Fenn v. Philips Electronics North America Corporation et al
MEMORANDUM OPINION AND ORDER: 1)Defs' 9 and 15 JOINT Motion to Dismiss is granted in full; 2)Pla's Complaint is dismissed with prejudice; 3)Matter is stricken from the Court's active docket. Signed by Judge David L. Bunning on 2/13/2015. (LST)cc: COR
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF KENTUCKY
CIVIL ACTION NO. 14-96-DLB-JGW
MEMORANDUM OPINION AND ORDER
NORTH AMERICA CORPORATION, et al.
Defendants Philips Respironics, Inc. and Philips Electronics North America
Corporation (hereinafter “the Philips Defendants”) move to dismiss this action for lack of
subject-matter jurisdiction, arguing that Plaintiff Patricia Fenn’s (hereinafter “Fenn”) state
tort claims do not present a federal question simply because they incorporate alleged
violations of the Food, Drug, and Cosmetic Act (“FDCA”), as modified by the Medical
Device Amendments of 1976 (“MDA”). The Philips Defendants also contend that dismissal
is appropriate because Fenn did not properly serve them or file suit within the applicable
statute of limitations. Defendants Rotech Healthcare and Rothert’s Hospital Equipment,
Inc. (hereinafter “the Rotech Defendants”) also filed a Joint Motion, adopting and
incorporating by reference all arguments raised by the Philips Defendants (Doc. # 15).
Factual and Procedural Background
Patricia Fenn is a 71 year old woman who suffers from asthma, chronic obstructive
pulmonary disease (“COPD”), diabetes mellitus, morbid obesity and sleep apnea. (Doc.
# 1, p. 5, ¶ 12). These medical conditions made it difficult for Fenn to breathe while asleep,
so she began using a Continuous Positive Airway Pressure (“CPAP”) device at night. (Id.
at p.3, ¶ 1). Fenn’s CPAP machine, the REMStar Auto with A-Flex Sleep Therapy System,
was manufactured by the Philips Defendants. (Id.). The Rotech Defendants, who provide
home healthcare equipment and services, distributed the device to Fenn. (Id.).
On May 10, 2013, Fenn fell asleep while using the CPAP device, only to awake later
that night with a bad taste in her mouth. (Id. at p. 7, ¶ 19). The machine was emitting a
bad odor, like something burning, and the mask was covered with a brownish coating.
(Id.). Although Fenn had been feeling fine earlier that evening, she began experiencing
headache, nausea, abdominal pain and vomiting shortly after removing the mask. (Id.).
When her symptoms worsened, Fenn called 911 and EMS transported her to the
emergency room at St. Elizabeth Hospital. (Id.).
After arriving at St. Elizabeth, Fenn continued to report difficulty breathing, throbbing
headache with an 8/10 pain level and blurry vision in her left eye. (Id. at p. 7-8, ¶ 19-20).
Fenn also told hospital staff that the CPAP machine had an “explosive event where the
mask actually slammed her in the face.” (Id. at p. 8, ¶ 20). It is unclear how long Fenn
stayed at the hospital, what kind of treatment she received or whether chronic injuries
resulted. (Id.). The Complaint offers only a general statement that Fenn’s damages for
physical pain and suffering, emotional distress, loss of earning capacity, loss of enjoyment
of life, incurred medical and hospital expenses and loss of earning capacity “have occurred
in the past and will continue into the future.” (Id. at p. 16, ¶ 53).
According to the Complaint, the Rotech Defendants took custody of Fenn’s CPAP
machine after the incident. (Id. at p. 3, ¶ 1). The Rotech Defendants then sent the FDA
a “grievously inaccurate” Medwatch Form FDC 3500A, which failed to described Fenn’s
injuries or identify corrective measures taken. (Id. at p. 8, ¶ 21). Fenn alleges that the
device is still in the custody of the Rotech Defendants. (Id. at p. 3, ¶ 1).
Fenn filed this civil action on May 9, 2014. (Doc. # 1). That same day, her attorney
sent blank summonses to both the Philips Defendants and the Rotech Defendants.1 The
Philips Defendants responded by filing their Joint Motion to Dismiss for Lack of Jurisdiction
(Doc. # 9), which the Rotech Defendants adopted (Doc. # 15). About one month later, the
Clerk of Court issued a Notice of Deficiency as to these summonses and directed Fenn to
file the summonses stating the method of service. Fenn did as required and the Clerk of
Court issued the summonses, which were returned executed on June 25, 2014 (Doc. # 17).
Defendants then renewed their Joint Motion (Doc. # 19).
Standard of Review
“Motions to dismiss for lack of subject matter jurisdiction fall into two general
categories: facial attacks and factual attacks.” United States v. Ritchie, 15 F.3d 592, 598
(6th Cir. 1994). While factual attacks focus on the factual existence of subject matter
jurisdiction, facial attacks challenge the sufficiency of the pleadings. Id. Facial attacks are
evaluated under the same standard applicable to Rule 12(b)(6) motions. Id. Accordingly,
courts must “accept all material allegations as true and construe them in the light most
favorable to the nonmoving party.” Id.
1) The blank summonses were deficient because they were not issued by the Clerk of Court.
Although Fenn’s attorney filled out the necessary information, he did not present the completed
documents to the Clerk of Court for signature and sealing. See Fed. R. Civ. P. 4(b); LR 4.3.
Although Defendants have not specified whether their Motion qualifies as a factual
attack or a facial attack, it reads as a facial attack. Instead of disputing any of the facts
alleged in the Complaint, Defendants focus on why federal question jurisdiction should not
lie. Accordingly, the Court will evaluate Defendants’ Motion under the Rule 12(b)(6)
Clarification of the Complaint
Before delving into its substantive analysis, the Court must address a few
ambiguities in Plaintiff’s Complaint. Patricia Fenn brings a total of ten state law claims
against the Philips Defendants and the Rotech Defendants: (1) negligence; (2) negligence
per se; (3) breach of express warranty; (4) breach of warranty as to merchantability; (5)
breach of implied warranty; (6) strict liability for failure to warn; (7) strict liability for design
defect; (8) strict liability for manufacturing defect; (9) strict liability for failure to adequately
test; and (10) punitive damages. (Doc. # 1, p. 14-24, ¶ 47-112). According to the
Complaint, the Court has federal question jurisdiction over some of these claims because
they include alleged violations of the Food, Drug, and Cosmetic Act (“FDCA”) and Medical
Device Amendments (“MDA”), thereby raising issues of “federal statutory and regulatory
interpretation.” (Id. at p. 6, ¶ 14). Other claims are supposedly subject to supplemental
jurisdiction because they “are so related to claims in the action within such original
jurisdiction that they form part of the same case or controversy.” (Id. at p. 6-7, ¶ 16).
It would certainly be helpful to know which claims are subject to the federal question
jurisdiction analysis, and which are merely before the Court on supplemental jurisdiction,
but the Complaint makes no such distinctions. The individual counts also provide dubious
guidance. Although the Complaint includes an introductory section about the mechanics
of the FDCA and MDA, only one of the counts specifically cites to FDCA and MDA
requirements. (Id. at p. 16, ¶ 55). But because the Complaint also generally alleges that
some of the state law claims impose requirements that are parallel to those imposed by the
FDCA and MDA, the Court hesitates to limit its federal question analysis to just one claim.
Thus, out of an abundance of caution, the Court will analyze the Complaint as if all claims
were predicated on federal question jurisdiction, as any supplemental jurisdiction
arguments are likely to rise and fall with that determination.
The Food, Drug, and Cosmetic Act and Medical Device Amendments
The FDCA “specifically empowers the Food and Drug Administration (“FDA”) to
regulate production and labeling practices of medical product manufacturers and
distributors.” Sadler v. Advanced Bionics, Inc., 929 F. Supp. 2d 670, 674 (W.D. Ky. 2013);
21 U.S.C. § 301 et seq; see also Food and Drug Admin. v. Brown & Williamson Tobacco
Corp., 529 U.S. 120, 134 (2000) (finding that one of the FDCA’s “core objectives is to
ensure that any product regulated by the FDA is ‘safe’ and ‘effective’ for its intended use”).
However, ”Congress did not intend, either expressly or by implication, to create a private
cause of action under the FDCA.” Bailey v. Johnson, 48 F.3d 965, 968 (6th Cir. 1995); see
also Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n. 4 (2001) (“The FDCA
leaves no doubt that it is the Federal Government rather than private litigants who are
authorized to file suit for noncompliance with the medical device provisions.”).
For many years, “the introduction of new medical devices was left largely for the
States to supervise as they saw fit.” Reigel v. Medtronic, Inc., 552 U.S. 312, 315 (2008).
However, the Medical Device Amendments of 1976 “imposed a regime of detailed federal
oversight,” in which the level of administrative control varies according to the complexity
of the device and the risk of usage. Id. at 316; 21 U.S.C. § 360c et seq; see also Sadler,
929 F. Supp. 2d at 674. The MDA also “swept back some state obligations” with the
following express preemption clause:
Except as provided in subsection (b)2 of this section, no State or political
subdivision of a State may establish or continue in effect with respect to a
device intended for human use any requirement–
which is different from, or in addition to, any requirement
applicable under this chapter to the device, and
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); Sadler, 929 F. Supp. 2d at 674. This clause does not prevent states
“from providing a damages remedy for claims premised on a violation of FDA regulations;
the state duties in such a case ‘parallel,’ rather than add to, federal requirements.” Riegel,
552 U.S. at 330 (internal quotations omitted).
Federal Question Jurisdiction
Evolution of ‘Arising Under’ Jurisdiction
District courts “have original jurisdiction of all civil actions arising under the
Constitution, laws, or treaties of the United States.” 28 U.S.C. § 1331 (emphasis added).
A claim is said to ‘arise under’ federal law if a federal question is “presented on the face of
the plaintiff’s properly pleaded complaint.” Caterpillar Inc. v. Williams, 482 U.S. 386, 392
(1987); Merrell Dow Pharm., Inc. v. Thompson, 478 U.S. 804, 808 (1986). “It is not enough
that the plaintiff alleges some anticipated defense to his cause of action, and asserts that
2) Subsection (b) “permits the FDA to exempt some state and local requirements from
preemption.” Reigel, 552 U.S. at 316.
the defense is invalidated by some provision of the Constitution of the United States.“
Louisville & Nashville R.R. Co. v. Mottley, 211 U.S. 149, 152 (1908).
In the vast majority of federal question cases, this “well-pleaded complaint rule” is
easily satisfied because federal law actually creates the cause of action. Merrell Dow, 478
U.S. at 808-809.
However, a case may also ‘arise under’ federal law “‘where the
vindication of a right under state law necessarily turn[s] on some construction of federal
law.’” Id. (quoting Franchise Tax Board v. Constr. Laborers Vacation Trust, 463 U.S. 1, 9
(1983)). Stated another way, it must “‘appear[ ] that some substantial, disputed question
of federal law is a necessary element of one of the well-pleaded state claims.’” Id. (quoting
Franchise Tax Bd., 463 U.S. at 13). The “mere presence of a federal issue in a state cause
of action does not automatically confer federal question jurisdiction.” Id.
If the state claim incorporates a federal standard for which there is no private right
of action, the inquiry becomes more difficult. In Merrell Dow v. Thompson, the Supreme
Court of the United States considered whether a state negligence action, based in part on
a pharmaceutical company’s alleged violations of the FDCA, gave rise to federal question
jurisdiction. 478 U.S. at 804. The Court answered this question in the negative, reasoning
that “the congressional determination that there should be no federal remedy for the
violation of this federal statute is tantamount to a congressional conclusion that the
presence of a claimed violation of the statute as an element of a state cause of action is
insufficiently ‘substantial to confer federal question jurisdiction.’” Id. at 814.
Over the next twenty years, a circuit split developed as to whether Merrell Dow
“always requires a federal cause of action as a condition for exercising federal-question
jurisdiction,” prompting the Court to revisit its federal question analysis. Grable & Sons
Metal Prod., Inc. v. Darue Eng’g & Mfg. 545 U.S. 308, 311-12 (2005). In Grable, the Court
considered “whether want of a federal cause of action to try claims of title to land obtained
at a federal tax sale precludes removal to federal court of a state action with nondiverse
parties raising a disputed issue of federal title law.” Id. at 310. This time, the Court found
that the case warranted federal jurisdiction because “Grable has premised its superior title
claim on a failure by the IRS to give it adequate notice, as defined by federal law.” Id. at
314-15. The notice question was not only a necessary element of Grable’s state quiet title
action, but also a substantial and disputed federal issue, as the parties disagreed on the
meaning of ‘notice’ for purposes of federal tax law. Id. The Court further reasoned that it
was possible to entertain the case “without disturbing any congressionally approved
balance of federal and state judicial responsibilities” because so few state quiet title actions
involve contested issues of federal law. Id. at 315.
The Court then turned its attention to Merrell Dow, clarifying that the case “should
be read in its entirety as treating the absence of a federal private right of action as evidence
relevant to, but not dispositive of the ‘sensitive judgments about congressional intent’ that
§ 1331 requires.” Id. at 318. The absence of a private right of action became important in
Merrell Dow “when the Court treated the combination of no federal cause of action and no
preemption of state remedies for misbranding as an important clue to Congress’s
conception of the scope of jurisdiction to be exercised under § 1331.” Id. Under the
circumstances presented in Merrell Dow, the exercise of jurisdiction would have effectively
opened the floodgates, “[f]or if the federal labeling standard without a federal cause of
action could get a state claim into federal court, so could any other federal standard without
a federal cause of action.” Id. By contrast, “jurisdiction over actions like Grable’s would not
materially affect, or threaten to affect, the normal currents of litigation.” Id. at 319.
Examination of the Federal Issue
Like Merrell Dow and Grable, the instant case also involves state law claims that
allegedly turn on interpretations of federal law. Accordingly, the Court will focus on
“whether the federal issue is: (1) necessarily raised; (2) actually disputed; (3) substantial;
and (4) capable of resolution in federal court without disrupting the federal-state balance
approved by Congress.” Gunn v. Minton, 133 S.Ct. 1059, 1065 (2013).
In analyzing the first factor, the Court looks to Mauk v. Medtronic, Inc., in which the
Western District of Kentucky considered whether state law claims referencing the MDA
necessarily raised a federal issue. See No. 3:13-CV-01066-CRS-JDM, 2014 WL 4203134
at *7 (W.D. Ky. Aug. 22, 2014). The court answered this question in the affirmative. Id.
Not only would the plaintiffs have to avoid preemption by alleging a violation of state law
that paralleled a violation of federal law, thereby proving a violation of federal law, but the
preemption analysis would likely require the court to interpret the MDA. Id.; see also 21
U.S.C. § 360k(a)(1) (preempting any state requirements that are different from, or in
addition to, any requirements imposed by the MDA).
Fenn’s state law claims similarly reference the FDCA and MDA, so she too must
demonstrate that the alleged violations of state law parallel violations of federal law in order
to escape preemption. Because Fenn must essentially prove a violation of federal law, and
because this analysis will require the Court to interpret the MDA, a federal issue is
necessarily raised in this case.
As for the second factor, Fenn broadly states that the Court will have to determine
whether Defendants’ conduct conformed to FDCA and MDA requirements, and if they did
not, in what manner Defendants violated the FDCA and MDA. Although Fenn fails to
identify a more precise legal or factual dispute, the Complaint’s in-depth treatment of the
FDCA’s § 510k marketing requirements leads the Court to believe that compliance with §
510k may be the central issue in this case. Thus, the Court will infer at this juncture that
there is an actually disputed federal issue. See Mauk, 2014 WL 4203134 at *7 (finding that
“the federal issue is disputed, as the central issue to be resolved is whether Medtronic
promoted off-label uses of Infuse, and whether this promotion was the source of Plaintiffs’
The Supreme Court of the United States has recently clarified the third factor. In
Gunn v. Minton, the Court held that the ‘substantiality’ requirement is not met simply
because the resolution of that federal issue is “vitally important to the particular parties in
that case.” 133 S.Ct. at 1068. There must be “something more, demonstrating that the
question is significant to the federal system as a whole.” Id. The possibility that a state
court might incorrectly resolve the issue is insufficient. Id. at 1066.
Nothing in the record suggests that the federal questions involved in this case are
significant to the federal system as a whole. The few other courts that have addressed this
issue in the context of the FDCA and MDA reached a similar conclusion. See Mauk, 2014
WL 4203134 at *8 and Goade v. Medtronic, Inc., No. 13-5123-CV-SW-ODS, 2013 WL
6237853 at *5-6 (W.D. Mo. Dec. 3, 2013) (noting that federal issues have been found
substantial when they directly affect the government’s operations, as in Grable). While
these cases may have involved slightly different aspects of the FDCA, the Court is not
aware of any nuances in this case that would dictate a different result.
Thus, the Court arrives at the final, and arguably most important, factor–whether the
federal issue is capable of resolution in federal court without disrupting the federal-state
balance approved by Congress. Although case law is clear that the lack of a private right
of action for FDCA and MDA violations does not control the federal question jurisdiction
analysis, it is a relevant factor for the Court’s consideration. Grable, 545 U.S. at 318.
Moreover, the lack of a private right of action, when combined with no preemption of state
remedies, is “an important clue to Congress’s conception of the scope of jurisdiction to be
exercised under § 1331.” Id. After all, “if the federal labeling standard without a federal
cause of action could get a state claim into federal court, so could any other federal
standard without a federal cause of action. Id.
These conditions, which ultimately led the Merrell Dow Court to find that federal
question jurisdiction was lacking, are also present in this case. Fenn’s state law claims
include alleged violations of the FDCA/MDA, for which there is no private right of action.
While the preemption issue has not been extensively briefed, Fenn has repeatedly stated
that her state law claims parallel the federal requirements, and there is case law to suggest
that at least some of her claims would not be preempted. See Waltenburg v. St. Judge
Med., Inc., No. 3:13-CV-011-06-TBR, 2014 WL 3586471 (W.D. Ky. July 21, 2014) (holding
that negligence, strict liability manufacturing defect and negligent failure to warn claims
under Kentucky law are not preempted by the MDA’s express preemption provision); Sadler
v. Advanced Bionics, Inc., 929 F. Supp. 2d 670 (W.D. Ky. Mar. 8, 2013) (concluding that
negligence and strict liability for failure to test claims were not expressly preempted). If this
Court were to exercise federal jurisdiction over this case, its decision might “attract [ ] a
horde of original filings and removal cases raising other state claims with embedded federal
issues,” which would certainly disrupt the federal-state balance approved by Congress.
Grable, 545 U.S. at 318.
Thus, the Court concludes that federal question jurisdiction is not present in this
case. Although there seems to be a necessarily raised and disputed federal issue, it simply
does not have the broader implications for the federal system to qualify as ‘substantial,’ nor
is it capable of resolution without disrupting the federal-state balance. Having found that
federal question jurisdiction is lacking, the Court need not address the parties’ arguments
with respect to improper service and the statute of limitations.
Since the Court has determined that federal question jurisdiction does not exist,
supplemental jurisdiction will not lie either. While there are situations in which it is proper
to resolve the supplemental jurisdiction claims after disposition of the original jurisdiction
claims, this is certainly not one of those instances. See Landefeld v. Marion Gen. Hosp.,
Inc., 994 F.2d 1178, 1182 (6th Cir. 1993) (finding no error in the district court’s decision to
dismiss the plaintiff’s pendent state breach of contract and tort claims following dismissal
of his federal handicap discrimination claim); Aschinger v. Columbus Showcase Co., 934
F.2d 1402, 1412 (6th Cir. 1991) (stating that district courts should balance the interests of
judicial economy and the avoidance of multiplicity of litigation against the possibility of
needlessly deciding state law issues). Thus, this action must be dismissed in full. Fenn
is free to re-file her action in the appropriate state court within ninety (90) days of the entry
of this Order. See Ky. Rev. Stat. Ann. § 413.270 (stating that “[t]he time between the
commencement of the first and last action shall not be counted in applying any statute of
Accordingly, for the reasons stated herein,
IT IS ORDERED as follows:
Defendants’ Joint Motion to Dismiss (Docs. # 9 and 15) be, and is hereby,
granted in full;
Plaintiff’s Complaint is hereby dismissed with prejudice; and
This matter is hereby stricken from the Court’s active docket.
This 13th day of February, 2015.
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