Scanlon v. Medtronic Sofamor Danek USA, Inc. et al

Filing 63

MEMORANDUM OPINION. Signed by Judge Sue L. Robinson on 7/28/2014. (nmfn)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

EILEEN SCANLON

)
)
Plaintiff,
)
)
v.
) Civ. No. 13-224-SLR
)
MEDTRONIC SOFAMOR DANEK USA )
INC. and MEDTRONIC, INC.
)
)
Defendants.
)

Jeffrey M. Gentilotti, Esquire and Robin M. Grogan, Esquire of Bifferato Gentilotti LLC,
Wilmington, Delaware. Counsel for Plaintiff. Of Counsel: Aaron J. Freiwald, Esquire
and Glenn A. Ellis, Esquire of Layser & Freiwald, P.C.
M. Duncan Grant, Esquire and James H.S. Levine, Esquire of Pepper Hamilton LLP,
Wilmington, Delaware. Counsel for Defendants. Of Counsel: Murray S. Levin, Esquire
and Sean P. Fahey, Esquire of Pepper Hamilton LLP and DanielL. Ring, Esquire and
Andrew E. Tauber, Esquire of Mayer Brown LLP.

MEMORANDUM OPINION

Dated: JulyJ-~ 2014
Wilmington, Delaware

~0

, D1strict Judge

I. INTRODUCTION
On May 11, 2012, plaintiff Eileen Scanlon ("plaintiff') filed this action in the Court
of Common Pleas of Philadelphia County, Pennsylvania. On June 7, 2012, defendants
Medtronic Sofamor Danek USA, Inc. and Medtronic, Inc. (collectively "defendants")
removed this action to the United States District Court for the Eastern District of
Pennsylvania. (D. I. 1) On July 5, 2012, plaintiff filed an amended complaint alleging
violations of Delaware law. (D. I. 8) Defendants moved to dismiss the amended
complaint. 1 (D.I. 13) The court took the motion to dismiss under advisement and
granted plaintiff leave to file a second amended complaint by December 13, 2012. (D.I.
23) Plaintiff moved for discovery on December 13, 2012 and separately filed a second
amended complaint on December 17,2012. (D.I. 24; D.l. 25) On January 3, 2013,
defendants moved to dismiss the second amended complaint. (D. I. 28) On January
11, 2013, the court determined that diversity jurisdiction was proper, but that the United
States District Court for the District of Delaware was the proper venue. The court
ordered the action transferred and the outstanding motions were denied without
prejudice for reconsideration by the transferee court. (D.I. 31)
After transfer to this court, on April 3, 2013, the court denied plaintiff's request for
limited discovery and ordered briefing on defendants' arguments regarding dismissal for
failure to state a claim. Currently before the court is defendants' motion to dismiss for
failure to state a claim. (D. I. 43) The court has jurisdiction over these matters pursuant
to 28 U.S.C. §§ 1332(a)(1) and 1332(c)(1). Venue is proper under 28 U.S.C. § 1391(b).

1

Later denied as moot. (D.I. 31)

II. STANDARD OF REVIEW
A motion filed under Federal Rule of Civil Procedure 12(b)(6) tests the
sufficiency of a complaint's factual allegations. Bell At/. Corp. v. Twombly, 550 U.S.
544, 555 (2007); Kost v. Kozakiewicz, 1 F.3d 176, 183 (3d Cir. 1993). A complaint
must contain "a short and plain statement of the claim showing that the pleader is
entitled to relief, in order to give the defendant fair notice of what the ... claim is and
the grounds upon which it rests." Twombly, 550 U.S. at 545 (internal quotation marks
omitted) (interpreting Fed. R. Civ. P. 8(a)). Consistent with the Supreme Court's rulings
in Twombly and Ashcroft v. Iqbal, 556 U.S. 662 (2009), the Third Circuit requires a twopart analysis when reviewing a Rule 12(b)(6) motion. Edwards v. A.H. Cornell & Son,
Inc., 610 F.3d 217,219 (3d Cir. 2010); Fowlerv. UPMC Shadyside, 578 F.3d 203,210
(3d Cir. 2009). First, a court should separate the factual and legal elements of a claim,
accepting the facts and disregarding the legal conclusions. Fowler, 578 F.3d. at 21011. Second, a court should determine whether the remaining well-pled facts sufficiently
show that the plaintiff "has a 'plausible claim for relief."' /d. at 211 (quoting Iqbal, 556
U.S. at 679). As part of the analysis, a court must accept all well-pleaded factual
allegations in the complaint as true, and view them in the light most favorable to the
plaintiff. See Erickson v. Pardus, 551 U.S. 89, 94 (2007); Christopher v. Harbury, 536
U.S. 403, 406 (2002); Phillips v. Cnty. of Allegheny, 515 F.3d 224, 231 (3d Cir. 2008).
In this regard, a court may consider the pleadings, public record, orders, exhibits
attached to the complaint, and documents incorporated into the complaint by reference.
Tellabs, Inc. v. Makar Issues & Rights, Ltd., 551 U.S. 308, 322 (2007); Oshiver v. Levin,

2

Fishbein, Sedran & Berman, 38 F.3d 1380, 1384-85 n.2 (3d Cir. 1994).
The court's determination is not whether the non-moving party "will ultimately
prevail" but whether that party is "entitled to offer evidence to support the claims."
United States ex ref. Wilkins v. United Health Grp., Inc., 659 F.3d 295, 302 (3d Cir.
2011 ). This "does not impose a probability requirement at the pleading stage," but
instead "simply calls for enough facts to raise a reasonable expectation that discovery
will reveal evidence of [the necessary element]." Phillips, 515 F.3d at 234 (quoting
Twombly, 550 U.S. at 556). The court's analysis is a context-specific task requiring the
court "to draw on its judicial experience and common sense." Iqbal, 556 U.S. at 66364.
Ill. BACKGROUND
A. Statutory and Regulatory Framework
The Federal Food, Drug, and Cosmetic Act, 52 Stat. 1040, as amended, 21
U.S.C. § 301 et seq., has long required approval by the Food and Drug Administration
("FDA") for the introduction of new drugs into the market. The introduction of new
medical devices was left largely for the states to oversee. Riegel v. Medtronic, Inc., 552
U.S. 312, 315 (2008). As more complex medical devices entered the marketplace, 2
Congress passed the Medical Device Amendments of 1976 ("MDA"), 21 U.S.C. § 360c
et seq} "which swept back some state obligations and imposed a regime of detailed

2

And failed. Introduced in 1970, "the Dalkon Shield intrauterine device ... was
linked to serious infections and several deaths, not to mention a large number of
pregnancies." Riegel, 552 U.S. at 315.
3

The MDA amended the Federal Food, Drug, and Cosmetic Act, (collectively
referred to as the "FDCA").

3

federal oversight." Riegel, 552 U.S. at 316.
The MDA divides medical devices into three classes and provides varying levels
of oversight for each, according to the risks they present. Class Ill devices, defined as
such because they are "purported or represented to be for a use in supporting or
sustaining human life or for a use which is of substantial importance in preventing
impairment of human health, or ... presentD a potential unreasonable risk of illness or
injury."§ 360c(a)(1)(C)(ii). Class Ill devices receive the most oversight and undergo a
rigorous premarket approval process. Riegel, 552 U.S. at 316-17.
The approval process starts with the manufacturer submitting a multivolume
application to the FDA, which spends an average of 1 ,200 hours reviewing each such
application. /d. at 318. The FDA grants premarket approval ("PMA") only if it finds that
there is "a reasonable assurance of safety and effectiveness, [and] if the proposed
labeling is neither false nor misleading." § 360e(d). The agency must "weig[h] any
probable benefit to health from the use of the device against any probable risk of injury
or illness from such use." § 360c(a)(2)(C). "It may thus approve devices that present
great risks if they nonetheless offer great benefits in light of available alternatives."
Riegel, 552 U.S. at 317-18.

Once a device has received PMA, "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 effectiveness." /d. at 319
(citing§ 360e(d)(6)(A)(i)). Should the applicant wish to make such a change, it must
submit an application for supplemental premarket approval, which the FDA evaluates
under largely the same criteria as an initial application. § 360e(d)(6); 21 CFR §

4

814.39(c); Riegel, 552 U.S. at 319. Medical devices are subject to continuing reporting
requirements, § 360i, including
the obligation to inform the FDA of new clinical investigations
or scientific studies concerning the device which the
applicant knows of or reasonably should know of, 21 CFR §
814.84(b)(2), and to report incidents in which the device may
have caused or contributed to death or serious injury, or
malfunctioned in a manner that would likely cause or
contribute to death or serious injury if it recurred, §
803.50(a).
Riegel, 552 U.S. at 319. The FDA retains the power to withdraw PMA based on newly
reported data or existing information. Further, it must withdraw approval if it finds "that
such device is unsafe or ineffective under the conditions of use prescribed,
recommended, or suggested in the labeling thereof." § 360e(e)(1); see also§ 360h(e)
(recall authority); Riegel, 552 U.S. at 319-20.
The MDA contains an express preemption provision:
Except as provided in subsection (b) of this section, 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, and
(2) which relates to the safety or effectiveness of the device
or to any other matter included in a requirement applicable
to the device under this chapter.
21 U.S.C. § 360k(a). The exception contained in subsection (b) permits the FDA to
exempt some state and local requirements from preemption.

B. Infuse Device
The device at issue ("the infuse device") is a Class Ill medical device, approved

5

by the FDA through the PMA process, 4 made by defendants. The infuse device
consists of a recombinant human bone morphogenetic protein ("rhBMP-2") embedded
in a collagen sponge (collectively, "the infuse bone graft component") and an interbody
fusion device ("a cage"). The infuse device is used in a surgical spinal fusion to treat
degenerative disc disease and has been approved for use in anterior lumbar interbody
fusion procedures (lumbar surgery that is performed through the abdomen) involving a
single level fusion in the L4-S1 region of the lumbar spine. The infuse device was
initially approved on July 2, 2002. The FDA has since approved forty-four supplements
to its PMA. (D. I. 25; D. I. 44 at 5-6)

C. Plaintiff
After suffering from back pain for a number of years, plaintiff was "diagnosed
with lumbar discogenic back pain and radiculopathy with severely collapsed and
degenerative L5-S1 disk space." (D.I. 25 at 111135-36) Plaintiff's doctor recommended
that she undergo an anterior lumbar interbody fusion of the L5-S1, in which he would
use a SynFix interbody cage along with the infuse bone graft component. 5 (/d. at 11113839) The doctor discussed the off-label use of the infuse bone graft component with

4

ln October 1996, Sofamor Danek (purchased by Medtronic in 1999) filed an
application for an Investigational Device Exemption with the FDA to conduct a pilot
study on the effects of recombinant human bone morphogenetic protein in humans.
Medtronic filed its application for PMA on January 12, 2001. (D. I. 25 at 111118, 26, 27,
29)
5

Piaintiff's complaint uses "INFUSE" to refer to both the infuse device (D.I. 25 at
1120) and the infuse bone graft component (id. at 1128). Plaintiff uses "BMP" to refer to
the recombinant protein rhBMP-2 and to such rhBMP-2 embedded in a collagen
sponge. (/d. at 1111 35-57). The court has assigned the broadest meaning to plaintiff's
allegations.

6

plaintiff and assured her it was safe and effective. (/d. at

,m 39-42) On November 4,

2009, plaintiff underwent the spinal fusion. After her surgery, plaintiff experienced a
system wide inflammatory reaction, which included debilitating headaches, loss of
balance, vertigo and pain. 6 (/d. at

,m 51-52, 84)

Plaintiff alleges that she understood the following. Defendants' representatives
("the representatives") "aggressively, intentionally and systemically marketed and sold
its [infuse device or infuse bone graft component] for off[-]label uses not covered by the
FDA review or approval," including using the infuse bone graft component with any
fusion cage. (/d.

at~~

33, 43) Her doctor preferred to use the SynFix cage and

discussed this preference with the representatives, who assured him that "he could
continue using the SynFix cage in combination with [the infuse bone graft component]." 7
(/d. at ~~ 45-50)

Plaintiff further alleges that defendants "misrepresented the safety and efficacy
data of [the infuse bone graft component]" to her doctor, who in turn "passed on those
misrepresentations to [her]." (/d.

at~~

53-54) Plaintiff alleges that defendants "altered

the safety data on [the infuse device] by paying authors to downplay and in some cases
hide the adverse consequences of using [the infuse bone graft component]" and "paid
physicians to publish articles describing off-label uses of [the infuse bone graft
component], which were presented as safe and effective." (/d.

at~~

56-57) According

6

Piaintiff's original complaint alleged that she was injured by the entry of
rhBMP-2 into her spinal fluid through a "dural tear." (D. I. 1 at~~ 26-29)
7

Defendants "flew [plaintiff's doctor] to Russia to attend a conference on the off[]label use of [the infuse device] and its superior safety and efficacy over allografts and
autografts." (D.I. 25 at~ 49)
7

to plaintiff, defendants' representatives "falsified or distorted safety data to help sell [the
infuse device] for off[-]label uses." (ld.

at~

65)

Plaintiff asserts the following claims: (1) negligence for the off-label use of the
infuse device; (2) negligent misrepresentation concerning the risk of the infuse device;
(3) fraud based on defendants' agents and sales representatives making material
misrepresentations regarding off-label uses; (4) failure to warn of known dangers based
on the off-label use; and (5) breach of express warranty. (/d.

at~~

85-129)

IV. DISCUSSION
A. Preemption
Congress has empowered the FDA to regulate medical devices, enacting a
rigorous approval process for both medical devices and their labeling. The MDA
expressly preempts most state laws attempting to create requirements having to do with
medical devices. 21 U.S.C. § 360k(a). The Supreme Court has stated that "the only
indication available-the text of the statute-suggests that the solicitude for those
injured by FDA-approved devices, which the dissent finds controlling, was overcome in
Congress's estimation by solicitude for those who would suffer without new medical
devices if juries were allowed to apply the tort law of [fifty] States to all innovations."
Riegal, 552 U.S. at 326. The Supreme Court acknowledged that "[t]he dissent would
narrow the pre-emptive scope ... on the grounds that it is 'difficult to believe that
Congress would, without comment, remove all means of judicial recourse' for
consumers injured by FDA-approved devices. But, as we have explained, this is
exactly what a pre-emption clause for medical devices does by its terms." /d.

8

The Supreme Court has directed that courts analyze express preemption in two
steps: first, courts should "determine whether the Federal Government has established
requirements applicable to" the accused medical device; and second, courts should
determine whether state law claims asserted against the medical device manufacturer
are based upon requirements "with respect to the device that are 'different from, or in
addition to,' the federal ones, and that relate to safety and effectiveness." /d. at 321-22
(citing§ 360k(a)). In doing so, "§ 360k does not prevent a State from providing a
damages remedy for claims premised on a violation of FDA regulations; the state duties
in such a case 'parallel,' rather than add to, federal requirements." /d. at 330.
Implied preemption is based on the fact that any suit to enforce the FDCA "shall
be by and in the name of the United States." 21 U.S.C. § 337(a). "[T]he federal
statutory scheme amply empowers the FDA to punish and deter fraud against the
Administration, and ... this authority is used by the Administration to achieve a
somewhat delicate balance of statutory objectives." Buckman Co. v. Plaintiffs' Legal
Comm., 531 U.S. 341, 348 (2001 ). The Supreme Court in Buckman found that "fraud
[on the FDA] claims exist solely by virtue of the FDCA disclosure requirements" and are
impliedly preempted by federal law as they "inevitably conflict with the FDA's
responsibility to police fraud consistently with the Administration's judgment and
objectives." /d. at 350, 353. The Supreme Court further noted:
As a practical matter, complying with the FDA's detailed
regulatory regime in the shadow of 50 States' tort regimes
will dramatically increase the burdens facing potential
applicants- burdens not contemplated by Congress in
enacting the FDCA and the MDA. Would-be applicants may
be discouraged from seeking§ 51 O(k) approval of devices
with potentially beneficial off-label uses for fear that such
9

use might expose the manufacturer or its associates (such
as petitioner) to unpredictable civil liability. In effect, then,
fraud-on-the-FDA claims could cause the Administration's
reporting requirements to deter off-label use despite the fact
that the FDCA expressly disclaims any intent to directly
regulate the practice of medicine, ... and even though
off-label use is generally accepted.

/d. at 350-51 .
In light of the Riegel and Buckman preemption schemes, courts have generally
agreed that there is a narrow path that plaintiffs must follow to successfully assert statelaw claims against medical device manufacturers. "In order to survive preemption, such
claims 'must be premised on conduct that both (1) violates the FDCA and (2) would
give rise to a recovery under state law even in the absence of the FDCA."' Schouest v.
Medtronic, Inc., Civ. No. 13-203,2014 WL 1213243, at 5 (S.D. Tex. 2014) (citing Riley
v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009)). See a/so In re Medtronic,
Inc., Sprint Fide/is Leads Prods. Liab. Litig., 623 F.3d 1200, 1205 (8th Cir. 2010);
Caplingerv. Medtronic, Inc., 921 F. Supp. 2d 1206, 1215 (W.O. Okla. 2013).

B. Application to Plaintiff's Claims
The infuse device (and its labeling) is regulated by the FDA. Moreover, the
Supreme Court recognized in Buckman that '"off-label' usage of medical devices ... is
an accepted and necessary corollary of the FDA's mission to regulate in this area
without directly interfering with the practice of medicine." Buckman, 531 U.S. at 350.
Thus, allegations of off-label use and the promotion thereof do not immunize a plaintiff's
claims from preemption. See Caplinger, 921 F. Supp. 2d at 1215 ("[N]othing in§
360k(a) suggests that the preemption analysis somehow depends on how the device is

10

being promoted to be used."). Morever, contrary to plaintiff's suggestion, "plaintiff's
off-label promotion allegations do not somehow turn plaintiff's claims into 'parallel'
claims that are not preempted." /d. at n.4. Instead, plaintiff's claims are subject to the
preemption analysis discussed above.
Plaintiff alleges that Medtronic "had a duty to warn," and should have "performed
the studies and reported the actual results necessary to determine that [the infuse
device] should not be used off[-]label .... " (0.1. 25 at

,m 87, 92)

Plaintiff alleges that

Medtronic "failed to provide warnings of the product[']s known dangers, including
the known dangers associated with the off[-]label usage that Medtronic was promoting."

(/d.

at~

120) Plaintiff also alleges that Medtronic negligently "failed to disclose material

facts concerning the risks" of the infuse device. (0.1. 25

at~

96)

Plaintiff's negligence cause of action 8 would impose requirements on Medtronic to perform and report additional studies -which are different from and in addition to
those imposed by the FDA. Plaintiff's failure to warn cause of action 9 would require that
Medtronic provide warnings in addition to or different from those required by the FDA. 10

8

Count I.

9

Count IV.

10

Piaintiff appears to argue in its briefing that Medtronic should have sought FDA
approval to change the labeling of the infuse device to reflect such dangers. (D.I. 49 at
18) However, such an allegation requires additional action than that required by the
FDCA. See McMullen v. Medtronic, Inc., 421 F.3d 482, 482, 489 (7th Cir. 2005)
("Where a federal requirement permits a course of conduct and the state makes it
obligatory, the state's requirement is in addition to the federal requirement and thus is
preempted.").
11

To the extent plaintiff's cause of action for negligent misrepresentation 11 alleges that
Medtronic failed to disclose material facts, plaintiff has not alleged that Medtronic's
warning label for the infuse device did not comply with the FDA. Therefore, any
"material facts" which plaintiff asserts are missing would require a change in those
warnings or disclosures required by the FDA. 12 Each of these causes of action is
expressly preempted. See, e.g., Caplinger, 921 F. Supp. 2d at 1219 (finding certain
claims preempted when allowing them "would establish labeling and warning
requirements different from, or in addition to, federal requirements for the Infuse
Device"); Ledet v. Medtronic, Civ. No. 13-200, 2013 WL 6858858, at *5 (S.D. Miss.
Dec. 30, 2013).
Plaintiff additionally alleges that Medtronic "negligently misrepresented" the
infuse device, i.e., made representations (through its representatives) which plaintiff
alleges were false. (/d. at ,-r,-r 96-97) Moreover, plaintiff alleges that Medtronic
representatives made false representations with the intent to defraud, deceive, and
mislead. (/d. at ,-r,-r 112-13) Plaintiff claims that defendants "downplayed, understated
and/or disregarded their knowledge of the serious and permanent side effects
associated with the use of their products, despite the existence of information available
to [d]efendants that should have demonstrated that Medtronic products were likely to
cause serious injuries to product users." (/d. at ,-r 112) Plaintiff superficially alleges that

11

Count II.

12

Piaintiff's allegation that she was injured by the entry of rhBMP-2 into her spinal
fluid through a "dural tear" is a risk noticed in the Important Medical Information, which
lists "dural tears" as one of the "potential adverse events which may occur with spinal
fusion surgery with the" infuse device. (D.I. 44, ex. 5 at 9-10)
12

Medtronic did not report adverse events to the FDA. (/d. at 1J92; D. I. 49 at 19-20)
Plaintiff's negligent misrepresentation 13 and fraud 14 causes of action each allege
that Medtronic representatives made false representations regarding the infuse device
and its use. The FDCA governs both marketing and promotion of medical devices
(even off-label). To the extent plaintiff asserts that such representations are "fraud on
the FDA," these claims "exist solely by virtue of the FDCA disclosure requirements," and
are impliedly preempted. Buckman, 531 U.S. at 350, 353. To the extent plaintiff
asserts such representations are parallel claims, the court disagrees. While such
conduct (making false representations regarding the infuse device) might violate the
FDCA, such conduct would not exist apart from the FDCA. The same analysis applies
to plaintiff's allegations that Medtronic did not report adverse events. 15 Therefore, these
causes of action likewise are preempted. See, e.g., Caplinger, 921 F. Supp. 2d at
1219; Ledet v. Medtronic, Civ. No. 13-200, 2013 WL 6858858, at *4 (S.D. Miss. Dec.
30, 2013).
As to plaintiff's breach of express warranty claim, plaintiff fails to respond to
defendants' argument regarding disclaimer of warranty. The document titled "Important
Medical Information for Infuse Bone Graft!LT-Cage Lumbar Tapered Fusion Device,"

13

Count II.

14

Count Ill.

15

Moreover, plaintiff does not and cannot show that reporting adverse events
would necessarily have resulted in a change in the labeling or warnings of the infuse
device.
13

on file on the FDA's website, includes a conspicuous disclaimer of all warranties. 16
Delaware law permits such disclaimers. 6 Del. C. § 2-316; see also, Strange v. Keiper
Recaro Seating, Inc., 117 F. Supp. 2d 408, 411 (D. Del. 2000). The court concludes
that the disclaimer language is sufficient and dismisses this cause of action. 17 See
Scovil v. Medtronic, Inc., 2014 WL 502923, at *11 (D. Ariz. Feb. 7, 2014).

V. CONCLUSION
For the aforementioned reasons, defendants' motion to dismiss is granted. An
appropriate order shall issue.

16

Defendants request that the court take judicial notice of the FDA document
titled InFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Device Important Medical
Information ("Important Medical Information"), available on the FDA's public website.
(D. I. 44 at n.3, ex. 5) Plaintiff does not specifically oppose the request, instead arguing
that defendants' inclusion of many additional documents converts the motion to dismiss
into a motion for summary judgment. As to the Important Medical Information
document, such document reflects final agency action and is included in a database
maintained by the FDA in the normal course of business. The court takes judicial
notice of the veracity of the document.
17

Without reaching defendants' preemption arguments.
14