Paul v. Angeles, (A14-1149), Charlene Mead, (A14-1150), Charles Starovasnik, Jr., (A14-1151), Trudy Marse, (A14-1152), Rebecca Manuel, (A14-1153), Claude Davenport, (A14-1154) v. Medtronic, Inc.
Opinion text
STATE OF MINNESOTA
IN COURT OF APPEALS
A14-1149
A14-1150
A14-1151
A14-1152
A14-1153
A14-1154
Paul V. Angeles, et al.,
Appellants (A14-1149),
Charlene Mead, et al.,
Appellants (A14-1150),
Charles Starovasnik, Jr.,
Appellant (A14-1151),
Trudy Marse, et al.,
Appellants (A14-1152),
Rebecca Manuel, et al.,
Appellants (A14-1153),
Claude Davenport, et al.,
Appellants (A14-1154),
vs.
Medtronic, Inc., et al.,
Respondents.
Filed April 20, 2015
Affirmed in part, reversed in part, and remanded
Connolly, Judge
Hennepin County District Court
File Nos. 27-CV-13-1838; 27-CV-13-2611; 27-CV-13-5993;
27-CV-13-8438; 27-CV-13-1952; 27-CV-13-10478
Stuart L. Goldenberg, Marlene J. Goldenberg, Goldenberglaw, PLLC, Minneapolis,
Minnesota; and
Louis M. Bograd, (pro hac vice), Center for Constitutional Litigation, P.C., Washington,
D.C.; and
Wilbur W. Fluegel, Fluegel Law Office, Minneapolis, Minnesota (for appellants)
Michael T. Nilan, Andrew J. Sveen, Nilan Johnson Lewis, P.A., Minneapolis, Minnesota;
and
Andrew E. Tauber (pro hac vice), Mayer Brown LLP, Washington, D.C. (for
respondents)
Considered and decided by Peterson, Presiding Judge; Worke, Judge; and
Connolly, Judge.
SYLLABUS
1. Minnesota state law failure-to-warn patients and physicians claims and design-
defect claims impose general requirements that are different from federal device-
specific requirements and are therefore preempted by 21 U.S.C. § 360k(a) (2014).
2. Claims based on a failure to warn the FDA of adverse effects impose parallel
requirements to federal device-specific requirements and are not preempted by 21
U.S.C. § 360k(a).
3. Minnesota state law express-warranty claims impose parallel requirements to
federal device-specific requirements and are not expressly preempted by 21 U.S.C.
§ 360k(a).
OPINION
CONNOLLY, Judge
In these consolidated appeals, appellants challenge the dismissal of their claims
arising out of respondents’ advertising and promotion of a medical device that was used
and allegedly caused injury to appellants during spinal surgeries. Appellants argue that
the district court erred by (1) dismissing as expressly or impliedly preempted by the
federal Food, Drug, and Cosmetic Act (FDCA) their claims for negligence, breach of
2
warranty, unjust enrichment, and violation of state consumer-protection statutes; and
(2) dismissing their fraud claims for failure to plead with particularity pursuant to Minn.
R. Civ. P. 9.02. We affirm in part, reverse in part, and remand.
FACTS
Respondent Medtronic, Inc., et al. (Medtronic) manufactures and markets the
Infuse Bone Graft/LT-CAGE Lumbar Tapered Fusion Device (the Infuse Device), a
Class III medical device. The Infuse Device is generally used for patients seeking a
vertebral fusion and is composed of three components: (1) a tapered metallic spinal
fusion cage (LT-Cage), (2) a recombinant human bone morphogenetic protein (the Infuse
Protein), and (3) a carrier/scaffold for the Infuse Protein and resulting bone. Class III
medical devices pose the highest level of risk and receive the highest level of regulatory
scrutiny before marketing. See 21 U.S.C. §§ 360c, 360e (2014). A manufacturer of a
Class III device must submit to the Food and Drug Administration (FDA) a premarket
approval application before distributing and marketing the device, which must specify the
intended use of the product. Id. § 360e(c)(2)(A)(iv).
On July 2, 2002, the FDA granted initial premarket approval of the Infuse Device
pursuant to the Medical Device Amendment of 1976 (the MDA), finding that it was safe
and effective for its intended use. The FDA specified that the premarket approval was
limited to the use of the three components together and to uses in surgeries featuring an
anterior approach. The FDA label also states: “The safety and effectiveness of the Infuse
Bone Graft component with other spinal implants, implanted at locations other than the
3
lower lumbar spine, or used in surgical techniques other than anterior open or anterior
laparoscopic approaches have not been established.”
Appellants in this case are patients who underwent surgeries involving allegedly
unapproved, off-label uses of the Infuse Device. Each appellant alleges that he or she
was injured after the Infuse Protein was used without the other components of the Infuse
Device. Each appellant brought suit against Medtronic for his or her injuries in Hennepin
County District Court, where the cases were companioned. Appellants alleged the
following 11 causes of action against Medtronic: (1) negligence, (2) strict liability,
(3) breach of express and implied warranty, (4) actual fraud, (5) constructive fraud,
(6) violation of the Minnesota False Statements in Advertising Act, (7) violation of the
Minnesota Deceptive Trade Practices Act, (8) unjust enrichment, (9) violation of
Minnesota’s consumer protection statutes, (10) negligence per se, and (11) loss of
consortium. Generally, appellants allege that Medtronic compensated doctors who
agreed to promote off-label uses of the Infuse Device, and that consequently, the off-label
use is now the primary use.
The parties agreed to adjudicate Medtronic’s arguments for dismissal in all the
lawsuits in the lawsuit brought by Stephen and Barbara Lawrence. The district court
ruled that the Lawrences’ nonfraud claims were expressly or impliedly preempted by the
FDCA. See 21 U.S.C. §§ 360k(a), 337(a) (2014). The district court dismissed the
Lawrences’ fraud claims on the basis of inadequate pleading under Minn. R. Civ. P. 9.02.
The Lawrence plaintiffs amended their complaint, survived a subsequent motion to
dismiss, and their fraud-based claims are proceeding on the merits.
4
After the district court issued this ruling, appellants were allowed to amend their
fraud pleadings to include allegations that Medtronic misled their respective surgeons
into using the Infuse Protein without the other components in their surgeries. The
amended complaints alleged that Medtronic promoted the off-label use of the Infuse
Protein in the following ways:
M[edtronic] communicated with the medical community
about the purported safe and efficacious use of its Infuse®
product by playing an active role in authoring and editing
medical journal articles published on Infuse®, utilizing Key
Opinion Leaders and other paid physicians to actively
promote the off-label use of Infuse®, utilizing M[edtronic]
sales representatives to actively promote the off-label use of
Infuse®, by directly and through its distributors purchasing
gifts for physicians, hospitals and clinics, by paying for
physician attendance at sponsored medical conferences (both
on and off MDT headquarters), and by actively concealing
the role played by Defendants in shaping the safety profile of
Infuse® through all actions mentioned above.
The district court concluded that these allegations of fraud were insufficiently pleaded
under Minn. R. Civ. P. 9.02 and entered final judgments for Medtronic. These appeals
followed.
ISSUES
I. Did the district court err by dismissing as expressly or impliedly preempted
by the FDCA appellants’ claims for negligence, strict liability, breach of warranty, unjust
enrichment, and violation of state consumer-protection statutes?
II. Did the district court err by dismissing appellants’ fraud claims for failure
to plead with particularity pursuant to Minn. R. Civ. P. 9.02?
5
ANALYSIS
I. Preemption
Appellants argue that the district court erred by dismissing their claims for
negligence, breach of warranty, unjust enrichment, and violation of state consumer-
protection statutes as preempted by the FDCA. We review de novo the district court’s
grant of a motion to dismiss under Minn. R. Civ. P. 12.02(e). Sipe v. STS Mfg., Inc., 834
N.W.2d 683, 686 (Minn. 2013). “[W]e review de novo the question of whether federal
law preempts state law.” Angell v. Angell, 791 N.W.2d 530, 534 (Minn. 2010).
Congress enacted the MDA “to provide for the safety and effectiveness of medical
devices intended for human use.” Medtronic v. Lohr, 518 U.S. 470, 474, 116 S. Ct. 2240,
2245 (1996) (quotation omitted). As stated above, a Class III device must undergo
premarket approval pursuant to the MDA before it may be introduced into the market.
Id. at 477, 116 S. Ct. at 2246-47. The Infuse Device received premarket approval in
2002.
With respect to federally approved medical devices like the Infuse Device,
Congress enacted 21 U.S.C. § 360k(a), which contains the following express preemption
provision:
[N]o 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.
6
21 U.S.C. § 360k(a). In considering whether appellants’ claims are expressly preempted
“we must determine whether the Federal Government has established requirements
applicable to [the specific device at issue].” Riegel v. Medtronic, Inc., 552 U.S. 312, 321,
128 S. Ct. 999, 1006 (2008). We then must determine whether the state common-law
claim would impose a requirement different from or in addition to the specific federal
requirement. Id. at 323, 128 S. Ct. at 1007.
Additionally, the implied-preemption provision in 21 U.S.C. § 337(a) requires “all
such proceedings for the enforcement, or to restrain violations, [of the FDCA] shall be by
and in the name of the United States.” 21 U.S.C. § 337(a). State law claims that only
enforce federal law are impliedly preempted. Buckman Co. v. Plaintiffs’ Legal Comm.,
531 U.S. 341, 343, 121 S. Ct. 1012, 1015 (2001).
A. Specific federal requirements applicable to the Infuse Device
Appellants argue that there are no specific federal requirements applicable to the
use of Infuse Protein in these cases, because “[t]he FDA has not established federal
requirements for the Infuse Protein alone.” The district court concluded:
Regarding the first step, the Court finds that the FDA has
established requirements for the Infuse device through its
premarket approval of the device. [Appellants] sought to
convince the Court that the FDA’s premarket approval
applies only to the Infuse device in its on-label usage.
[Appellants] argue that because they have alleged usage of
some but not all components of the Infuse device in an off-
label procedure, the first Riegel step is not satisfied.
[Appellants] contend that the individual components of the
Infuse device are somehow different from the device
including all of those components which received the FDA’s
premarket approval. The Court disagrees. Section 360k(a)
preempts state requirements “with respect to” a particular
7
device that is subject to federal requirements. [Appellants’]
claims relating to the usage of the Infuse device in this case
are made “with respect to” a device that is covered by federal
requirements.
The Infuse Device containing all three components received premarket approval
from the FDA. “[T]he FDA may grant premarket approval only after it determines that a
device offers a reasonable assurance of safety and effectiveness.” Riegel, 552 U.S. at
323, 128 S. Ct. at 1007 (citing 21 U.S.C. § 360e(d)). And “the FDA requires a device
that has received premarket approval to be made with almost no deviations from the
specifications in its approval application.” Id. The Supreme Court has decided that
premarket approval imposes specific federal requirements that are “specific to individual
devices.” Id.
Appellants argue that the FDA specifically limited its approval of the Infuse
Device to the use of all components together to support its argument that there is no
specific federal requirement regarding the Infuse Protein. We disagree. The premarket
approval states: “These components must be used as a system. The InFUSE[] Bone Graft
component must not be used without the LT-CAGE[] Lumbar Tapered Fusion Device
component.” Appellants’ argument receives support from a few federal district courts
that have concluded that premarket approval does not establish federal requirements
applicable to the Infuse Protein when it is used without the LT-Cage. See, e.g., Hornbeck
v. Medtronic, Inc., No. 13C7816, 2014 WL 2510817, at *3 (N.D. Ill. June 2, 2014)
(“[T]he requirement that one use the two components together suggests that the FDA
considered the design of the two components together . . . . Therefore, the FDCA does
8
not preempt the Plaintiffs’ claims premised on . . . the use of the [Infuse Protein]
component alone.”).
In Hornbeck, the court considered claims based on facts almost identical to this
case. Plaintiff Donna Hornbeck underwent a Transforaminal Lumbar Interbody Fusion
procedure, which involved a posterior approach and used the Infuse Protein without the
LT-Cage. 2014 WL 2510817, at *2. After experiencing complications from her surgery,
she filed claims against Medtronic for (1) fraudulent misrepresentation and fraud in
inducement; (2) strict products liability—failure to warn; (3) strict products liability—
design defect; (4) strict products liability—negligence; (5) products liability—negligence;
(6) breach of express warranty; and (7) breach of implied warranties of merchantability
and fitness. Id. Medtronic claimed that federal law expressly and impliedly preempted
the plaintiff’s claims. Id. at *1.
In Hornbeck, the district court concluded that § 360k of the FDCA does not
preempt the plaintiffs’ claims by reasoning:
It is true that if the Medtronic Defendants marketed and
promoted the InFUSE® Bone Graft/LT-CAGETM Lumbar
Tapered Fusion Device for the use approved by the FDA and
in the manner required by the FDA, then the only warnings
necessary would be those imposed by the FDA. The
gravamen of the Plaintiffs’ claims, however, is that the
Medtronic Defendants marketed and promoted the InFUSE®
Bone Graft component in contravention of the FDA’s
requirements. To the extent that the Medtronic Defendants
failed to market and promote their device as required by the
FDA, then they have also removed themselves from whatever
protection federal oversight of medical devices would have
provided.
....
9
Because the FDA’s approved use requires one to use
the InFUSE® Bone Graft/LT–CAGETM Lumbar Tapered
Fusion Device together as a system, it follows that the FDA
considers the two safe and effective when used together. In
other words, there is no indication that the FDA considered
either component as safe and effective when used
independent of the other. If anything, the requirement that
one use the two components together suggests that use of one
without the other is not safe and effective.
Id. at *3-4.
Medtronic counters this reasoning by arguing that “[t]he FDA approves devices,
not uses,” and that “the FDA may not interfere with the practice of medicine, and thus
approves only devices—their design, manufacture, and labeling—not how devices may
be used.” We agree. Section 360k(a) applies if federal requirements are applicable to the
device rather than a particular use of a device. See § 360k(a)(1) (“[N]o State . . . may
establish . . . any requirement which is different from, or in addition to, any requirement
applicable under this chapter to the device.”). The FDCA’s definition of “device”
includes “any component, part, or accessory.” 21 U.S.C. § 321(h). And section 360k(a)
broadly preempts state requirements “with respect to” a device, if the state requirement is
(1) “different from, or in addition to” any federal requirement “applicable . . . to the
device,” and (2) relates to the “safety or effectiveness of the device or to any other matter
included in a requirement applicable to the device.” See Houston v. Medtronic, Inc., 957
F. Supp. 2d 1166, 1176 (C.D. Cal. 2013) (Houston I). These requirements are device-
specific and not use-specific and therefore are applicable to the device in off-label uses.
See Riegel, 552 U.S. at 318, 320, 322-33, 128 S. Ct. at 1004-08 (holding that Class III
premarket approval imposed federal requirements on a device, even though it was used in
10
an off-label manner); Perez v. Nidek Co., 711 F.3d 1109, 1112, 1118 (9th Cir. 2013)
(holding that premarket approval imposed requirements on a device even when used in an
off-label manner).
Moreover, the FDA’s “approval process generally contemplates that approved
[devices] will be used in off-label ways,” United States v. Caronia, 703 F.3d 149, 166
(2d Cir. 2012); see also Caplinger v. Medtronic, 921 F. Supp. 2d 1206, 1218 n.3 (W.D.
Okla. 2013) (noting that off-label use is not illegal or disfavored but an accepted and
valuable part of the practice of medicine). Off-label use may even be a recognized
standard of care. Caronia, 703 F.3d at 153. And congress has prohibited the FDA from
“limit[ing] or interfer[ing] with the authority of a health care practitioner to prescribe or
administer any legally marketed device to a patient for any condition or disease.” 21
U.S.C. § 396 (2014). Although the Infuse Device was approved as a system, the statutory
definition supports our conclusion that each component is a “device” under the FDA that
must follow specific federal requirements. See Riley v. Cordis Corp., 625 F. Supp. 2d
769, 780 (D. Minn. 2009) (“It makes no sense—indeed, it would probably be
impossible—to pick apart the components of a medical device and apply different
preemption analyses to different components.”). Consequently, we conclude that the
FDA established specific federal requirements for the Infuse Device, even when the
Infuse Protein is used alone.
Alternatively, appellants argue that “the [premarket approval] only established
federal requirements for the [Infuse Device] when marketed for use in accordance with
its labeling.” We disagree. Appellants acknowledge that the Infuse Device went through
11
the premarket approval process, but argue that the premarket approval only applies to the
Infuse Device that contained all three components and that was used in a specific manner.
Thus, appellants argue that the federal requirements were imposed only for that use and
that premarket approval does not establish federal requirements applicable to the
unapproved uses of the Infuse Protein component by itself.
When a manufacturer submits a premarket approval application for a Class III
device, the FDA evaluates the device’s safety and efficacy for its “intended use” as set
forth in the application. 21 U.S.C. § 360e(d)(1)(B)(iii)(II); 21 U.S.C.
§ 360e(d)(2)(A)&(B) (secretary shall deny premarket approval if device not shown to be
safe and effective under “conditions of use” in proposed labeling). The requirements
applicable to the Infuse Device include strict limitations on the ability of Medtronic to
change the Infuse Device. See 21 U.S.C. § 360e(d)(6)(A)(i).
Appellants argue that they were injured due to an off-label use of the Infuse
Device that resulted from Medtronic’s intentional promotion of such uses and request that
this court adopt the reasoning set forth in Ramirez v. Medtronic, Inc., 961 F. Supp. 2d 977
(D. Ariz. 2013) so that their claims may proceed. In Ramirez, the plaintiff had a lumbar
fusion operation in which her surgeon used only the Infuse Protein without the LT-Cage.
961 F. Supp. 2d at 983. The plaintiff sued Medtronic under several state tort claims, and
Medtronic moved to dismiss. Id. The court held that the plaintiff’s claims were not
expressly preempted under 21 U.S.C. § 361k(a) because:
The fundamental purpose of § 360k’s express
preemption provision is to avoid having another entity . . .
arrive at a determination regarding a device’s safety that
12
conflicts with the conclusion the FDA made after the rigorous
PMA process. . . . That concern vanishes when the plaintiff
brings a claim against a manufacturer that arises out of a use
that has not been reviewed by the FDA but has been
promoted by the manufacturer.
....
When the device is not being used in the manner the
FDA pre-approved and the manufacturer is actually
promoting such use, there is no law or policy basis on which
to pre-empt the application of state law designed to provide
that protection. It is true that federal requirements are still
applicable to the device, including requirements that
Medtronic not alter the design or label of the device without
FDA consent. But when Medtronic allegedly violated federal
law by engaging in off-label promotion that damaged the
Plaintiff and thereby misbranded the Infuse device, it
departed the realm of federal regulation and returned to the
area of traditional state law remedies.
Id. at 991. The court went on to conclude that “[i]n the absence of federal approval of the
new use, there is nothing to preempt state law requirements.” Id. at 993.
But, Ramirez has been rejected by most federal district courts that have reviewed
this issue. See, e.g., Houston v. Medtronic, Inc., No. 2:13-cv-01679-SVW-SHx, 2014
WL 1364455, at *5-6 (C.D. Cal. Apr. 2, 2014) (Houston II); Beavers-Gabriel v.
Medtronic, Inc., 15 F. Supp. 3d 1021, 1035 (D. Haw. Apr. 10, 2014) (“Ramirez has been
rejected—for good reason—by numerous courts.”); Martin v. Medtronic, Inc., 32 F.
Supp. 3d 1026, 1036 (D. Ariz. July 23, 2014). The court in Houston II explained:
[T]he Ramirez holding is not consistent with the text of
§ 360k(a), the scope of federal requirements imposed on
Class III devices, or . . . precedent. First, as noted above,
§ 360k(a) applies when the FDA imposes requirements on a
“device.” The scope of the provision is not limited to
particular “uses” of a device. See Riegel, 552 U.S. at 320-33;
Perez, 711 F.3d at 1112, 1118. If § 360k(a) does not
distinguish between uses of a device, it surely does not
13
distinguish between whether a particular use of a device was
promoted by the manufacturer. See Gavin v. Medtronic, Inc.,
No. 12-0851, 2013 WL 3791612, at *11 (E.D. La. July 19,
2013) (holding that “nothing in § 360k(a) or Riegel suggests
that applicability of the preemption analysis depends on how
the device is being promoted to be used” (emphasis added));
Hawkins v. Medtronic, Inc., No. 13-cv-0499 AWI SKOx,
2014 WL 346622, at *5-6 (E.D. Cal. Jan. 30, 2014) (holding
that “premarket approval imposes federal requirements on the
Infuse device regardless of off-label promotion or use”
(emphasis added)); Caplinger v. Medtronic, Inc., 921 F.
Supp. 2d 1206, 1218 (W.D. Okla. 2013) (same).
Houston II, 2014 WL 1364455, at *5. Moreover, there are several MDA requirements
that apply to devices used in off-label manners promoted by the manufacturer. For
example, device manufacturers are required to report to the FDA any information which
shows the device “[m]ay have caused or contributed to a death or serious injury,”
regardless of whether the device is used in an off-label manner. 21 C.F.R. § 809.50(a).
Additionally, off-label promotion equates to misbranding, which is subject to FDA
enforcement. See 21 U.S.C. § 331(a). Based on this reasoning, we conclude that the
FDA imposed specific federal requirements applicable to the Infuse Device.
B. Parallel claims
Appellants argue that, even if there are specific federal requirements applicable to
the Infuse Device, their claims still escape express preemption because their state law
claims are parallel to and not different from or in addition to the requirements of federal
law.
Common-law product-liability claims result in state requirements that are
preempted to the extent that they relate to the safety of the device and are different from
14
or in addition to, the federal requirements established by premarket approval. Riegel, 552
U.S. at 322-24, 128 S. Ct. at 1006-08. But section 360k “does not prevent a [s]tate 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.” Id. at 330,
128 S. Ct. at 1011. “Section 360k does not preclude [s]tates from imposing different or
additional remedies, but only different or additional requirements.” Lohr, 518 U.S. at
513, 116 S. Ct. at 2264 (O’Connor, J., concurring).
1. Failure to warn of off-label use
In their complaints, appellants allege that Medtronic failed to warn patients and
physicians of the known risk of off-label use of the Infuse Protein.1 They specifically
argue that “the FDA never evaluated the adequacy of the Infuse Protein’s labeling and
warnings when it promoted for off-label uses,” and that when the FDA approved the
Infuse Device, that approval only pertained to the device when all three components were
used together, and that Medtronic changed the intended use of the device when it began
promoting the Infuse Protein. The district court dismissed this claim, reasoning that it is
“different from or in addition to” the federal requirements imposed on Medtronic by the
FDA.
The federal district court for the District of Minnesota considered a similar
preemption issue in Riley v. Cordis Corp., 625 F. Supp. 2d 769 (D. Minn. 2009).
Plaintiff Riley was implanted with a stent manufactured by Cordis and subsequently
1
Appellants’ failure-to-warn claims include claims for negligence, negligence per se,
strict liability, Minnesota statutory claims, and unjust enrichment.
15
suffered a heart attack due to a blood clot that formed at the site of the stent. Riley, 625
F. Supp. 2d at 773. “Riley and his wife, Debra Riley, [brought] state-law claims of
negligence, strict liability, breach of express and implied warranties, negligent
misrepresentation, fraud, and loss of consortium against Cordis.” Id. Cordis moved for
judgment on the pleadings and the court dismissed the Rileys’ claims as expressly
preempted, impliedly preempted, or insufficiently pled. Id.
Riley brought a number of claims alleging that Cordis was liable for pre- and post-
sale failures to warn about or disclose the defective nature of the stent. Id. at 780. His
primary claim was that “Cordis should have disclosed the need for long-term use of
antiplatelet therapy,” but he generally alleged that “Cordis failed to warn of risks and
adverse side [e]ffects associated with the Cypher stent, failed to warn of the need for
comprehensive medical screening of potential recipients of the Cypher stent, and failed to
warn that Cordis itself had not conducted adequate testing of the stent.” Id. at 781.
With respect to the plaintiff’s failure-to-warn claim, the court concluded that it
was preempted because “Riley [sought] to impose liability on Cordis for failing to do
more than the FDA required.” Id. In dictum, the court mentioned one possible exception
in which Riley’s claim may escape preemption. Id. at 783. The court noted that Riley
could plead a narrow failure-to-warn claim that would escape preemption if he pleaded
“(1) Cordis affirmatively promoted the off-label use of the Cypher stent in a manner that
violated federal law, and (2) that, while promoting the device in violation of federal law,
Cordis failed to include adequate warnings and directions about the off-label use that it
was promoting.” Id. The court reasoned that the first allegation would protect the claim
16
from being expressly preempted because the manufacturer’s conduct of promoting the
off-label use of the product violated federal law. Id. at 784. It also reasoned that the
second claim would not be impliedly preempted because “traditional [Minnesota] state
tort law imposes a duty to warn on a supplier of a product if it is reasonably foreseeable
that an injury could result from the use of the product—and this duty includes the duty to
give adequate instructions for the safe use of the product.” Id. Although the court
concluded that “Riley [could have] succeed[ed] in asserting a claim that is neither
expressly nor impliedly preempted,” it concluded that he did not adequately plead such a
claim. Id.
In this case, appellants do not allege that Medtronic failed to provide warnings
required by the FDA by violating the labeling requirements set forth by the premarket
approval for the Infuse Device. Thus, unlike the claim hypothesized in Riley, appellants
do not allege that Medtronic promoted the Infuse Device in a manner that violated federal
law. Rather, they allege that, while promoting the off-label use of the Infuse Device,
Medtronic should have given warnings that were different or additional to those required
by the FDA.
Appellants also cite to Garross v. Medtronic, Inc., ___ F. Supp. 3d ___, 2015 WL
264903 (E.D. Wis. Jan. 21, 2015), to argue that their state-law tort claims are neither
expressly nor impliedly preempted. The plaintiff in Garross brought claims similar to
those in this case against Medtronic based on the alleged off-label use of the Infuse
Device. Garross, 2015 WL 264903, at *1. The court reasoned that “plaintiffs may rely
on alleged violations [of Medtronic’s duty to investigate adverse events and submit
17
follow-up reports] as evidence that Medtronic violated state common law duty to warn
patients of the risks of off-label use.” Id. at *4. The plaintiff did not claim that state law
imposed an additional requirement on Medtronic to warn patients directly, but instead
argued that a breach of these federal requirements is enough to establish liability under
her various common-law claims. Id. Without providing much analysis, the court
concluded that “none of plaintiff’s state law claims are expressly preempted . . . . Nor are
plaintiff’s claims impliedly preempted . . . because none of them arise solely from a
violation of federal law.” Id. Because the Garross court reached its conclusion without
providing much guidance as to its legal analysis, we do not find this case persuasive.
Medtronic cites a case from this court, Lamere v. St. Jude Medical, Inc., 827
N.W.2d 782 (Minn. App. 2013), to support its argument that appellants’ failure-to-warn
claims are preempted by § 360k(a) because the state law duties and the federal
requirements regarding warnings are not substantially identical. In Lamere, a patient’s
wife brought a wrongful death action against device manufacturer St. Jude Medical Inc.
arising out of an alleged product defect in a mechanical heart valve. 827 N.W.2d at 784.
Her claims included wrongful death, loss of consortium, strict liability (manufacturing
defect), breach of express and implied warranty, negligence, misrepresentation and fraud.
Id. at 785. The district court granted St. Jude’s motion for summary judgment on
preemption grounds. Id. The plaintiff subsequently appealed and “argue[d] that the
district court erred by concluding that appellant’s manufacturing-defect claim was
preempted by the Medical Device Amendments (MDA) of 1976 to the federal Food,
Drug and Cosmetic Act.” Id. at 784.
18
On appeal, the plaintiff argued that St. Jude violated federal Good Manufacturing
Practices (GMPs) and “therefore her claim parallels federal requirements for the
manufacture of the device at issue.” Id. at 790. Because the circuit courts were split as to
whether federal GMPs may form the basis of a parallel claim, this court discussed federal
circuit court cases regarding GMPs before concluding that the plaintiff failed to
sufficiently plead a parallel claim without concluding that a GMP may never form the
basis of a valid parallel claim. Id. at 790-91. Unlike Lamere, this case does not concern
whether a GMP may form a basis for a valid parallel claim to escape preemption.
Furthermore, the court did not decide whether the plaintiff’s GMP claim was preempted
because it was not sufficiently pled. Id. at 791. Thus, we conclude that Lamere is
inapposite.
Although Lamere is not directly applicable, the majority of federal district courts
that have addressed this issue support Medtronic’s position, holding that failure-to-warn
claims based on the off-label promotion of the Infuse Protein are expressly preempted.
See, e.g., Beavers-Gabriel, 15 F. Supp. 3d. at 1039 (failure-to-warn-claim based on off-
label promotion preempted because it “seeks to impose on Defendants a duty to provide
warnings beyond those already outlined by the FDA, which Riegel prohibits”); Houston
II, 2014 WL 1364455, at *6 (“Houston’s claim that Medtronic failed to warn Houston or
her physician is expressly preempted”); Kashani-Matts v. Medtronic, Inc., No. SACV-13-
01161-CJC(RNBx), 2013 WL 6147032, at *4 (C.D. Cal. Nov. 22, 2013) (holding that
failure-to-warn-claim based on allegations “that Medtronic failed to warn Plaintiff and
her physicians of the risks and dangers involved in the off[-]label use of the Infuse
19
Device and that the warnings accompanying the Infuse Device did not adequately warn
of the dangers of using the Device in cervical fusion surgery” is expressly preempted by
the MDA). As explained in Houston I:
[F]or Plaintiff to prevail, a jury would have to find either that
Defendants were required to include warnings beyond those
in the FDA-approved label for the Infuse Device, or that
Defendants were obligated to issue post-sale warnings about
potential adverse effects of using the Infuse Device in an off-
label manner. While FDA regulations permit Defendants to
issue such post-sale warnings, those regulations do not
require such warnings.
957 F. Supp. 2d at 1177. Further, appellants’ failure-to-warn claim based on off-label
promotion does not parallel state-law claims because there is no state-law duty to abstain
from off-label promotion. Thorn v. Medtronic Sofamor Danek, USA, Inc., ___ F. Supp.
3d ___, 2015 WL 328885, at *8 (W.D. Mich. Jan. 23, 2015); see also Caplinger, 921 F.
Supp. 2d at 1219-20 (“[E]ven the concept of ‘off-label use’ is a creature of the FDCA, is
defined by the FDCA, and is not a part of [state] substantive law.”). Requiring a
manufacturer to provide directions and warnings for off-label uses in addition to the
FDA-required warnings would include requirements in addition to those set forth by the
FDA. Consequently, we conclude that the district court did not err by holding that claims
based on failure to warn doctors and patients are expressly or impliedly preempted.
Appellants also argue that their failure-to-warn claims based on Medtronic’s
failure to warn the FDA runs parallel to Medtronic’s violations of the FDCA’s
requirement to submit reports to the FDA of adverse events. After receiving premarket
approval, Medtronic has ongoing reporting duties to the FDA. See 21 C.F.R. § 803.1-.58
20
(2014). Manufacturers must report specific adverse consequences, a summary of
“[u]npublished reports of data from any clinical investigation or nonclinical laboratory
studies involving the device or related devices and known to or that reasonably should be
known to the applicant,” and a summary of “[r]eports in the scientific literature
concerning the device and known to or that reasonably should be known to the
applicant.” 21 C.F.R. § 814.84(b) (2014). The manufacturer must make an FDA report
“no later than 30 calendar days” after it “become[s] aware of information, from any
source, that reasonably suggests that a device [it] market[s] . . . has malfunctioned and
this device or a similar device that [it] market[s] would be likely to cause or contribute to
a death or serious injury, if the malfunction were to recur.” Id. § 803.50(a)(2). These
self-reporting regulations assist the FDA in protecting “the public health by helping to
ensure that devices are . . . safe and effective for their intended use.” Id. § 803.1(a).
Appellants rely on Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013), cert.
denied, 134 S. Ct. 2839 (2014), to support their alternative argument that Medtronic
failed to warn the FDA of adverse events. “Richard Stengel had a SynchroMed EL Pump
and Catheter surgically implanted in his abdomen to deliver pain relief medication
directly into his spine,” which subsequently rendered him paralyzed. Stengel, 704 F.3d at
1227. When the device at issue in Stengel went through premarket approval, Medtronic
was not aware of certain risks. Id. But, before Stengel became paralyzed, Medtronic
knew of the risks but failed to disclose them to the FDA. Id. Stengel amended his
complaint and alleged,
21
under federal law, Medtronic had a “continuing duty to
monitor the product after pre-market approval and to discover
and report to the FDA any complaints about the product’s
performance and any adverse health consequences of which it
became aware and that are or may be attributable to the
product.” It further alleges that Medtronic failed to perform
its duty under federal law to warn the FDA. Finally, the
complaint alleges that, because Medtronic failed to comply
with its duty under federal law, it breached its “duty to use
reasonable care” under Arizona negligence law.
Id. at 1232. The Ninth Circuit held that this claim was not preempted insofar as it
paralleled a federal-law duty under the FDA and explained:
Plaintiffs’ claim is brought under settled Arizona law that
protects the safety and health of Arizona citizens by imposing
a general duty of reasonable care on product manufacturers.
The whole modern law of negligence, with its many
developments, enforces the duty of fellow-citizens to observe
in varying circumstances an appropriate measure of prudence
to avoid causing harm to one another. Arizona tort law
includes a cause of action for failure to warn. Under Arizona
law, negligence standards impose a duty to produce products
with appropriate warning instructions. A product may be
unreasonably dangerous in the absence of adequate warnings.
The manufacturer of a product must warn of dangers which
he knows or should know are inherent in its use. This duty
may be a continuing one applying to dangers the
manufacturer discovers after sale.
If a more precise parallel were necessary, the Stengels
have alleged it and Arizona law provides it. The Stengels’
new claim specifically alleges, as a violation of Arizona law,
a failure to warn the FDA. Arizona law contemplates a
warning to a third party such as the FDA. Under Arizona
law, a warning to a third party satisfies a manufacturer’s duty
if, given the nature of the warning and the relationship of the
third party, there is reasonable assurance that the information
will reach those whose safety depends on their having it.
Id. at 1233 (quotations and citations omitted).
22
Appellants argue that, like the situation in Stengel, once Medtronic began to
promote the Infuse Protein for intended uses that had not been approved by the FDA,
federal law required it to report adverse effects to the FDA and revise its labeling to warn
of risks associated with these uses. The court in Beavers-Gabriel discussed a similar
issue. 15 F. Supp. 3d at 1038-40. In that case, the plaintiff filed an action against
Medtronic, asserting state law claims based on injuries she sustained after undergoing
spinal surgery in which her surgeon used Medtronic’s Infuse Protein in an off-label
manner. Id. at 1025. Medtronic moved to dismiss the plaintiff’s claims as expressly
preempted by 21 U.S.C. § 360k(a) and impliedly preempted by the “no private right of
action” clause of 21 U.S.C. § 337(a). Id.
With respect to the plaintiff’s claim that Medtronic unilaterally changed the Infuse
Device’s intended use by promoting off-label uses and failed to notify the FDA of the
intended use, the court granted Medtronic’s motion to dismiss. Id. at 1039. The court
reasoned that, “although Defendants were prohibited from engaging in any off-label
promotion of [the Infuse Device] in the first place, they also were prohibited from
making changes to the FDA-approved label.” Id. (quotation omitted). The plaintiff also
argued that her failure-to-warn claim “runs parallel to Medtronic’s violations of the
FDCA’s requirements to submit reports of adverse events and include those events in its
labeling.” Id. at 1040. But the Beavers-Gabriel court did not address this issue because
the plaintiff’s complaint alleged that Medtronic failed to provide warnings to patients and
physicians and not to the FDA. Thus, the court granted Medtronic’s motion to dismiss
this count in the complaint with leave for the plaintiff to amend her complaint as to a
23
failure-to-warn claim based on Medtronic’s failure to submit reports of adverse events to
the FDA. Id.
The court in Houston II also addressed this issue. 2014 WL 1364455, at *1.
Houston commenced a lawsuit against Medtronic alleging that she suffered adverse side
effects after undergoing back surgery in which her surgeon used the Infuse Device in an
off-label manner. Id. Medtronic moved to dismiss Houston’s complaint and the court
granted this motion, with leave to amend, and held that some of Houston’s claims were
expressly preempted, impliedly preempted, or insufficiently pleaded. Id.; see Houston I,
957 F. Supp. 2d at 1166 (concluding that Houston’s claims that Medtronic failed to warn
her or her physician were expressly preempted). Houston amended her complaint and
alleged that Medtronic failed to warn the FDA of certain adverse effects associated with
off-label use of the Infuse Device. 2014 WL 1364455, at *2. In the amended complaint,
Houston alleged that Medtronic knew that the off-label use of the Infuse Device had
caused death and serious injuries, but failed to report these adverse events to the FDA.
Id. at *6.
The Houston II court noted that the Ninth Circuit held in Stengel that such a
failure-to-warn claim may escape express preemption under § 360k(a) because MDA
regulations require manufacturers to report certain post-sale adverse events to the FDA.
Id. Thus, the court reasoned that “a state law claim premised on a manufacturer’s failure
to warn the FDA does not impose state law requirements ‘different from, or in addition
to’ federal requirements.” Id. But the court noted that this claim must also escape
implied preemption under 21 U.S.C. § 337(a), and reasoned that “for a claim premised on
24
a violation of the MDA to survive implied preemption under § 337(a), the claim must
also be moored in traditional state tort law,” and indicated that relevant questions in
determining whether this type of claim is impliedly preempted are: (1) is a claim based
on failure to warn the FDA also moored in state tort law; and if so, (2) does the plaintiff
plead sufficient facts to support such a claim. Id. at *6-7.
Thus, to the extent that appellants’ failure-to-warn claim is based on Medtronic’s
failure to warn the FDA, we conclude that this claim is not expressly preempted.
Appellants’ claim based on a failure to warn the FDA must also escape implied
preemption under 21 U.S.C. § 377(a). In order for this type of claim to escape implied
preemption under § 337, the claim must be based in traditional state tort law. Buckman,
531 U.S. at 343, 121 S. Ct. at 1015. Under Minnesota law, “where the manufacturer or
the seller of a product has actual or constructive knowledge of danger to users, the seller
or manufacturer has a duty to give warning of such dangers.” Frey v. Montgomery Ward
& Co., 258 N.W.2d 782, 788 (Minn. 1977).
Because appellants’ claim that Medtronic failed to warn the FDA of adverse
events is based in traditional state tort law, we conclude that this claim is not expressly or
impliedly preempted by federal law to the extent that appellants allege that Medtronic
failed to report adverse events to the FDA. In reaching this conclusion, we do not reach
the issue of whether appellants’ claim is sufficiently pleaded, and thus, the district court
must decide this issue.2 However, in order to sufficiently plead this claim, we do believe
2
We do note that the sole reference in appellants’ amended complaint, which totaled
approximately 90 pages, to this claim is found in paragraph 68 and simply states,
25
that appellants must show how Medtronic’s alleged failure to warn the FDA about
adverse events concerning the Infuse Device contributed to their injuries. See Martin v.
Medtronic, Inc., ___ F. Supp. 3d ___, 2014 WL 6633540, at *5 (D. Ariz. Nov. 24, 2014).
Appellants must allege factual support for their claims, such as details about adverse
events that should have been reported in order to determine if timely reporting would
have affected the off-label use of the Infuse Protein in their surgeries. See id. Without
such detail, it strikes us that it would be difficult if not impossible to determine whether
timely reporting would have affected the off-label use of the Infuse Device in appellants’
surgeries. Nevertheless, because the claim is not preempted, we reverse the district
court’s order with regard to appellants’ failure-to-warn-the-FDA claims and remand to
the district court for further proceedings.
2. Design defect
Appellants alleged in their amended complaints that the Infuse Device was
defectively designed because it was unsafe when used in the manner promoted by
Medtronic. Appellants argue that the district court erred by determining that their design-
defect claims were not parallel claims because “the district court’s conclusion ignores the
fact that the FDA only conducted a risk/benefit analysis of the design of the [Infuse
Device] for certain particular anterior spinal procedures.”
“Medtronic knew that Infuse Bone Graft was being used in cervical fusion and other off-
label lumbar procedures and failed to warn the FDA, surgeons, the medical community,
and the general public in a timely manner.” (Emphasis added.)
26
The district court concluded that appellants’ claims based on the Infuse Device’s
unreasonably dangerous design, including their claims for negligence, negligence per se,
strict liability, and breach of express and implied warranty, were expressly preempted
because they “attack[ed] the risk/benefit analysis performed by the FDA in issuing its
premarket approval,” which is “precisely the kind of claim that is expressly preempted.”
In Ramirez, the court found that a design-defect claim was not preempted because
the fact that Medtronic is alleged to have actively promoted
the use of Infuse outside of the prescribed federal approval
process has opened up state law claims premised on the new,
unapproved use of Infuse. Infuse may indeed be defectively
designed for the off-label uses that Medtronic may have
actively promoted. Certainly the FDA has not made a finding
one way or the other. Because there are no applicable federal
regulations that govern the product for this new use, there is
no conflict for preemption purposes.
Ramirez, 961 F. Supp. 2d at 999. But most courts have held otherwise. See, e.g., Dunbar
v. Medtronic, Inc., No. CV 14-01529-RGK (AJWx), 2014 WL 3056026, at *4 (C.D. Cal.
June 25, 2014) (holding that design-defect claim is preempted because for the plaintiffs
“[t]o prevail on this claim, a jury would have to make findings that conflict with those of
the FDA”); Scovil v. Medtronic, Inc., 995 F. Supp. 2d 1082, 1095 (D. Ariz. 2014)
(holding that the plaintiffs’ design-defect claim was preempted); Houston I, 957 F. Supp.
2d at 1177 (finding a strict liability design-defect claim preempted because it “attack[ed]
the risk/benefit analysis that led the FDA to approve an inherently dangerous Class III
device”) (quotation omitted); Beavers-Gabriel, 15 F. Supp. 3d at 1040 (“The court joins
the majority of courts finding that this claim is expressly preempted—to prevail on this
27
claim, Plaintiffs would need to establish that the Infuse Device should have been
designed in a manner different than that approved by the FDA.”).
The majority of courts reach the more persuasive conclusion. To prevail on their
design-defect claims, appellants would need to show that the Infuse Device should have
been designed in a way that is different than the FDA-approved design. See Beavers-
Gabriel, 15 F. Supp. 3d at 1040. Therefore, we conclude that the district court did not err
by dismissing these claims as preempted because it imposes a requirement different from
or in addition to the specific federal requirement.
3. Express warranty claims
Appellants also argue that the district court erred by dismissing their express
warranty claims. We agree. Appellants alleged in their complaints that Medtronic made
express warranties regarding the safety and efficacy of off-label uses of the Infuse
Protein. They allege that, as a result of continuing sales and marketing campaigns
concerning the safety of the Infuse Protein while knowing the risk of product failure,
Medtronic breached these warranties.
The district court held that appellants’ breach of express warranty claims were
preempted based on the reasoning set forth in In re Medtronic, Inc., Sprint Fidelis Leads
Prods. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) (Sprint Fidelis). In that case, the
plaintiffs alleged that Medtronic breached express warranties that Sprint Fidelis Leads
were safe, effective, fit and proper for their intended use. Sprint Fidelis, 623 F.3d at
1207. The court did not decide whether the plaintiffs’ breach-of-warranty claim was
28
expressly preempted because it concluded that it was impliedly preempted. The court
reasoned:
To succeed on the express warranty claim asserted in this
case, Plaintiffs must persuade a jury that Sprint Fidelis Leads
were not safe and effective, a finding that would be contrary
to the FDA’s approval of the PMA Supplement. 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. The MDA in § 360k
expressly prohibits States from imposing requirements in
addition to federal requirements. The district court correctly
concluded that this express warranty claim interferes with the
FDA’s regulation of Class III medical devices and is therefore
conflict preempted.
Id. at 1208 (quotations and citation omitted).
But in Beavers-Gabriel, the court held that a breach-of-warranty claim “survives
both express preemption and implied preemption,” because
[f]ederal law already prohibits false or misleading off-label
promotion. Therefore, to the extent that Plaintiff seeks to
impose liability on Defendants for voluntarily making
misleading warranties outside the label, Plaintiff is not
imposing any requirement different from or additional to
what federal law already requires. In other words, to avoid
state law liability on this claim, Defendants need only to
refrain from making misleading warranties, which adds no
burden beyond what federal law already imposes.
15 F. Supp. 3d at 1042 (quoting Houston I, 957 F. Supp. 2d at 1180-81.
The court in In re Medtronic, Inc., Implantable Defibrillators Litig., 465 F. Supp.
2d 886, 898 (D. Minn. 2006) (Implantable Defibrillators) reached a similar conclusion.
In that case, the plaintiffs alleged that “Medtronic expressly warranted to the public,
29
through promotional statements and product literature, that its [products] were safe,” and
that “[a]s a result of continuing sales and marketing campaigns which touted the safety of
its products while knowing of the possible defect and risk of product failure . . .
Medtronic breached these express warranties.” Implantable Defibrillators, 465 F. Supp.
2d at 898. The court decided that the plaintiffs’ breach-of-warranty claims survived
preemption for two reason: (1) “to the extent plaintiffs’ breach of express warranty claim
is predicated on Medtronic’s failure to adhere to FDA labeling or packaging
requirements, the claim is not preempted,” and (2) “while the FDA may approve the
devices’ product label, Medtronic is silent on the issue of whether the FDA imposes
requirements for its promotional statements.” Id. The court further reasoned that express
warranties “arise from the representations of the parties,” and “[a]ny requirements
imposed by the warranty are created by the warrantor and [are] not imposed by state
law.” Id. (quotations and citations omitted).
Appellants here seek to impose liability on Medtronic for voluntarily making
misleading warranties outside of the Infuse Device label. We are persuaded by the
reasoning in Beavers-Gabriel and Implantable Defibrillators, and conclude that this
claim is parallel to federal requirements regarding false or misleading off-label promotion
because the requirements allegedly imposed by the warranty were created by Medtronic
representatives and not imposed by Minnesota law. Because Medtronic has voluntarily
undertaken these requirements, we conclude that the district court erred by holding that
appellants’ express-warranty claims are preempted by the FDCA.
30
We also conclude that these claims are not impliedly preempted. The breach-of-
warranty claim is well established under Minnesota law. The elements of a breach-of-
warranty claim in Minnesota are (1) the existence of a warranty, (2) breach of the
warranty, and (3) causation of damages. Peterson v. Bendix Home Sys., Inc., 318 N.W.2d
50, 52-53 (Minn. 1982). Because this breach of warranty exists independently of FDCA
requirements, appellants’ claims would exist absent any federal law. Therefore, we
conclude that the district court erred by dismissing this claim and remand for further
proceedings.
We conclude that the district court properly dismissed appellants’ failure-to-warn
claims based on Medtronic’s failure to warn physicians and patients of risks of off-label
use and design-defect claims. But, we conclude that the district court erred by dismissing
appellants’ failure-to-warn claims based on Medtronic’s failure to report adverse events
to the FDA and their breach-of-warranty claims. This is not to say that appellants will
prevail on these claims. In reaching our conclusion, we do not reach the issue of whether
appellants have adequately pleaded their non-preempted claims. Therefore, we reverse
and remand for further proceedings.
II. Fraud pleading requirement
Appellants argue that the district court erred by dismissing their fraud-based
claims as inadequately pled under Minn. R. Civ. P. 9.02. We disagree.
“In all averments of fraud or mistake, the circumstances constituting fraud or
mistake shall be stated with particularity.” Minn. R. Civ. P. 9.02. “[T]he circumstances
required to be pled with particularity under Rule [9.02] are the time, place, and contents
31
of the false representations, as well as the identity of the person making the
misrepresentation and what he obtained thereby.” Baker v. Best Buy Stores, LP, 812
N.W.2d 177, 184 (Minn. App. 2012) (quotation omitted), review denied (Minn. Apr. 25,
2012). Claims that lack sufficient particularity under rule 9.02 fail as a matter of law and
can be dismissed under rule 12.02(e). Martens v. Minn. Mining & Mfg. Co., 616 N.W.2d
732, 747-48 (Minn. 2000).
The elements of a claim of fraud are: (1) there was a false representation by a
party of a past or existing material fact susceptible of knowledge; (2) made with
knowledge of the falsity of the representation or made as of the party’s own knowledge
without knowing whether it was true or false; (3) with the intention to induce another to
act in reliance thereon; (4) that the representation caused the other party to act in reliance
thereon; and (5) that the party suffer pecuniary damage as a result of the reliance.
Specialized Tours, Inc. v. Hagen, 392 N.W.2d 520, 532 (Minn. 1986).
The district court, in its August 7, 2013 order in the Lawrences’ case, dismissed
the plaintiffs’ claims for fraud and misrepresentation because they failed to plead such
claims with the requisite particularity. The district court held:
Plaintiffs do not . . . identify what representations were
made to them or their physicians and allegedly relied on by
them in deciding to go ahead with the surgical procedure at
issue in this case. It is unclear from the Complaint which
specific alleged misrepresentations caused Steven Lawrence
and his doctors to choose an off-label use of the Infuse device
for Mr. Lawrence’s surgery . . . . Plaintiffs’ allegations
regarding what Mr. Lawrence’s physicians knew and what
they relied upon in deciding to recommend an off-label use of
the Infuse device in his case are conclusory, at best, and are
32
stated upon information and belief, signaling that they are not
within Plaintiffs’ personal knowledge.
. . . Plaintiffs have alleged that Defendants paid
consulting fees to various physicians who published favorable
studies about their use of the Infuse device, but Plaintiffs have
identified no statements in any of those studies that were
allegedly false or misleading and that were relied upon by
Plaintiffs or their physicians. . . . In order to give rise to a
claim of fraud in such a case, the plaintiff must plead facts to
show that his or her physician was affirmatively misled in
assessing the potential risk by misrepresentations made by the
defendant.
(Citation omitted). Subsequently, the district court allowed appellants to amend their
complaints with the expectation that they would supply the district court with particulars
missing from the original complaints.
As a preliminary matter, appellants argue that in ruling that appellants had not pled
their fraud claims with sufficient particularity, the trial court did not apply the standard
set forth in Hardin Cnty. Sav. Bank v. Hous. & Redevelopment Auth. of Brainerd, 821
N.W.2d 184, 191 (Minn. 2012). Instead, Medtronic argued for, and the trial court
adopted, a stricter pleading standard articulated . . . in Baker v. Best Buy Stores, 812
N.W.2d 177 (Minn. App. 2012).” Appellants claim that the Minnesota Supreme Court
declined to adopt the stricter Baker standard when it issued Hardin. But, this appears to
be an overstatement. Baker has not received a negative response since it was issued, and
the supreme court issued Hardin without discussing Baker. In fact, since being issued,
this court has continually cited Hardin for the proposition that fraud plaintiffs must plead
“the time, place, and contents of the false representations, as well as the identity of the
person making the misrepresentation and what he obtained thereby,” with particularity in
33
order to escape dismissal. See, e.g., Janssen v. Lommen, Abdo, Cole, King & Stageberg,
P.A., No. A14-0452, 2014 WL 7237121, at *6 (Minn. App. Dec. 22, 2014); Capital
Midwest Fund, LP v. Johnson, No. A13-2023, 2014 WL 3396580 (Minn. App. July 14,
2014), review denied (Minn. Oct. 14, 2014).
Appellants alleged in their amended complaints that the fraud occurred through
their treating physicians, who received alleged misrepresentations from Medtronic.
Appellants argue that they sufficiently pleaded facts that show that Medtronic made false
representations of past or existing material facts and that the amended complaints
“contained allegations [that] demonstrated that Medtronic misrepresented the safety and
efficacy of [the] Infuse [Device] by . . . actively concealing adverse events, publishing
medical literature and deliberately omitting risks associated with unapproved applications
of Infuse Protein, and promoting unapproved uses as safer and more effective than they
were.” Specifically, the amended complaints allege:
MEDTRONIC communicated with the medical community
about the purported safe and efficacious use of its Infuse®
product by playing an active role in authoring and editing
medical journal articles published on Infuse, utilizing Key
Opinion Leaders and other paid physicians to actively
promote the off-label use of Infuse, utilizing MEDTRONIC
sales representatives to actively promote the off-label use of
Infuse®, by directly and through its distributors purchasing
gifts for physicians, hospitals and clinics, by paying for
physician attendance at sponsored medical conferences (both
on and off MDT headquarters), and by actively concealing
the role played by Defendants in shaping the safety profile of
Infuse[] through all actions mentioned above.
But the allegations in the amended complaints do not identify who made the
alleged false representations to the treating physicians, which medical journal articles
34
were read and relied on by the physicians, or what false statements were contained
therein. Appellants also alleged that Medtronic representatives were present in the
operating rooms during their surgeries, but they could not identify the representatives, nor
did they set forth allegations regarding the role that the representatives played in their
physicians’ decisions to use the Infuse Protein in an off-label manner. Because
appellants did not identify the contents of the false representations or the identity of the
person making the misrepresentation, we conclude that the district court did not err when
it dismissed appellants’ fraud-based claims.
DECISION
State law failure-to-warn and design-defect claims impose general requirements
that are different from federal device-specific requirements and are preempted by 21
U.S.C. § 360k(a). But sufficiently pleaded claims based on a failure to warn the FDA of
adverse effects or breach of express warranty impose parallel requirements to federal
device-specific requirements and are not preempted by 21 U.S.C. § 360k(a). Because
appellants’ fraud claims do not identify the alleged false representations regarding the
role that Medtronic representatives played in their physicians’ decisions to use the Infuse
Protein in an off-label manner, this claim is not adequately pleaded under Minn. R. Civ.
P. 9.02.
Affirmed in part, reversed in part, and remanded.
35