Thorn v. Medtronic, Inc. et al

Filing 63

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

UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF MICHIGAN
SOUTHERN DIVISION

CLINTON THORN,
Plaintiff,

Case No. 1:13-cv-239

v.

HON. JANET T. NEFF

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

OPINION
Pending before the Court in this diversity-products liability action is Defendants’ Motion to
Dismiss (Dkt 50). Plaintiff filed a response in opposition to Defendants’ motion (Dkt 52), and
Defendants filed a reply (Dkt 53). Defendants have also since filed numerous supplemental
authorities for the Court’s consideration (Dkts 54-57, 61-62). 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.
I. BACKGROUND
Defendants designed and manufactured the medical device at issue in this case: “Infuse,”
a bio-engineered bone filling material containing a bone morphogenetic protein (Dkt 35, Amend.

Compl. ¶ 7).1 Infuse is used as an alternative in certain spinal surgeries to graft a patient’s own bone
(id.). The purpose of Infuse is to accomplish the same clinical outcomes as grafting a patient’s own
bone, without the pain often associated with grafting bone from the hip or other sites (id.).
The Food and Drug Administration (FDA) approved Infuse on July 2, 2002 for use in the
lower, lumbar region of the spine to treat degenerative disc disease (Dkt 35, Amend. Compl. ¶ 10).
It was approved by the FDA for anterior-approach lumbar surgery (performed through the abdomen)
surgeries at L4 though S1 in combination with an “LT-Cage” and a spongy carrier or scaffold (id.).
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 51-3 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
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, a Michigan resident, had a spinal surgery on March 4, 2010 using Defendants’
Infuse device in an off-label manner, i.e., in a posterior-approach lumbar surgery (performed through

1

This Court has another case on its docket, Wright v. Medtronic, No. 1:13-cv-716, involving
the same device also implanted in an off-label manner.
2

the back) (Dkt 35, Amend. Compl. ¶ 10). Plaintiff claims that “his body produced ectopic and
uncontrollable bone growth” because the Infuse “created bone grown outside of the cage in which
it was to be confined and into Plaintiff’s spinal column with the ultimate result that his spinal cord
was compressed and he suffered intractable pain” (id. ¶ 14). Plaintiff alleges that Defendants failed
to accurately explain the risks to his surgeon and, in fact, “actively misled him (and ultimately
Plaintiff) by their off-label promotion of Infuse, including their financial sponsoring of physicians
and articles determined to portray Infuse as safe even for off-label use” (id. ¶ 16). Plaintiff
underwent a revised interbody fusion in April 2012, which was performed by using a piece of
Plaintiff’s hip bone as the grafting material in lieu of Infuse (id. ¶ 34). Plaintiff alleges that despite
the revision surgery, he continues to suffer from significant pain and disability as a result of his
exposure to Infuse (id. ¶ 35).
In his three-count Amended Complaint filed on October 25, 2013, Plaintiff alleges “Failure
to Warn” (Count I); “Negligence and Gross Negligence” (Count II); and “Breach of Warranty”
(Count III) (Dkt 35). In lieu of answering the Amended Complaint, Defendants filed a Pre-Motion
Conference request, proposing to file a motion to dismiss Plaintiff’s Amended Complaint (Dkt 36).
Following a Pre-Motion Conference in December 2013, this Court issued a briefing schedule on the
proposed motion (Dkt 41). The parties filed their motion papers in March 2014 (Dkts 50-53).
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

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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 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

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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,
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

5

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
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

6

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
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

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are different from or in addition to the federal requirements imposed by the FDA (Dkt 51 at 17-21).
In response, Plaintiff does not dispute that the FDA controls approval of medical devices (Dkt 52
at 6). Plaintiff rejects, however, the notion that once the FDA approves the device, the manufacturer
“essentially has complete immunity from any liability (apparently regardless of whatever they do)”
(id. at 6, 10). Plaintiff also asserts that he has stated a parallel state claim under Michigan’s products
liability statute, MICH. COMP. LAWS § 600.2945 (id. at 17-19). Plaintiff emphasizes that “it is
Medtronic’s knowledge of the consequences of off-label use, combined with both its silence and
cover up of adverse information which should result in liability” (id. at 18). Defendants reply that
Plaintiff’s principal argument—that § 360k(a) does not apply here because the premarket approval
of the Infuse device extends only to certain uses of that device—is contrary to law and to FDA
practice (Dkt 53 at 6).
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

8

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 to the extent that Plaintiff’s claims seek to enforce the provisions of
federal law purportedly governing the promotion of medical devices for “off-label” uses or a
manufacturer’s communications with the FDA, these claims are also impliedly preempted under
Buckman and prohibited by the FDCA’s “no private right of action” provision, 21 U.S.C. § 337(a)
(Dkt 51 at 21-32). In response, Plaintiff emphasizes that he is not claiming that Defendants
committed “some fraud on the FDA,” but a “fraud on the end-users of Infuse: surgeons and their
patients” (Dkt 52 at 17). Plaintiff argues that his claim is “clearly viable under Buckman” and points
out that several of the district courts that have addressed Defendants’ preemption argument have
held that the claims Plaintiff pursues here are not impliedly preempted under Buckman (id.).
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 51 at 33-36). 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 33-34). Defendants also cite multiple reasons why Plaintiff’s

9

breach-of-warranty claim fails: Defendants unambiguously disclaimed all warranties; there is no
privity of contract between the parties; and Plaintiff failed to identify any affirmation of fact or
promise that was the basis of the sale of the Infuse device (id. at 34-35). Last, Defendants argue that
Plaintiff has not satisfied the federal pleading requirements regarding his claim that Medtronic failed
to submit adverse event reports to the FDA as required by federal law (id. at 35).
As Defendants point out in reply (Dkt 53 at 6-7), Plaintiff wholly failed to address in his
response to their motion any of Defendants’ arguments that his claims fail on independent federal
and state-law grounds.
B. Plaintiff’s Claims
1.

Failure to Warn
In Count I (“Failure to Warn”), Plaintiff alleges that (1) Defendants had a “duty to refrain

from promoting, either directly or indirectly, the off-label use of Infuse;” (2) Plaintiff and his
physician relied on Defendants’ representations and omissions during off-label promotion,
specifically, Defendants’ “failure to warn physicians and the public in general of the dangers of offlabel use of Infuse;” and (3) Plaintiff was proximately injured by Defendants’ failure to warn about
the dangers of off-label use of Infuse “for the reason that he never would have consented to the use
of Infuse during his spinal surgery had he known or been told of the risks of harm or that it had not
been approved by the FDA for his particular surgery” (Dkt 35, Amend. Compl. ¶¶ 37-39).
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

10

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); 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).
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).

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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 51 at 19). 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 52 at 13-16). The Court is not persuaded. In Ramirez, 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 990-91
(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

12

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
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

13

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
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.

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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 he 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) (“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

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

15

impliedly preempted. In sum, Count I, in its entirety, is both expressly and impliedly preempted and
will be dismissed.
2.

Negligence & Gross Negligence
In Count II of his Amended Complaint, Plaintiff alleges “Negligence and Gross Negligence”

based on Defendants’ duties to (a) “[p]rovide truthful information to the FDA when seeking
approval of its device,” (b) “[m]arket and sell Infuse only for its approved purposes,” (c) “[m]arket
and sell Infuse only in ways which do not present an unreasonable risk of harm to the end users of
the product,” and (d) “[c]omply with all direction of the FDA, including the obligation to provide
the FDA with updated information, research and testing which could affect the original FDA
approval of its device” (Dkt 35, Amend. Compl. ¶ 41). Plaintiff alleges that the product was not
reasonably safe for off-label use at the time it left the control of Defendant seller because Defendants
intended and did in fact promote the off-label use of Infuse, which use had not been approved by the
FDA (id. ¶ 42). Plaintiff alleges that Defendants breached their duties by committing or omitting
the following acts: (a) “failing to report adverse consequences of its preapproval testing of Infuse,”
(b) “failing to refrain from promoting off-label use of Infuse,” (c) “failing to warn the public of the
dangers and risks of off-label use of Infuse,” and (d) “failing to report adverse consequences to the
FDA as the Defendants became more and more aware of the dangers of off-label use of Infuse” (id.
¶ 43). The Court will address each of the four allegations, in turn.
Plaintiff’s negligence claim in ¶ 41(a) based on a duty to “[p]rovide truthful information to
the FDA when seeking approval of its device,” even if not expressly preempted, is impliedly
preempted under Buckman and prohibited by the “no private right of action” provision of the

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FDCA.2 “[A] state-law claim that the defendant made misrepresentations to the FDA is preempted
because such a claim would not exist absent the federal regulatory scheme established by the
FDCA.” Caplinger, 921 F. Supp. 2d at 1214. “If the claim would not exist in the absence of the
FDCA, it is impliedly preempted.” Loreto v. Procter & Gamble Co., 515 F. App’x 576, 579 (6th
Cir. 2013). See Purchase v. Advanced Bionics, LLC, 896 F. Supp. 2d 694, 696 (W.D. Tenn. 2011))
(“[E]ven if a claim survives express preemption, it may be impliedly preempted if it amounts to a
disguised fraud-on-the-FDA claim.”).
Turning next to Plaintiff’s negligence in marketing claims in ¶ 41(b) and (c), the Court
agrees with Defendants that the “gravamen” of these claims, like 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 51 at 19). The Court’s prior analysis and
conclusion is therefore applicable here, too, and the Court concludes that Plaintiff’s negligence
claims in ¶ 41(b) and (c) are 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 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 claims 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

2

Further, Plaintiff appears to abandon this claim inasmuch as he indicated in response to
Defendants’ motion that he “does not claim that Defendants (or their predecessors) did anything
improper during the actual approval process” (Dkt 52 at 3).
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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”).
Last, the Court determines that the negligence claim in ¶ 41(d) based on a duty “to provide
the FDA with updated information, research and testing which could affect the original FDA
approval of its device” is not expressly preempted because the claim “seeks to hold Medtronic
accountable only for failing to do what federal law mandated.” Stengel v. Medtronic, 704 F.3d 1224,
1234 (9th Cir. 2013) (claims arising from medical pain pump). However, the claim is impliedly
pre-empted. Plaintiff points to no adverse event reporting requirements under Michigan law, and
the Court agrees that the requirements are administrative requirements of the FDCA. See Littlebear
v. Advanced Bionics, LLC, 896 F. Supp. 2d 1085, 1092 (N.D. Okla. 2012); cf. Schouest, 13 F. Supp.
3d at 706 (“to the extent Schouest can point to a state law duty to report adverse events, and,
critically, what FDA reporting regulations Medtronic allegedly violated, this claim could escape
preemption”). In sum, Count II, in its entirety, will also be dismissed as preempted.
3.

Breach of Warranty
Last, in Count III (“Breach of Warranty”) of his Amended Complaint, Plaintiff alleges that

“[t]hrough its schemes to promote the off-label use of Infuse, Defendants warranted and represented
that Infuse was safe for spinal surgeries without causing unreasonable risk of harm” (Dkt 35,
Amend. Compl. ¶ 47).

Plaintiff bases his “Breach of Warranty” claim on Defendants’

“representation and/or statements of express warranty” (id. ¶ 48).

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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—his 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 III is adequately pleaded, and the determinative
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). 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”).

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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
use are specifically excluded” (Defs.’ Ex. 3, Dkt 51-3 at 4). Defendants argue, with no opposition
from Plaintiff, that this unambiguous declaration defeats any warranty claim based on alleged
statements outside the Infuse device’s labeling (Dkt 51 at 34, 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”)).
Defendants also argue that there is no privity of contract between the parties, and that
Plaintiff failed to identify any affirmation of fact or promise that was the basis of the sale of the
Infuse device (Dkt 51 at 34-35). Again, Plaintiff fatally provides no opposition to Defendants’
arguments. See Notredan, L.L.C. v. Old Republic Exch. Facilitator Co., 531 F. App’x 567 (6th Cir.
2013) (recognizing that the plaintiff had waived claim by failing to respond to or refute arguments
made by the defendants in the district court); Allstate Ins. Co. v. Global Med. Billing, Inc., 520 F.
App’x 409, 412 (6th Cir. 2013) (same); Humphrey v. U.S. Att’y Gen.’s Office, 279 F. App’x 328,
331 (6th Cir. 2008) (holding that the defendant waived any argument on the issue by failing to
oppose a motion to dismiss); Scott v. Tenn., 878 F.2d 382 (6th Cir.1989) (affirming district court’s
grant of the defendant’s unopposed motion to dismiss, and noting that “if a plaintiff fails to respond
or to otherwise oppose a defendant’s motion, then the district court may deem the plaintiff to have
waived opposition to the motion”).
Thus, Defendants’ motion operates to defeat Plaintiff’s Count III, and Count III will also be
dismissed. See, e.g., Martin, 2014 WL 3635292, at *16 (the plaintiff’s express warranty claim is
dismissed, “not because it is preempted, but because she has not alleged what specific warranties

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were made to her or to her physicians”); Mendez v. Shah, No. 13-1585, 2014 WL 2921023, at *8 (D.
N.J. 2014) (“Although [the] plaintiff refers to advertising and marketing of Medtronic products offlabel, she does not specifically state what Medtronic expressly warranted”); Schouest, 13 F. Supp.
3d at 708 )“While conceptually an express warranty claim could avoid express preemption, what is
missing from Schouest’s complaint, in its current form, is a description of what specific warranties
Medtronic made to Schouest or her physicians”); Ramirez, 961 F. Supp. 2d at 1001 (dismissing
breach of express warranty claim because “any affirmation that forms the basis of an express
warranty must be between the seller and the buyer” and Ramirez “does not allege (in anything other
than the most conclusory manner) that Medtronic targeted her with its guarantees of safety in
off-label use of Infuse”); Houston I, 957 F. Supp. 2d at 1181 (holding that although the express
warranty claim was not federally preempted, the plaintiff had not alleged sufficient facts for the
claim to survive dismissal under Rule 8 where the “[p]laintiff alleged no facts demonstrating that
Defendants made any affirmations specifically to Plaintiff or her physician so as to form the basis
of the bargain”).
IV. CONCLUSION
For the foregoing reasons, the Court determines that Defendants’ Motion to Dismiss (Dkt
50) is granted. An Order will be entered consistent with this Opinion. As this Order resolves all
pending claims, a corresponding Judgment will also enter. See FED. R. CIV. P. 58.

Dated: January ___, 2015
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/s/ Janet T. Neff
JANET T. NEFF
United States District Judge

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