Schmidt v. Boston Scientific Corporation, et al

Filing 45

Order and Decision dismissing the amended complaint. Judge John R. Adams on 3/31/16. (K,C)

UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF OHIO
EASTERN DIVISION
LOGAN M. SCHMIDT,

)
)
Plaintiff,
)
)
vs.
)
)
)
BOSTON SCIENTIFIC CORPORATION,)
et al.,
)
)
Defendants.
)

CASE NO. 5:15CV00488
JUDGE JOHN R. ADAMS

ORDER AND DECISION
(Resolving Doc. 31, 33)

This matter is before the Court on two motions to dismiss filed by Defendant Medtronic,
Inc. (“Medtronic”) and Defendants Boston Scientific Corporation and Guidant LLC (collectively
“Boston Scientific”). Docs. 31, 33.

Pursuant to Fed.R.Civ.P. 8 and the Supreme Court’s

holdings in Bell Atlantic Corp. v. Twombly and Ashcroft v. Iqbal, this Court finds that Plaintiff
Logan Schmidt has failed to plead the requisite facts and elements necessary to state parallel
claims for defective design, manufacture, formulation, construction, and inadequate warning of a
Class III medical device. Furthermore, Schmidt has failed to sufficiently plead a claim for
supplier liability. Finally, Schmidt’s claims for common law negligence are preempted by
federal law and abrogated by Ohio statute. As such, this Court hereby DISMISSES Schmidt’s
Amended Complaint.
I. FACTS AND PROCEDURAL HISTORY
Schmidt has had a number of medical procedures since childhood for his heart, including
implantation of Implantable Cardioverter Defibrillators (“ICDs”) and their components,
including leads and shocking coils. Doc. 27. Schmidt believes these medical devices were
manufactured, designed, and distributed by Medtronic, Boston Scientific and Doe Entities 1-3.
Doc. 27. Consequently, he then filed the underlying lawsuit in the Stark County, Ohio Court of
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Common Pleas, alleging damages from a short-circuit in 2009 of a lead, electrical coil, or its
component. The original Complaint set forth five causes of action:
1)

Products Liability Defective Design, Manufacture, Formulation, Construction,
“brought pursuant to Ohio Revised Code § 2307.75 et seq.”

2)

Products Liability – Inadequate Warning, “brought pursuant to Ohio Revised
Code § 2307.75 et seq.”

3)

Products Liability – Supplier Liability, “brought pursuant to Ohio Revised Code
§ 2307.78 et seq.”

4)

Negligence – Inadequate Warning, brought pursuant to Ohio common law.

5)

Negligence – Defective Design/Manufacture, brought pursuant to Ohio common
law.

Doc. 1-1.
Boston Scientific later removed the case to federal court. Medtronic and Boston
Scientific then filed motions to dismiss under Fed.R.Civ.P. 8(a) and 12(b)(6). Schmidt filed a
response and sought leave to amend the Complaint, which was granted. Schmidt filed an
Amended Complaint alleging the same causes of action, but including additional details such as
device identification numbers. Doc. 27. Medtronic and Boston Scientific re-filed their motions
to dismiss, arguing the following:
1) Schmidt failed to sufficiently plead his claims for relief;
2) Schmidt’s claims are preempted by federal law and Schmidt has failed to satisfy the
narrow exception of state law claims; and,
3) Schmidt’s common law negligence claims are barred by the Ohio Products Liability
Act.
Docs. 31, 33. Medtronic and Boston Scientific’s motions raise the same issues and will therefore
be addressed together. After reviewing the briefing in the matter, the Court finds the motions are
well-taken.

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II. LAW AND ANALYSIS
A. Legal Standard
The Supreme Court has set forth the standard for a motion to dismiss under Rule 8 as
follows:
We turn to respondent's complaint. Under Federal Rule of Civil Procedure
8(a)(2), a pleading must contain a “short and plain statement of the claim
showing that the pleader is entitled to relief.” As the Court held in Twombly,
550 U.S. 544, 127 S.Ct. 1955, 167 L.Ed.2d 929, the pleading standard Rule
8 announces does not require “detailed factual allegations,” but it demands
more than an unadorned, the-defendant-unlawfully-harmed-me accusation.
Id., at 555, 127 S.Ct. 1955 (citing Papasan v. Allain, 478 U.S. 265, 286, 106
S.Ct. 2932, 92 L.Ed.2d 209 (1986)). A pleading that offers “labels and
conclusions” or “a formulaic recitation of the elements of a cause of action
will not do.” 550 U.S., at 555, 127 S.Ct. 1955. Nor does a complaint suffice
if it tenders “naked assertion[s]” devoid of “further factual enhancement.”
Id., at 557, 127 S.Ct. 1955.
To survive a motion to dismiss, a complaint must contain sufficient factual
matter, accepted as true, to “state a claim to relief that is plausible on its
face.” Id., at 570, 127 S.Ct. 1955. A claim has facial plausibility when the
plaintiff pleads factual content that allows the court to draw the reasonable
inference that the defendant is liable for the misconduct alleged. Id., at 556,
127 S.Ct. 1955. The plausibility standard is not akin to a “probability
requirement,” but it asks for more than a sheer possibility that a defendant
has acted unlawfully. Ibid. Where a complaint pleads facts that are “merely
consistent with” a defendant's liability, it “stops short of the line between
possibility and plausibility of ‘entitlement to relief.’ ” Id., at 557, 127 S.Ct.
1955 (brackets omitted).
Two working principles underlie our decision in Twombly. First, the tenet
that a court must accept as true all of the allegations contained in a
complaint is inapplicable to legal conclusions. Threadbare recitals of the
elements of a cause of action, supported by mere conclusory statements, do
not suffice. Id., at 555, 127 S.Ct. 1955 (Although for the purposes of a
motion to dismiss we must take all of the factual allegations in the
complaint as true, we “are not bound to accept as true a legal conclusion
couched as a factual allegation” (internal quotation marks omitted))…
Second, only a complaint that states a plausible claim for relief survives a
motion to dismiss.

Ashcroft v. Iqbal, 556 U.S. 662, 677-79 (2009).
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B. Insufficient Pleading to State a Claim
It is undisputed that the equipment that forms the basis of Schmidt’s claims are Class III
medical devices under 21 U.S.C. §360c(a)(1)(C). 1 It appears from the pleadings and the briefing
that the parties do not dispute that the 1938 Food, Drug, and Cosmetic Act, as amended (“FDA”)
exclusively enforces Class III device requirements. Although “citizens may report wrongdoing
and petition the agency to take action,” there is no private right of action under the FDA in the
event a violation is uncovered. Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 349
(2001). However, individuals may assert certain state law claims related to the devices as long
as they are considered “parallel claims,” that is, as long as they assert a claim for damages
premised on a violation of the FDA regulations that are not “different from, or in addition to” the
requirements imposed by federal law. Reigel, 552 U.S. at 330, citing Medtronic, Inc. v. Lohr,
518 U.S. 470, 495 (1996).
Armed with the Supreme Court’s ruling in Reigel, courts have held that “[p]arallel claims
must be specifically stated in the initial pleadings. A plaintiff must allege that ‘[the] defendant

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In 1976, Congress enacted the Medical Device Amendments (“MDA”) to the 1938 Food, Drug, and Cosmetic Act
(“FDA”), in order to “provide for the safety and effectiveness of medical devices intended for human use.” Riegel v.
Medtronic, Inc., 451 F.3d 104, 108 (2nd Cir. 2006), aff’d by Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008). Those
devices for which “‘general controls’ and ‘special controls’ are insufficient to provide reasonable assurance of safety
and effectiveness, and which either ‘present a potential unreasonable risk of illness or injury’ or are ‘for a use in
supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of
human health’ are classified as Class III devices.” Id. at 109 (citing21 U.S.C. § 360c(a)(1)(C)).
To market a Class III device within the United States, the manufacturer must either submit its
product to the FDA for premarket approval (“PMA process”), or qualify for one of two exceptions
to this time-intensive regulatory review. The PMA process involves close scrutiny of the device by
the FDA, and approval requires that the FDA conclude that it has received “reasonable assurances
of [the device's] safety and effectiveness” from the manufacturer. Id. § 360c(a)(1)(C). To that end,
manufacturers must provide the FDA with samples of the device, an outline of the device's
components, a description of the manufacturing process, copies of the proposed labels, and
various other information. See 21 C.F.R. § 814.20(b). The FDA then reviews such submissions for
an average of 1200 hours before either approving or disapproving the device. Id. §§ 812.1–.150;
see also Mitchell v. Collagen Corp., 126 F.3d 902, 905 (7th Cir.1997).
Kemp v. Medtronic, Inc., 231 F.3d 216, 221 (6th Cir. 2000).

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violated a particular federal specification referring to the device at issue.’” Wolicki-Gables v.
Arrow Intern., Inc., 634 F.3d 1296, 1301 (11th Cir. 2011) (quoting Ilarraza v. Medtronic, Inc.,
677 F.Supp.2d 582, 589 (E.D.N.Y.2009)). “‘To properly allege parallel claims, the complaint
must set forth facts ‘pointing to specific PMA [FDA premarket approval process] requirements
that have been violated.’” Id. (quoting Parker v. Stryker Corp., 584 F.Supp.2d 1298, 1301
(D.Colo.2008)).
In the underlying case, Schmidt focuses his Amended Complaint solely on asserting
parallel claims under Ohio Revised Code §§ 2307.75 et seq. and 2307.78 et seq. generally.
Schmidt does not identify the specific FDA requirement that is alleged to have been violated or
the specific, parallel Ohio requirement. Instead, Schmidt makes the general legal conclusion that
Medtronic and Boston Scientific’s “…failure to comply with relevant Federal statutes and
regulations pertaining to the cardiac devices” proximately caused him harm. Doc. 27 at ¶¶23.
37, 42. “Threadbare recitals of the elements of a cause of action, supported by mere conclusory
statements, do not suffice” to overcome a motion to dismiss. Iqbal, 556 U.S. at 677-79. As
such, Schmidt’s mere conclusory statements that Medtronic and Boston Scientific have failed to
comply with federal statutes and regulations are insufficient for the purposes of Rule 8 and the
requirements of Iqbal and Twombly.
Schmidt argues that he is unable to identify the federal provisions or the Ohio statutes
that have been violated without discovery.

However, Schmidt has sufficient information

accessible without discovery to identify both the federal provision and state statutes. Schmidt
has exclusive control over his medical records, which would include device information, along
with access to the FDA website, which describes in detail the PMA approval process for the
ICDs, leads and related components that are within the public domain. Schmidt could have, with

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reasonable effort, described the federal requirements that have allegedly been violated and any
parallel state statute. Other courts have likewise determined that a general argument for more
discovery does not necessarily save a defective pleading. See Johnson v. Eli Lilly and Co.,
1:14CV453, 2015 WL 1120009 (S.D. Ohio March 12, 2015) (dismissing plaintiff’s claim for
defective manufacturing/construction even though plaintiff argues she could not identify a
specific manufacturing defect without discovery and plaintiff alleged drug was not made in
accordance with manufacturer’s specifications or standards); see also Frey v. Novartis
Pharmaceuticals Corp., et al., 642 F.Supp.2d 787 (S.D. Ohio 2009).
Finally, it appears undisputed by the parties that Schmidt’s negligence claims are
preempted. Reigel, 552 U.S. at 320. It is also undisputed that the negligence claims are
abrogated by the Ohio Product Liability Act. Schmidt does not oppose the defendants’ motions
on this negligence issues. As such, the Court hereby dismisses Schmidt’s negligence claims as
being preempted.
Because Schmidt has already had an opportunity to amend the Complaint to make it
compliant with Rule 8, Iqbal, and Twombly, the Court hereby DISMISSES the Amended the
Complaint.
IV.

CONCLUSION
The Court finds that Plaintiff’s Amended Complaint fails to comply with the

requirements of Rule 8 and the Supreme Court’s decisions in Iqbal and Twombly. As such, the
Amended Complaint is hereby DISMISSED.
IT IS SO ORDERED.
DATE: March 31, 2016

/s/ John R. Adams_________________
Judge John R. Adams
UNITED STATES DISTRICT COURT

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