Aaron et al v. Medtronic Inc et al
Filing
67
ORDER GRANTING DEFENDANTS' MOTION TO DISMISS (Doc. 61 ). Signed by Judge Timothy S. Black on 9/22/2016. (mr)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF OHIO
WESTERN DIVISION
FRIEDA AARON., et al.,
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Plaintiffs,
v.
MEDTRONIC, INC., et al.,
Defendants.
Case No.
1:13-cv-301 (lead case)
1:13-cv-202
1:13-cv-214
1:14-cv-325
1:14-cv-483
Judge Timothy S. Black
ORDER GRANTING DEFENDANTS’ MOTION TO DISMISS (Doc. 61)
This civil action is before the Court upon Defendants’ motion to dismiss the
Omnibus Complaint filed August 28, 2015 (Doc. 61). The Omnibus Complaint (Doc. 54)
consolidates the claims from five cases brought against Defendants. See 4/20/15 Minute
Entry and Notation Order. Plaintiffs filed a response to the motion to dismiss on October
26, 2015 (Doc. 63), and Defendants filed a reply on December 15, 2015 (Doc. 65).
I.
BACKGROUND
Defendants Medtronic, Inc. and Medtronic Sofamor Danek, USA, Inc. (hereinafter
referred to collectively as the singular “Medtronic”) are medical device manufacturers.
Medtronic manufactures many products, but the product at the center of this case is called
Infuse. Infuse is used to stimulate bone growth in spinal fusion surgeries.
Infuse, like all medical devices sold in the United States, is regulated by the Food
and Drug Administration (FDA), which draws its regulatory authority in this area from
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the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA).
21 U.S.C. § 360c et seq. Under the MDA, different types of devices receive different
levels of FDA scrutiny. Devices that “support[] or sustain[] human life” or “present[] a
potential unreasonable risk . . . of injury” are designated “Class III” devices. 21 U.S.C.
§360c(a)(1)(C)(ii). Infuse has been classified as a Class III medical device by the FDA.
Class III devices like Infuse “incur the FDA’s strictest regulation” and must receive
Premarket Approval (PMA) from the FDA before being sold. Buckman Co. v. Plaintiffs’
Legal Comm., 531 U.S. 341, 344 (2001).
“Premarket Approval is a ‘rigorous’ process.” Riegel v. Medtronic, Inc., 552 U.S.
312, 317 (2008). To obtain PMA, a manufacturer “must submit a detailed PMA
application” that contains, among other things, “specimens for the proposed labeling of
the device.” Riegel v. Medtronic, Inc., 451 F.3d 104, 109 (2d Cir. 2006), aff’d, 552 U.S.
312 (2008). The FDA closely scrutinizes PMA applications, “weigh[ing] any probable
benefit to health from the use of the device against any risk of injury or illness from such
use.” Riegel, 552 U.S. at 318 (quotation marks omitted). “The FDA spends an average
of 1,200 hours reviewing each application” and “grants premarket approval only if it
finds there is a ‘reasonable assurance’ of the device’s ‘safety and effectiveness.’” Id. If
the FDA decides that the device’s proposed design, manufacturing methods, or labeling is
inadequate, the FDA can require revisions prior to approval. Id. at 319.
“Once a device has received premarket approval, the MDA forbids the
manufacturer to make, without FDA permission, changes in design specifications,
manufacturing processes, labeling, or any other attribute, that would affect safety or
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effectiveness. § 360e(d)(6)(A)(i).” Id. A manufacturer which wishes to make such
changes “must submit, and the FDA must approve, an application for supplemental
premarket approval, to be evaluated under largely the same criteria as an initial
application. § 360e(d)(6); 21 CFR § 814.39(c).” Id.
Infuse is one component of a medical device that was granted PMA by the FDA in
2002. The device itself consists of a collagen carrier sponge soaked with liquid protein
rhBMP–2 (this is the portion of the device referred to by the parties and by this Order as
“Infuse”) and a metallic cage, the LT–Cage. (Doc. 54, at 86–87). The protein-soaked
sponge is placed inside the LT–Cage which is inserted into the patient’s spine. (Id., at
87). The premarket approval specifies that the FDA-approved Infuse device consists of
all component parts which must be used together. (Id. at 92). The Infuse device was
approved only for use in a single-level fusion in the L4–S1 region of the lumbar spine via
the Anterior Lumbar Interbody Fusion procedure and in combination with the LT–Cage.
(Id. at 92–93). Use of the device in a manner not approved by the FDA is considered an
“off-label” use. (Id. at 92). Nevertheless, medical practitioners are not prohibited from
using a legally marketed device like Infuse in a manner that has not been approved by the
FDA. See 21 U.S.C. §396; Buckman, 531 U.S. at 341.
Plaintiffs in this case are several hundred former patients of Dr. Atiq Durrani,
M.D., an orthopedic surgeon operating in the Cincinnati area (in the past). The Omnibus
Complaint alleges that Dr. Durrani either directly performed or ordered surgeries utilizing
Infuse on Plaintiffs. The Complaint further alleges that each surgery was done using
Infuse in a manner that was “off-label,” meaning that Infuse was not used in the specific
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manner for which the FDA gave PMA to the device. Specifically, Plaintiffs allege that
they were subjected to the following off-label uses of Infuse:
[s]ome of the Omnibus Plaintiffs were implanted with Infuse® without the
LT–Cage. Some were subjected to a posterior surgical approach. Others
had Infuse® implanted in multiple levels of the spine. And some Omnibus
Plaintiffs had Infuse® implanted in their cervical or thoracic spines.
(Doc. 63, at 9–10). Plaintiffs further allege that, as a result of off-label use of Infuse,
each Plaintiff has suffered injury.
The Omnibus Complaint raises the following claims against Medtronic on behalf
of all Plaintiffs:
(1) fraudulent concealment, misrepresentation and fraud in the inducement;
(2) strict products liability (failure to warn);
(3) strict products liability (design defect);
(4) strict products liability (misrepresentation);
(5) products liability (negligence); and
(6) breach of express and implied warranties.
II.
STANDARD OF REVIEW
A motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6) operates to test the
sufficiency of the complaint and permits dismissal of a complaint for “failure to state a
claim upon which relief can be granted.” To show grounds for relief, Fed. R. Civ. P. 8(a)
requires that the complaint contain a “short and plain statement of the claim showing that
the pleader is entitled to relief.”
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While Rule 8 of the Federal Rules of Civil Procedure “does not require ‘detailed
factual allegations,’ . . . it demands more than an unadorned, the-defendant-unlawfullyharmed-me accusation.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (citing Bell Atl.
Corp. v. Twombly, 550 U.S. 544 (2007)). Pleadings offering mere “‘labels and
conclusions’ or ‘a formulaic recitation of the elements of a cause of action will not do.’”
Id. (citing Twombly, 550 U.S. at 555). In fact, in determining a motion to dismiss,
“courts ‘are not bound to accept as true a legal conclusion couched as a factual
allegation[.]’” Twombly, 550 U.S. at 555 (citing Papasan v. Allain, 478 U.S. 265
(1986)). Further, “[f]actual allegations must be enough to raise a right to relief above the
speculative level[.]” Id.
Accordingly, “[t]o survive a motion to dismiss, a complaint must contain
sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its
face.’” Iqbal, 556 U.S. at 678. A claim is plausible where “plaintiff pleads factual
content that allows the court to draw the reasonable inference that the defendant is liable
for the misconduct alleged.” Id. Plausibility “is not akin to a ‘probability requirement,’
but it asks for more than a sheer possibility that a defendant has acted unlawfully.” Id.
“[W]here the well-pleaded facts do not permit the court to infer more than the mere
possibility of misconduct, the complaint has alleged—but it has not ‘show[n]’—‘that the
pleader is entitled to relief,’” and the case shall be dismissed. Id. (citing Fed. Rule Civ.
P. 8(a)(2))
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III.
A.
ARGUMENT
Pleading Standards
An important issue argued by both parties, and relevant to all of Plaintiff’s claims,
is with what specificity these claims must be pleaded.
Generally, pleadings are governed by Rule 8 of the Federal Rules of Civil
Procedure, which states in relevant part:
A pleading that states a claim for relief must contain:
(1) a short and plain statement of the grounds for the court’s jurisdiction,
unless the court already has jurisdiction and the claim needs no new
jurisdictional support;
(2) a short and plaint statement of the claim showing that the pleader is
entitled to relief; and
(3) a demand for the relief sought, which may include relief in the
alternative or different types of relief.
Fed. R. Civ. P. 8(a).
As previously stated above, Federal Rule of Civil Procedure 8 “demands more
than an unadorned, the-defendant-unlawfully-harmed-me accusation.” Iqbal, 556 U.S. at
678 (citing Twombly, 550 U.S. at 555). Thus, Defendants argue that:
Conclusory allegations that the defendant violated FDA regulations in the
manufacture, labeling, or marketing of the premarket approved medical
device are insufficient to state a parallel state-law claim and thereby avoid
preemption under § 360k(a).” Ali v. Allergan USA, Inc., 2012 WL 3692396,
at *6 (E.D. Va. 2012). Thus, “Plaintiffs cannot simply incant the magic
words ‘Medtronic violated FDA regulations’ in order to avoid preemption.”
In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F. Supp.
2d 1147, 1158 (D. Minn. 2009), aff'd sub nom. Bryant v. Medtronic, Inc.,
623 F.3d 1200 (8th Cir. 2010); accord, e.g., Caplinger I, 921 F. Supp. 2d at
1224. Rather, “to avoid preemption, Plaintiff must sufficiently allege a
‘parallel’ claim in accordance with general pleading standards.” Franklin
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v. Medtronic, Inc., 2010 WL 2543579, at *8 (D. Colo. 2010), report and
recommendation adopted, 2010 WL 2543570 (D. Colo. 2010). “To state a
‘parallel’ claim” that escapes preemption under § 360k(a), “a plaintiff must
allege … the violation of a specific federal requirement.” Millman, 2015
WL 778779, at *4 n.2 (emphasis added); accord, e.g., Wolicki-Gables v.
Arrow Int’l, Inc., 634 F.3d 1296, 1300–01 (11th Cir. 2011). Moreover,
“‘[t]o properly allege parallel claims, the complaint must set forth facts’”
that, if true, would establish the predicate federal violation. Franklin, 2010
WL 2543579, at *8 (quoting Parker v. Stryker Corp., 584 F. Supp. 2d 1298,
1301 (D. Colo. 2008)) (emphasis by court).
(Doc. 65, at 36–37).
Plaintiffs admit that, for several of the claims in the Omnibus Complaint, Plaintiffs
did not plead specific federal laws nor regulations that were allegedly violated. (See Doc.
63, at 28). However, Plaintiffs argue that the specific circumstances behind a medical
device products liability case merit a more permissive review of a Complaint’s Rule 8
compliance. Thus, Plaintiffs ague that:
The better reasoned analysis regarding the specificity required in the
context of a design defect claim (or any other claim) and MDA preemption
is that a plaintiff need not identify the precise defect or the specific federal
regulatory requirements that were alleged violated in order to comply with
Rule 8. Waltenburg v. St. Jude Medical, Inc., 33 F. Supp.3d 818, 827
(W.D. Ky. 2014). The Walternberg [sic] Court relied upon the following
quote from the Court of Appeals for the Seventh Circuit in Bausch v.
Stryker Corp., 630 F.3d at 560 (7th Cir. 2010):
Defendants object that the original complaint does not specify the
precise defect or the specific federal regulatory requirements that were
allegedly violated. Although the complaint would be stronger with
such detail, we do not believe the absence of those details shows a
failure to comply with Rule 8 of the Federal Rules of Civil Procedure
or can support a dismissal under Rule 12(b)(6). Id.
The Seventh Circuit based its decision in part on the fact that “in the
context of Class III medical devices, much of the critical information is
kept confidential as a matter of federal law [and] there is no public access
to complete versions of [the FDA’s premarket approval] documents.” Id.
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Thus, the Bausch Court reasoned that “[i]f plaintiffs must allege that the
defendant violated a particular FDA-approved specification before
discovery, then it is difficult to appreciate how any plaintiff will ever be
able to defeat a Rule 12(b)(6) motion.” Id. at 561. See also Garross v.
Medtronic, Inc., 77 F. Supp.3d 809, 817 (E.D. Wis. 2015).
(Id. at 28 fn. 8).
Several courts have disagreed with Bausch’s holding that particularity was not
required in a products liability pleading involving FDA Class III medical devices. See,
e.g., Bertini v. Smith & Nephew, Inc., 2013 WL 6332684, at *4 (E.D.N.Y. 2013); Ali v.
Allergen USA, Inc., 2012 WL 3692396, at *14 (E.D. Va. 2012). While the Sixth Circuit
has not directly addressed the holding in Bausch, it did recently reject the notion that
Rule 8’s pleading standards should be lowered in circumstances where there was a
natural imbalance of information, stating that to survive a motion to dismiss, a “plaintiff
must allege specific facts . . . even if those facts are only within the head or hands of the
defendants.” New Albany Tractor, Inc. v. Louisville Tractor, Inc., 650 F.3d 1046, 1051
(6th Cir. 2011). That ruling has been applied in the medical device context by a recent
ruling within this district that articulately summarized the issue:
Plaintiffs seem to contend that their complaint should be allowed to
proceed because they can't get to the facts that would support their causes
of action without discovery (doc. 8, “it is impossible for Plaintiff to be
certain how the [medical device] injured her because there has not yet been
discovery”). Unfortunately for Plaintiffs, discovery cannot be used as a
fishing expedition to uncover the facts necessary to support the causes of
action presented in the complaint, “even when the information needed to
establish a claim . . . is solely within the purview of the defendant or a third
party.” New Albany Tractor, Inc., v. Louisville Tractor, Inc., 650 F.3d
1046, 1051 (6th Cir.2011). Plaintiffs “may not use the discovery process to
obtain facts after filing suit.” Id. Absent factual support from which the
Court may plausibly infer negligence, Count One fails to meet the pleading
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standard set forth by the Supreme Court in Iqbal and Twombly and must
therefore be dismissed.
Anderson v. Boston Scientific Corp., 2013 WL 632379 (S.D. Ohio 2013). Application of
such an analysis is also appropriate in this case, and this Court finds that Plaintiffs’
claims must meet the pleading standards of Rule 8 as defined in Iqbal and Twombly in
order to survive a motion to dismiss.
Furthermore, even were the Court to apply the lowered pleading standard from
Bausch, several of Plaintiffs’ claims would still be deficient because they are not
adequately pleaded even under that standard. Here, “unlike [the plaintiffs in Bausch],
Plaintiffs simply do not allege—or provide any factual support for an allegation of—
violations of federal law” with respect to several of their claims. Id. at *4 fn. 1
(dismissing a products liability claim as insufficiently pleaded to be a parallel claim
allowed by the MDA).
B.
Plaintiffs’ State Law Claims and Causes of Action
Are Preempted by Federal Law
1.
Express Preemption
The MDA’s preemption clause, 21 U.S.C. § 360k(a), prohibits the use of state law
to enforce any requirement that is “different from, or in addition to” requirements
imposed by the FDA. Congress adopted § 360k(a) as a “general prohibition on nonFederal regulation” of medical devices to ensure “that innovations in medical device
technology are not stifled by unnecessary restrictions” and to protect device
manufacturers from the “undu[e] burdens” of “differing requirements . . . imposed by
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jurisdictions other than the Federal government.” H.R. Rep. No. 94-853, at 12, 45. The
MDA thus “swept back some state obligations and imposed a regime of detailed federal
oversight,” enforced by an expert federal agency rather than by private plaintiffs and lay
juries applying state tort law. Riegel, 552 U.S. at 316.
Although preemption of state-law tort claims may leave some injured individuals
“without . . . judicial recourse,” Congress determined that the loss to those comparatively
few individuals was outweighed by the benefit to the far greater number “who would
suffer without new medical devices if juries were allowed to apply the tort law of 50
states to all innovations.” Riegel, 552 U.S. at 326; see also Caplinger v. Medtronic, Inc.,
784 F.3d 1335, 1346 (10th Cir. 2015) (“Any additional state duties on top of those
already imposed by federal law, even if nominally limited to off-label uses, might check
innovation, postpone access to life-saving devices, and impose barriers to entry without
sufficient offsetting safety gains.”). As an alternative to private tort suits, Congress
granted the FDA extensive authority to police device manufacturers under deferral law.
See Buckman, 531 U.S. at 349.
However, not all state law claims involving medical devices are preempted by the
MDA. The Supreme Court has explicitly held that “[n]othing in [21 U.S.C.] § 360k
denies [a state] the right to provide a traditional damages remedy for violations of
common-law duties when those duties parallel federal requirements.” Medtronic, Inc. v.
Lohr, 518 U.S. 470, 495 (1996). With this holding, the Supreme Court has recognized
that it cannot be an abrogation of federal supremacy for a state to impose restrictions on
medical devices that are already imposed by the FDA; only by imposing different or
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additional requirements to those imposed by federal regulations can a state common-law
claim be preempted by the MDA.
Accordingly, 21 U.S.C. § 360k(a) creates a two-step test for determining whether
state-law claims are preempted. See, e.g., Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d
1296, 1300–01 (11th Cir. 2011); In re Medtronic, Inc., Sprint Fidelis Leads Prod. Liab.
Litig., 623 F.3d 1200, 1204 (8th Cir. 2010); Thorn v. Medtronic Sofamor Danek, USA,
Inc. et al., 81 F. Supp. 3d 619, 623–24 (W.D. Mich. 2015). First, a court must determine
whether “the Federal Government has established requirements applicable to” the
medical device. Riegel, 552 U.S. at 321. If the Federal Government has, the court must
then determine whether the state-law claims impose “requirements with respect to the
device that are ‘different from, or in addition to’” the federal requirements. Id. at 322;
Hafer et al. v. Medtronic Inc., et al., 99 F. Supp. 3d 844, 855–56 (W.D. Tenn. 2015).
a.
Established Federal Requirements
Plaintiffs argue that their state-law claims are not preempted because the FDA has
not established any requirements for Infuse as it was used on the Plaintiffs in this case.
This claim is without merit.
The crux of Plaintiffs’ argument is that the product that was used on each of the
Plaintiffs, Infuse, was only one component of the medical device that received PMA from
the FDA, and that the FDA therefore did not impose any requirements upon Infuse itself:
The device that received PMA approval from the FDA was a combination
device consisting of two components—the Infuse® bone protein and the
LT-Cage. The LT-Cage™ is an intervertebral spacer cage that must be
used in combination with the bone protein. The FDA’s 2002 approval of
Medtronic’s PMA for this device was expressly restricted to the use of both
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components together: “These components must be used as a system. The
InFuse™ Bone Graft component must not be used without the LT-CAGE™
Lumbar Tapered Fusion Component.” These are not merely requirements
the FDA is imposing on an approved device. This is the FDA’s definition
of the device it approved.
(Doc. 63, at 19 (emphasis in original)).
Plaintiffs’ argument that the FDA has not established federal requirements for
Infuse’s rhBMP-2 component when used without the LT-Cage component is incorrect.
Premarket approval extends to all components of an approved device, even when a
physician uses the components separately. Thus, nearly every court to consider this issue
in an Infuse case has held that “premarket approval is as controlling of the individual
components . . . as it is to the device as a whole.” Hawkins v. Medtronic, Inc., 2014 WL
346622, at *5 (E.D. Cal. 2014). 1 Courts addressing other devices have likewise held that
claims arising from use of a particular component of a device are “also subject to PMA
preemption.” Smith v. Depuy Orthopedics Inc., 552 F. App’x 192, 196 (3d Cir. 2014). 2
There is therefore no doubt that § 360k(a) applies here.
Plaintiffs cite two cases to support the proposition that § 360k(a) does not impose
FDA requirements on the individual components of an approved medical device.
1
Accord, e.g., Hafer v. Medtronic, Inc., 99 F. Supp. 3d 844, 858 (W.D. Tenn. 2015); BeaversGabriel v. Medtronic, Inc., 15 F. Supp. 3d 1021, 1032–33 (D. Haw. 2014); Ledet v. Medtronic,
Inc., 2013 WL 6858858, at *3 (S.D. Miss. 2013); Houston v. Medtronic, Inc., 957 F. Supp. 2d
1166, 1176 (C.D. Cal. 2013); Gavin v. Medtronic, Inc., 2013 WL 3791612, at *11–12 (E.D. La.
2013); Latimer v. Medtronic, Inc., 2015 WL 5222644, at *7 (Ga. Super. Ct. 2015)
2
Accord, e.g., Bertini v. Smith & Nephew, Inc., 8 F. Supp. 3d 246, 251–55 (E.D.N.Y. 2014);
Gross v. Stryker Corp., 858 F. Supp. 2d 466, 487 (W.D. Pa. 2012); Riley v. Cordis Corp., 625 F.
Supp. 2d 769, 779 (D. Minn. 2009); Duggan v. Medtronic, Inc., 840 F. Supp. 2d 466, 471 (D.
Mass. 2012).
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The first case, Samet v. Procter & Gamble Co., 2013 WL 3124647 (N.D. Cal.
2013), deals with food packaging as regulated by the FDCA, not medical devices.
Although 21 U.S.C. §360k(a) is discussed by the court in Samet, it is not directly bearing
upon the case, and the court’s ruling in that case contains no discussion of whether the
FDA’s regulating a system of components establishes requirements on the individual
components themselves.
Plaintiffs’ other cited case, Purchase v. Advanced Bionics, LLC, 896 F.Supp.2d
694 (W.D. Tenn. 2011), is also not analogous to the present case. In Purchase, the
defendant manufacturer modified a Class III medical device that had received PMA by
replacing one component that had gone through the approval process with an entirely
separate component that did not go through that process. Id. at 697. In the present case,
third parties (such as Dr. Durrani) used one component of an approved medical device
either in a manner that was not approved by the FDA or without using the complete
device. In Purchase, a component that had not undergone FDA scrutiny was being used
in procedures on patients; in this case, Infuse has been subjected to that scrutiny, and is
subject to the same regulations as the complete device itself.
Several courts throughout the country have examined this exact issue and have
held that “the FDA established specific federal requirements for the Infuse Device, even
when the Infuse Protein is used alone.” Angeles v. Medtronic, Inc., 863 N.W.2d 404, 412
(Minn. Ct. App. 2015); accord, e.g., Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166,
1176 (C.D. Cal. 2013) (rejecting “Plaintiff[’s] argu[ment] that the PMA process for the
Infuse Device only establishes federal requirements for the InFUSE Bone Graft used in
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conjunction with the LT–Cage, but not the InFUSE Bone Graft used alone”); see also,
e.g., Hafer, 99 F. Supp. 3d at 858 (“the PMA does impose federal requirements upon the
BMP/Sponge”); Beavers-Gabriel, 15 F. Supp. 3d at 1033 (“[E]ven though off-label use
of only a component of the Infuse Device is at issue, the FDA approval applies ‘with
respect to’ the Infuse Device generally and therefore such approval includes its
components.”).
Indeed, Plaintiffs’ assertion that premarket approval of the Infuse device does not
extend to the device’s constituent components cannot be reconciled with the FDCA,
which explicitly defines “[t]he term ‘device’” to “includ[e] any component” of a device.
21 U.S.C. § 321(h) (emphasis added). See also Angeles, 863 N.W.2d at 411 (“The
FDCA’s definition of ‘device’ includes ‘any component, part, or accessory.’”) (quoting
21 U.S.C. § 321(h)); accord Hafer, 99 F. Supp. 3d at 858. Thus, “[t]here is no merit to
Plaintiff[s’] assertion that § 360k(a) does not apply because Plaintiff[s’] surgeon[s]
supposedly implanted the Infuse device without its LT-Cage component.” Latimer, 2015
WL 5222644, at *7.
The FDA’s granting of PMA to the Infuse protein and LT-Cage medical device
concomitantly established federal requirements on Infuse alone.
b.
Parallel Claims
As the FDA’s granting of PMA to the Infuse medical device created federal
requirements applicable to the device, Plaintiff’s state law claims can survive only if the
requirements imposed by the state laws are parallel to those imposed by the FDA. Any
state-law requirement imposed on FDA-regulated medical devices that is “different from,
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or in addition to” FDA requirements is expressly preempted and cannot support a
Complaint. 21 U.S.C. § 360k(a).
1) Failure to Warn
Plaintiffs’ Omnibus Complaint alleges that Medtronic is liable for Plaintiffs’
injuries due to Plaintiffs’ failure to warn of the dangers of Infuse. Specifically, the
Complaint states:
At all relevant times, Defendants misrepresented the safety of Infuse® to
physicians and spine patients, including to Plaintiffs and Dr. Durrani, and
recklessly, willfully, or intentionally failed to inform each Plaintiff and Dr.
Durrani of the significant dangers to patients resulting from the off-label
use of Infuse®.
Any warnings Defendants may have issued concerning the dangers of offlabel uses of Infuse® or regarding the specific risks of those uses were
insufficient in light of Defendants’ contradictory prior, contemporaneous,
and continuing illegal promotional efforts and promotion of Infuse® for
non-FDA-approved off-label uses in the spine and Defendants’
contemporaneous efforts to hide or downplay the true risks and dangers of
the off-label uses of Infuse®.
(Doc. 54, at 82).
Plaintiffs’ failure to warn claims are expressly preempted by 21 U.S.C. § 360k(a).
First and most obviously, to the extent that Plaintiffs allege that Defendants were required
to give any warning other than those that were required by the FDA as part of its PMA of
Infuse, those claims are expressly denied as being inconsistent with federal law. 21
U.S.C. § 360k(a).
Plaintiffs argue that “the failure to warn claim is premised upon Medtronic’s
failure to file adverse-event reports with the FDA.” (Doc. 63, at 26). The FDA requires
that all manufacturers or importers of medical devices “shall report[] whenever the
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manufacturer or importer receives or otherwise becomes aware of information that
reasonably suggests that one of its marketed devices . . . may have caused or contributed
to a death or serious injury.” 21 U.S.C. § 360i(a)(1). Plaintiffs claim that Ohio’s duty to
warn extends to third parties, which in this case would include the FDA. Ohio’s
imposition of a duty to warn would therefore be a parallel requirement as it pertains to
warning the FDA, because federal law already requires that a device manufacturer do so
in the form of adverse-event reports.
Plaintiffs’ argument is without merit. Although federal law requires device
manufacturers to report certain adverse events to the FDA, there is no state-law duty to
report adverse events to the FDA. And the federal duty to report certain information to
the FDA is not “identical” (Lohr, 518 U.S. at 495), and thus not parallel, to the state-law
duty to provide warnings to patients or their physicians. See McClelland v. Medtronic,
Inc., 944 F. Supp. 2d 1193, 1199–1200 (M.D. Fla. 2013); McClelland v. Medtronic, Inc.,
2012 WL 5077401, at *6 (M.D. Fla. 2012). Because the state-law duty to warn is “not
genuinely equivalent to a duty imposed by the FDCA” (Pinsonneault v. St. Jude Med.,
Inc., 953 F. Supp. 2d 1006, 1016 (D. Minn. 2013)), Plaintiffs’ “allegations that Medtronic
failed to report adverse events to the FDA do not state a parallel claim.” (Cales v.
Medtronic Inc., 2014 WL 6600018, at *10 (Ky. Cir. Ct. 2014)). Doctors are warned of
the risks associated with a medical device through the device’s labeling, not through
adverse-event reports submitted to the FDA.
Adverse-event reports are not warnings. Although the FDA “may disclose”
adverse-event reports, it is not required to do so. 21 C.F.R. § 803.9(a) (emphasis added).
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Thus, adverse-event reports, unlike the warnings on a device label, “are not automatically
made public.” Pinsonneault, 953 F. Supp. 2d at 1016; accord Cline v. Advanced
Neuromodulation Sys., Inc., 17 F. Supp. 3d 1275, 1286 (N.D. Ga. 2014) (“[T]he FDA’s
disclosure of [adverse-event reports] to the public is not guaranteed”).
Furthermore, adverse-event reports do not necessarily result in labeling changes
and cannot be used by a manufacturer to unilaterally change the label. Labeling changes
require FDA approval (see 21 C.F.R. § 814.39), and the FDA may not approve a safetyrelated labeling change absent “valid scientific evidence” (id. § 814.20(b)(3)(vi)), a
category that specifically excludes “[i]solated case reports” and “reports lacking
sufficient details to permit scientific evaluation” (id. § 860.7(c)(2)). Because adverseevent reports are anecdotal and “do[] not necessarily reflect a conclusion by . . . FDA . . .
that the device . . . caused or contributed to the reportable event” (FDA, Manufacturer
and User Facility Device Experience Database, http://www.fda.gov/MedicalDevices
/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm1
27891.htm), adverse-event reports are not by themselves sufficient grounds for a labeling
change. Given that adverse-event reports are regulatory submissions, not warnings, that
must be submitted to the FDA, not to patients or their physicians, the federal duty to
submit adverse-event reports to the FDA is “not genuinely equivalent” to a state-law duty
to warn physicians, and thus cannot support a failure-to-warn claim, even if allegedly
violated. Pinsonneault, 953 F. Supp. 2d at 1016.
Moreover, because the FDCA does not require that a manufacturer furnish
adverse-event reports directly to physicians, any state-law requirement that a
17
manufacturer do so is “different from, or in addition to, any requirement applicable under
the FDCA and its implementing regulations, and is pre-empted.” Pinsonneault, 953 F.
Supp. 2d at 1016; see also Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir. 2005)
(“[a]ny claim, under state law, . . . that Defendant failed to warn patients beyond
warnings required by the FDA” is expressly preempted by § 360k(a)).
There is, conversely, no state-law requirement that medical-device manufacturers
submit adverse-event reports to the FDA. Plaintiffs’ Omnibus Complaint does not
identify any Ohio (or other state) authority that “recognize[s] a state common-law failureto-warn claim based on a failure to properly issue reports to a federal agency, such as the
FDA.” Pinsonneault, 953 F. Supp. 2d at 1015. Thus, a “state law duty to warn the
[patient] or her physician” does not parallel “manufacturer reporting requirements to the
FDA.” McClelland, 2012 WL 5077401, at *6. Accordingly, an alleged failure to submit
adverse-event reports to the FDA cannot support a state-law failure-to-warn claim. See
Pinsonneault, 953 F. Supp. 2d at 1016; Cales, 2014 WL 6600018, at *10; Lake v.
Kardjian, 874 N.Y.S.2d 751, 755 (Sup. Ct. 2008) (“[T]he alleged failure … to comply
with the MDA’s reporting requirements does not constitute a ‘parallel claim.’”); cf.
PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2578 (2011) (“State law demanded a safer label;
it did not instruct the Manufacturers to communicate with the FDA”).
Plaintiff has provided the Court with cases in other circuits in which state-law
failure-to-warn claims against medical device manufacturers were permitted to proceed
based on the theory that the defendants’ failure to provide adverse-event reports to the
FDA was a violation of parallel state and federal requirements on manufacturers. See
18
Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc), cert. denied, 134 S.
Ct. 2839 (2014); Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011).
However, this Court finds that the requirements imposed by Ohio state law and the
FDA’s adverse-event report rule are not parallel. This Court agrees with the many courts
cited by Defendants which have held that the requirement to file adverse-event reports
with the FDA is not parallel to state products liability law regarding failure to warn.
Accordingly, Plaintiffs’ failure to warn claims are expressly preempted under 21
U.S.C. § 360k(a) and are therefore dismissed.
2) Design Defect Claim
Plaintiffs have also raised a design defect claim against Defendants. Specifically,
the Omnibus Complaint alleges:
Defendants’ Infuse® device was defectively designed at the time that it left
their control and was placed into the stream of commerce. The device
reached each Plaintiff without a substantial change in the condition in
which it was sold.
Defendants’ Infuse® device was defectively designed because the design
was unsafe when used in the manner promoted by Defendants and/or in a
manner reasonably foreseeable by them. The Infuse® product failed to
perform as safely as an ordinary consumer would expect when used, as it
was promoted by Defendants and their agent, Dr. Durrani, for an off-label
manner in spine surgeries.
Defendants’ Infuse® device was defectively designed because the risks of
danger in the design outweigh the benefits of the design.
The Infuse® product was designed in a way that 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.
The foreseeable risks of harm posed by using the Infuse® product in a
manner promoted by Defendants and their agent, Dr. Durrani, could have
19
been reduced or avoided by adopting a reasonably alternative design.
Defendants did not adopt a design that would have rendered the Infuse®
product reasonably safe.
(Doc. 51, at 802–03).
Plaintiff’s design defect claim is expressly preempted by 21 U.S.C. § 360k(a).
Notably, the Omnibus Complaint does not allege, even in a conclusory fashion, that the
design of the Infuse device Plaintiffs received was anything other than the design
approved by the FDA through the PMA process. Thus, “to prevail on this claim,
Plaintiffs would need to establish that the Infuse Device should have been designed in a
manner different than that approved by the FDA.” Beavers-Gabriel, 15 F. Supp. 3d at
1040 (emphasis added). 3
However, the Supreme Court’s decision in Riegel—which held that § 360k(a)
preempts “claims of strict liability . . . and negligence in the design” of a device (552 U.S.
at 320)—squarely forecloses any such claim, which would necessarily “establish design
requirements different from, or in addition to, federal requirements for the Infuse
Device.” Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206, 1222 (W.D. Okla. 2013).
Indeed, a state-law claim that would require a medical device to have a design different
from that approved by the FDA through the PMA process is a frontal “attack[] on the
risk/benefit analysis that led the FDA to approve” the device. In re Medtronic, 623 F.3d
3
Accord, e.g., Byrnes v. Small, 60 F. Supp. 3d 1289, 1298 (M.D. Fla. 2015); Blankenship v.
Medtronic, Inc., 6 F. Supp. 3d 979, 989 (E.D. Mo. 2014); Schouest v. Medtronic, Inc., 13 F.
Supp. 3d 692, 707 (S.D. Tex. 2014); Angeles, 863 N.W.2d at 420.
20
at 1206. 4 Accordingly, “this is the exact type of claim that is expressly preempted under
§ 360k(a).” Caplinger, 921 F. Supp. 2d at 1222.
Plaintiffs’ response argues that, although there were no specific allegations that
Defendants manufactured Infuse contrary to FDA specifications in the Complaint, the
design defect claim should still be allowed to proceed. The response lists several statutes,
unmentioned in the Omnibus Complaint, that “may have been violated by Medtronic.”
(Doc. 63, at 28–30). However, many of these statutes are irrelevant, and several of them
are statutes regulating manufacturing defects rather than design defects. Even read in the
manner most possibly favorable to Plaintiffs, the Omnibus Complaint cannot be said to
allege manufacturing defects (i.e., that the Infuse used in Plaintiffs’ surgeries was not
produced according to FDA specifications); only design defects (i.e., that the process for
manufacturing Infuse that was approved by the FDA is faulty) are properly alleged.
However, allowing a design defect claim to proceed would be tantamount to holding that
a medical device design that has been approved by the FDA can nonetheless be legally
deficient—an encroachment on federal regulatory authority that 21 U.S.C. § 360(k) was
specifically designed to prevent.
Accordingly, Plaintiffs’ design defect claims are preempted and therefore warrant
dismissal.
4
Accord, e.g., Kemp v. Medtronic, Inc., 231 F.3d 216, 219 (6th Cir. 2000); Martin v. Medtronic,
Inc., 32 F. Supp. 3d 1026, 1044 (D. Ariz. 2014); Houston, 957 F. Supp. 2d at 1177; Kashani–
Matts v. Medtronic, Inc, 2013 WL 6147032, at *4 (C.D. Cal. 2013).
21
3) Breach of Express Warranty
Count Six of Plaintiffs’ Omnibus Complaint alleges that Medtronic breached
purported express warranties with respect to the “effectiveness [and] safety” of the Infuse
device and the “absence of complications” associated with its use. (Doc. 54, at 810–11).
For Plaintiffs to prevail on this claim, a jury would need to find that Infuse “was not safe
and effective” as labeled. Gavin, 2013 WL 3791612, at *15–16 (emphasis added); Hafer,
2015 WL 1648978, at *16 (same); Caplinger, 921 F. Supp. 2d at 1222 (same); Lawrence
v. Medtronic, Inc., 2013 WL 4008821, at *5 (Minn. Dist. Ct. 2013) (same). But that
would conflict with the FDA’s conclusive determination in granting premarket approval
that “there is a ‘reasonable assurance’ of the device’s ‘safety and effectiveness.’” Riegel,
552 U.S. at 318. Indeed, because the imposition of state-law liability for the alleged
breach of a purported warranty as to the safety or effectiveness of medical device that has
received premarket approval would effectively require that such a device be safer or more
effective than demanded by the FDA, “[c]ourts have consistently found that state law
claims for breach of warranties based on the safety or effectiveness of [such a] device,
impose requirements ‘that “are different from, or in addition to”’ federal regulations, and
thus are preempted.” Thomas v. Alcon Labs., 2013 WL 10888983, at *5 (N.D. Ga. 2013)
(dismissing express-warranty claim as expressly preempted under § 360k(a)) (quoting
Riegel, 552 U.S. at 330, in turn quoting 21 U.S.C. § 360k(a)).
That the purported warranty at issue in this case allegedly encompassed off-label
uses is immaterial. When the FDA determined that Infuse is safe and effective as
labeled, it knew that medical devices often are—and that Infuse in particular likely would
22
be (cf. Doc. 54, at 74–75)—used in an off-label manner. See United States v. Caronia,
703 F.3d 149, 166 (2d Cir. 2012) (“[T]he FDA’s . . . approval process generally
contemplates that approved [devices] will be used in off-label ways.”). The expresswarranty claim is therefore preempted. See, e.g., Gavin, 2013 WL 3791612, at *15
(warranty claims involving off-label use of Infuse are preempted because they would
finding “the Device was not safe and effective … contrary to the FDA’s approval”);
accord Caplinger, 921 F. Supp. 2d at 1222; Wendt, 2013 WL 3199361, at *1; see also
Williams v. Cyberonics, Inc., 388 F. App’x 169, 171 (3d Cir. 2010); Depuy Orthopaedics,
Inc., 2013 WL 1108555, at *10.
Furthermore, Plaintiffs’ breach of express warranty claim fails to articulate in any
fashion what the express warranty made by Defendants was and how that express
warranty could be enforced by Ohio law in a parallel fashion to federal law so as to avoid
preemption. Plaintiffs’ response cites Hawkins v. Medtronic, Inc., 909 F. Supp. 2d 901
(S.D. Ohio 2012), in support of their breach of express warranty claim. In Hawkins, the
court allowed a claim of breach of implied warranty on a FDA Class III medical device to
survive a motion to dismiss despite the plaintiff’s failure to plead “the precise contours of
[the plaintiff’s] theory of recovery” because “it [was] clear from the allegations that [the
plaintiff]’s claim is in fact premised upon the theory that Defendant violated federal law.”
Id. at 911.
This argument is without merit for two reasons. First, as explained in Part III.A,
supra, this Court rejects the reduced pleading standard for products liability cases
involving FDA Class III medical devices articulated in cases such as Bausch. Second,
23
Plaintiffs’ express warranty claim in this case fails to meet even the more lax standard
articulated by the court in Hawkins, as it is absolutely not “clear from the allegations that
[the plaintiff]’s claim is in fact premised upon the theory that Defendant violated federal
law.” Id.
Accordingly, Plaintiffs’ claim of breach of express warranty is preempted by 21
U.S.C. § 360k(a) and therefore warrants dismissal.
2.
Implied Preemption
Defendants’ motion to dismiss also argues that “[e]ven if Plaintiffs had stated a
parallel claim that escapes express preemption under [21 U.S.C.] § 360k(a), any such
claim predicated on alleged off-label promotion or an alleged failure to submit adverseevent reports to the FDA would be impliedly preempted[.]” (Doc. 61, at 63 (quoting
Cales, 2014 WL 6600018)).
In enacting the FDCA, Congress not only declined to create a private cause of
action, but also affirmatively required that any action to enforce the FDCA “shall be by
and in the name of the United States” (21 U.S.C. § 337(a)), thereby mandating that the
FDCA and its implementing regulations be “enforced exclusively by the Federal
Government.” Buckman, 531 U.S. at 352. Moreover, Congress granted the FDA
“complete discretion” in deciding “how and when [its enforcement tools] should be
exercised.” Heckler v. Chaney, 470 U.S. 821, 835 (1985). That discretion is necessary “to
achieve a somewhat delicate balance of statutory objectives,” a balance that “can be
skewed” if private tort suits are allowed. Buckman, 531 U.S. at 348. “This flexibility is a
critical component of the statutory and regulatory framework under which the FDA
24
pursues difficult (and often competing) objectives.” Id. at 349. Thus, “[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.” Id. at 349 n.4.
Consequently, through 21 U.S.C. § 337(a), Congress impliedly preempted any
private action seeking to enforce duties created by the FDCA and its implementing
regulations. As the Sixth Circuit has explained, any claim that relies on the FDCA or its
implementing regulations “‘[a]s a critical element’” is barred by § 337(a). Marsh v.
Genentech, Inc., 693 F.3d 546, 553 (6th Cir. 2012) (quoting Buckman, 531 U.S. at 353);
see also In re Darvocet, Darvon, & Propoxyphene Prods. Liab. Litig., 756 F.3d 917, 936
(6th Cir. 2014) (“negligence claims” premised on “a violation of the FDCA” are
impliedly preempted “because the FDA has the exclusive power to enforce the FDCA”
and there is therefore “no private right to enforce the statute”). 5
Indeed, § 337(a) forbids private plaintiffs from asserting any “state claim [that]
would not exist if the FDCA did not exist,” or any claim for which “‘the existence of
[the] federal enactments is a critical element,’” because such a claim “is in substance
(even if not in form) a claim for violating the FDCA” and may be enforced only by the
federal government. Riley, 625 F. Supp. 2d at 777, 790 (quoting Buckman, 531 U.S. at
353); see also Leonard v. Medtronic, Inc., 2011 WL 3652311, at *7 (N.D. Ga. 2011).
5
See also Hafer, 2015 WL 1648978, at *9 (“A plaintiff cannot bring a state-law claim that is in
substance a claim to enforce the FDCA.”); Arnold v. Alphatec Spine, Inc., 2014 WL 2896838, at
*6 (S.D. Ohio 2014) (“[C]laims for violations of the FDCA brought by private litigants are
impliedly preempted”); accord, e.g., Caplinger, 784 F.3d at 1339; McClelland, 944 F. Supp. 2d
at 1200.
25
a.
Claims Based on a Failure to Submit Adverse-Event
Reports to the FDA are Impliedly Preempted
The Sixth Circuit has squarely held that claims premised on an alleged “failure to
submit reports to the FDA” are impliedly preempted by § 337(a), as interpreted by
Buckman, because any such claim would be an impermissible attempt to enforce
exclusively federal requirements with no counterpart in state law. Marsh, 693 F.3d at
553. 6
As Buckman teaches, “the relationship between a federal agency and the entity it
regulates is inherently federal in character because the relationship originates from, is
governed by, and terminates according to federal law.” 531 U.S. at 347; see also Dawson
v. Medtronic, Inc., 2013 WL 4048850, at *7 (D.S.C. 2013) (“[T]hese [reporting]
regulations relate to information that manufacturers are required to provide to the FDA,
and Plaintiff cannot usurp the FDA’s regulatory oversight role for policing purported
violations of the agency’s regulations.”). Any tort claim based on an alleged failure to
submit adverse-event reports to the FDA “would not be relying on traditional state tort
law which had predated” the FDCA (Buckman, 531 U.S. at 353), because no duty to
6
Accord Cupek, 405 F.3d at 423–24 (claim that manufacturer failed to comply with the FDA’s
“conditions of approval,” which incorporate the FDCA’s reporting requirements, “is a disguised
fraud on the FDA claim” preempted by Buckman); see also, e.g., Bryant v. Medtronic, Inc., 623
F.3d 1200, 1205 (8th Cir. 2010) (claim that manufacturer was negligent for “not timely fil[ing]
adverse-event reports, as required by federal regulations” impliedly preempted as “simply an
attempt by private parties to enforce the MDA”); Hafer, 2015 WL 1648978, at *13 (claims based
upon “failure to file adverse-event reports with the FDA . . . [are] impliedly preempted under
Buckman”); Byrnes, 60 F. Supp. 3d at 1297 (“[T]o the extent that the claim is based on [an
alleged] failure to report adverse events to the FDA, it is impliedly preempted”); McClelland,
2012 WL 5077401, at *7 (“[C]laims based upon FDCA disclosure requirements . . . are …
impliedly preempted”); Cales, 2014 WL 6600018, at *10 (failure-to-warn claim “predicated
on . . . an alleged failure to submit adverse-event reports to the FDA would be impliedly
preempted under Buckman and 21 U.S.C. § 337(a)”) (quotation marks and alteration omitted).
26
submit reports to the FDA would exist absent the FDA and the FDCA. Since “the
existence of these federal enactments” is therefore “a critical element” of any such
claims, those claims are impliedly preempted. Id.
Plaintiff’s failure to warn claim, negligence claim, and products liability
(misrepresentation) claim all rely upon Defendants’ alleged failure to report adverse
events to the FDA. Therefore, these claims are all impliedly preempted and warrant
dismissal.
b.
Claims Based on “Off-label Promotion” are Impliedly
Preempted
“[T]here is no state-law duty to abstain from off-label promotion.” Thorn, 81 F.
Supp. 3d at 628; accord, e.g., Martin, 32 F. Supp. 3d at 1045; Beavers-Gabriel, 15 F.
Supp. 3d at 1041. Indeed, the very concept of off-label promotion did not exist—and
could not exist—until Congress enacted the MDA and required that manufacturers obtain
FDA approval of devices and their labels. See Caplinger, 921 F. Supp. 2d at 1219–20,
1224 (“[T]he concept of ‘off-label use’ is a creature of the FDCA, is defined by the
FDCA, and is not a part of [state] law.”). 7 Thus, the distinction between on-label and offlabel use—and, hence, between on-label and off-label promotion—exists only by virtue
of the federal regulatory scheme.
7
See also Gavin, 2013 WL 3791612, at *17 (“[T]he very concept of ‘off-label’ use and
promotion is derived from the regulatory system imposed by the MDA and the FDCA.”); In re
Zyprexa Prods. Liab. Litig., 2008 WL 398378, at *5 (E.D.N.Y. 2008) (“[T]here is no state-law
equivalent of ‘off-label.’ The concept is entirely federal.”); accord, e.g., Hafer, 2015 WL
1648978, at *9; Blankenship, 6 F. Supp. 3d at 990; Hawkins, 2014 WL 346622, at *19.
27
Claims predicated on off-label promotion are thus “impliedly preempted under
Buckman and § 337(a),” Caplinger, 921 F. Supp. 2d at 1219, “because promoting the offlabel use of an FDA-approved medical device is not unlawful under ‘traditional state tort
law’” and any claim based on off-label promotion “would be in substance a claim for
violating the FDCA.” Dawson, 2013 WL 4048850, at *6 (quoting Buckman, 531 U.S. at
353). 8 Section 337(a) bars private enforcement of such claims because those claims
would “usurp the FDA’s regulatory oversight role for policing purported violations of”
the statutes and regulations it has exclusive authority to administer. Dawson, 2013 WL
4048850, at *7.
Plaintiffs’ failure to warn, design defect, negligence, and breach of implied
warranty claims all rely on Defendants’ alleged off-label promotion of Infuse.
Accordingly, those claims are impliedly preempted and warrant dismissal.
C.
Alternative Grounds for Dismissing Plaintiffs’ Liability Claims
In addition to arguments based on preemption by the MDA, Defendants also
advance several alternative arguments as to why Plaintiffs’ product liability claims
should fail. As this Court has held Plaintiffs’ product liability claims to be preempted,
8
Accord Hafer, 2015 WL 1648978, at *9 (given 21 U.S.C. § 337(a), “[a]ny claim based solely
on off-label promotion would . . . be impliedly preempted”); Blankenship, 6 F. Supp. 3d at 990
(holding that claims based on alleged off-label promotion impliedly preempted because they are
“not based on conduct that would give rise to a recovery under state law . . . in the absence of the
FDCA”); Evans v. Rich, 2014 WL 2535221, at *2 (E.D.N.C. 2014) (off-label promotion “claim
is impliedly preempted as it exists solely by virtue of the requirements of the FDCA”); Thorn,
2015 WL 328885, at *10; Arthur v. Medtronic, Inc., 2014 WL 3894365, at *6–7 (E.D. Mo.
2014); Brady, 2014 WL 1377830, at *8; Martin, 32 F. Supp. 3d at 1045; Beavers-Gabriel, 15 F.
Supp. 3d at 1041; Dawson, 2013 WL 4048850, at *6; Gavin, 2013 WL 3791612, at *17;
Houston, 957 F. Supp. 2d at 1177–78; Lawrence, 2013 WL 4008821, at *4.
28
the Court need not rule upon these arguments. However, in the interest of completeness,
the Court will address certain additional grounds for dismissal of Plaintiffs’ claims.
1)
Ohio Product Liability Act
Defendant claims that Plaintiff’s product liability claims are preempted by the
Ohio Product Liability Act (OPLA). Ohio Rev. Code Ann. §§ 2307.71 et seq. The
OPLA established in Ohio a comprehensive statutory scheme governing product liability
claims. As part of this scheme, the Act expressly states that it is intended “to abrogate all
common-law product liability claims or causes of action.” O.R.C. § 2307.71(B).
Therefore, any product liability claim not brought under the OPLA would be subject to
dismissal.
Plaintiffs did not adequately plead their claims under the OPLA. The OPLA is
cited only once in the Omnibus Complaint, in the section establishing jurisdiction:
The Ohio Product Liability Act (R.C. §§2307.71, et. seq.) does not impose
requirements that are different from or in addition to those imposed by the
federal Food and Drug Administration (hereafter the “FDA”), the Medical
Device Amendments and Combination Drug and Device Amendments, the
Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301, et seq., and the
regulations promulgated thereunder at 21 CFR § 800, et seq. or elsewhere.
(Doc. 54, at 73). There is no citation to, or even mention of, the Act in any of the
sections of the Omnibus Complaint outlining the claims against Defendants. These
claims are all clearly pleaded as common-law causes of action arising from the design,
production, or marketing of Infuse, or the warnings associated with Infuse, or the alleged
failure of the Infuse device to conform to purported representations or warranties. These
claims are therefore preempted by the OPLA.
29
Plaintiffs argue that the fact that their Omnibus Complaint failed to plead any
claim under the OPLA is immaterial, citing the Seventh Circuit in Bausch for the
proposition that a relaxed pleading standard is required in products liability cases
involving medical devices. (Doc. 63, at 26). However, as explained in Part III.A, supra,
this Court finds that Plaintiffs’ complaint must be held to the traditional pleading
standards of Rule 8 of the Federal Rules of Civil Procedure. Plaintiffs’ failure to identify
any specific statutory basis for their claims will not save them from dismissal.
Accordingly, Plaintiffs’ products liability claims are abrogated by the Ohio
Product Liability Act.
2)
Comment K to Section 402A of the Restatement (Second) of
Torts
Ohio has adopted Section 402A of the Restatement (Second) of Torts, according
to White v. Wyeth Labs., Inc., 533 N.E.2d 748, 752 (Ohio 1988). That section provides:
(1) One who sells any product in a defective condition unreasonably
dangerous to the user or consumer or to his property is subject to liability
for physical harm thereby caused to the ultimate user or consumer, or to his
property, if
(a) the seller is engaged in the business of selling such a product, and
(b) it is expected to and does reach the user or consumer without
substantial change in the condition in which it is sold.
(2) The rule stated in subsection (1) applies although
(a) the seller has exercised all possible care in the preparation and
sale of his product, and
(b) the user or consumer has not bought the product from or entered
into any contractual relation with the seller.”
30
However, Comment K to Section 402A provides an exemption to strict liability of
manufacturers for injuries caused by defective products for “unavoidably unsafe”
products. Specifically, the comment provides:
“Unavoidably unsafe products. There are some products, which, in the
present state of human knowledge, are quite incapable of being made safe
for their intended and ordinary use. These are especially common in the
field of drugs. An outstanding example is the vaccine for the Pasteur
treatment of rabies, which not uncommonly leads to very serious and
damaging consequences when it is injected. Since the disease itself
invariably leads to a dreadful death, both the marketing and the use of the
vaccine are fully justified, notwithstanding the unavoidably high degree of
risk which they involve. Such a product, properly prepared, and
accompanied by proper directions and warning, is not defective, nor is it
unreasonably dangerous. The same is true of many other drugs, vaccines,
and the like, many of which for this very reason cannot legally be sold
except to physicians, or under the prescription of a physician. It is also true
in particular of many new or experimental drugs as to which, because of
lack of time and opportunity for sufficient medical experience, there can be
no assurance of safety, or perhaps even of purity of ingredients, but such
experience as there is justifies the marketing and use of the drug
notwithstanding a medically recognizable risk. The seller of such products,
again with the qualification that they are properly prepared and marketed,
and proper warning is given, where the situation calls for it, is not to be
held to strict liability for unfortunate consequences attending their use,
merely because he has undertaken to supply the public with an apparently
useful and desirable product, attended with a known but apparently
reasonable risk.” (Emphasis sic.) 2 Restatement of the Law 2d, Torts,
supra, at 353-354.
White, 533 N.E.2d at 752. Therefore, Plaintiffs in this case cannot bring any state-law
products liability claims against Defendants if Infuse is an “unavoidably unsafe” product.
Plaintiffs argue that “the determination as to whether any particular medical
device is ‘unavoidably unsafe’ is necessarily made on a case by case basis,” and that
dismissal at this stage based on the Restatement is therefore inappropriate. (Doc. 63, at
36). Defendants argues in response that Infuse’s classification by the FDA as a Class III
31
medical device inherently means that it is unavoidably unsafe and that Comment K’s
prohibition of strict liability claims therefore applies. (Doc. 65, at 49–50).
Defendant’s argument is well taken. Class III devices such as Infuse are, as
relevant here, defined as devices that are “for a use which is of substantial importance in
preventing impairment of human health, or . . . present[] a potential unreasonable risk of
illness or injury.” 21 U.S.C. § 360c(a)(1)(C)(ii). That Infuse in particular “presents a
potential unreasonable risk of illness or injury” is evidenced by the fact that the FDA has
both: (1) designated Infuse a “restricted device” given “its potentiality for harmful effect”
(id. § 360j(e); Mem. Ex. 1 at 1 (designating Infuse a restricted device pursuant to 21
U.S.C. § 360e(d)(1)(B)(ii)) and (2) categorically determined that the less stringent
regulatory controls applicable to Class II devices “are insufficient to provide reasonable
assurance of safety and effectiveness for an intervertebral body fusion device when it
contains a therapeutic biologic grafting material,” as Infuse does. See Orthopedic
Devices; Reclassification of the Intervertebral Body Fusion Device, 72 Fed. Reg. 32,170,
32,171 (June 12, 2007); see also 21 C.F.R. § 888.3080(b)(2) (classifying “intervertebral
body fusion devices that include any therapeutic biologic (e.g., bone morphogenic
protein)” as Class III devices).
Plaintiffs suggest that it would be “inappropriate to determine at this juncture
whether, for the Infuse device, ‘there existed no alternative design which would have as
effectively accomplished the same purpose or result with less risk,’ such that the device
can necessarily be said to be ‘unavoidably unsafe’ under Comment k.” (Doc. 63, at 37
(quoting White, 533 N.E.2d at 753 (Ohio 1988)). Yet there is no alternative design for
32
Infuse that could lawfully be marketed. “Once a device has received premarket approval,
the MDA forbids the manufacturer to make, without FDA permission, changes in design
specifications . . . that would affect safety or effectiveness.” Riegel, 552 U.S. at 319
(citing 21 U.S.C. § 360e(d)(6)(A)(i)). There is therefore no basis for “an in-depth
evidentiary inquiry into alternative designs.” (Doc. 63, at 39).
Plaintiffs also contend that Comment K does not apply to Infuse because the
warnings that Medtronic provided were purportedly inadequate. Opp. 37 (“[P]roper
warnings were not properly given.”). But this argument also runs headlong into the
device’s receipt of premarket approval and the FDA’s conclusive determination that the
warnings contained in the Infuse label are adequate. See Riegel, 552 U.S. at 319 (“Once a
device has received premarket approval, the MDA forbids the manufacturer to make,
without FDA permission, changes in … labeling … that would affect safety or
effectiveness.”) (citing 21 U.S.C. § 360e(d)(6)(A)(i)).
Accordingly, Plaintiffs’ strict liability claims are barred by Ohio’s adoption of
Section 402A of the Restatement (Second) of Torts due to the fact that Infuse is an
“unavoidably unsafe product.”
3)
Medtronic expressly disclaimed all warranties
Defendants’ motion to dismiss argues that Plaintiffs’ claims for breach of express
and implied warranties must fail because the FDA-approved labeling for Infuse 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.”
33
(Doc. 61-2, at 4). Defendant argues that this explicit disclaimer of warranties defeats
Plaintiffs’ warranty claims.
Plaintiffs do not argue that Defendant did not disclaim all warranties. Instead,
Plaintiffs’ response argues that “[Medtronic] may or may not have disclaimed warranties.
However, since this subject was not mentioned within the Complaint, the topic of
disclaimers is not proper in the context of a motion to dismiss.” (Doc. 63, at 33).
Plaintiffs’ argument is not well taken. This Court may take judicial notice of
Infuse’s receipt of PMA from the FDA, including the device’s FDA-mandated warning
label which includes the warranty disclaimers. See, e.g., Chapman v. Abbott Labs., 930
F. Supp. 2d 1321, 1323 (M.D. Fla. 2013) (taking judicial notice of FDA-approved drug
label published on FDA website). 9 Moreover, “[t]aking judicial notice of matters of
public record need not convert a motion to dismiss into a motion for summary judgment.”
Ennega v. Starns, 677 F.3d 766, 773 (7th Cir. 2012). This Court may therefore consider
the FDA-approved label of the Infuse device in determining whether Defendants have
effectively disclaimed all warranties. And here, Defendants have in fact done so.
Plaintiffs also argue that, even if Defendants disclaimed all warranties, an express
warranty from Defendants overrides any warranty disclaimer. (Doc. 63, at 33 (citing
Scovil v. Medtronic, Inc., 2015 WL 880614 (D. Nev. 2015)). However, as explained in
9
See also Gross, 858 F. Supp. 2d at 481 n.26 (taking judicial notice of Summary of Safety and
Effectiveness Data); White v. Striker Corp., 818 F. Supp. 2d 1032, 1034–36 (W.D. Ky. 2011)
(taking judicial notice of Summary of Safety and Effectiveness Data); In re Amgen Inc. Sec.
Litig., 544 F. Supp. 2d 1009, 1023–24 (C.D. Cal. 2008) (taking judicial notice of drug labels
posted on FDA website).
34
Part III.B.1.b.3, supra, Plaintiffs have failed to adequately allege any express warranty
made by Defendants.
Accordingly, Defendants’ explicit disclaimer of all warranties defeats Plaintiffs’
breach of express and implied warranty claims.
D.
Fraud Claims
Unlike Plaintiffs’ other claims, the fraud claims in the Omnibus Complaint are not
implicated by any preemption analysis. While the other claims all would require some
finding that either the Infuse product itself or the Infuse labeling imposed by the FDA
were legally deficient in some way, Plaintiffs’ fraud claim is solely related to actions
allegedly taken by Defendants—i.e.,affirmative misrepresentations about the safety or
effectiveness of Infuse and its off-label use—wholly separate from their manufacturing or
labeling of Infuse.
Plaintiffs’ fraud claims are subject to the heightened pleading standard outlined in
Federal Rule of Civil Procedure 9. That rule states in relevant part:
(b) Fraud or Mistake; Conditions of Mind. In alleging fraud or mistake, a
party must state with particularity the circumstances constituting fraud or
mistake. Malice, intent, knowledge, and other conditions of a person's mind
may be alleged generally.
Fed. R. Civ. P. 9(b). The Sixth Circuit has held that Rule 9(b) specifically requires a
claim of fraud to “allege the time, place, and content of the alleged misrepresentations on
which he or she relied; the fraudulent scheme; the fraudulent intent of the defendants; and
the injury resulting from the fraud.” Sanderson v. HCA—The Healthcare Co. et al., 447
35
F.3d 873, 877 (6th Cir. 2006) (quoting Yuhasz v. Brush Wellman, Inc., 341 F.3d 559, 563
(6th Cir. 2003)).
Defendants have identified several portions of Plaintiffs’ fraud claim that fail to
meet the Rule 9(b) pleading standard. The most glaring flaw in Plaintiffs’ fraud claim is
that it simultaneously alleges two contradictory sets of facts. On the one hand, Plaintiffs
allege that they were defrauded by Dr. Durrani—who Plaintiffs allege was acting as an
agent for Medtronic—when he allegedly misled Plaintiffs concerning the safety of Infuse.
On this theory, “Dr. Durrani was an Opinion Leader for Defendants” (Doc. 54, at 127)
and as such had purportedly “known . . . for many years” that “off-label use of Infuse in
the spine frequently causes serious adverse events” (Id. at 94), yet not only “conceal[ed]
these risks from the Plaintiffs” (Id. at 163) but also “fraudulently and intentionally
misrepresented” them to Plaintiffs (Id. at 793). On the other hand, Plaintiffs allege that
Medtronic “misrepresented the safety of Infuse to . . . Dr. Durrani.” Id. at 82. On this
theory, under which Medtronic supposedly “did not adequately inform . . . Dr.
Durrani . . . of the true incidence of dangerous side effects resulting from the use of
Infuse in off-label surgeries or . . . in any surgery, whether off-label or otherwise” (Id. at
163), Dr. Durrani was purportedly “justified in relying . . . on Defendants’ concealment
of information and misrepresentations about the safety risks related to Infuse in deciding
to make off-label use of Infuse for spine surgery” (Id. at 797). Thus, Plaintiffs allege that
Dr. Durrani simultaneously had and did not have knowledge of the true facts regarding
the safety of Infuse.
36
The inconsistent factual statements of the Omnibus Complaint are not saved by the
Federal Rules of Civil Procedure’s allowance of alternative pleading. While Rule 8(d)(3)
allows inconsistent claims—a plaintiff may, for example, bring claims for both
intentional and unintentional torts, even where recovery on both would impossible—it
does not allow what Plaintiffs are attempting to do here—namely, to make “clashing
factual assertions . . . in the context of the same claim.” Nat’l W. Life Ins. Co. v. Merrill
Lynch, Pierce, Fenner & Smith, Inc., 175 F. Supp. 2d 489, 492 (S.D.N.Y. 2000)
(emphasis added) (dismissing fraud claim where plaintiff made contradictory factual
allegations as to knowledge).
The distinction between inconsistent claims, which are permissible, and
inconsistent factual allegations in support of a single claim, which are not, “is especially
pertinent in cases alleging fraud.” In re Livent, Inc. Noteholders Sec. Litig., 151 F. Supp.
2d 371, 406–07 (S.D.N.Y. 2001); cf. Merchant v. Davies, 244 F.2d 347, 348 (D.C. Cir.
1957) (Rule 8(d)(3) “creates no exception to the principle that a charge of fraud must be
clear and specific.”). Here, whether Plaintiffs claim that they were defrauded by Dr.
Durrani acting as Medtronic’s agent or claim that Dr. Durrani was defrauded by
Medtronic, Plaintiffs’ fraud-based claims against Medtronic necessarily depend on what
Dr. Durrani knew about the risks associated with Infuse. Yet Plaintiffs simultaneously
allege that Dr. Durrani both did, and did not, have knowledge of those risks. These
contradictory factual allegations made in support of the same fraud-based claims defeat
those claims.
37
Accordingly, Plaintiffs’ claim of fraudulent concealment, misrepresentation and
fraud in the inducement warrants dismissal.
IV.
CONCLUSION
Ultimately, with the exception of Plaintiffs’ fraud-based claims, all of the claims
raised in the Omnibus Complaint represent an attempt to use state law to violate the
regulatory monopoly on medical devices which was granted to the FDA via 21 U.S.C.
§ 360(k). This Court therefore finds, as have many of the other courts across the country
that have considered these exact issues, that product liability claims of this nature cannot
survive a motion to dismiss. Plaintiffs’ fraud claims independently fail for failing to meet
the heightened pleading standard of Rule 9 of the Federal Rules of Civil Procedure.
Accordingly, IT IS ORDERED as follows:
1)
Defendants’ motion to dismiss (Doc. 61) is GRANTED;
2)
The Clerk shall enter judgment in each of the consolidated cases
accordingly, whereupon those cases are TERMINATED on the docket of
this Court.
Date: 9/22/16
s/ Timothy S. Black
Timothy S. Black
United States District Judge
38
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