Steed v. Boston Scientific Corporation et al
Memorandum of Opinion and Order For the reasons set forth herein, the Court grants Plaintiff Karen S. Steed's Motion to Remand to State Court (ECF No. 5 ). The case is remanded to the Columbiana County, Ohio Court of Common Pleas forth with. Defendant BSC's Motion to Dismiss (ECF No. 11 ) remains pending and shall be transmitted to the Columbiana County, Ohio Court of Common Pleas. Defendant BSC's Motion for Leave to File Sur-Reply Brief Instanter (ECF No. 18 ) is granted. Plaintiff's Motion to Strike (ECF No. 19 ) is denied. Defendant BSC's Motion for a Consolidated Response Date (ECF No. 22 ) is denied as moot. Judge Benita Y. Pearson on 7/12/2017. (JLG)
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF OHIO
KAREN S. STEED
BOSTON SCIENTIFIC CORPORATION, et
CASE NO. 4:17CV0824
JUDGE BENITA Y. PEARSON
MEMORANDUM OF OPINION AND
[Resolving ECF Nos. 5, 18, 19, and 22]
Pending is the Motion to Remand to State Court filed by Plaintiff Karen S. Steed (ECF
No. 5) which removing Defendant Boston Scientific Corporation (“BSC”) opposes (ECF No.
13). The Court has been advised, having reviewed the record, the parties’ briefs, telephonic
argument, and the applicable law. For the reasons set forth below, Plaintiff’s motion to remand
Plaintiff underwent a surgical procedure involving a Hydro Thermal Endometrial
Ablation System- Genesys HTA Procerva Kit (the “Device”). ECF No. 1-3 at PageID #: 27-28,
¶¶ 15-27. The procedure resulted in second and third degree burns to Plaintiff’s perineum,
perianal area, and buttocks. ECF No. 1-3 at PageID #: 29, ¶¶ 32-41. On March 10, 2017,
Plaintiff brought this products liability and medical malpractice action against Defendants Boston
Scientific Corporation (“BSC”), Salem Regional Medical Center (“Salem Regional”), and Dr.
Fu-Nen Lee, M.D. (“Dr. Lee”) in the Columbiana County, Ohio Court of Common Pleas. See
Complaint, ECF No.1-3 PageID #: 23-43. As to Defendant BSC, the alleged manufacturer of the
Device, the eleven-count Complaint asserts product liability claims for defective manufacture or
construction (First Claim) (ECF No. 1-3 at PageID #:30-31, ¶¶ 43-53), defective design or
formulation (Third Claim) (ECF No. 1-3 at PageID #: 33-34, ¶¶ 65-73), and defect due to
inadequate warning or instruction (Fifth Claim) (ECF No. 1-3 at PageID #: 36-37, ¶¶ 83-90)
pursuant to Ohio Revised Code §§ 2307.73(A)(1) and 2307.76. Plaintiff also alleges claims of
medical malpractice against Defendants Salem Regional (Ninth Claim) (ECF No. 1-3 at PageID
#: 39-40, ¶¶ 109-13) and Dr. Lee (Eleventh Claim) (ECF No. 1-3 at PageID #: 41, ¶¶ 119-24).1
On April 17, 2017, Defendant BSC removed the case to the Northern District of Ohio on
the basis of federal question jurisdiction pursuant to 28 U.S.C. §§ 1331, 1441(a), (c)(1) and 1446.
ECF No. 1 at PageID #: 1.2 Defendant BSC avers that federal jurisdiction exists because
Plaintiff’s allegations are controlled and preempted by the Food and Drug Administration’s
Plaintiff also asserts product liability and medical malpractice claims against
John/Jane Doe defendants. See Complaint, ECF No. 1-3 PageID #: 23-43.
Contrary to Plaintiff’s assertion (ECF No. 5 at PageID #: 86), the consent of
Defendants Salem Regional and Dr. Lee is not required for removal of this action.
Pursuant to 28 U.S.C. § 1441( c), “only defendants against whom [a claim arising under
the laws of the United States] has been asserted are required to join in or consent to
removal” when a civil action includes a claim arising under the laws of the United States
and a claim not within the original jurisdiction of the district court. But see 28 U.S.C. §
1446(2)(A) (“when a civil action is removed solely under section 1441(a), all
defendants . . . must join in or consent to the removal of the action.”) (emphasis added).
(“FDA”) Premarket Approval (“PMA”) process for a Class III medical device. ECF No.1 at
PageID #: 1-3. On April 26, 2017, Plaintiff moved the Court to remand this action back to the
Columbiana County, Ohio Court of Common Pleas on grounds that: (1) Plaintiff’s claims do not
raise a substantial federal issue; and (2) allowing the issue to be heard in federal court would
disrupt the federal-state balance. ECF No. 5 at PageID #: 90. Defendant BSC responded (ECF
No. 13); Plaintiff replied (ECF No. 14). The matter is now ripe for adjudication.
II. Standard of Review
Pursuant to 28 U.S.C. § 1441(a), “any civil action brought in a State court of which the
district courts of the United States have original jurisdiction, may be removed by the defendant or
defendants, to the district court of the United States for the district and division embracing the
place where such action is pending.” District courts have original jurisdiction over civil actions
that arise under federal law, see 28 U.S.C. § 1331. An action “arises under” federal law if (1)
“federal law creates the cause of action,” or (2) “the vindication of a right under state law
necessarily turned on some construction of federal law.” Merrell Dow Pharm. Inc. v. Thompson,
478 U.S. 804, 808-09 (1986) (quoting Franchise Tax Bd. v. Constr. Laborers Vacation Tr., 463
U.S. 1, 9 (1983)).
“The presence or absence of federal-question jurisdiction is governed by the
‘well-pleaded complaint rule,’ which provides that federal jurisdiction exists only when a federal
question is presented on the face of the plaintiff’s properly pleaded complaint.”
Caterpillar v. Williams, 482 U.S. 386, 392 (1987); see also Husvar v. Rapoport, 430 F.3d 777,
781 (6th Cir. 2005) (“Pursuant to that ‘rule,’ the federal judiciary recognizes that ‘the plaintiff is
the master of the complaint, a federal question must appear on the face of the complaint,
andthe plaintiff may, by eschewing claims based on federal law, choose to have the cause heard
in state court.’”) (quoting Caterpillar, 482 U.S. at 399). “The existence of subject matter
jurisdiction is determined by examining the complaint as it existed at the time of removal.”
Harper v. AutoAlliance Int'l., Inc., 392 F.3d 195, 210 (6th Cir. 2004).
Even though a claim originates in state law, the Supreme Court has recognized a
“‘special and small category’ of cases in which arising under jurisdiction lies.” Gunn v. Minton,
133 S. Ct. 1059, 1064 (2013).
[F]ederal jurisdiction over a state law claim will lie if a 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. Where all four of these
requirements are met, we have held, jurisdiction is proper because
there is a serious federal interest in claiming the advantages thought
to be inherent in a federal forum, which can be vindicated without
disrupting Congress's intended division of labor between state and
Id. at 1065 (citing Grable & Sons Metal Prods., Inc. v. Darue Eng’g & Mfg., 545 U.S. 308, 31314 (2005)) (internal quotations omitted). The removing party bears the burden of showing that
federal question jurisdiction exists. Long v. Bando Mfg. of Am., Inc., 201 F.3d 754, 757 (6th Cir.
2000). “All doubts as to the propriety of removal are resolved in favor of remand.” Coyne v.
Am. Tobacco Co., 183 F.3d 488, 493 (6th Cir. 1999).
Here, the parties concede that the first two factors of the Grable/Gunn test are met. ECF
No.5 at PageID #: 90; ECF No.13 at PageID #: 191-92. The parties agree that Plaintiff’s claims
raise the issue of whether Defendant BSC complied with the requirements of the Federal Food,
Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq. See ECF No.1 at PageID #: 1-2, ¶¶
2-5 (“Plaintiff pleads violations of state law [that are] truly based upon the federal regulatory
system—the FDA, [therefore,] Plaintiff’s right to relief turns on resolution and interpretation of
the federal-law questions”); ECF No. 5 at PageID #: 93 (“[Plaintiff’s state law] claims essentially
run parallel to the federal regulations for device manufacturers. . . . [and] may be proven by
evidence of conduct violating the [FDCA].”). Accordingly, and in the interest of judicial
efficiency, the Court considers below only the parties’ arguments as to whether Defendant BSC
has met the third and fourth factors of the Grable/Gunn test—substantiality and federal-state
balance. See Gunn, 133 S. Ct. at 1065; Grable, 545 U.S. at 314.
For an issue to be substantial, the Court must “look to the importance of the issue to the
federal system as a whole.” Gunn, 133 S. Ct. at 1066. It is clear from the parties’ briefs that
federal courts are split in their interpretation of this third factor. The Sixth Circuit has not
considered the issue in the context of FDA-regulated products since the Supreme Court’s ruling
in Gunn.3 But, post-Gunn, the majority of federal courts considering the issue have remanded
these actions and held that state tort claims concerning FDA-regulated products do not raise a
substantial federal issue, despite the claims’ reliance on violations of the FDCA. See, e.g.,
Schilmiller v. Medtronic, Inc.,44 F. Supp. 3d 721, 731 (W.D. Ky. 2014) (“ [I]t is not enough that
the plaintiff’s state law claims arise under the backdrop of a federal issue . . . .[T]he importance
of the federal issue must ‘transcend the parties.’”); Goade v. Medtronic, No. 13-5123, 2013 WL
6237853, at *5 (W.D. Mo. Dec. 3, 2013) (“This degree of importance has been found only when
the Government’s operations are affected by the federal issue.”); Carmine v. Poffenbarger, 154
F. Supp. 3d 309, 318 (E.D. Va. 2015) (“None of the issues in this case would affect the
Government’s operation. The disputes related to whether medical manufacturers designed,
manufactured, and promoted an unreasonably dangerous product.”); Waitz v. Yoon, No. 1:14-cv2875-MHC, 2015 WL 11511577 (N.D. Ga., June 30, 2015) (“The federal issue here carries no
substantial significance to the federal system as a whole but rather involves purely state law
claims that revolve around a federal regulatory scheme.”).4
The Court notes that the Sixth Circuit has announced four factors that the Court
must consider under the “subtantial-federal-issue doctrine” in Mikulski v. Centerior
Energy Corp., 501 F.3d 555, 570 (6th Cir. 2007). However, Mikulski did not consider the
most recent discussion of the substantiality factor by the Supreme Court in Gunn.
The Court recognizes that the Medtronic cases cited involved claims of products
liability and medical malpractice involving the off-label use of an FDA-regulated biologic
product—specifically, a bone graft product used during spinal fusion surgeries. The
Court finds the parties’ attempts to distinguish these cases based on the type of product at
issue (e.g., medical device, biologic, drug, etc.) unavailing. At the crux of the removing
See also Sangimino v. Bayer Corp., No. C 17-01488 WHA, 2017 WL 2500904, at *1 (N.D. Cal.
June 9, 2017) (remanding action to state court because plaintiffs claims against manufacturer
alleging a defective permanent contraceptive device did not raise substantial federal issue).5
Still, other federal courts have denied motions to remand and held that state tort claims
concerning FDA-regulated products raise a substantial federal issue. However, the Court
recognizes that the cases, on which Defendant BSC’s argument chiefly relies, did not analyze the
third Grable/Gunn factor under the standard for substantiality that was announced in Gunn. See
H.R. ex rel. Reuter v. Medtronic, Inc., 996 F. Supp. 2d 671 (S.D. Ohio 2014) (Black, J.); Jenkins
v. Medtronic, Inc., 984 F. Supp. 2d 873 (W.D. Tenn. 2013). Moreover, the Southern District of
Ohio subsequently ruled in favor of remand on the same issue and recognized that it did not
consider Gunn when it decided Reuter. See Baker v. UC Health, No. 1:16-CV-00853-TSB, 2017
WL 510271, at *6 (S.D. Ohio Feb. 8, 2017) (Black, J.) (“However, that decision [in Reuters] did
parties’ arguments in each instance is the pursuit of federal question jurisdiction based on
the FDA’s regulation of the product’s use, safety, or effectiveness (be it a medical device,
biologic, or drug) pursuant to the FDCA. Each case disputes whether the defendants
designed, manufactured, or promoted an unreasonably dangerous product. Accordingly,
in deciding whether to remand this action, the Court finds no reason to distinguish postGunn case law based on the nature of Plaintiff’s claims.
The Court also recognizes that, in support of its arguments on the federal-state
balance, Defendant relies on a conflicting ruling out of the Western District of North
Carolina on a motion to remand involving the same permanent birth control device at
issue in Sangimino. See Burrell v. Bayer Corp., Case No. 1:17-cv-00032-MOC-DSC
(W.D.N.C. Mar. 17, 2017). In Burrell, however, the Court did not consider the refined
substantiality standard announced in Gunn. See Order, ECF No. 28 in Case No. 1:17cv0032-MOC-DSC (W.D.N.C.) at PageID #: 6-8.
not take into account the United States Supreme Court's holding in Gunn[. ] Gunn clarified the
substantiality inquiry to require that the disputed federal issue be “significant to the federal
system as a whole.’”).
The Court finds Defendant BSC’s argument that there is significant interest in
“adjudicating the safety and effectiveness concerns . . . in a unified federal court system”
unpersuasive. ECF No. 13 at PageID #: 192. The gist of Defendant BSC’s argument is that
Plaintiff’s state tort claims raise a substantial federal issue because the Device required the
approval and continuous review of the FDA. ECF No.1 at PageID #: 1-3, ¶¶ 2-5. The Court is
inclined to rule in harmony with those federal courts that analyzed the substantiality of the
federal issue when a plaintiff’s complaint involves violations of the FDCA pursuant to the
standard announced by the Supreme Court in Gunn—that is, by focusing on the importance of
the issue to the federal system as a whole. While the federal question at issue in the present case
is significant to the parties, it does not transcend the parties, affect the government’s operations,
or challenge federal law in a manner evidencing importance of the issue to the federal system as a
Accordingly, Defendant BSC has not met its burden of showing that federal question
jurisdiction exists under § 1331.
B. Federal-State Balance
Even if Plaintiff’s claims raise a substantial federal issue, should the Court exercise its
jurisdiction in this case, it would likely upset the federal-state balance approved by Congress.
Congress has not provided a private right of action under the FDCA. See Merrell Dow Pharm.
Inc. v. Thompson, 478 U.S. 804, 806-07 (2014) (“[T]he FDCA does not create or imply a private
right of action for individuals injured as a result of violations of the Act[.]”) (quoting Franchise
Tax Bd. v. Constr. Laborers Vacation Tr., 463 U.S. 1 (1983)); 21 U.S.C. § 337(a). Nor has
Congress preempted all state remedies under the FDCA; discussed infra. While the lack of a
private right of action does not by itself preclude federal jurisdiction, the combination of its
absence and the absence of preemption is “an important clue to Congress’s conception of the
scope of the jurisdiction to be exercised under 1331.” Grable, 545 U.S. at 318 (2005).
Defendant BSC’s argument that the federal-state balance will not be interrupted “in light
of the extraordinary federal involvement in the very issues that are at the heart of this case, and
the small number of medical devices subject to such extraordinary federal oversight” is
unpersuasive. ECF No. 1 at PageID #: 2. Accordingly, Defendant fails to meet the fourth factor
under the Grable/Gunn test.
Finally, the Court finds Defendant BSC’s preemption arguments unavailing. While the
Medical Device Amendments (“MDA”) to the FDCA contains a preemption provision, 21 U.S.C.
§ 360k(a), it has long been settled that a federal court may not exercise jurisdiction on the basis
of a defense, including preemption, alone. Caterpillar, 482 U.S. at 392; see Franchise Tax Bd.,
463 U.S. at 14. Moreover, preemption under the MDA does not “prevent a State from providing
a damages remedy for claims premised on a violation of the FDA regulations; the state duties in
such a case ‘parallel,’ rather than add to, federal requirements.” Riegel v. Medtronic, Inc., 552
U.S. 312, 330 (2008).
For the foregoing reasons, the Court grants Plaintiff Karen S. Steed’s Motion to Remand
to State Court (ECF No. 5). The case is remanded to the Columbiana County, Ohio Court of
Common Pleas forthwith. Defendant BSC’s motion to dismiss (ECF No. 11) remains pending
and shall be transmitted to the Columbiana County, Ohio Court of Common Pleas.
Defendant BSC’s motion for leave to file sur-reply brief instanter (ECF No. 18) is
granted. Plaintiff’s motion to strike (ECF No. 19) is denied. Defendant BSC’s motion for a
consolidated response date (ECF No. 22) is denied as moot.
IT IS SO ORDERED.
July 12, 2017
/s/ Benita Y. Pearson
Benita Y. Pearson
United States District Judge
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