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
2

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. 

S Y L L A B U S

1. Minnesota state law failure-to-warn patients and physicians claims and designdefect claims impose general requirements that are different from federal devicespecific 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).

O P I N I O N

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 
3

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 
4

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. 
5

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?
6

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 consumerprotection 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.
7

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 offlabel 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 
8

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 
9

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.

. . . . 
10

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 devicespecific 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 
11

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 
12

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 
13

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 
14

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 
15

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.
16

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 postsale 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 
17

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 
18

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.
19

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 offlabel 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 
20

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 offlabel 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
21

(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,
22

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).
23

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 
24

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 
25

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, 
26

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 designdefect 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 offlabel lumbar procedures and failed to warn the FDA, surgeons, the medical community, 

and the general public in a timely manner.” (Emphasis added.)
27

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 
28

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 BeaversGabriel, 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 
29

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, 
30

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. 
31

We also conclude that these claims are not impliedly preempted. The breach-ofwarranty claim is well established under Minnesota law. The elements of a breach-ofwarranty 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 
32

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 
33

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 
34

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 
35

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. 

D E C I S I O N

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.