., 552 U.S.
312, 322 (2008).
The MDA’s savings provision provides: “Compliance with an order issued under this
section shall not relieve any person from liability under Federal or State law.” 21
U.S.C. § 360h(d). This provision does not apply to devices subject to the premarket
Whether or not the defendant’s product was unreasonably dangerous
cannot be determined by the court on the basis of the present record. Likewise,
resolution of issues regarding the timeliness of plaintiff’s warranty claim and
plaintiff’s ability to prove negligence per se depends on evidence that has not been
presented to the court. A motion to dismiss under Rule 12(b)(6) is not the proper
vehicle for evaluating the merits of the plaintiff’s claims.
Having reviewed the
complaint, the court finds that it includes “enough facts to state a claim to relief
that is plausible on its face.”
Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570
For the reasons discussed above,
IT IS HEREBY ORDERED that defendant’s motion to dismiss [Doc. #11] is
CAROL E. JACKSON
UNITED STATES DISTRICT JUDGE
Dated this 3rd day of March, 2015.
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