Wright v. Medtronic Inc. et al

Filing 134

OPINION; Order to issue; signed by Judge Janet T. Neff (Judge Janet T. Neff, clb)

UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF MICHIGAN
SOUTHERN DIVISION

ANGIE L. WRIGHT,
Plaintiff,

Case No. 1:13-cv-716

v.

HON. JANET T. NEFF

MEDTRONIC, INC., MEDTRONIC
SOFAMOR DANEK, USA, INC., and
MEDTRONIC VERTELINK, INC.,
Defendants.
____________________________________/

OPINION
Pending before the Court in this diversity-products liability action is Defendants’ Motion to
Dismiss (Dkt 113). Plaintiff filed a response in opposition to Defendants’ motion (Dkt 115), and
Defendants filed a reply (Dkt 116). Defendants have also since filed numerous supplemental
authorities for the Court’s consideration (Dkts 123-26, 131-33). Having conducted a Pre-Motion
Conference in this matter and having fully considered the parties’ written briefs and accompanying
exhibits, the Court finds that the relevant facts and arguments are adequately presented in these
materials and that oral argument would not aid the decisional process. See W.D. Mich. LCivR
7.2(d). For the reasons that follow, the Court determines that Defendants’ motion is properly
granted in part and denied in part.
I. BACKGROUND
Defendants, whom Plaintiff sometimes collectively references as “Medtronic,” design,
manufacture, construct, assemble, inspect and sell various types of medical drugs and devices,

including spinal surgery drugs and devices, and specifically the Infuse Bone Graft and LT-Cage,
collectively known as “Infuse,” which is the medical device at issue in this case (Dkt 95, First
Amend. Compl. ¶ 5).1 Infuse, the trade name for rhBMP-2, a bone morphogenetic protein, is used
as an alternative to procuring bone graft material from another part of a patient’s body or from a
cadaver (id. ¶¶ 79-82).
On July 2, 2002, the Food and Drug Administration (FDA) approved Infuse for use in an
Anterior Lumbar Interbody Fusion (ALIF) procedure involving a single-level fusion in the L4-S1
region of the lumbar spine (Dkt 95, First Amend. Compl. ¶¶ 57-58, 84, 88). ALIF is performed by
approaching the spine from the front through an incision in the abdomen and is primarily used to
treat pain resulting from disc collapse (id. ¶¶ 58, 88). Infuse’s FDA-approved label indicates the
following:
The InFUSETM Bone Graft/LT-CAGETM Lumbar Tapered Fusion Device consists of
two components containing three parts—a tapered metallic spinal fusion cage, a
recombinant human bone morphogenetic protein and a carrier/scaffold for the bone
morphogenetic protein and resulting bone. The InFUSETM Bone Graft is inserted
into the LT-CAGETM Lumbar Tapered Fusion Device component to form the
complete InFUSETM Bone Graft/LT-CAGETM Lumbar Tapered Fusion Device.
These components must be used as a system. The InFUSETM Bone Graft
component must not be used without the LT-CAGETM Lumbar Tapered Fusion
Device component.
(Defs.’ Ex. 3, Dkt 114-3 at 2) (emphases in original). The label further indicates that the device “is
to be implanted via an anterior . . . approach,” warning that “[t]he safety and effectiveness of the
InFUSE Bone Graft component . . . used in surgical techniques other than anterior . . . approaches

1

This Court has another case on its docket, Thorn v. Medtronic, No. 1:13-cv-239, involving
the same device also implanted in an off-label manner.
2

have not been established” (id. at 4-5). The label expressly cautions that “the potential for ectopic
. . . or undesirable exuberant bone formation exists” (id. at 6).
Plaintiff indicates that while the product’s label remains substantially the same as that
approved by the FDA in 2002, the FDA has made minor amendments to the label through
post-approval supplements (Dkt 95, First Amended Compl. at 22 n.1). For example, on July 29,
2004, the FDA approved a supplement expanding the indicated spinal region from L4-S1 to L2-S1
and later granted approval for uses in certain oral maxillofacial surgeries (id.). Similarly, Plaintiff
represents that while Infuse was initially approved in 2002 for use with the LT-CAGE component,
the FDA later approved it for use with an INTER FIX Cage component in 2003 (id. at 34 n.2).
On March 11, 2010, Plaintiff, a Michigan resident, had a spinal surgery using Defendants’
Infuse device in an off-label manner (Dkt 95, First Amend. Compl. ¶¶ 1, 105). “Instead of
performing an anterior procedure, Plaintiff’s surgeon opted for a posterior procedure with an
unapproved cage/spacer product” (id. ¶ 106). Plaintiff alleges that Defendants, through their sales
representatives and paid “Key Opinion Leaders,” directly and indirectly promoted, trained and
encouraged Plaintiff’s surgeon to use the Infuse Bone Graft in an off-label manner, including using
it in posterior procedures and using the rh-BMP2 component of Infuse with an unapproved cage or
spacer (id. ¶ 107). Plaintiff alleges that she “never recovered from her surgery and continues to have
daily severe disabling back and nerve pain, and has had to have two spinal cord stimulators
implanted into her back on two separate occasions” (id. ¶¶ 53, 108).
In her five-count First Amended Complaint filed on November 21, 2013, Plaintiff alleges
“Failure to Warn” (Count I); “Design Defect” (Count II); “Negligence” (Count III); “Fraud” (Count
IV); and “Breach of Express and Implied Warranties” (Count V) (Dkt 95). In lieu of answering the

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First Amended Complaint, Defendants filed a Pre-Motion Conference request, proposing to file a
motion to dismiss Plaintiff’s First Amended Complaint (Dkt 97). Following a Pre-Motion
Conference in December 2013, this Court issued a briefing schedule on the proposed motion (Dkt
102). The parties filed their motion papers in March 2014 (Dkts 113-22).
II. MOTION STANDARD
Defendants filed their motion to dismiss under FED. R. CIV. P. 12(b)(6), arguing, in pertinent
part, that Plaintiff’s claims are preempted. See Trollinger v. Tyson Foods, Inc., 370 F.3d 602, 608
(6th Cir. 2004) (explaining that preemption does not normally concern the subject-matter
jurisdiction of a court to hear a claim, but “the merits of the claim itself—namely, whether it is
viable and which sovereign’s law will govern its resolution”).
Defendants also assert under Rule 12(b)(6) that Plaintiff’s claims fail on independent federal
and state-law grounds. Under Rule 8(a)(2) of the Federal Rules of Civil Procedure, a complaint
must contain a “short and plain statement of the claim showing that the pleader is entitled to relief.”
FED. R. CIV. P. 8(a)(2). A complaint will survive a motion to dismiss if the plaintiff alleges facts
that “state a claim to relief that is plausible on its face” and that, if accepted as true, are sufficient
to “raise a right to relief above the speculative level.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544,
545 (2007). 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. Where a complaint pleads facts that
are ‘merely consistent with’ a defendant’s liability, it ‘stops short of the line between possibility and
plausibility . . . .’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Twombly, 550 U.S. at 570).
“In alleging fraud or mistake, a party must state with particularity the circumstances
constituting fraud or mistake.” FED. R. CIV. P. 9(b). Specifically, the Sixth Circuit Court of Appeals

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has held that “[i]n complying with Rule 9(b), a plaintiff, at a minimum, must allege the time, place,
and content of the alleged misrepresentation on which he or she relied; the fraudulent scheme; the
fraudulent intent of the defendants; and the injury resulting from the fraud.” United States ex rel.
Bledsoe v. Cmty. Health Sys., Inc., 501 F.3d 493, 504 (6th Cir. 2007) (quoting Coffey v. Foamex
L.P., 2 F.3d 157, 161-62 (6th Cir. 1993) (internal quotation marks omitted)). “Malice, intent,
knowledge, and other conditions of a person’s mind may be alleged generally.” FED. R. CIV. P. 9(b).
In deciding a motion to dismiss for failure to state a claim under FED. R. CIV. P. 12(b)(6), the
court must treat all well-pleaded allegations in the complaint as true and draw all reasonable
inferences from those allegations in favor of the nonmoving party. Total Benefits Planning Agency,
Inc. v. Anthem Blue Cross & Blue Shield, 552 F.3d 430, 434 (6th Cir. 2008). “[W]hen a document
is referred to in the pleadings and is integral to the claims, it may be considered without converting
a motion to dismiss into one for summary judgment.” Commercial Money Ctr., Inc. v. Ill. Union
Ins. Co., 508 F.3d 327, 335-36 (6th Cir. 2007). Also, “[a] court may consider public records without
converting a Rule 12(b)(6) motion into a Rule 56 motion.” Jones v. City of Cincinnati, 521 F.3d
555, 562 (6th Cir. 2008). See, e.g., Chapman v. Abbott Labs., 930 F. Supp. 2d 1321, 1323 (M.D.
Fla. 2013) (taking judicial notice of the FDA-approved label and the statements contained therein
because the label “can be accurately and readily determined from sources whose accuracy cannot
reasonably be questioned”); In re Epogen & Aranesp Off-Label Mktg. & Sales Practices Litig., 590
F. Supp. 2d 1282, 1286 (C.D. Cal. 2008) (granting request for judicial notice of drug labels publicly
available on FDA website in connection with motion to dismiss).
“[T]he 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,

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supported by mere conclusory statements, do not suffice.” Iqbal, 556 U.S. at 678. Further, “the
court need not accept as true a legal conclusion couched as a factual allegation, or an unwarranted
factual inference.” Handy-Clay v. City of Memphis, Tenn., 695 F.3d 531, 539 (6th Cir. 2012)
(citation and internal quotation marks omitted). The parties do not dispute for purposes of this
motion that the substantive law of Michigan, the forum state, applies to the issues presented. See
generally Hardy v. Reynolds & Reynolds Co., 311 F. App’x 759, 761 (6th Cir. 2009) (discussing
choice of law rules in a diversity case).
III. ANALYSIS
A. Overview of the Parties’ Arguments
The federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., has long
required FDA approval for the introduction of new drugs into the market; however, the introduction
of new medical devices was left largely for the states to supervise as they saw fit. Riegel v.
Medtronic, Inc., 552 U.S. 312, 315 (2008). With the passage of the Medical Device Amendments
of 1976 (MDA), 21 U.S.C. § 360c et seq., Congress swept back some state obligations and imposed
a regime of detailed federal oversight of medical devices. Id. “The federal statutory scheme amply
empowers the FDA to punish and deter fraud against the Administration, and [] this authority is used
by the Administration to achieve a somewhat delicate balance of statutory objectives.” Buckman
Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348 (2001) (indicating that the FDA is empowered
to investigate suspected fraud, see 21 U.S.C. § 372; 21 C.F.R. § 5.35, and citizens may report
wrongdoing and petition the agency to take action, § 10.30).
“Off-label” usage of medical devices (use of a device for some other purpose than that for
which it has been approved by the FDA) is “an accepted and necessary corollary of the FDA’s

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mission to regulate in this area without directly interfering with the practice of medicine.” Buckman,
531 U.S. at 350. The FDCA expressly states in part that “[n]othing in this chapter shall be construed
to limit or interfere with the authority of a health care practitioner to prescribe or administer any
legally marketed device to a patient for any condition or disease within a legitimate health care
practitioner-patient relationship.” 21 U.S.C. § 396. Thus, “the FDA is charged with the difficult
task of regulating the marketing and distribution of medical devices without intruding upon
decisions statutorily committed to the discretion of health care professionals.” Buckman, 531 U.S.
at 350. Defendants argue that Plaintiff’s state-law claims against them encroach upon the federal
enforcement scheme and are preempted by the MDA, either expressly or impliedly. Defendants
further argue that Plaintiff’s claims fail on several independent federal and state-law grounds.
1.

Express Preemption
Congress included an express pre-emption provision in the MDA, which provides in

pertinent part that “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—(1) which is different from, or
in addition to, any requirement applicable under this chapter to the device, (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 chapter.” 21 U.S.C. § 360k(a).
The United States Supreme Court set forth a two-step analysis for courts to determine
whether the MDA expressly preempts a state-law claim within the meaning of § 360k(a). First, a
court must determine whether the FDA has established requirements applicable to the particular
medical device at issue. Riegel, 552 U.S. at 321. If the first step is answered in the affirmative,
then the court must proceed to the second step. The second step requires a court to determine

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whether the state law claims are based on state requirements that are “different from, or in addition
to,” the federal requirements. Id. at 321-22. “State requirements” include a state’s common law
legal duties. Id. at 324-25. If the state requirements stemming from the claim differ from, or add
to, the federal requirements, then the state claim is expressly preempted by operation of § 360k(a).
However, state claims that are premised on a violation of FDA regulations escape express
preemption, as they are considered “parallel,” rather than different from, or in addition to, the federal
requirements. Riegel, 552 U.S. at 324-25. See generally Dunbar v. Medtronic, Inc., No. CV
14-01529-RGK AJWX, 2014 WL 3056026, at *2 (C.D. Cal. June 25, 2014) (discussing two-step
analysis). “The plaintiff must be suing for conduct that violates the FDCA (or else his claim is
expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates
the FDCA (such a claim would be impliedly preempted under Buckman).” Perez v. Nidek Co., Ltd.,
711 F.3d 1109, 1120 (9th Cir. 2013) (emphases in original).
Defendants argue that Plaintiff’s claims are expressly preempted in their entirety by the
MDA, as interpreted by the Supreme Court in Riegel, because the claims seek to impose state-law
requirements on the design, manufacture or labeling of the medical device at issue in this case that
are different from or in addition to the federal requirements imposed by the FDA (Dkt 114 at 17-20).
Defendants argue that Plaintiff’s allegations of off-label use or promotion do not negate premarket
approval or its preemptive effect (id. at 23-24). Defendants emphasize that federal preemption under
§ 360k(a) does not turn on how a device is promoted (id. at 24).
In response, Plaintiff argues that this case does not present a preemption issue because the
FDA has not set requirements applicable to the bone protein without the LT-CAGE or in posterior

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approaches (Dkt 117 at 9-11). Plaintiff also asserts that she has stated parallel claims under
Michigan’s tort law and its products liability statute, MICH. COMP. LAWS § 600.2945 (id. at 11-23).
2.

Implied Preemption
Section 337(a) of the MDA provides that all actions to enforce FDA requirements “shall be

by and in the name of the United States.” 21 U.S.C. § 337(a). Citing § 337(a), the United States
Supreme Court opined that “[t]he 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.” Buckman, 531 U.S. at 349, n.4. Indeed, the Supreme Court interpreted this provision
to mean that even state claims that run parallel to federal requirements are impliedly preempted
unless they are grounded in traditional state tort law and do not depend exclusively on a federal
requirement. Id. at 353.
As pointed out by other courts, this does not mean that a plaintiff can never bring a state law
claim based on conduct that violates the FDCA. Dunbar, 2014 WL 3056026, at *3. In fact, the
conduct that gives rise to the claim must violate the FDCA to escape express preemption. Id.
Instead, to avoid implied preemption, the conduct giving rise to the state claim must also be the type
of conduct that would traditionally give rise to liability under state law “even if the FDCA had never
been enacted.” Id. (citing Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166, 1175 (C.D. Cal. 2013)
(Houston I)).
Defendants argue that there is no traditional state-law duty to abstain from off-label
promotion and that, even if Plaintiff had stated such a parallel claim, any claim predicated on offlabel promotion must be dismissed as impliedly preempted under Buckman and § 337(a) (Dkt 114
at 29-31). Defendants emphasize that the distinction between on-label and off-label use is a creation

9

of federal law and exists only by virtue of the federal regulatory scheme (id. at 31). In response,
Plaintiff argues that the Supreme Court’s decision in Buckman does not fit the facts here, where
Plaintiff’s claims arise “entirely under Michigan law” and where Defendants’ violations of federal
prohibitions against off-label promotion and failure to report adverse events “are not an element of
any of Ms. Wright’s claims” (Dkt 117 at 27).
3.

Independent Federal & State Law Grounds
Last, Defendants argue that in addition to being expressly and impliedly preempted,

Plaintiff’s claims fail on independent federal and state-law grounds (Dkt 114 at 32). Specifically,
Defendants argue that Plaintiff’s failure to warn and negligence claims must both be dismissed
because, pursuant to the learned intermediary doctrine and Michigan’s codification of the
sophisticated user doctrine, Defendants had no duty to provide Plaintiff’s surgeons warnings beyond
those required by the FDA through the premarket approval process, to wit: the FDA-approved
labeling for the Infuse device (id. at 32-33). Defendants argue that Plaintiff’s warranty claim fails
because Defendants unambiguously disclaimed all warranties and there is no privity of contract
between the parties (id. at 33-34). Last, Defendants argue that Plaintiff’s fraud claim is fatally
flawed where the allegations (1) are based upon “information and belief,” (2) are “confusing and
contradictory,” (3) are inadequate for alleging that (a) her surgeon was an agent of Medtronic, (b)
treating patients was within the scope of any purported agency, or (c) her surgeon made a false
representation of fact upon which she relied; and (4) do not include an actual representation or
omission that was made by Medtronic and relied on by her surgeon (id. at 34-39).
Relative to her negligence and failure-to-warn claims, Plaintiff responds that Defendants’
reliance on the learned intermediary and sophisticated user doctrines is misplaced (Dkt 117 at 29-

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30). Plaintiff argues that her warranty claims also prevail because (1) the claims are based on
Defendants’ “express warranties made to the medical community,” (2) it is sufficient that privity of
contract existed between Plaintiff’s physician and Medtronic; (3) Plaintiff’s First Amended
Complaint is “replete with representations made by Medtronic to the medical community;” and (4)
Defendants are not exempt from strict liability where they improperly marketed the device for
dangerous off-label uses (id. at 31). Last, Plaintiff argues that her fraud claim is pleaded with
sufficient particularity (id. at 32-37).
B. Plaintiff’s Claims
1.

Failure to Warn
In Count I (“Failure to Warn”), Plaintiff alleges that Defendants “illegally promoted the

Infuse Bone Graft for off-label uses in violation of federal law—thereby forfeiting U.S.C. § 360k
protection” (Dkt 95, First Amend. Compl. ¶ 110). Plaintiff alleges that Defendants had (1) “a
parallel common law duty to fully and adequately warn Plaintiff and Plaintiff’s physicians of the true
health and safety risks related to the off-label use of Infuse;” (2) “a duty to disclose their dangerous
and irresponsible practices of improperly promoting to physicians the off-label use of Infuse without
an LT-Cage or INTER FIX Cage and the placement of Infuse posteriorly for lumbar spine
surgeries;” (3) “a duty not to conceal the dangers of the off-label use of Infuse to Plaintiff and her
physicians;” and (4) a duty to “fully and accurately disclose [to] the Plaintiff and her physicians the
true health and safety risks related to Infuse and a duty to disclose their dangerous and irresponsible
off-label promotion and marketing practices” (id. ¶¶ 110-11). Plaintiff alleges that through their
described conduct, Defendants “breached their duties to Plaintiff and to Plaintiff’s physicians” (id.
¶ 112). According to Plaintiff’s First Amended Complaint, Defendants “negligently, carelessly and

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recklessly failed to adequately warn the medical community, the general public, Plaintiff’s surgeon
and Plaintiff of the dangers, contra-indications, and side effects from the off-label use of Infuse Bone
Graft” and “negated its own warnings by promoting the Infuse Bone Graft for off-label uses, such
as the off-label procedures used in Plaintiff’s surgeries” (id. ¶ 113).
The first step of the express preemption analysis, whether the FDA has established
requirements applicable to the particular medical device at issue, Riegel, 552 U.S. at 321, is
automatically satisfied where, as here, the device has received premarket approval (PMA). The
second step of the express preemption analysis, the only step at issue here, requires this Court to
determine whether the state requirements upon which Plaintiff’s claim is based are “different from,
or in addition to,” the federal requirements. See id. at 321-22. The parties do not dispute that
Michigan law requires manufacturers to provide adequate warnings, and, like the parties, the Court
assumes for purposes of the motion that Defendants’ conduct allegedly violates state law.
Federal law does not expressly define or ban off-label promotion. Courts have held that the
FDCA’s misbranding provisions and 21 C.F.R. § 814.80 together constitute “the federal
requirements” for purposes of Riegel’s second step. Arthur v. Medtronic, Inc., No. 4:14-CV-52 CEJ,
2014 WL 3894365, at *5 (E.D. Mo. Aug. 11, 2014) (citing Beavers-Gabriel v. Medtronic, Inc., 15
F. Supp. 3d 1021, 1034-35 (D. Hawaii 2014); Eidson v. Medtronic, Inc., 981 F. Supp. 2d 868, 88485 (N.D. Cal. 2013) (Eidson I); and Houston I, 957 F. Supp. 2d at 1179). Specifically, the FDCA
prohibits “[t]he adulteration or misbranding of any food, drug, [or] device ... in interstate commerce”
and “[t]he introduction or delivery for introduction onto interstate commerce of any food, drug, [or]
device ... that is adulterated or misbranded.” 21 U.S.C. §§ 331(a) and (b). A device is misbranded
if its labeling, or advertising, is “false or misleading.” § 352(a) (labeling), § 352(q) (advertising).

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Whether the labeling or advertising is misleading is determined by considering the “representation
made or suggested by statement, word, device, or any combination thereof.” § 321(n). Last, FDCA
regulations restrict a manufacturer’s ability to engage in off-label promotion: 21 C.F.R. § 814.80
states that “[a] device may not be manufactured, packaged, stored, labeled, distributed, or advertised
in a manner that is inconsistent with any conditions to approval specified in the PMA approval order
for the device” (emphasis added). Out of this “muddy statutory and regulatory framework,” courts
have determined that “federal law bars off-label promotion when it is false or misleading.” Schouest
v. Medtronic, Inc., 13 F. Supp. 3d 692, 702 (S.D. Tex. Mar. 24, 2014).
Defendants argue that the “gravamen” of Plaintiff’s failure-to-warn claim is that Defendants
should have made “different” or “additional” statements about Infuse, i.e., warnings beyond those
specified by the FDA (Dkt 114 at 20). As other courts have determined, a jury finding that
Defendants’ labeling was inadequate “would be tantamount to a requirement that Medtronic do
something ‘different from, or in addition to,’ what the FDA already approved.” Schouest, 13 F.
Supp. 3d at 703. Specifically, “a jury would have to find either that Defendants were required to
include warnings beyond those in the FDA-approved label for the Infuse Device, or that Defendants
were obligated to issue post-sale warnings about potential adverse effects of using the Infuse Device
in an off-label manner.” Houston I, 957 F. Supp. 2d at 1177. Under this line of cases, Plaintiff’s
failure-to-warn claim here would be expressly preempted.
Plaintiff argues that this Court should instead follow Ramirez v. Medtronic, Inc., 961 F.
Supp. 2d 977 (D. Ariz. 2013), clarified on denial of reconsideration (Oct. 24, 2013), where the
district court held that the FDA’s express preemption provision does not apply when a manufacturer
engages in off-label promotion (Dkt 117 at 25, 28, 36). The Court is not persuaded. In Ramirez,

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the “core” of the plaintiff’s claim was that she was injured due to an off-label use of Infuse that
resulted from Medtronic’s practice of promoting such uses. Id. at 990. Citing 21 U.S.C. § 331(a),
the district court decided that “when Medtronic allegedly violated federal law by engaging in
off-label promotion that damaged the Plaintiff and thereby misbranded the Infuse device, it departed
the realm of federal regulation and returned to the area of traditional state law remedies.” Id. at 99091 (footnote omitted). Thus, according to Ramirez, the plaintiff’s claims were not preempted
because “[s]ection 360k protects manufacturers who adhere to the federal regulatory program, but
it does not expand federal law into heretofore unregulated areas,” which Ramirez determined
included the area of off-label promotion. Id. at 996.
As evidenced by the plethora of supplemental authorities provided by Defendants, the
reasoning of the Ramirez district court has been rejected by numerous district courts, although no
appellate court has yet considered the precise issue. See, e.g., Arthur, 2014 WL 3894365, at *5;
Martin v. Medtronic, No. 2:14-cv-0385, 2014 WL 3635292 (D. Ariz. 2014) (joining the “majority
of other courts” that have held that failure-to-warn claims based on off-label promotion of Infuse
are expressly preempted) (citing cases therein); Beavers-Gabriel, 15 F. Supp. 3d at 1035 (“Ramirez
has been rejected—for good reason—by numerous courts.”); McCormick v. Medtronic, Inc., 101
A.3d 467, 486 (Md. Ct. App. 2014) (indicating that “Ramirez has been almost universally rejected”).
The reasoning of Ramirez has been rejected as inconsistent with the text of § 360(k), which
applies if federal requirements are applicable “to the device,” not merely to specific uses of devices.
The premarket approval application presented to the FDA includes “[a]n identification, discussion,
and analysis of any other data, information, or report relevant to an evaluation of the safety and
effectiveness of the device known to or that should reasonably be known to the applicant from any

14

source, foreign or domestic, including information derived from investigations other than those
proposed in the application and from commercial marketing experience.”

21 C.F.R.

§ 814.20(b)(8)(ii) (emphasis added). “Once the FDA has cleared a device for introduction into the
stream of commerce, physicians may use the device in any manner they determine to be best for the
patient, regardless of whether the FDA has approved the device for this usage.” Cooper v. Smith
& Nephew, Inc., 259 F.3d 194, 197 (4th Cir. 2001). “‘[O]ff-label’ usage of medical devices ... is an
accepted and necessary corollary of the FDA’s mission to regulate in this area without directly
interfering with the practice of medicine.” Buckman, 531 U.S. at 350.
A second related reason courts have therefore determined the reasoning in Ramirez is not
sound is that the Ramirez court presumed that the state-law claims before it were premised on
off-label promotion that violated the FDCA. See, e.g., Alton v. Medtronic, Inc., 970 F. Supp. 2d
1069, 1096 (D. Or. 2013) (“[T]he reasoning of Ramirez, although largely persuasive, ... depend[s]
in part on a flawed premise ... in connection with the court’s finding that Medtronic violated federal
law specifically by promoting off-label applications of the Infuse device.”).
Section 331(a), the provision the Ramirez court cited in support of the proposition that “[a]
manufacturer is ... prohibited from promoting a use of the product that is not the specified use,” does
not expressly prohibit such promotion; rather, as recounted above, § 331 prohibits manufacturers
only from the “introduction or delivery for introduction into interstate commerce of any ... device
... that is ... misbranded,” 21 U.S.C. § 1331(a). Alton, 970 F. Supp. 2d at 1096. Misbranding is
defined in part as labeling a device without including “adequate directions for use,” 21 U.S.C.
§ 352(f)(1), and directions for use “may be inadequate because ... of omission, in whole or in part,
or incorrect specification of ... [s]tatements of all conditions, purposes, or uses for which such device

15

is intended,” 21 C.F.R. § 801.5(a), and whether a particular use is intended may be inferred from,
inter alia, the manufacturer’s statements in promotion of the device and its applications, 21 C.F.R.
§ 801.4. Id. Hence, contrary to the conclusion of the Ramirez court, “the promotion itself did not
violate any provision of the FDCA, but rather constituted evidence material to the question whether
the Infuse device was misbranded.” Id.
In other words, “rather than escaping federal requirements by promoting an off-label use, a
device manufacturer’s off-label promotion itself is subject to specific MDA provisions.” Arthur,
2014 WL 3894365, at *5 (quoting Houston II, 2014 WL 1364455, at *5). See also McCormick, 101
A.3d at 486 (indicating that “Ramirez has been almost universally rejected” because “federal law
does impose requirements regarding off-label use and promotion of devices”). Therefore, after
careful consideration of the parties’ arguments and review of the legal authorities, the Court agrees
that off-label promotion is governed by federal law, which sets the parameters and occupies the field
for deciding whether a representation is false or misleading. Accordingly, Plaintiff’s Count I,
seeking reimbursement for the injuries she suffered due to the alleged inadequacy of the warnings
for an off-label use, is a claim that falls within § 360k protection.
Further, Plaintiff’s Count I does not state a parallel state-law claim because there is no state
law duty to abstain from off-label promotion. “Off-label promotion itself exists only as a creation
of the FDCA scheme.” Hawkins v. Medtronic, Inc., No. 1:13-CV-00499 AWI SK, 2014 WL
346622, at *19 (E.D. Cal. Jan. 30, 2014) (Hawkins I) (“A state law cause of action cannot rest solely
on the off-label promotion of INFUSE.”); see also Caplinger v. Medtronic, Inc., 921 F. Supp. 2d
1206, 1219-20 (W.D. Okla. 2013) (“even the concept of ‘off-label use’ is a creature of the FDCA,
is defined by the FDCA, and is not a part of Oklahoma substantive law”). “A successful

16

failure-to-warn claim premised on inadequate labeling would therefore disturb the FDA’s policy
with respect to the regulation of these devices.” Schouest, 13 F. Supp. 3d at 703-04 (citing
Buckman, 531 U.S. at 350). Defendants correctly argue that this lack of a traditional state-law duty
to refrain from off-label promotion means that Plaintiff’s failure-to-warn claim in Count I is also
impliedly preempted. In sum, Count I, in its entirety, is both expressly and impliedly preempted and
will be dismissed.
2.

Design Defect
In Count II of her First Amended Complaint, Plaintiff alleges that a manufacturer has a duty

to use reasonable care in designing its product and guard against a foreseeable and unreasonable risk
of injury (Dkt 95, First Amend. Compl. ¶ 127). Plaintiff alleges that the Infuse device was
defectively designed at the time that it left Defendants’ control and was placed into the stream of
commerce (id. ¶ 121). Specifically, Plaintiff alleges that the device was defectively designed
because (1) “the design was unsafe when used in the off-label manner promoted by Medtronic
and/or in a manner reasonably foreseeable by Medtronic;” (2) “the risks of danger in the design
outweigh the benefits of the design;” and (3) the Infuse device “caused users to suffer injuries,
including, but not limited to, pain and weakness in limbs, radiculitis, ectopic bone formation,
osteolysis, and poorer global outcomes than equally-effective, alternative designs and treatments”
(id. ¶¶ 122-24). Plaintiff alleges that as a legal and proximate result of the aforementioned defects
of Infuse, she has sustained injuries and damages (id. ¶ 130).
The Court agrees with Defendants that under Riegel, Plaintiff’s claim is foreclosed (Dkt 114
at 21). The Supreme Court held that “[s]tate tort law that requires a manufacturer’s [device] to be
safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme.”

17

Riegel, 552 U.S. at 325 (ultimately affirming the district court’s decision that the MDA preempts
“claims of strict liability ... and negligence in the design” of a device). Hence, the Eighth Circuit
Court of Appeals has held that “attacks on the risk/benefit analysis that led the FDA to approve an
inherently dangerous Class III device ... are expressly preempted by § 360k.” In re Medtronic, Inc.,
Sprint Fidelis Leads Products Liab. Litig., 623 F.3d 1200, 1206 (8th Cir. 2010) (Sprint Fidelis Lead
medical device).
More specifically, in Caplinger, where the plaintiff who underwent a posterior-approach
lumbar spine surgery utilizing the Infuse device alleged nearly an identical design-defect claim to
Plaintiff’s claim here, the district court held that allowing the design-defect claim to proceed “would
permit a finding that a design defect rendered the Infuse Device unreasonably dangerous, even if
defendants complied with all FDA regulations addressed to design.” 921 F. Supp. 2d at 1222. “To
permit a jury to second-guess the Infuse Device’s design would risk interference with the
federally-approved design standards and criteria. Plaintiff’s strict products liability design defect
claim would, therefore, establish design requirements different from, or in addition to, federal
requirements for the Infuse Device.” Id. In short, the Court finds that the design defect claim is
expressly preempted under § 360k(a), and Count II will therefore be dismissed.
3.

Negligence
In Count III of her First Amended Complaint, Plaintiff alleges “Negligence” based on

Defendants’ “duty to comply with federal law by promoting Infuse only for purposes approved by
the FDA” (Dkt 95, First Amend. Compl. ¶ 136). Plaintiff alleges that Defendants were
A.

Negligently and carelessly engaging in the illegal off-label promotion of
Infuse Bone Graft by recommending to physicians, including Plaintiff’s
physicians, and instructing them to use it in procedures for which it had not
been approved;
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B.

Negligently, carelessly and recklessly promoting the off-label use of Infuse
Bone Graft by instructing, promoting and directing the use of the product
without an approved cage device;

C.

Negligently, carelessly and recklessly failing to disclose that usage of
Infuse® Bone Graft in non-ALIF procedures had not been approved by the
FDA;

D.

Negligently, carelessly and recklessly failing to disclose to physicians that
the promoted off-label use of Infuse Bone Graft can result in serious side
effects;

E.

Negligently, carelessly and recklessly failing to fully disclose the results of
the testing and other information in its possession regarding the possible
adverse reactions associated with the off-label use of Infuse Bone Graft;

F.

Negligently, carelessly and recklessly representing that the off-label use of
Infuse Bone Graft was safe when, in fact, it was unsafe;

G.

Negligently, carelessly and recklessly promoting Infuse® Bone Graft beyond
the narrow and limited uses for which it was approved;

H.

Negligently, carelessly and recklessly failing to adequately warn the medical
community, the general public, Plaintiff’s surgeon and Plaintiff of the
dangers, contra-indications, and side effects from the off-label use of Infuse
Bone Graft; and

I.

Negligently, carelessly and recklessly failing to act as a reasonably prudent
device manufacturer.

(Dkt 95, First Amend. Compl. ¶ 139) (footnote omitted).
The Court agrees with Defendants that the “gravamen” of these allegations, like those in
Plaintiff’s failure-to-warn claim in Count I, is that Medtronic should have made “different” or
“additional” statements about Infuse, i.e., warnings beyond those specified by the FDA (Dkt 114 at
20). The Court’s prior analysis and conclusion is therefore applicable here, too, and the Court
concludes that Plaintiff’s negligence claim is expressly preempted. See Scanlon v. Medtronic, No.
13-224, 2014 WL 3737501, at *6 (D. Del. 2014) (the plaintiff’s negligence cause of action is
19

preempted because it would “impose requirements on Medtronic—to perform and report additional
studies—which are different from and in addition to those imposed by the FDA”); Martin, 2014 WL
3635292, at *14 (same).
Moreover, Plaintiff’s negligence allegations based solely on illegal off-label promotion are
impliedly preempted because any claim that Defendants engaged in illegal off-label marketing of
the Infuse device “‘exists solely by virtue’ of federal regulations, and is not rooted in any traditional
state tort law.” See Houston I, 957 F. Supp. 2d at 1178 (quoting Buckman, 531 U.S. at 353); see also
Blankenship v. Medtronic, Inc., 6 F. Supp. 3d 979, 990 (E.D. Mo. 2014) (determining that although
Missouri products liability law supported recovery, the conduct the plaintiff alleged relates to
Medtronic’s promotion of the Infuse device for the off-label uses, “which is a negligence claim that
would not exist if the FDCA did not exist”). Therefore, Count III will be dismissed.
4.

Fraud
In Count IV (“Fraud”) of her First Amended Complaint, Plaintiff alleges that Defendants

paid illegal kickbacks to physicians in connection with promoting the off-label use of Infuse,
kickbacks that included “lucrative consulting and royalty agreements” and “lavish all-expense paid
trips” (Dkt 95, First Amend. Compl. ¶¶ 146-51). Plaintiff alleges that her surgeon, Dr. Michael
Kasten, took “part in Medtronic’s fraudulent scheme” and received “sham consulting fees” and
“therefore acted as an agent of Medtronic” (id. ¶¶ 152-54). Plaintiff alleges that Dr. Kasten
“represent[ed] to Ms. Wright that her specific surgery, which utilized Infuse in an unapproved and
unsafe manner, was ‘safe’—when, in fact, Plaintiff’s [sic] off label procedures using Infuse in a
posterior approach or without the use of an approved cage were unsafe and known by Medtronic to
be unsafe” (id. ¶ 155).

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Plaintiff delineates, at length, how Medtronic continues to drive sales through off-label
indications, despite entering into a “Corporate Integrity Agreement” and the “material risk of further
regulatory action or other liability, and in conscious disregard for the health and welfare of spine
patients such as Ms. Wright” (id. ¶¶ 162-86). Plaintiff alleges that “the Medtronic Defendants
fraudulently and intentionally misrepresented material and important health and safety product risk
information to Plaintiff and Plaintiff’s physicians” and that “Plaintiff and her physicians would not
have decided to use Infuse without an LT-Cage or INTER FIX Cage had they known of the safety
risks related to Infuse” (id. ¶¶ 187-91).
Last, Plaintiff alleges that “Medtronic intended to cause Plaintiff and her physicians to rely
on their concealment of information and misrepresentations about the safety risks related to Infuse
to induce them to make off-label use of Infuse for Plaintiff’s lumbar spine fusion surgery” (Dkt 95,
First Amend. Compl. ¶ 192). Plaintiff alleges that she and her physicians were “justified in relying,
and did rely, on Medtronic’s fraudulent concealment of information and misrepresentations about
the safety risks related to Infuse in deciding to use Infuse in an off-label manner for Plaintiff’s fusion
surgery” (id. ¶ 193). Plaintiff alleges that she was injured and incurred damages as the direct,
proximate and legal cause of Defendants’ fraudulent concealment and misrepresentations and
suppression (id. ¶¶ 194-99).
In contrast to Plaintiff’s failure-to-warn claim in Count I, a claim that this Court determined
is expressly preempted because the claim would require warnings beyond those specified by the
FDA, Plaintiff’s fraud claim is not expressly preempted. The state tort law duties underlying
Plaintiff’s fraud claim are not “different from, or in addition to” federal requirements, which prohibit
fraudulent promotion or advertising. See Belle Isle Grill Corp. v. Detroit, 666 N.W.2d 271, 280

21

(Mich. Ct. App. 2003) (setting forth the elements a plaintiff must show to establish fraud based on
misrepresentation). Indeed, mere off-label promotion, divorced from any negligent or fraudulent
misrepresentations, is not prohibited by federal law. Rather, to reiterate this Court’s conclusion in
analyzing Plaintiff’s Count I, off-label promotion is itself governed by federal law.
Because Plaintiff’s allegations of affirmative misrepresentations are based on independent
state law duties, neither is the fraud claim impliedly preempted. “[T]hese claims would apply to a
seller of a product not subject to any federal regulations who engaged in similar alleged
misconduct.” Schouest, supra (citing Houston I, 957 F. Supp. 2d at 1179 (holding that state
fraud-based claims that include off-label promotion allegations are not impliedly preempted under
Buckman “because they are moored in traditional state common law that exists independently from
the FDCA”); Eidson I, 981 F. Supp. 2d at 885 (finding that fraud claims based on off-label
promotion escape preemption because such claims “are based on state common law tort duties that
exist independently from the FDCA and not solely by virtue of the FDCA”); see also Hawkins v.
Medtronic, Inc., ___ F. Supp. 3d ___, 2014 WL 6611876, at *7 (E.D. Cal. 2014) (Hawkins II)
(explaining that a state tort duty exists independent of the FDCA for the plaintiff’s allegation that
the defendants were negligent by making misrepresentations during the course of off-label
promotion and “removes it from the grasp of implied preemption because he [did not merely allege]
they engaged in off-label promotion”).
Defendants argue that even if this Court determines Plaintiff’s fraud claim is not preempted,
the claim must nonetheless be dismissed. The Court agrees with Defendants that Plaintiff’s fraud
claim, in its currently filed version, is internally inconsistent. As Defendants point out, the
contradiction in the claim is that Plaintiff alleges “both that her surgeon defrauded her—which

22

requires that he had knowledge of the true facts—and that her surgeon was defrauded by
Medtronic—which requires that he did not have knowledge of the true facts” (Dkt 116 at 20).
However, in responding to Defendants’ motion to dismiss, Plaintiff “withdrew” from her First
Amended Complaint the references to her surgeon acting as Medtronic’s “agent” and attached to her
response a proposed Second Amended Complaint, which omits the references to her surgeon acting
as Medtronic’s “agent” as well as references to her surgeon’s representations to her that her off-label
surgery was “safe” (Dkt 117 at 35; Pl.’s Ex. 2, Dkt 117-2). The Court determines that these changes
cure the internal inconsistency in Plaintiff’s fraud claim and that placing this case in proper posture
for resolution is in the interest of justice; therefore, the Court will grant Plaintiff leave to file the
Second Amended Complaint. See, e.g., Crabbs v. Copperweld Tubing Prods. Co., 114 F.3d 85, 91
(6th Cir. 1997) (affirming the district court’s decision to permit the plaintiff to amend his complaint
to conform to his position).
The Court is not convinced by Defendants’ argument that Plaintiff’s fraud claim should
nonetheless be dismissed because Plaintiff failed to plead it with the particularity required by Rule
9(b). Plaintiff details how Defendants, from 1998 to the present, sponsored medical literature,
conferences, and statements by sales representatives to persuade physicians to use Infuse in
dangerous off-label uses, while misrepresenting, downplaying and/or falsifying the seriousness of
adverse events resulting from such uses. As another district court observed of a substantially similar
complaint, Plaintiff alleged “who” the Medtronic-sponsored authors were, “when” the articles were
published, the “content” of the allegedly false articles promoting off-label procedures, and “why”

23

that content was false. Hawkins II, ___ F. Supp. 3d at ___; 2014 WL 6611876, at *11.2 In other
words, the allegations serve to “state with particularity the circumstances constituting fraud.” FED.
R. CIV. P. 9(b).
Further, the Court rejects Defendants’ argument that the fraud claim must be dismissed
because Plaintiff failed to allege “an actual representation or omission that was made by Medtronic
and relied on by her surgeon” (Dkt 114 at 39). Given the landscape Plaintiff describes, “a course
of conduct that promotes Infuse as safe in spite of Medtronic’s knowledge that such procedures are
‘high risk and experimental,’” Hawkins II, ___ F. Supp. 3d at ___; 2014 WL 6611876, at *12, the
Court finds sufficient for purposes of Iqbal/Twombly Plaintiff’s additional allegation that Defendants
“fraudulently and intentionally misrepresented material and important health and safety product risk
information to Plaintiff and Plaintiff’s physicians” and that “Plaintiff and her physicians would not
have decided to use Infuse without an LT-Cage or INTER FIX Cage had they known of the safety
risks related to Infuse” (Dkt 95, First Amended Compl. ¶ 187). Compare Hawkins I, 2014 WL
346622, at *13 (dismissing the plaintiff’s original fraud claims where the plaintiff failed to allege
“not only the content of the off-label promotion directed at his spine surgeon and on which the
surgeon relied, but he also fails to allege who made those representations to his surgeon and when
the representations were made”) with Hawkins II, ___ F. Supp. 3d. at ___, 2014 WL 6611876, at
*13-14 (considering the plaintiff’s amended fraud claim and agreeing with the cited decisions of
other courts that “the general allegation that a plaintiff’s doctor relied upon misrepresentations made

2

The district court also accurately observed that the extensive pleading extends well beyond
what is necessary to state a claim for fraud based on off-label misrepresentation and extends into
allegations of on-label misrepresentation, which falls within the FDA’s premarket approval purview.
Hawkins II, ___ F. Supp. 3d at ___; 2014 WL 6611876, at *12.
24

by

Medtronic

sponsored

medical

literature,

conferences,

and

statements

by

sales

representatives—despite the failure to plead what statements were relied upon, who made the
misstatements, when they were made—were sufficient to plead reliance”). The Court will therefore
deny Defendants’ motion as to Count IV.
5.

Breach of Express and Implied Warranties
Last, in Count V (“Breach of Warranty”) of her First Amended Complaint, Plaintiff alleges

that Defendants “utilized journal articles, advertising media, sales representatives and paid Key
Opinion Leaders and other physicians to urge the use, purchase, and utilization of the off-label use
of the Infuse Bone Graft and expressly and impliedly warranted to physicians and other members
of the general public and medical community that such off-label uses, including the type of off-label
procedure that Plaintiff underwent, was safe and effective” (Dkt 95, First Amend. Compl. ¶ 201).
Plaintiff alleges that “Medtronic knew or, in the exercise of reasonable diligence, should have
known that such off-label uses had the serious side effects set forth herein” (id. ¶ 202). Plaintiff
alleges that “Ms. Wright’s treating surgeon and his [sic] other physicians and medical professionals,
relied on Medtronic’s express and implied warranty representations” (id. ¶ 203).
Plaintiff alleges that “Medtronic breached the implied warranties of merchantability and
fitness because the Infuse Bone Graft is unsafe for the promoted uses, is not merchantable, is unfit
for its promoted use when sold, is unfit for the purpose for which it was sold, and/or is not
adequately packaged and labeled, and did not reasonably conform to the promises or affirmations
of fact made by Medtronic” (Dkt 95, First Amend. Compl. ¶ 204). Plaintiff alleges that she was
injured and incurred damages as the direct and proximate cause of Defendants’ acts and conduct (id.

25

¶ 205). Plaintiff alleges that Medtronic’s acts also constitute “misbranding” under the FDCA, 21
U.S.C. §§ 331(a) and 333(a)(2), for which Defendants are subject to civil liability (id. ¶ 206).
The Court agrees with those courts that have found that an adequately pleaded claim for
breach of express warranty is not expressly preempted by § 360k(a). Federal law “already requires
[Medtronic] to ensure that any warranty statements it voluntarily makes are truthful, accurate, not
misleading, and consistent with applicable federal and state law.” Riley, 625 F. Supp. 2d at 788; 21
U.S.C. § 331(b). See also Arthur, 2014 WL 3894365, at *8; Houston I, 957 F. Supp. 2d at 1180-81.
An adequately pleaded express-warranty claim also survives implied preemption because
Michigan recognizes claims for breach of express warranty. See infra. In other words, Plaintiff’s
theory is not wholly dependent on federal law—her breach of express warranty claim would exist
absent the FDCA and MDA. See, e.g., Arvizu v. Medtronic, Inc., No. CV-14-00792, 2014 WL
4204933, at *9 (D. Ariz. Aug. 25, 2014); Schouest, 13 F. Supp. 3d at 707 (the plaintiff’s “express
warranty claim can survive to the extent she seeks to recover based on false warranties that
Medtronic voluntarily and falsely made beyond the federally approved warning”).
The remaining question is whether Count V is adequately pleaded, and the threshold issue
is whether Plaintiff adequately pleaded that Defendants made an express warranty. The Uniform
Commercial Code, as adopted by Michigan, defines an express warranty as “[a]n affirmation of fact
or promise made by the seller to the buyer which relates to the goods and becomes part of the basis
of the bargain creates an express warranty that the goods shall conform to the affirmation or
promise.” MICH. COMP. LAWS § 440.2313(1)(a).
Here, the FDA label for the Infuse device states that “[n]o warranties, express or implied,
are made” and that “[i]mplied warranties of merchantability and fitness for a particular purpose or

26

use are specifically excluded” (Defs.’ Ex. 3, Dkt 114-3 at 4). Defendants argue that this
unambiguous declaration defeats any warranty claim based on alleged statements outside the Infuse
device’s labeling (Dkt 114 at 33, citing Bailey Farms, Inc. v. NOR-AM Chem. Co., 27 F.3d 188, 193
(6th Cir. 1994) (applying Michigan law and holding that “both the UCC and common law allow
defendant to disclaim implied warranties”)).
Plaintiff does not dispute that a seller may disclaim implied warranties under Michigan law
as long as the disclaimer is conspicuous. See MICH. COMP. LAWS § 440.2316(2); see also MICH.
COMP. LAWS § 440.1201(10) (providing that a term or clause is conspicuous “when it is so written
that a reasonable person against whom it is to operate ought to have noticed it”). Rather, Plaintiff
clarifies that her claim is not premised on any warranty set forth in the Infuse labeling but on
“alleged express warranties made to the medical community” (Dkt 117 at 31). To that end, Plaintiff
emphasizes that her complaint is “replete” with representations made by Medtronic to the medical
community (id.).
Under Michigan law, however, Plaintiff is bound by what she signed. See Pitts v. Monaco
Coach Corp., 330 F. Supp. 2d 918, 923 (W.D. Mich. 2004) (rejecting the plaintiff’s argument that
his reliance on the salesperson’s “various assurances” could save his warranty claim from dismissal
where the defendant had notified the plaintiff of his disclaimer of warranties). Thus, Defendants
have demonstrated that Plaintiff’s Count V fails to state a claim for relief, and Count V will be
dismissed.
IV. CONCLUSION
For the foregoing reasons, the Court determines that Plaintiff’s failure-to-warn, design defect
and negligence claims in Counts I, II and III do not survive preemption. Plaintiff’s fraud and

27

warranty claims in Counts IV and V survive preemption, but Plaintiff’s Count V fails to state a claim
under Michigan law. Therefore, Defendants’ Motion to Dismiss (Dkt 113) is granted in part and
denied in part, with the end result being that only Plaintiff’s fraud claim in Count IV will proceed.
An Order will be entered consistent with this Opinion.

Dated: January ___, 2015
23

/s/ Janet T. Neff
JANET T. NEFF
United States District Judge

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