Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-azd-2_14-cv-00792/USCOURTS-azd-2_14-cv-00792-0/pdf.json

Nature of Suit Code: 367
Nature of Suit: TORTS - Personal Injury - Health Care/Pharmaceutical Personal Injury/Product Liability
Cause of Action: 28:1332 Diversity-Product Liability

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WO 

IN THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF ARIZONA 

John Arvizu, et al., 

Plaintiffs, 

v. 

Medtronic Incorporated, et al., 

Defendants.

No. CV-14-00792-PHX-DGC

ORDER 

 Defendants Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. have filed a 

motion to dismiss pursuant to Rule 12(b)(6). Doc. 20. The motion is fully briefed. The 

Court will grant the motion in part and deny it in part.1

I. Background. 

Defendants produce the “Infuse Device,” which is the Class III medical device at 

issue in this case. Doc. 20 at 4. The Infuse Device consists of a “metallic spinal fusion 

cage,” known as the LT-Cage, a “bone graft substitute which consists of liquid rhBMP-2” 

(“Bone Protein”), and “an absorbable collagen sponge (ACS) which holds the protein and 

then is placed inside the cage.”2

 Doc. 1, ¶ 57. The Infuse Device was initially approved 

by the Food and Drug Administration (“FDA”) via its Premarket Approval (“PMA”) 

 

1

 The requests for oral argument are denied because the issues have been fully briefed and oral argument will not aid the Court’s decision. See Fed. R. Civ. P. 78(b); 

Partridge v. Reich, 141 F.3d 920, 926 (9th Cir. 1998). 

2

 Defendants define “rhBMP-2” as “recombinant human bone morphogenetic protein-2.” Doc. 20 at 4. This substance is used to help fuse vertebrae in the spine as part of a spinal fusion surgery as an alternative to grafting a piece of the patient’s own bone harvested from another location. Doc. 1, ¶¶ 51-55. 

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process on July 2, 2002.3 Id., ¶ 64. The approval was “for one limited and very specific 

spinal fusion procedure with the LT-Cage.” Id. Plaintiffs John and Josephine Arvizu 

allege that “[t]here are numerous lumbar and cervical spine procedures for which [the 

Infuse Device] was not initially approved and for which it has never subsequently been 

approved.” Doc. 1, ¶ 78. Plaintiffs allege that, despite the limited purpose for which the 

Infuse Device was approved, Defendants “engaged in a multi-faceted campaign to 

promote off-label uses of [the Infuse Device],” which included having sales 

representatives present in operating rooms to assist physicians during surgery, 

distributing false or misleading medical literature, referring physicians to paid patients, 

using distributors to purchase gifts for physicians, using paid physician consultants to 

promote off-label uses at conferences and meetings, and “playing an active role in the 

writing and editing of nearly all published medical literature on [the Infuse Device] from 

at least 2001 through 2006.” Doc. 1, ¶ 158. 

 Some of the off-label uses allegedly promoted by Defendants used only the bone 

protein component of the Infuse Device. Plaintiffs allege that Defendants sold the bone 

protein and the LT-Cage separately despite the fact that the FDA approval for the Infuse 

Device required them to be used together. Id., ¶¶ 76. Plaintiffs contend that the FDA had 

concerns about off-label uses of the Infuse Device because some studies showed that 

“uncontrolled bone growth developed in a number of patients” (id., ¶ 81), which resulted 

in these other uses not receiving FDA approval. 

 

3

 Defendants ask the Court to take judicial notice of documents related to the PMA 

process for the Infuse Device. See Doc. 21. Although courts generally may not consider evidence or documents beyond the complaint in considering a Rule 12(b)(6) motion, a 

court may consider documents “whose contents are alleged in a complaint and whose authenticity no party questions, but which are not physically attached to the [plaintiff’s] pleading.” Knievel v. ESPN, 393 F.3d 1068, 1076 (9th Cir. 2005). The Court may take judicial notice of facts that are “not subject to reasonable dispute” that “can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.” Fed. R. Evid. 201(b). Because the documents presented by Defendants are publicly available on the FDA’s website and Plaintiffs do not dispute their authenticity, the Court will take judicial notice of these documents. See Daniels–Hall v. Nat’l Educ. Ass’n, 629 

F.3d 992, 998-99 (9th Cir. 2010) (finding it appropriate to take judicial notice of information made publicly available on government websites where the authenticity of the information was not challenged) (citing Fed. R. Evid. 201). 

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 Plaintiffs allege that Mr. Arvizu’s physician used the Infuse Device in an “offlabel” manner. They specifically allege that Mr. Arvizu “underwent a transforaminal 

lumber interbody fusion at L5-S1[.]” Doc. 1, ¶ 299. Plaintiffs further allege that 

Defendants, “through their sales representatives and paid Key Opinion Leaders, directly 

and indirectly promoted, trained and encouraged Plaintiff’s surgeon to engage in the offlabel procedure of utilizing a transforaminal approach without the required LT Cage.” 

Id., ¶ 300. 

 Plaintiffs brought this action on April 15, 2014, asserting claims for fraudulent 

misrepresentation and fraud in the inducement, failure to warn, design defect, 

misrepresentation, negligence, breach of express warranty, violation of Arizona’s 

Consumer Protection Statutes, loss of consortium, and punitive damages. See Doc. 1, 

¶¶ 305 -420. Defendants argue that these claims are expressly preempted by section 

360k of the Medical Devices Amendments (“MDA”) to the Federal Food, Drug, and 

Cosmetic Act (“FDCA”), and the holding in Riegel v. Medtronic, Inc., 552 U.S. 312 

(2008). Doc. 20 at 2. They also contend that Plaintiffs’ claims are impliedly preempted 

by Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). Doc. 20 at 2. 

II. Legal Framework. 

 A. Rule 12(b)(6). 

When analyzing a complaint for failure to state a claim to relief under 

Rule 12(b)(6), the well-pled factual allegations are taken as true and construed in the light 

most favorable to the nonmoving party. Cousins v. Lockyer, 568 F.3d 1063, 1067 (9th 

Cir. 2009). Legal conclusions couched as factual allegations are not entitled to the 

assumption of truth, Ashcroft v. Iqbal, 556 U.S. 662, 680 (2009), and therefore are 

insufficient to defeat a motion to dismiss for failure to state a claim, In re Cutera Sec. 

Litig., 610 F.3d 1103, 1108 (9th Cir. 2010). To avoid a Rule 12(b)(6) dismissal, the 

complaint must plead enough facts to state a claim to relief that is plausible on its face. 

Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). This plausibility standard “is not 

akin to a ‘probability requirement,’ but it asks for more than a sheer possibility that a 

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defendant has acted unlawfully.” Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 

556). “[W]here the well-pleaded facts do not permit the court to infer more than the mere 

possibility of misconduct, the complaint has alleged B but it has not ‘show[n]’ B ‘that the 

pleader is entitled to relief.’” Id. at 679 (quoting Fed. R. Civ. P. 8(a)(2)). 

B. Rule 9(b). 

Rule 9(b) requires that a plaintiff “state with particularity the circumstances 

constituting fraud or mistake.” Fed. R. Civ. P. 9(b). Rule 9(b) has been interpreted by 

the Ninth Circuit to require the pleader to “state the time, place, and specific content of 

the false representations as well as the identities of the parties to the misrepresentation.” 

Schreiber Distrib. Co. v. Serv-Well Furniture Co., 806 F.2d 1393, 1401 (9th Cir. 1986). 

The plaintiff must also “set forth . . . an explanation as to why the disputed statement was 

untrue or misleading when made.” Yourish v. Cal. Amplifier, 191 F.3d 983, 993 (9th 

Cir. 1999); see also Vess v. Ciba-Geigy Corp. USA, 317 F.3d 1097, 1103 (9th Cir. 2003) 

(“Averments of fraud must be accompanied by the who, what, when, where, and how of 

the misconduct charged.”). 

C. Federal Preemption. 

 1. Express and Implied Preemption.4

 Section 360k of the MDA includes this preemption clause: 

Except as provided in subsection (b) of this section, no State 

or political subdivision of a State may establish or continue in 

effect with respect to a device intended for human use any 

requirement (1) which is different from, or in addition to, any 

requirement applicable under this chapter to the device, and 

(2) which relates to the safety or effectiveness of the device or 

 

4

 In recent years, many cases across the country have considered both the express and implied preemption of claims under the MDA. Several courts have thoroughly and ably summarized the legal background. See, e.g., Scovil v. Medtronic, Inc., -- F. Supp. 2d --, 2014 WL 502923, at *4-8 (D. Ariz., Feb. 7, 2014); Hawkins v. Medtronic, Inc., No. 1:13-CV-0049AWISKO, 2014 WL 346622, at *3-5 (E.D. Cal., Jan. 30, 2014); 

Kashani-Matts v. Medtronic, Inc., No. SACV 13-01161-CJC (RNBx), 2013 WL 

6147032, at *3 (C.D. Cal., Nov. 22, 2013); Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166, 1173-76 (C.D. Cal. 2013) (Houston I); Ramirez v. Medtronic Inc., 961 F. Supp. 2d 977, 985-87 (D. Ariz. 2013). 

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to any other matter included in a requirement applicable to 

the device under this chapter. 

21 U.S.C. § 360k. 

 In Riegel, the Supreme Court outlined a two-part test to determine whether state 

law claims are expressly preempted under § 360k: (1) whether the federal government 

established “requirements” applicable to the device in question, and, if so, (2) whether the 

state common law claims are based on state law requirements “that are different from, or 

in addition to the federal ones” and “relate to safety and effectiveness.” 552 U.S. at 321-

22 (citing § 360k(a)); see also Hawkins, 2014 WL 346622, at *3 (quoting Riegel). 

 In Buckman, the court held that claims that a device manufacturer had made 

fraudulent representations to the FDA were “inherently federal in nature” because the 

relationship between the manufacturer and the FDA “originates from, is governed by, and 

terminates according to federal law.” 531 U.S. at 347-48. The court held that such 

“fraud-on-the-FDA” claims were impliedly preempted (id. at 348) because they “exist 

solely by virtue of the FDCA disclosure requirements” (id. at 353). See also KashaniMatts, 2014 WL 819392, at *2 (“Implied preemption under the MDA bars claims seeking 

to enforce an exclusively federal requirement not grounded in traditional state tort law.”); 

Hawkins, 2014 WL 346622, at *4 (“Claims not tied to state law tort duties are essentially 

private actions to enforce the FDCA and are barred by [21 U.S.C. § 337(a)][.]”). 

 2. Parallel Claims. 

The Riegel court also affirmed the Supreme Court’s earlier holding in Medtronic, 

Inc. v. Lohr, 518 U.S. 470 (1996), that § 360k “does not prevent a State from providing a 

damages remedy for claims premised on a violation of FDA regulations; the state duties 

in such a case ‘parallel,’ rather than add to, federal requirements.” Id. at 330. The Ninth 

Circuit has confirmed that “the MDA does not preempt a state-law claim for violating a 

state-law duty that parallels a federal-law duty under the MDA.” Perez v. Nidek Co., 711 

F.3d 1109, 1117 (9th Cir. 2013) (quoting Stengel v. Medtronic, Inc., 704 F.3d 1224, 1228 

(9th Cir. 2013) (en banc), cert. denied by Medtronic Inc. v. Stengel, -- S. Ct. --, 2014 WL 

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2807193 (June 23, 2014)). The Ninth Circuit has also observed that state law claims 

must fit through a “narrow gap” to avoid preemption, meaning that the “plaintiff must be 

suing for conduct that violates the FDCA,” but also “must not be suing because the 

conduct violates the FDCA.” Perez, 711 F.3d at 1120. 

 Applying this framework, the Court must first consider whether Plaintiffs’ claims 

are expressly preempted under the test outlined in Riegel. If not, it must consider 

whether they seek to enforce a federal law or state a parallel state law cause of action 

based on conduct that violates federal law. 

 3. Cases Involving Off-Label Promotion. 

Plaintiffs argue that because the use of the Infuse Device here was “off-label,” 

neither aspect of Riegel is satisfied. Doc. 23 at 8. They contend that there “are not 

federal requirements applicable to the use of the Bone Protein component without the 

LT-Cage,” and that their claims are therefore not expressly preempted. Id. at 8-9. In the 

alternative, they argue that they have stated parallel claims. Id. at 9. More specifically, 

Plaintiffs ask the Court to adopt the reasoning advanced in Ramirez v. Medtronic, where 

the court concluded that there were no federal requirements applicable to the off-label 

uses of the Infuse Device and that the plaintiff’s claims were accordingly not preempted. 

961 F. Supp. 2d at 997-1001. Defendants point to cases that have rejected the reasoning 

of Ramirez and have found that claims based on off-label promotion are preempted. 

Doc. 20 at 2 n.2 (citing cases). 

 In Ramirez, the plaintiff underwent a lumbar fusion in which her surgeon used 

only the “rhBMP-2 bone graft” component of the Infuse Device and not the LT-Cage. 

961 F. Supp. 2d at 983. The court observed that “[t]he fundamental purpose of § 360k’s 

express preemption provision is to avoid having another entity . . . arrive at a 

determination regarding a device’s safety that conflicts with the conclusion the FDA 

made after the rigorous PMA process.” Id. at 991. The court went on to reason that this 

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 

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manufacturer.” Id. The court concluded that “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 bases on which to pre-empt the application of state law designed to 

provide that protection.” Id. The court ultimately found that although there were federal 

requirements that were applicable to the Infuse Device, Medtronic “departed the realm of 

federal regulation and returned to the area of traditional state law remedies” when it 

“allegedly violated federal law by engaging in off-label promotion that damaged the 

Plaintiff and thereby misbranded the Infuse device[.]” Id. Plaintiffs cite two unreported 

state court cases that have reached the same result. Doc. 23 at 9 (citing cases). 

 The court in Hornbeck v. Medtronic, Inc., 13 C 7816, 2014 WL 2510817 (N.D. Ill. 

June 2, 2014), also reached a similar result, noting that “[i]t is simply disingenuous for 

[Medtronic] to argue that the Plaintiffs seek to enforce safety requirements different from 

or in addition to those imposed by the FDA when the FDA imposed those requirements 

on the two components used together.” Id. at *4. The Court concluded that “[t]o the 

extent that [Medtronic] failed to comply with federal requirements, the Plaintiffs may 

proceed with their claims.” Id. 

 Sever courts have disagreed with Ramirez. See 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); Scovil, 2014 WL 502923, at *8-9; Beavers-Gabriel v. Medtronic Inc., -- F. Supp. 2d -

-, 2014 WL 1396582, at *9-10 (D. Haw. Apr. 10, 2014) (“Ramirez has been rejected – for 

good reason – by numerous courts.”); Martin v. Medtronic, Inc., -- F. Supp. 2d --, 2014 

WL 3635292, at *6 (D. Ariz. July 23, 2014) (following Beavers-Gabriel). 

 The Houston II court expressly rejected the conclusion in Ramirez that § 360k 

does not apply where a manufacturer promotes off-label use. Id. at 5. The court 

observed that “§ 360k(a) applies when the FDA imposes requirements on a ‘device,’” and 

that its scope “is not limited to particular ‘uses’ of a device.” Id. (emphasis in original). 

The court reasoned that if § 360k “does not distinguish between uses of a device, it surely 

does not distinguish between whether a particular use of the device was promoted by the 

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manufacturer.” Id. The court also observed that “there are multiple MDA requirements 

that apply to devices, even when they are used in an off-label manner and the off-label 

use is promoted by the manufacturer.” Id. As examples, the court noted that 

manufacturers are required to report to the FDA information that reasonably suggests the 

device may have caused or contributed to a death or serious injury, and that 

manufacturers are prohibited from making changes in design specifications, 

manufacturing processes, or labeling without FDA approval. Id. The court also observed 

that “[o]ff-label promotion amounts to misbranding . . . and misbranding is subject to an 

extensive FDA enforcement scheme[.]” Id. (citing Carson v. Depuy Spine, Inc., 365 F. 

App’x 812, 815 (9th Cir. 2010); 21 U.S.C. § 331). Houston II also concluded that “the 

Ninth Circuit in Perez implicitly held that the MDA imposes requirements on devices 

that are used in off-label manners, even when the off-label uses are promoted by the 

device manufacturer.” Id. (citing Perez, 711 F.3d at 1112-13, 1118-19). 

Ramirez and similar cases make valid points. It does seem unfair for Defendants 

on one hand to promote the use of the Bone Protein component of the Infuse Device in a 

manner not approved or even considered by the FDA during the PMA process, and “with 

the other hand put forth as justification for preemption the federal regulations that 

admittedly govern [the Infuse Device], but were nonetheless premised on [Defendants’] 

initial representations that [the device] would only be used in certain procedures[.]” 

Ramirez, 961 F. Supp. 2d at 991. But the Court finds the reasoning of Houston II and 

related cases to be more persuasive. Section 360k applies when the FDA imposes 

requirements on a “device,” not specific uses of the device, and off-label uses remain 

subject to federal regulation and therefore to preemption. See Houston II, 2014 WL 

1364455, at *5-6; Beavers-Gabriel, 2014 WL 1396582, at *9-10. 

 In addition, the Court is bound by § 360k, which instructs that states and their 

political subdivisions may not establish any requirement “with respect to any device 

intended for human use” which is “different from, or in addition to, any requirement 

applicable under this chapter to the device[.]” 21 U.S.C. § 360k(a)(1). The FDCA’s 

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definition of “device” includes “any component, part, or accessory,” which would include 

components not used together as originally intended. 21 U.S.C. § 321(h). Thus, although 

it is true that the Infuse Device was approved as a system that included three components, 

the statutory definition makes clear that each of these components is a “device” for 

purposes of the FDCA. Therefore, even the Bone Protein used alone is a “device” with 

applicable federal requirements, and the first aspect of Riegel is satisfied if Plaintiffs’ 

claims impose requirements different from or in addition to those imposed on the device 

by federal law. 

III. Analysis.

A. Fraud Claims – First, Fourth, and Seventh Causes of Action. 

Plaintiffs assert three claims based on fraud: (1) fraudulent misrepresentation and 

fraud in the inducement, (2) strict liability based on misrepresentations, and (3) violation 

of Arizona’s Consumer Protection Statute. Plaintiffs’ fraudulent misrepresentation claim 

alleges that Defendants fraudulently concealed and misrepresented the health and safety 

hazards of the Infuse Device, their practice of promoting and marketing off-label uses to 

physicians, and information about the risks of the Infuse Device. Doc 1, ¶ 308. Their 

strict liability claim alleges that while marketing the Infuse Device “Defendants made 

untrue representations of material facts and omitted material information” regarding offlabel uses of the Infuse Device. Id., ¶ 353. Plaintiffs’ claim based on Arizona’s 

Consumer Protection Statute alleges that Defendants violated their statutory duty to 

refrain from unfair or deceptive acts and engaged in fraudulent and unconscionable 

business practices “by knowingly and falsely representing that [the Infuse Device] was fit 

to be used for the purpose for which it was advertised, when in fact [the Infuse Device] 

was defective and dangerous when used off-label[.]” Id., ¶¶ 391, 397. 

Any claim based on misrepresentation or omission dealing with the FDAapproved label of the Infuse Device is expressly preempted. See Beavers-Gabriel, 2014 

WL 1396582, at *10 (“[A]llowing such a claim to proceed would permit a finding that 

defendants were required to alter the Infuse Device’s warning and label and to provide 

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additional warnings above and beyond those on the Infuse Device’s label and 

accompanying the device – a label and warnings that were specifically approved by the 

FDA as part of the PMA process.”) (quoting Caplinger v. Medtronic, Inc., 921 F. Supp. 

2d 1206, 1219 (W.D. Okla. 2013)) (internal quotation marks and brackets omitted). But 

Plaintiffs do not allege misrepresentations or omissions based on the FDA approved 

label. Rather, they allege that Defendants “fraudulently concealed and misrepresented 

information” about the off-label uses of the Infuse Device. See Doc. 1, ¶¶ 305-18. These 

claims lie parallel to federal requirements. See Houston I, 957 F. Supp. 2d at 1179-80 

(noting that federal law prohibits manufacturers from making false or misleading 

representations in advertising “beyond the subject device’s label,” and from promoting 

off-label uses, and concluding that there was no risk that the defendants “could be held 

liable under state law without having violated the federal law”). 

 Although Plaintiffs’ fraud claims are not preempted, they must still be pleaded 

with the particularity required by Rule 9(b). Fraud claims under Arizona law require nine 

elements: (1) a representation; (2) its falsity; (3) its materiality; (4) the speaker’s 

knowledge of its falsity or ignorance of its truth; (5) his intent that it should be acted 

upon by the person and in the manner reasonably contemplated; (6) the hearer’s 

ignorance of its falsity; (7) his reliance on its truth and his right to rely thereon; and 

(9) his consequent and proximate injury. See Jennings v. Lee, 461 P.2d 161, 164 

(Ariz. 1969). Defendants argue that Plaintiffs have failed to meet these pleading 

requirements (Doc. 20 at 16), but the Court does not agree. Plaintiffs have alleged who 

made representations about the Infuse Device as well as when and where the 

representations were made (see Doc. 1, ¶¶ 158, 161 -273), and they have alleged that, as a 

result of these representations, Mr. Arvizu’s physician used the Infuse Device in an 

unsafe manner (id., ¶¶ 159, 300), resulting in harm to Plaintiffs (id., ¶ 301). These 

allegations are sufficient to “give defendants notice of the particular misconduct so that 

they can defend against the charge and not just deny that they have done anything 

wrong.” See Kearns v. Ford Motor Co., 567 F.3d 1120, 1124 (9th Cir. 2009). See also 

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Scovil, 2014 WL 502923, at *11 (declining to dismiss fraud claims). 

 The Court disagrees with other cases cited by Defendants (Doc. 20 at 16) that have 

found fraud claims to be insufficiently pleaded. See Beavers-Gabriel, 2014 WL 

1396582, at *12 (“Missing from the Complaint, however, is the connection between 

Defendants’ alleged misdeeds and Plaintiff and Plaintiff’s physicians – i.e., that Plaintiff 

and Plaintiff’s physicians relied on these misrepresentations.”); Martin, 2014 WL 

3635292, at *9 (dismissing similar fraud claims because the plaintiff “has not alleged 

which misrepresentations were relied on by her and her surgeon.”). Plaintiffs have 

alleged numerous misrepresentations made by Defendants and have alleged that they and 

Mr. Arvizu’s physician relied upon those representations. Doc. 1, ¶¶, 158-59, 161 -273, 

300. The Court will deny Defendants’ motion to dismiss Plaintiffs’ first, fourth, and 

seventh causes of action on this basis. 

 B. Failure to Warn – Second Cause of Action. 

Plaintiffs argue that “§ 360k(a) does not preempt a state-law duty to warn that 

parallels the manufacturer’s federal duty to monitor PMA products on the market and to 

report adverse events to the FDA.” Doc. 23 at 18. The Ninth Circuit has held that claims 

for failure to warn the FDA are not preempted. See Stengel, 704 F.3d at 1233. But the 

majority of Plaintiffs’ allegations are that Defendants failed to warn them and their 

physicians. Doc. 1, ¶¶ 320-31. Plaintiffs contend that the “acts that violated the state-law 

duty to warn also violated requirements imposed on [Defendants] by the FDA,” such as 

“the prohibition against misbranding.” Doc. 23 at 16-17. 

 These claims are preempted because they would require Defendants to take 

actions that are different from or in addition to the requirements imposed by federal law. 

See Beavers-Gabriel, 2014 WL 1396582, at *13 (finding a claim for failure to warn 

doctors preempted because it would seek “to impose on Defendants a duty to provide 

warnings beyond those already outlined by the FDA”); Scovil, 2014 WL 502923, at *10 

(same); Martin, 2014 WL 3635292, at *11 (same). See also Stengel, 705 F.3d at 1234 

(Watford, J., concurring, joined by six judges) (“[A]ny attempt to predicate the [claim] on 

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an alleged state law duty to warn doctors directly would have been expressly preempted 

under [§ 360k][.]”). 

 Plaintiffs also contend that their “failure to warn allegations are consistent with 

those in Stengel,” and that Defendants “failed to report certain adverse events to the 

FDA[.]” Doc. 23 at 18. Plaintiffs’ complaint alleges that “the FDCA requires medical 

device manufacturers to maintain and submit information as required by regulation, 21 

U.S.C. § 360i, including submitting adverse event reports[.]” Doc. 1, ¶ 147. Plaintiffs 

allege that Defendants “violated these FDCA statutes and accompanying regulations . . . 

by failing to account for adverse events[.]” Id., ¶ 148. Plaintiffs provide little factual 

detail concerning this alleged failure to warn, but little factual detail is necessary or 

available when a plaintiff is alleging that the defendant failed to act. It is the absence of 

action that gives rise to the claim. The Court finds Plaintiffs’ failure-to-warn-the-FDA 

claim to be sufficiently pled to defeat preemption.5

 The Court will dismiss Plaintiffs’ 

failure to warn cause of action except as to Plaintiffs’ allegations that Defendants failed 

to warn the FDA of adverse events. See Stengel, 704 F.3d at 1233. 

 C. Design Defect – Third Cause of Action. 

To prevail on their design defect claim, “Plaintiffs would need to establish that the 

Infuse Device should have been designed in a manner different than that approved by the 

FDA.” Beavers-Gabriel, 2014 WL 1396582, at *15; see also Scovil, 2014 WL 502923, 

at *9; Houston I, 957 F. Supp. 2d at 1177. This would impose requirements that are 

different from or in addition to federal law. Although Plaintiffs argue that the use of the 

Bone Protein component without the LT-Cage component was never approved by the 

FDA (Doc. 23 at 19), this does not change the analysis. As discussed above, there are 

federal requirements applicable to the Infuse Device and its components, and § 360k and 

Riegel do not permit state law claims that impose requirements different from or in 

 

5

 As Judge Watford noted, however, this claim could have difficulty at the causation stage because Plaintiff must show that had Defendants timely notified the FDA, the FDA would have passed the information along to Plaintiff’s doctor in time to prevent his harm and Plaintiff’s doctor would have timely heeded the FDA warning. Stengel, 705 

F.3d at 1234 (Watford, J., concurring, joined by six judges). 

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addition to the federal requirements. This claim is preempted. 

D. Negligence – Fifth Cause of Action. 

 For reasons stated in part III(B) above, the Court will dismiss Plaintiffs’ 

negligence claim to the extent it relies on Defendants’ alleged failure to warn Plaintiffs 

and their physician. 

 Defendants argue that Plaintiffs’ negligence claim is preempted because it would 

require a finding that, as a matter of state law, the FDA-approved manufacturing, design, 

and label of the Infuse Device was defective. Doc. 20 at 13. The Court does not agree. 

Plaintiffs allege that “Defendants had a duty to disclose their dangerous and irresponsible 

practices of improperly promoting to physicians the off-label use of Infuse without an LT 

Cage[.]” Doc. 1, ¶ 368. 

 Some courts have held that similar negligence claims are impliedly preempted 

because there is no state law duty to refrain from off-label promotion. See BeaversGabriel, 2014 WL 1396582, at *16 (“Defendants’ duty (as an element of the negligence 

claim) to abstain from off-label promotion exists solely by virtue of the federal 

prohibition of off-label promotion and finds no independent source from traditional state 

law.”); Martin, 2014 WL 3635292, at *14 (following Beavers-Gabriel). Other courts that 

have found that negligence claims based on off-label promotion in violation of federal 

law are not preempted. See Scovil, 2014 WL 502923, at *10 (“[T]he Court finds that 

Plaintiffs’ allegations concerning the marketing of the device . . . are not preempted.”). 

The Court concludes that Plaintiffs’ claims are impliedly preempted because they “exist 

solely by virtue” of FDCA requirements. See Buckman, 531 U.S. at 353. Allowing 

Plaintiffs’ claims to go forward would be essentially authorizing an impermissible action 

to enforce the provisions of the FDCA that prohibit misbranding. See Kashani-Matts, 

2014 WL 819392, at *2 (“Implied preemption under the MDA bars claims seeking to 

enforce an exclusively federal requirement not grounded in traditional state tort law.”); 

Hawkins, 2014 WL 346622, at *4 (“Claims not tied to state law tort duties are essentially 

private actions to enforce the FDCA and are barred by [21 U.S.C. § 337(a)][.]”). 

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 E. Breach of Express Warranty – Sixth Cause of Action. 

Several courts have found that claims for breach of express warranty are neither 

expressly nor impliedly preempted in the context of off-label promotion. See BeaversGabriel, 2014 WL 1396582, at *17 (noting that “federal law already prohibits false or 

misleading off-label promotion” and that in order to avoid state law liability “Defendants 

need only to refrain from making misleading warranties, which adds no burden beyond 

what federal law imposes”) (quoting Houston I, 957 F. Supp. 2d at 1180-81); Martin, 

2014 WL 3635292, at *15 (quoting Beavers-Gabriel). The Court agrees. The Court also 

agrees that this claim is not impliedly preempted because it could exist even in the 

absence of federal law. 

 The claim is nonetheless defective. Under Arizona law, “[a]ny affirmation of fact 

or promise made by the seller to the buyer which relates to the goods and becomes part of 

the basis of the bargain creates an express warranty that the goods shall conform to the 

affirmation or promise.” Dillon v. Zeneca Corp., 42 P.3d 598, 602 (Ariz. Ct. App. 2002) 

(quoting A.R.S. § 47-2313(A)). Of course, “any affirmation that forms the basis of an 

express warranty must be between the seller and the buyer.” Ramirez, 961 F. Supp. 2d 

at 1001. Plaintiffs do not allege that Defendants made any affirmations about the offlabel uses of the Infuse Device directly to them, and their allegations that their physician 

relied on misleading off-label promotion cannot support a claim for breach of express 

warranty by Plaintiffs. The Court will grant Defendants’ motion to dismiss this claim. 

 F. Loss of Consortium and Punitive Damages. 

Defendants argue that “Plaintiffs’ loss of consortium claim is barred because it is 

dependent on other claims all of which are preempted,” and that “Plaintiffs’ punitive 

damages ‘claim’ fails because the predicate claims fail.” Doc. 20 at 25. Because the 

Court has not dismissed all of Plaintiffs’ claims, it will decline to dismiss these claims.

G. Other Arguments for Dismissal. 

 1. No Prohibition on Off-Label Promotion. 

Late in their motion, Defendants advance the argument that “Plaintiffs do not – 

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and cannot—identify a federal prohibition on off-label promotion.” Doc. 20 at 18. 

Defendants cite several cases where courts have concluded that federal law does not bar 

off-label promotion and found that claims based on off-label promotion are preempted. 

Id. (citing United States v. Caronia, 703 F.3d 149, 160 (2d Cir. 2012)). The Court is 

unconvinced. Caronia was an appeal of a criminal case and the court considered whether 

the FDCA criminalized off-label promotion of prescription drugs. 703 F.3d at 160. The 

court said that the misbranding provisions of the FDCA do not prohibit and criminalize 

“the truthful off-label promotion of FDA-approved prescription drugs,” and then stated 

that its conclusion was “limited to FDA-approved drugs for which off-label use is not 

prohibited[.]” Id. at 168-69. This case involves allegations of misrepresentation in offlabel promotion of a Class III medical device. Caronia is not relevant to this claim, nor 

are the district court cases cited by Defendants that have relied on it. 

 Defendants also argue that the Perez court “recognized that even if off-label 

promotion violates federal law, whether a particular example of off-label promotion ‘was 

in violation of the FDCA’ is a matter that ‘rest[s] within the enforcement authority of the 

FDA, not [the] Court.’” Doc. 20 at 18 (citing Perez, 711 F.3d at 1120). The Perez court 

considered only a fraud by omission claim and specifically noted that “courts have 

acknowledged that some fraud and false advertising claims related to FDA status may go 

forward,” but found that Perez had presented no authority wherein “a court has allowed a 

plaintiff to bring suit solely for failure to disclose lack of FDA approval.” Id. at 1119-20. 

Plaintiffs’ claims go beyond mere failure to disclose lack of FDA approval, and the Court 

will not read Perez so broadly as to preempt any claim based on off-label promotion. 

 Defendants further argue that the Ninth Circuit has dismissed claims based on offlabel promotion, but again their cited authority has no purchase here because it involved a 

motion for summary judgment. Doc. 20 at 18 (citing Carson, F. App’x at 815). 

Defendants have filed a motion to dismiss. That the Ninth Circuit upheld a grant of 

summary judgment where there was no evidence in the record that the defendant had 

illegally promoted an off-label use of a medical device, Carson, F. App’x at 815, does 

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not mean that all claims premised on off-label promotion should be dismissed. 

 Defendants also contend that Plaintiffs fail to state a parallel claim because “there 

is no state-law duty to abstain from off-label promotion.” Doc. 20 at 19. There may 

indeed be no such state law duty, but that does not bar Plaintiffs’ claims. There is a duty 

under Arizona law to avoid making fraudulent misrepresentations. See Jennings, 461 

P.2d at 164. As noted above, claims based on fraudulent misrepresentations are parallel 

to federal requirements. 

 2. Statute of Limitations. 

Defendants also argue that all of Plaintiffs’ claims are barred by the applicable 

statute of limitations. Doc. 20 at 21. Defendants contend that the relevant statutes of 

limitations are two years after the cause of action accrues for personal injury actions 

(A.R.S. §§ 12-542 and 12-551), three years for fraud claims (A.R.S. § 12-543(3)), four 

years for breach of warranty claims (A.R.S. § 47-2725(A) & (B)), and one year for 

violations of the Consumer Fraud Act (Murry v. W. Am. Mortg. Co., 604 P.2d 651, 654 

(Ariz. Ct. App. 1979)). Plaintiffs do not dispute the applicability of these statutes, but 

note correctly that when a statute of limitations defense is raised in a motion to dismiss, 

the “complaint cannot be dismissed unless it appears beyond doubt that the plaintiff can 

prove no set of facts that would establish the timeliness of the claim.” Hernandez v. City 

of El Monte, 138 F.3d 393, 402 (9th Cir. 1998) (quoting Supermail Cargo, Inc. v. United 

States, 68 F.3d 1204, 1206 (9th Cir. 1995)). 

 Plaintiffs argue that “a cause of action accrues, and the statute of limitations 

commences, when one party is able to sue another.” Gust, Rosenfeld & Henderson v. 

Prudential Ins. Co. of Am., 898 P.2d 964, 967 (Ariz. 1995). “Under the ‘discovery rule,’ 

a plaintiff’s cause of action does not accrue until the plaintiff knows or, in the exercise of 

reasonable diligence should know, the facts underlying the cause.” Id. “[I]t is not 

enough that a plaintiff comprehends a ‘what’; there must also be reason to connect the 

‘what’ to a particular ‘who’ in such a way that a reasonable person would be on notice to 

investigate whether the injury might result from fault.” Walk v. Ring, 44 P.3d 990, 996 

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(Ariz. 2002) (en banc). 

 Plaintiffs argue that “Mr. Arvizu was not aware that [the Infuse Device] might

have caused his injuries until April 17, 2012, when he saw a television commercial 

regarding the side effects caused by [the device].” Doc. 23 at 25. They further contend 

that he did not “know that his injuries were caused by [the Infuse Device] or that he had a 

cause of action against [Defendants] until his medical records were reviewed by an 

orthopedist in on (sic) or around April 7, 2014.” Id. Although Defendants argue that 

Plaintiffs “were on constructive notice of the precise claims at issue” based on the labels 

of the Infuse Device (Doc. 20 at 22), the Court cannot conclude that it is “beyond doubt” 

that Plaintiffs can prove no set of facts that would establish the timeliness of the claims, 

with the exception of Plaintiffs’ claim under the Consumer Fraud Act. The limitations 

period for that claim is one year and Plaintiffs concede that Mr. Arvizu became aware 

that his injuries may have been caused by the Infuse Device on April 17, 2012. This 

action was filed on April 15, 2014, more than one year after Mr. Arvizu knew, or in the 

exercise of reasonable diligence, should have known of the claim. The Court will dismiss 

only Plaintiffs’ seventh cause of action on timeliness grounds.6

 

H. Leave to Amend. 

Plaintiffs seek leave to amend their complaint. Doc. 23 at 25. Rule 15 makes 

clear that the Court “should freely give leave [to amend] when justice so requires.” Fed. 

R. Civ. P. 15(a)(2). The Court will therefore grant Plaintiffs’ request for leave to amend. 

 IT IS ORDERED: 

1. Defendants’ motion to dismiss (Doc. 20) is granted in part and denied in 

part as set forth above. 

 

6

 Defendants have also filed a motion requesting permission to file a supplemental brief (Doc. 33) in response to a notice of supplemental authority filed by Plaintiffs (Doc. 32). Defendants argue that Plaintiffs’ notice impermissibly included supplemental briefing. Doc. 33 at 2. This supplemental briefing is essentially a sur-reply, which the Local Rules do not permit (see LRCiv 7.2), and Plaintiffs did not seek the Court’s 

permission to file any additional memoranda. The Court will disregard Plaintiffs’ supplemental briefing and deny Defendants’ motion to file a supplemental brief as moot. 

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2. Plaintiffs shall file an amended complaint on or before 

September 19, 2014. 

3. Defendants’ motion to file a supplemental brief (Doc. 33) is denied as 

moot. 

 Dated this 25th day of August, 2014. 

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