Caplinger v. Medtronic Inc et al
Filing
37
ORDER granting 31 defendants' Motion to Dismiss Plaintiff's Amended Complaint (as more fully set out in order). Signed by Honorable Vicki Miles-LaGrange on 2/6/2013. (ks)
IN THE UNITED STATES DISTRICT COURT FOR THE
WESTERN DISTRICT OF OKLAHOMA
PATRICIA CAPLINGER,
Plaintiff,
vs.
MEDTRONIC, INC., a Minnesota
corporation, and MEDTRONIC
SOFAMOR DANEK USA, INC.,
a Tennessee corporation,
Defendants.
)
)
)
)
)
)
)
)
)
)
)
)
Case No. CIV-12-630-M
ORDER
Before the Court is defendants’ Motion to Dismiss Plaintiff’s Amended Complaint, filed
August 9, 2012. On September 4, 2012, plaintiff filed her response, and on September 20, 2012,
defendants filed their reply.
I.
Background
On August 25, 2010, plaintiff had a posterior lumbar interbody fusion surgery at the L5-S1
spine to correct a degenerative disc condition.1 The Infuse® Bone Graft product (“Infuse Device”)
was used in the surgery. In October and November 2010, plaintiff’s symptoms returned and
worsened and included a drop foot condition in her right leg allegedly resulting from exuberant bone
growth caused by the use of the Infuse Device. In December 2010, plaintiff’s drop foot condition
caused a tear of the anterior cruciate ligament in her right knee, which required surgery in February
2011. Because of exuberant bone growth in plaintiff’s lumbar spine, revision surgery was required
on September 9, 2011. Exuberant bone growth is continuing and will likely require a second
revision surgery.
1
A posterior lumbar interbody fusion surgery is performed through the back.
The Infuse Device was made by defendants. It is a medical device consisting of three parts:
(1) a recombinant human bone morphogenetic protein, (2) a collagen scaffold, and (3) an interbody
fusion device (essentially, a cage). The Infuse Device is used for the treatment of degenerative disc
disease in a surgical procedure known as spinal fusion. The Infuse Device is a Class III medical
device approved by the Federal Drug Administration (“FDA”) through the Premarket Approval
(“PMA”) process. The Infuse Device has been approved for use in lumbar surgery that is performed
through the abdomen (anterior) but has not been approved for use in lumbar surgery that is
performed through the back (posterior). The Infuse Device was initially approved on July 2, 2002.
The FDA has since approved thirty-seven supplements to its PMA.
On June 4, 2012, plaintiff filed the instant action. On July 23, 2012, plaintiff filed an
Amended Complaint. In her Amended Complaint, plaintiff alleges seven causes of action against
defendants in connection with their Infuse Device: (1) fraudulent misrepresentation and fraud in the
inducement, (2) constructive fraud, (3) strict products liability – failure to warn, (4) strict products
liability – design defect, (5) breach of express and implied warranty, (6) negligence, and (7)
negligent misrepresentation.
Pursuant to Federal Rule of Civil Procedure 12(b)(6), defendants now move this Court to
dismiss plaintiff’s Amended Complaint with prejudice. Defendants assert that plaintiff’s claims are
expressly preempted in their entirety by the Medical Device Amendments of 1976, 21 U.S.C. §
360(k), as interpreted by the Supreme Court in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008),
because they seek to impose state-law requirements on the design, manufacture, or labeling of the
Infuse Device that are different from or in addition to the federal requirements imposed by the FDA.
Moreover, defendants assert that to the extent plaintiff’s claims seek to enforce the provisions of
2
federal law governing the promotion of medical devices for “off-label” uses, they are impliedly
preempted under Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) and prohibited by
the “no private cause of action” clause of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §
337(a).
II.
The Statutory and Regulatory Framework and the PMA Process
The Federal Food, Drug, and Cosmetic Act (“FDCA”), 52 Stat. 1040, as amended, 21 U.S.C.
§ 301 et seq., has long required FDA approval for the introduction of new drugs into the market;
however, the introduction of new medical devices was left largely for the states to supervise as they
saw fit. See Riegel, 552 U.S. at 315. The regulatory landscape changed in the 1960’s and 1970’s,
as complex devices proliferated and some failed, most notably the Dalkon Shield. See id. As a
result, Congress stepped in with the passage of 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
federal oversight. See id. at 316.
The new regulatory regime established various levels of
oversight for medical devices, depending on the risks they present.
Class I, which includes such devices as elastic bandages and
examination gloves, is subject to the lowest level of oversight:
“general controls,” such as labeling requirements. § 360c(a)(1)(A);
FDA, Device Advice: Device Classes, http:// www.fda.gov/ cdrh/
devadvice/ 3132.html (all Internet materials as visited Feb. 14, 2008,
and available in Clerk of Court’s case file). Class II, which includes
such devices as powered wheelchairs and surgical drapes, ibid., is
subject in addition to “special controls” such as performance
standards and postmarket surveillance measures, § 360c(a)(1)(B).
The devices receiving the most federal oversight are those in
Class III, which include replacement heart valves, implanted
cerebella stimulators, and pacemaker pulse generators, FDA, Device
Advice: Device Classes, supra. In general, a device is assigned to
Class III if it cannot be established that a less stringent classification
would provide reasonable assurance of safety and effectiveness, and
3
the device is “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 “presents
a potential unreasonable risk of illness or injury.”
§
360c(a)(1)(C)(ii).
Id. at 316-17.
The MDA established a rigorous regime of premarket approval for new Class III devices.
A manufacturer must submit what is typically a multivolume
application. FDA, Device Advice – Premarket Approval (PMA) 18,
http://www.fda.gov/cdrh/devadvice/pma/printer.html. It includes,
among other things, full reports of all studies and investigations of
the device’s safety and effectiveness that have been published or
should reasonably be known to the applicant; a “full statement” of the
device’s “components, ingredients, and properties and of the
principle or principles of operation”; “a full description of the
methods used in, and the facilities and controls used for, the
manufacture, processing, and, when relevant, packing and installation
of, such device”; samples or device components required by the
FDA; and a specimen of the proposed labeling. § 360e(c)(1). Before
deciding whether to approve the application, the agency may refer it
to a panel of outside experts, 21 CFR § 814.44(a) (2007), and may
request additional data from the manufacturer, § 360e(c)(1)(G).
The FDA spends an average of 1,200 hours reviewing each
application, [Medtronic, Inc. v.] Lohr, [518 U.S. 470,] 477 . . . and
grants premarket approval only if it finds there is a “reasonable
assurance” of the device’s “safety and effectiveness,” § 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. . . .
The premarket approval process includes review of the
device’s proposed labeling. The FDA evaluates safety and
effectiveness under the conditions of use set forth on the label, §
360c(a)(2)(B), and must determine that the proposed labeling is
neither false nor misleading, § 360e(d)(1)(A).
4
After completing its review, the FDA may grant or deny
premarket approval. § 360e(d). It may also condition approval on
adherence to performance standards, 21 CFR § 861.1(b)(3),
restrictions upon sale or distribution, or compliance with other
requirements, § 814.82. The agency is also free to impose devicespecific restrictions by regulation. § 360j(e)(1).
If the FDA is unable to approve a new device in its proposed
form, it may send an “approvable letter” indicating that the device
could be approved if the applicant submitted specified information or
agreed to certain conditions or restrictions. 21 CFR § 814.44(e).
Alternatively, the agency may send a “not approvable” letter, listing
the grounds that justify denial and, where practical, measures that the
applicant could undertake to make the device approvable. §
814.44(f).
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 effectiveness. §
360e(d)(6)(A)(i). If the applicant wishes to make such a change, it
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).
After premarket approval, the devices are subject to reporting
requirements. § 360i. These include 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). The FDA has the
power to withdraw premarket approval based on newly reported data
or existing information and must withdraw approval if it determines
that a device is unsafe or ineffective under the conditions in its
labeling. § 360e(e)(1); see also § 360h(e) (recall authority).
Id. at 317-320.
5
III.
Discussion
A.
Motion to dismiss standard
Regarding the standard for determining whether to dismiss a claim pursuant to Rule 12(b)(6),
the United States Supreme Court has held:
To survive a motion to dismiss, a complaint must contain sufficient
factual matter, accepted as true, to state a claim to relief that is
plausible on its face. A claim has facial plausibility when the
plaintiff pleads factual content that allows the court to draw the
reasonable inference that the defendant is liable for the misconduct
alleged. The plausibility standard is not akin to a “probability
requirement,” but it asks for more than a sheer possibility that a
defendant has acted unlawfully. Where a complaint pleads facts that
are merely consistent with a defendant’s liability, it stops short of the
line between possibility and plausibility of entitlement to relief.
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (internal quotations and citations omitted). Further,
“where 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 shown - that the pleader is entitled to relief.”
Id. at 679 (internal quotations and citations omitted). Additionally, “[a] pleading that offers labels
and conclusions or a formulaic recitation of the elements of a cause of action will not do. Nor does
a complaint suffice if it tenders naked assertion[s] devoid of further factual enhancement.” Id. at
678 (internal quotations and citations omitted). Finally, “[a] court reviewing the sufficiency of a
complaint presumes all of plaintiff’s factual allegations are true and construes them in the light most
favorable to the plaintiff.” Hall v. Bellmon, 935 F.2d 1106, 1109 (10th Cir. 1991).
B.
Express preemption
The MDA includes an express preemption provision that states:
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 –
6
(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).2 In Riegel, the United States Supreme Court employed a two-step analysis for
determining whether state law claims are preempted under § 360k(a). First, the Supreme Court
considered whether PMA of a medical device by the FDA imposes federal “requirements” under the
MDA. See Riegel, 552 U.S. at 321-23. The Court concluded that PMA imposes federal
“requirements” within the meaning of the MDA. See id. at 322-23. Second, the Supreme Court
considered whether the state common law claims would impose requirements “different from, or in
addition to” the requirements imposed by the PMA process and that relate to safety and
effectiveness. See id. at 322-23. The Court concluded that the plaintiffs’ state common law claims
for strict products liability, breach of implied warranty, and negligence in the design, testing,
inspection, distribution, labeling, marketing, and sale of the device would impose requirements
“different from, or in addition to” the requirements imposed by the PMA process. Id. at 323. In
reaching that conclusion, the Supreme Court noted that
excluding common law duties from the scope of pre-emption would
make little sense. State tort law that requires a manufacturer’s
[device] to be safer, but hence less effective, than the model the FDA
has approved disrupts the federal scheme no less than state regulatory
law to the same effect. Indeed, one would think that tort law, applied
by juries under a negligence or strict-liability standard, is less
deserving of preservation. A state statute, or a regulation adopted by
a state agency, could at least be expected to apply cost-benefit
analysis similar to that applied by the experts at the FDA: How many
more lives will be saved by a device which, along with its greater
2
The exception contained in subsection (b) permits the FDA to exempt some state and local
requirements from preemption.
7
effectiveness, brings a greater risk of harm? A jury, on the other
hand, sees only the cost of a more dangerous design, and is not
concerned with its benefits; the patients who reaped those benefits are
not represented in court.
Id. at 325.
When determining whether a state requirement is “in addition to” the requirements imposed
by federal law, courts have found “[w]here a federal requirement permits a course of conduct and
the state makes its obligatory, the state’s requirement is in addition to the federal requirement and
thus is preempted.” In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200,
1205 (8th Cir. 2010) (internal quotations and citation omitted).
However, the Supreme Court has made clear that “[s]tate requirements are pre-empted under
the MDA only to the extent that they are ‘different from, or in addition to’ the requirements imposed
by federal law. § 360k(a)(1). Thus, § 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.” Riegel, 552 U.S. at 330.
In order for a state requirement to be parallel to a federal
requirement, and thus not expressly preempted under § 360k(a), the
plaintiff must show that the requirements are “genuinely equivalent.”
State and federal requirements are not genuinely equivalent if a
manufacturer could be held liable under the state law without having
violated the federal law.
Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1300 (8th Cir. 2011) (quoting McMullen v.
Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005)) (emphasis in original). Further, “[t]o properly
allege parallel claims, the complaint must set forth facts pointing to specific PMA requirements that
have been violated.” Id. at 1301 (internal quotations and citation omitted). “Plaintiffs must also
8
allege a link between the failure to comply and the alleged injury.” Desabio v. Howmedica Osteonics
Corp., 817 F. Supp. 2d 197, 204 (W.D.N.Y. 2011).
C.
Implied preemption
The FDCA states that an action for “enforcement, or to restrain violations, of th[e] [FDCA]
shall be by and in the name of the United States.” 21 U.S.C. § 337(a). The Supreme Court
interpreted § 337(a) in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). The Supreme
Court found “clear evidence that Congress intended that the MDA be enforced exclusively by the
Federal Government. 21 U.S.C. § 337(a).” Buckman, 531 U.S. at 352. The Supreme Court then
found that “although Medtronic[, Inc. v. Lohr, 518 U.S. 470 (1996)] can be read to allow certain
state-law causes of actions that parallel federal safety requirements, it does not and cannot stand for
the proposition that any violation of the FDCA will support a state-law claim.” Buckman, 531 U.S.
at 353. Concluding, the Supreme Court found:
[i]n sum, were plaintiffs to maintain their fraud-on-the-agency claims
here, they would not be relying on traditional state tort law which had
predated the federal enactments in questions. On the contrary, the
existence of these federal enactments is a critical element in their
case.
Id.
Thus, a private litigant cannot sue a defendant for violating the
FDCA. Similarly, a private litigant cannot bring a state-law claim
against a defendant when the state-law claim is in substance (even if
not in form) a claim for violating the FDCA – that is, when the state
claim would not exist if the FDCA did not exist. So, for example, a
state-law claim that the defendant made misrepresentations to the
FDA is preempted because such a claim would not exist absent the
federal regulatory scheme established by the FDCA.
This does not mean . . . that a plaintiff can never bring a state-law
claim based on conduct that violates the FDCA. Indeed . . . the
conduct on which the plaintiff’s claim is premised must violate the
9
FDCA if the claim is to escape express preemption by § 360k(a).
Instead, to avoid being impliedly preempted under Buckman, a claim
must rely[ ] on traditional state tort law which had predated the
federal enactments in question[ ]. In other words, the conduct on
which the claim is premised must be the type of conduct that would
traditionally give rise to liability under state law – and that would
give rise to liability under state law even if the FDCA had never been
enacted. If the defendant’s conduct is not of this type, then the
plaintiff is effectively suing for a violation of the FDCA (no matter
how the plaintiff labels the claim), and the plaintiff’s claim is thus
impliedly preempted under Buckman.
Riley v. Cordis Corp., 625 F. Supp. 2d 769, 776-77 (D. Minn. 2009) (internal quotations and
citations omitted).
D.
Interplay between express and implied preemption
Considering the law regarding express preemption and the law regarding implied preemption
together,
Riegel and Buckman create a narrow gap through which a plaintiff’s
state-law claim must fit if it is to escape express or implied
preemption. The plaintiff must be suing for conduct that violates the
FDCA (or else his claim is expressly preempted by § 360k(a)), but
the plaintiff must not be suing because the conduct violates the
FDCA (such a claim would be impliedly preempted under Buckman).
In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d at 1204 (quoting Riley, 625
F. Supp. 2d at 777) (emphasis in original). Thus, “[f]or a state-law claim to survive, then, the claim
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.” Riley, 625 F. Supp. 2d at 777.
E.
The parties’ arguments
1.
Defendants’ arguments
Defendants assert that because plaintiff’s claims would require a determination that the
Infuse Device should have been labeled, designed or manufactured differently from the manner
10
required by the FDA, those claims are preempted and must be dismissed. Specifically, defendants
assert that because each of plaintiff’s claims seeks to impose state law requirements on the design,
manufacture, or labeling of the Infuse Device that are different from or in addition to those imposed
by the FDA through the PMA process, Riegel and its progeny compel dismissal. Defendants further
assert that to the extent that plaintiff’s claims seek to enforce the FDCA’s provisions governing the
approval or off-label promotion of medical devices, they also are impliedly preempted and barred
by § 337(a).
Regarding plaintiff’s fraudulent misrepresentation, fraud in the inducement, constructive
fraud, negligent misrepresentation, and failure to warn claims (both based in strict liability and
negligence), defendants contend that plaintiff does not allege that defendants failed to provide any
of the warnings required by the FDA through the PMA process but instead alleges that defendants
should have given additional warnings beyond those required by the FDA. Defendants, therefore,
conclude that plaintiff’s claims are preempted because they would require a finding that, as a matter
of Oklahoma law, defendants failed to provide adequate warnings despite having labeled the Infuse
Device as required by the FDA and would, thus, impose labeling requirements “different from, or
in addition to,” those imposed by federal law. Defendants further assert that plaintiff’s off-label
promotion allegations do not immunize plaintiff’s claims from express preemption under § 360k(a).
Defendants contend that to comply with the state law duty that plaintiff’s failure-to-warn theory
imposes, defendants would be forced to provide certain, unspecified warnings about the alleged risks
of off-label use and would thus be forced to provide labeling to accompany the Infuse Device that
is “different from, or in addition to” that already approved by the FDA through the PMA process.
11
Defendants also contend that plaintiff’s fraud and misrepresentation claims fail because they
are not pled with particularity as required by Federal Rule of Civil Procedure 9(b). Specifically,
defendants contend that plaintiff’s Amended Complaint does not set forth the time, place and
contents of the alleged false representations, the identity of the party making the alleged false
statements and the consequences thereof. Finally, defendants contend that plaintiff cannot base her
failure to warn claims on defendants’ representative’s failure to fully disclose all pertinent
information and properly instruct plaintiff’s surgeon regarding the off-label use of the Infuse Device
for plaintiff’s surgery because such a claim would require defendants, through their representative,
to have used warnings different from, or in addition to, those required by the FDA.
Regarding plaintiff’s strict liability design defect claim, defendants state that although
plaintiff alleges that the Infuse Device suffered from a defective design, she does not allege that the
design of the device that she received was anything other than the design approved by the FDA
through the PMA process. Defendants assert that claims that attack the FDA-approved design of
a Premarket Approved device are preempted regardless of whether they are based in strict liability
or negligence. Defendants further assert that plaintiff’s off-label allegations cannot save her design
defect claim from preemption because even if plaintiff could prevail on her design defect claim as
a matter of state law by convincing a jury that the Infuse Device was “unsafe” with respect to a
given off-label use, such a claim would impose a state law requirement that the device have been
designed differently from the manner approved by the FDA through the PMA process.
Regarding plaintiff’s breach of express and implied warranty claims, defendants contend that
for plaintiff to prevail on these claims, a jury would have to find that the Infuse Device was not safe
or effective but that such a jury finding would inevitably contradict the FDA’s conclusive
12
determination, via the PMA process, that the Infuse device is safe and effective. Defendants,
therefore, contend that because plaintiff’s warranty claims challenge the safety and effectiveness of
a Premarket Approved device, they are expressly preempted.
Additionally, defendants contend that plaintiff has failed to allege any parallel claim that
might survive preemption. Specifically, defendants assert that plaintiff has not demonstrated how
the duties and obligations imposed by state and federal law are genuinely equivalent or identical or
how the alleged federal violations caused injury. For example, defendants allegedly violated a
federal requirement that manufacturers not promote devices for off-label uses. The state law
requirement that defendants allegedly violated is the requirement that a manufacturer provide
adequate warnings to physicians about the risks of its medical device. But a duty not to promote
devices for off-label use is not parallel to a duty to warn of device risks. Defendants assert that it
is possible to violate the purported state law requirement while complying with the federal
requirement, and vice versa, thereby demonstrating that the two requirements are not “parallel” and
that an alleged violation of the federal duty to refrain from off-label promotion cannot save
plaintiff’s state law failure-to-warn claims from express preemption.
Finally, defendants contend that even if allegations of off-label promotion or other federal
statutory or regulatory violations could save plaintiff’s claims from express preemption, her claims
would still be impliedly preempted under Buckman and barred by § 337(a). Specifically, defendants
assert that by seeking to impose liability based on defendants’ alleged violation of the FDA’s
restriction on off-label promotion, plaintiff is trying to usurp the FDA’s exclusive authority to police
purported violations of its own regulations and this Court should reject plaintiff’s attempt to
encroach upon the FDA’s discretionary authority to enforce the restrictions on off-label promotion.
13
Defendants further contend that to the extent plaintiff’s claims rest on allegations of regulatory
violations, they are not only impliedly preempted but are also barred by the FDCA’s no-privateright-of-action clause, § 337(a). Any effort by plaintiff to fashion a state law cause of action out of
an alleged federal statutory violation with no counterpart in established state law is an attempt at
private enforcement of the FDCA barred by § 337(a). There is no pre-existing state law duty to
abstain from off-label promotion (or to comply with the various federal statutes and regulations
listed in the complaint). Defendants contend that plaintiff is seeking to hold defendants liable for
conduct that was not unlawful under traditional state tort law which had predated the federal
enactment and is attempting to pursue claims that include as a critical element something that exists
solely by virtue of the FDCA.
2.
Plaintiff’s arguments
Plaintiff asserts that the FDA only approved the Infuse Device for anterior procedures and
specifically asked defendants to take measures to prohibit the off-label use and off-label promotion
of posterior uses. Plaintiff further asserts that posterior use is considered a “new indication” for
which defendants were obligated to obtain FDA approval if it sought to promote such use, yet,
defendants never obtained the FDA’s approval for posterior use of the Infuse Device. Because
defendants failed to obtain said approval, plaintiff contends defendants’ intentional promotion of
the Infuse Device for such off-label uses was in violation of federal law and FDA regulations and,
thus, defendants are not entitled to the preemption defense.
Additionally, plaintiff asserts that she is alleging “parallel” claims arising out of defendants’
illegal off-label promotion that are not preempted by federal law. Plaintiff contends that defendants
were obligated to obtain FDA approval for all of the uses for which they intended to promote the
14
Infuse Device and once defendants chose to intentionally promote the Infuse Device for offlabel/unapproved uses, it resulted in a violation of federal law. Plaintiff then contends that
defendants’ failure to obtain approval for posterior use of the Infuse Device, their intentional offlabel promotion of the Infuse Device, and their failure to provide adequate warnings for the offlabel/unapproved uses, thus, subjects them to state law tort liability.
Plaintiff further asserts that the Buckman case is not applicable to the case at bar and does
not impliedly preempt plaintiff’s parallel claims of illegal off-label promotion. Plaintiff contends
that her claims are traditional state tort law claims based on negligence, warning defects, and fraud
on her, not fraud on a federal agency. Plaintiff states that she is not complaining of fraud on the
FDA but rather claims that she and her physician were deceived and injured by defendants’ actions
in (a) illegally promoting the Infuse Device for off-label/unapproved uses, (b) utilizing undisclosed
paid consultants to market the off-label use of the Infuse Device, and (c) failing to provide adequate
warnings regarding the risks and dangers associated with the promoted off-label uses.
Regarding her breach of warranty claims, plaintiff contends that even if the Court deems
plaintiff’s other claims preempted, her breach of warranty claims cannot be preempted because such
claims are specifically excluded from preemption by FDA regulations, 21 C.F.R. § 808.1(d), and
arise out of defendants’ own voluntary (as opposed to FDA imposed) off-label warranties and
representations. Plaintiff further asserts that imposing liability on defendants for violating their
express and implied warranties would not impose any additional state law obligations on defendants.
Finally, plaintiff contends that her claims arising out of defendants’ acts during her surgery
are not preempted. Plaintiff alleges that even though defendants’ representative was aware of the
specific use of the Infuse Device for plaintiff’s surgery, the representative breached her duty by
15
failing to provide the necessary information regarding the excessive danger involved in using the
Infuse Device for a posterior-approach lumbar spine fusion. Plaintiff asserts that her negligence and
constructive fraud claims against defendants arising out of the representative’s actions/inactions
during surgery do not challenge the design, manufacture, and labeling of the Infuse Device so as to
implicate Riegel preemption.
F.
Court’s analysis
1.
Effect of allegations of off-label promotion on preemption
As set forth above, plaintiff asserts that because defendants promoted off-label use of the
Infuse Device for posterior approach lumbar spine fusion in violation of federal law, § 360k(a)
preemption does not apply. In other words, plaintiff contends that § 360k(a) does not preempt any
claim that arises out of the promotion of an off-label use of a device.3
The Court finds that such a contention must fail because it is inconsistent with the text of §
360k(a) and allegations of promotion of off-label use of a device in violation of federal law does not
automatically immunize a plaintiff’s claims from being subject to a preemption analysis under §
360k(a). As the court is Riley aptly stated:
under § 360k(a)(1), the question is not whether there are federal
requirements applicable to a particular use of a device; the question
is whether there are federal requirements applicable “to the device.”
If there are – and, as Riegel makes clear, the PMA process
unquestionably imposes such requirements – then any state
requirements that are different from, or in addition to, those federal
3
The Court would note that the Supreme Court recognized in Buckman that off-label use is
not illegal or even disfavored under federal law but is an accepted and valuable part of the practice
of medicine. “‘[O]ff-label’ usage of medical devices . . . is an accepted and necessary corollary of
the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.”
Buckman, 531 U.S. at 350.
16
requirements are preempted. Nothing in the statute suggests that the
preemption analysis somehow depends on how the device is used.
Riley, 625 F. Supp. 2d. at 779 (emphasis in original). For the same reasons, the Court finds that
nothing in § 360k(a) suggests that the preemption analysis somehow depends on how the device is
being promoted to be used. Accordingly, the Court finds that regardless of plaintiff’s off-label
promotion allegations, each of plaintiff’s claims must be analyzed to determine whether it is
preempted under § 360k(a) or § 337(a).4
2.
Plaintiff’s fraudulent misrepresentation and fraud in the inducement claim
In her Amended Complaint, plaintiff alleges that “Defendants fraudulently and intentionally
misrepresented material and important health and safety product risk information from Plaintiff and
her physicians.” Amended Complaint at ¶ 93. Plaintiff further specifically alleges the following
to establish defendants’ liability for fraudulent misrepresentation and/or fraud in the inducement:
a. Defendants fraudulently concealed and misrepresented the health
and safety hazards, symptoms, constellation of symptoms, diseases
and/or health problems associated with the off-label posteriorapproach use of their Infuse® product;
b. Defendants fraudulently concealed and misrepresented their
practice of promoting and marketing to physicians, including
Plaintiff’s physician, the off-label use of Infuse® in posteriorapproach lumbar spine surgery;
c.
Defendants fraudulently concealed and misrepresented
information about the known comparative risks and benefits of the
use of Infuse® and the relative benefits and availability of alternate
products, treatments and/or therapies.
4
The Court also finds that plaintiff’s off-label promotion allegations do not somehow turn
plaintiff’s claims into “parallel” claims that are not preempted. Specifically, the Court finds that the
federal requirement that manufacturers not promote devices for off-label uses is not genuinely
equivalent to the state law requirements that a manufacturer provide adequate warnings to physicians
about the risks of its medical device and that a manufacturer not produce a product with a defective
design. It is possible to violate the state law requirement while complying with the federal
requirement and vice versa.
17
Amended Complaint at ¶ 94.
Having carefully reviewed plaintiff’s Amended Complaint, the Court finds that there are a
number of different possible bases for plaintiff’s fraudulent misrepresentation/fraud in the
inducement claim. First, plaintiff’s claim may be based upon alleged misrepresentations and
omissions contained in the actual warnings and labels accompanying the Infuse Device. The Court
finds that this basis for a fraudulent misrepresentation/fraud in the inducement claim is preempted
under § 360k(a).
Specifically, the Court finds that allowing this type of fraudulent
misrepresentation/fraud in the inducement claim to proceed would permit a finding that defendants
were required to alter the Infuse Device’s warning and label and to provide additional warnings
above and beyond those on the Infuse Device’s label and accompanying the device – a label and
warnings that were specifically approved by the FDA as part of the PMA process. This would
establish labeling and warning requirements different from, or in addition to, federal requirements
for the Infuse Device.
Second, plaintiff’s claim may be based upon alleged misrepresentations and omissions
regarding defendants’ practice of promoting and marketing to physicians the off-label use of the
Infuse Device in posterior-approach lumbar spine surgery. The Court finds that this basis for a
fraudulent misrepresentation/fraud in the inducement claim is impliedly preempted under Buckman
and § 337(a). While plaintiff’s allegations regarding defendants’ practice of promoting and
marketing to physicians the off-label use of the Infuse Device in posterior-approach lumbar spine
surgery could be a violation of the FDCA and, thus, plaintiff’s claim would not be expressly
preempted under § 360k(a), plaintiff’s fraudulent misrepresentation/fraud in the inducement claim
is not based on conduct that would give rise to a recovery under state law even in the absence of the
18
FDCA. The conduct plaintiff complains of – how defendants are promoting and marketing to
physicians the off-label use of the Infuse Device in posterior-approach lumbar spine surgery – is
governed by the FDCA. To determine whether said conduct is improper would require reliance on
the requirements of the FDCA. Further, even the concept of “off-label use” is a creature of the
FDCA, is defined by the FDCA, and is not a part of Oklahoma substantive law. While plaintiff
couches her claim as a state law fraudulent misrepresentation/fraud in the inducement claim, this
claim is in substance a claim for violating the FDCA and, thus, is clearly preempted under Buckman
and § 337(a).
Finally, plaintiff’s claim may be based upon alleged misrepresentations and omissions
defendants made while promoting and marketing to physicians the off-label use of the Infuse Device
in posterior-approach lumbar spine surgery.
Whether this basis for plaintiff’s fraudulent
misrepresentation/fraud in the inducement claim is preempted, however, can not be determined due
to the lack of specificity in plaintiff’s Amended Complaint. It is entirely unclear what specific
alleged misrepresentations and/or omissions plaintiff claims defendants made while promoting and
marketing the off-label use, and, thus, it is impossible for this Court to determine whether allowing
this type of fraudulent misrepresentation/fraud in the inducement claim to proceed would permit a
finding that would require statements and warnings to be made that would be different from or in
addition to the statements and warnings made on the label and materials that were specifically
approved by the FDA as part of the PMA process.
Additionally, whether this basis for plaintiff’s fraudulent misrepresentation/fraud in the
inducement claim is preempted or not, the Court finds that this basis should be dismissed because
it is not pled with particularity as required by Federal Rule of Civil Procedure 9(b). “[A] complaint
19
alleging fraud [must] set forth the time, place and contents of the false representation, the identity
of the party making the false statements and the consequences thereof.” Tal v. Hogan, 453 F.3d
1244, 1263 (10th Cir. 2006) (internal quotations and citations omitted). Plaintiff’s Amended
Complaint does not set forth any of these required items and should, therefore, be dismissed.
3.
Plaintiff’s constructive fraud claim
In her Amended Complaint, plaintiff alleges:
105. Defendants had specific knowledge of the use of the Infuse® in
Patricia Caplinger’s particular surgery. Defendants, participated in
the surgery, and breached her duty to fully disclose all pertinent
information to Dr. Rahman regarding the use of Infuse® for Patricia
Caplinger’s surgery. The representative’s failure to provide known
dangers for Plaintiff’s surgery fraudulently caused Infuse® to be used
in the surgery and subsequently caused Patricia Caplinger’s injuries.
106. Defendants owed Plaintiff duties to exercise reasonable or
ordinary care under the circumstances, in light of the generally
recognized and prevailing best scientific knowledge, and to produce
and market Infuse® in as safe a manner and condition as possible.
107. Specific defects . . . in the Infuse® product, rendered it
defective and unreasonably dangerous.
Amended Complaint at ¶¶ 105-107.
Having carefully reviewed plaintiff’s Amended Complaint, the Court finds that plaintiff’s
constructive fraud claim is preempted under § 360k(a). As set forth in the allegations above, in her
constructive fraud claim, plaintiff is specifically alleging that the Infuse Device was defective and
unreasonably dangerous and was not produced and marketed in as safe a manner and condition as
possible. To permit a jury to second-guess the Infuse Device’s design, manufacturing, labeling,
warning, and marketing would risk interference with the federally-approved design, manufacturing,
labeling, warning, and marketing requirements.
20
Plaintiff’s constructive fraud claim would,
therefore, establish design, manufacturing, labeling, warning, and marketing requirements different
from, or in addition to, federal requirements for the Infuse Device. The Court finds that this is the
exact type of claim that is expressly preempted under § 360k(a) and plaintiff’s constructive fraud
claim, therefore, should be dismissed.
To the extent that plaintiff’s constructive fraud claim is based on defendants’ representative’s
statements during plaintiff’s surgery, the Court finds that it is not pled with particularity as required
by Federal Rule of Civil Procedure 9(b). Specifically, the Court finds that plaintiff has not set forth
the contents of the alleged misrepresentations or omissions. It is impossible for the Court to know
if plaintiff is alleging that defendants’ representative failed to provide particular warnings and
information specific to plaintiff’s surgery or if plaintiff is alleging that defendants’ representative
failed to provide the same general warnings and information regarding the Infuse Device which the
Court has already found would risk interference with the PMA process and the federally-approved
warning and labeling requirements. Accordingly, the Court finds that plaintiff’s constructive fraud
claim should be dismissed.
4.
Plaintiff’s strict products liability – failure to warn claim
Plaintiff also alleges a strict products liability failure to warn claim. In her Amended
Complaint, plaintiff specifically alleges the following regarding this claim:
116. The warnings accompanying the Infuse® product did not
adequately warn Plaintiff and her physicians, in light of its scientific
and medical knowledge at the time, of the dangers associated with
Infuse® when used off-label in posterior-approach lumbar spine
surgery including, but not limited to, pain and weakness in limbs,
radiculitis, ectopic bone formation, osteolysis, and poorer global
outcomes than alternative treatments.
117. The warnings accompanying the Infuse® product failed to
provide the level of information that an ordinary physician or
21
consumer would expect when using the product in a manner
reasonably foreseeable to Medtronic. Medtronic either recklessly or
intentionally minimized and/or downplayed the risks of serious side
effects related to the off-label use of Infuse® for posterior-approach
lumbar spine fusion surgery had they known of the safety risks
related to Infuse®.
Amended Complaint at ¶ 116-117 (emphasis added).
Having reviewed the Amended Complaint, the Court finds plaintiff’s strict products liability
failure to warn claim is preempted under § 360k(a). Specifically, the Court finds that allowing
plaintiff’s strict products liability failure to warn claim to proceed would permit a finding that
defendants were required to provide warnings above and beyond those on the Infuse Device’s label
and accompanying the device – a label and warnings that were specifically approved by the FDA
as part of the PMA process. Plaintiff’s strict products liability failure to warn claim would,
therefore, establish labeling and warning requirements different from, or in addition to, federal
requirements for the Infuse Device. The Court finds that this is the exact type of claim that is
expressly preempted under § 360k(a) and plaintiff’s strict products liability failure to warn claim,
therefore, should be dismissed.
5.
Plaintiff’s strict products liability – design defect claim
In her Amended Complaint, plaintiff alleges that the Infuse Device was “defectively
designed at the time that it left the Defendants’ control and was placed into the stream of
commerce.” Amended Complaint at ¶ 122. Plaintiff alleges the Infuse Device was defectively
designed “because the design was unsafe when used in the manner promoted by Defendants and in
a manner reasonably foreseeable by Defendants” and “because the risks of danger in the design
outweigh the benefits of the design.” Amended Complaint at ¶¶ 123, 124. Finally, plaintiff alleges
“[t]he foreseeable risks of harm posed by using the Infuse® product in a manner promoted by
22
Defendants could have been reduced or avoided by adopting a reasonably alternative design.”
Amended Complaint at ¶ 126.
Having reviewed the Amended Complaint, the Court finds plaintiff’s strict products liability
design defect claim is preempted under § 360k(a). Specifically, the Court finds that allowing
plaintiff’s strict products liability design defect claim to proceed would permit a finding that a
design defect rendered the Infuse Device unreasonably dangerous, even if defendants complied with
all FDA regulations addressed to design. To permit a jury to second-guess the Infuse Device’s
design would risk interference with the federally-approved design standards and criteria. Plaintiff’s
strict products liability design defect claim would, therefore, establish design requirements different
from, or in addition to, federal requirements for the Infuse Device. The Court finds that this is the
exact type of claim that is expressly preempted under § 360k(a) and plaintiff’s strict products
liability design defect claim, therefore, should be dismissed.
6.
Plaintiff’s breach of express and implied warranty claim
In her Amended Complaint, plaintiff alleges that defendants “utilized journal articles,
advertising, media, sales representatives, consultants and paid Key Opinion Leaders to urge the use,
purchase, and utilization of the off-label use of Infuse® and expressly and impliedly warranted to
physicians and other members of the general public and medical community that such off-label uses,
including uses in posterior procedures was safe and effective.” Amended Complaint at ¶ 129.
Having carefully reviewed plaintiff’s Amended Complaint, the Court finds that plaintiff’s breach
of express and implied warranty claim is preempted. To succeed on the express and implied
warranty claim, as alleged by plaintiff in her Amended Complaint, plaintiff must persuade a jury that
the Infuse Device was not safe and effective, a finding that would be contrary to the FDA’s
23
approval. Additionally, “[a] state common law claim is preempted if it ‘actually conflicts with the
federal requirement – either because compliance with both is impossible, or because the state
requirement stands as an obstacle to the accomplishment and execution of the full purposes and
objectives of Congress.’” In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d
at 1208 (quoting Lohr, 518 U.S. at 507 (Breyer, J., concurring) (quotations and citations omitted)).
The Court finds that, as alleged, plaintiff’s breach of express and implied warranty claim interferes
with the FDA’s regulation of Class III medical devices and is, therefore, conflict preempted.
Finally, plaintiff contends her breach of express and implied warranty claim cannot be preempted
because such a claim is specifically excluded from preemption by FDA regulations, 21 C.F.R. §
808.1(d). Riegel explicitly rejected this contention, explaining that § 808.1(d) “add[s] nothing to
our analysis but confusion.” Riegel, 552 U.S. at 339. Accordingly, the Court finds that plaintiff’s
breach of express and implied warranty claim should be dismissed.
7.
Plaintiff’s negligence claim
In relation to her negligence claim, plaintiff alleges that defendants:
had an affirmative duty to fully and adequately warn Plaintiff and her
physicians of the true health and safety risks related to the off-label
use of Infuse®, and Defendants had a duty to disclose their
dangerous and irresponsible practices of improperly promoting to
physicians the off-label use of Infuse® for posterior-approach lumbar
spine fusion surgery. Independent of any special relationship of
confidence or trust, Defendants had a duty not to conceal the dangers
of the off-label use of Infuse® to Plaintiff and her physicians.
Amended Complaint at ¶ 136. Plaintiff also alleges that “[m]isrepresentations made by Defendants
about the health and safety of Infuse® independently imposed a duty upon Defendants to fully and
accurately disclose to Plaintiff and her physicians the true health and safety risks related to Infuse®,
and a duty to disclose their dangerous and irresponsible off-label promotion and marketing
24
practices.” Amended Complaint at ¶ 137. Plaintiff further specifically alleges the following to
establish defendants’ liability for negligence:
a. Unreasonable and improper promotion and marketing of Infuse®
to physicians, including but not limited to the promotion and
marketing of Infuse® for off-label use in posterior-approach lumbar
spine fusion surgeries;
b. Failure to warn physicians and Plaintiff of the dangers associated
with Infuse® when used off-label in posterior-approach lumbar spine
surgery including, but not limited to, pain and weakness in limbs,
radiculitis, extopic bone formation, osteolysis, and poorer global
outcomes than alternative treatments.
c. Failure to exercise reasonable care by not complying with federal
law and regulations applicable to the sale and marketing of Infuse®.
Amended Complaint at ¶ 139.
Having carefully reviewed plaintiff’s Amended Complaint, the Court finds that to the extent
that plaintiff’s negligence claim is based upon defendants’ failure to warn, plaintiff’s negligence
claim is preempted under § 360k(a). Specifically, the Court finds that allowing plaintiff’s
negligence claim based upon a failure to warn to proceed would permit a finding that defendants
were required to provide warnings above and beyond those on the Infuse Device’s label and
accompanying the device – a label and warnings that were specifically approved by the FDA as part
of the PMA process. Plaintiff’s negligence claim based upon a failure to warn would, therefore,
establish labeling and warning requirements different from, or in addition to, federal requirements
for the Infuse Device. The Court finds that this is the exact type of claim that is expressly preempted
under § 360k(a) and plaintiff’s negligence claim based upon a failure to warn, therefore, should be
dismissed.
To the extent that plaintiff’s negligence claim is based upon defendants’ promotion and
marketing of the Infuse Device for off-label uses, the Court finds it is impliedly preempted under
25
Buckman and § 337(a). While plaintiff’s allegations regarding defendants’ practice of promoting
and marketing to physicians the off-label use of the Infuse Device in posterior-approach lumbar
spine surgery could be a violation of the FDCA and, thus, plaintiff’s claim would not be expressly
preempted under § 360k(a), plaintiff’s negligence claim based upon defendants’ promotion and
marketing of the Infuse Device is not based on conduct that would give rise to a recovery under state
law even in the absence of the FDCA. As set forth in the Court’s analysis of plaintiff’s fraudulent
misrepresentation/fraud in the inducement claim, the conduct plaintiff complains of – how
defendants are promoting and marketing to physicians the off-label use of the Infuse Device in
posterior-approach lumbar spine surgery – is governed by the FDCA. To determine whether said
conduct is improper would require reliance on the requirements of the FDCA. Further, even the
concept of “off-label use” is a creature of the FDCA, is defined by the FDCA, and is not a part of
Oklahoma substantive law. While plaintiff couches her claim as a state law negligence claim, this
claim is, in substance, a claim for violating the FDCA and, thus, is clearly preempted under
Buckman and § 337(a).
Finally, to the extent that plaintiff is basing her negligence claim on some other violation of
federal law, the Court finds that plaintiff has not alleged sufficient facts to survive a motion to
dismiss. Plaintiff “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) (internal quotations and citation omitted). Merely alleging
that defendants failed to exercise reasonable care “by not complying with federal law and
regulations applicable to the sale and marketing” of the Infuse Device is insufficient to overcome
26
the preemptive reach of § 360k(a) without some factual detail as to how defendants violated the
federal regulations.
Accordingly, the Court finds that plaintiff’s negligence claim should be dismissed.
8.
Plaintiff’s negligent misrepresentation claim
Plaintiff’s final claim alleged in her Amended Complaint is a negligent misrepresentation
claim. In relation to her negligent misrepresentation claim, plaintiff alleges that specific defects in
the Infuse Device rendered it defective and unreasonably dangerous. See Amended Complaint at
¶ 146. Plaintiff further alleges that “Defendants made untrue representations and omitted material
information to Plaintiff and her physicians by sponsoring biased medical trials, reports and articles
that concluded that the dangers inherent to off-label use of Infuse® did not exist or were
significantly less than the actual dangers.” Amended Complaint at ¶ 147. Plaintiff also alleges that
“Defendants were negligent in making the untrue misrepresentations and omitting material
information because Defendants knew, or had reason to know, of the actual, unreasonable dangers
and defects in their Infuse® product.” Amended Complaint at ¶ 149.
Having carefully reviewed plaintiff’s Amended Complaint, the Court finds that plaintiff’s
negligent misrepresentation claim is preempted by § 360k(a). To permit a jury to second-guess the
Infuse Device’s design, manufacturing, labeling, and warnings would risk interference with the
federally-approved design, manufacturing, labeling, and warning requirements. Plaintiff’s negligent
misrepresentation claim would, therefore, establish design, manufacturing, labeling, and warning
requirements different from, or in addition to, federal requirements for the Infuse Device. The
Court, therefore, finds that plaintiff’s negligent misrepresentation claim should be dismissed.
27
G.
Need for discovery
Plaintiff also asserts that defendants’ motion is premature because she has not yet had a
chance to initiate, much less complete, discovery. Plaintiff contends that she will need to do
significant discovery into the full scope of defendants’ off-label promotional efforts, the warnings,
if any, it provided to physicians, including plaintiff’s physician, regarding such off-label posterior
uses, and the risks of off-label use known to defendants but which they failed to warn about when
they illegally promoted the Infuse Device for off-label uses.
Having reviewed the parties’ submissions, the Court finds that discovery is unnecessary to
resolve defendants’ motion to dismiss. Specifically, the Court finds that the issue of federal medical
device preemption is a question of law and may properly be decided on a motion to dismiss prior
to any discovery being conducted. Accordingly, the Court finds that defendant’s motion to dismiss
is not premature.
IV.
Conclusion
For the reasons set forth above, the Court GRANTS defendants’ Motion to Dismiss
Plaintiff’s Amended Complaint [docket no. 31].
IT IS SO ORDERED this 6th day of February, 2013.
28
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?