ORDER
Motion to Dismiss
Defendants move to dismiss plaintiffs’ complaint.
Background
Plaintiffs are Debra and Patrick Martin. Defendants sire Medtronic, Inc. and Med-tronic Sofamor Danek USA, Inc.
Defendants are alleged to have “researched, developed, manufactured, marketed, promoted, advertised, sold and distributed” a medical device known as the Infuse® Bone Graft device.
The Infuse device is considered a Class III medical device
Although physicians may independently ' decide to use a device off-label, plaintiffs allege that “medical dеvice companies are prohibited by federal law from promoting off-label uses for their medical devices or from paying doctors inducements or kickbacks to promote off-label uses[.]”
[i]n order to drive sales of Infuse®, ... engaged in a multifaceted campaign[11 ] to. promote off-label uses of Infuse® that consisted of the following techniques:
a. Utilizing its sales representatives to promote off-label uses of Infuse® by having the representatives be present in operating rooms during surgery to assist physicians, distribute the false and misleading medical literature that was written and/or edited by [defendants], make recommendations concerning dosing, and refer physicians to [defendants’] paid physicians;
b. Utilizing its distributors to purchase gifts for physicians and facilities with the aim of inducing those parties to use Infuse® off-label;
e. Utilizing “Opinion Leaders” and other paid physician consultants to promote off-label uses of Infuse® at сonferences, in VIP meetings, hands-on demonstrations, and by having these paid physicians serve as resources for other physicians seeking more information on off-label uses of Infuse®; and
d. Playing an active role in the writing and editing of nearly all published medical literature on Infuse® from at least 2001 through 2006[.12 ]
Plaintiffs further allege that defendants engaged in this off-label promotion even though defendants knew that the off-label uses they were promoting were dangerous and likely to cause side effects, “such as severe uncontrolled or ectopic bone growth, severe inflammatory reaction, adverse back and leg pain events, radiculitis, retrograde ejaculation in men, urinary retention, bone resorption, and implant displacement.”
“On July 14, 2010,” plaintiff Debra Martin “underwent a posterolateral lumbar in-terbody fusion at L4-5 and L5-S1. To achieve fusion, [Debra’s] surgeon performed an off-lаbel procedure by utilizing a posterolateral approach, as well as by failing to use the required LT-Cage-™.”
On February 27, 2014, plaintiffs commenced this action. Plaintiff Debra Martin asserts the following state law claims against defendants: 1) fraudulent misrepresentation/fraud in the inducement, 2)
Defendants now move to dismiss plaintiffs’ claims. »
Discussion
Defendants move to dismiss pursuant to Rules 9(b) and 12(b)(6), Federal Rules of Civil Procedure. “Rule 12(b)(6) authorizes courts to dismiss a complaint for ‘failure to state a claim upon which relief can be granted.’ ” In re Rigel Pharmaceuticals, Inc. Securities Litig.,
Defendants argue that plaintiffs’ claims must be dismissed because they are preempted. The FDA regulates medical devices pursuant to the Medical Device Amendments of 1976(MDA). The MDA contains an express preemption clause that provides:
Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
21 U.S.C. § 360k(a). “A state law claim will bе expressly preempted by Section 360k(a) when 1) there are federal requirements applicable to the medical device and 2) the state law claim seeks to impose requirements[
Plaintiffs’ claims may also be impliedly preempted. “Implied preemption under the MDA bars claims seeking to enforce an exclusively federal requirement not grounded in traditional state tort law.” Kashani-Matts v. Medtronic, Inc., Case No. SACV 13-01161-CJC(RNBx),
“Together, express preemption and implied preemption leave only a ‘narrow gap’ through which the plaintiffs claims must fit in order to survive.” Kashani-Matts,
Defendants first argue that plaintiffs’ claims are expressly preempted. To determine if state law claims are expressly preempted under § 360k(a), the court employs a two-part test. First, “[s]ince the MDA expressly pre-empts only state requirements ‘different from, or in addition to, any requirement applicable ... to the device’ under federal law, [the court] must determine whether the Federal Government has established requirements appli
Defendants argue that the first prong of the express preemption test is met because Riegel establishes that the PMA process for a medical device imposes federal requirements that preempt state-law tort claims. The Court in Riegel found that the PMA process for a Class III catheter “impose[d] ‘requirements’ ”, in large part because the PMA process “is [the] federal safety review.” Id. at 322-23,
Plaintiffs acknowledge that the Infuse device went through the PMA process, but they argue that the PMA process only applied to the Infuse device that contained all three components and that the FDA only reviewed the safety and effectiveness of the device for one specific use. Thus, plaintiffs argue that the federal requirements were imposed only for that use. Plaintiffs insist that the PMA does not establish federal requirements applicable to the unreviewed, unapproved uses of the bone protein component by itself. Plaintiffs rely primarily on Ramirez v. Medtronic Inc.,
Plaintiffs argue that similarly here, the court should find that the first prong of Riegel has not been met beсause the basis for their claims is defendants’ “false and misleading promotion of misbranded uses of the Bone Protein....”
However, “Ramirez has been rejected— for good reason — by numerous courts.” Beavers-Gabriel v. Medtronic, Inc.,
that Ramirez “is not consistent with the text of § 360(k), the scope of federal requirements imposed on Class III devices, or Ninth Circuit precedent.” Houston II,2014 WL 1364455 , at *5. Houston II explains that off-label promotion is in. fact regulated by the FDA— § 360(k) applies broadly to “devices” as opposed to particular “uses” of such devices, and the MDA prohibits off-label promotion through its statutes and regulations prohibiting misbranded devices. Id. In other words, contrary to Ramirez ’ suggestion that manufacturers coüld “escape[ ] federal requirements by promoting an off-label use, a device manufacturer’s off-label promotion [is] itself [] subject to specific MDA provisions.” Id.
Houston II further explains that Ramirez is contrary to Perez, which “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 ). Houston II reasons that Perez, in addressing claims for off-label use and promotion, held that “the [medical device at issue] was subject to device-specific requirements” as a result of the MDA’s premarket approval regulations. Id. (citing Perez,711 F.3d at 1118 ).
Id. This court joins the majority of other courts which have rejected Ramirez to the extent that it holds that the preemption analysis does not apply to claims based on off-label promotion. The preemption analysis does apply to plaintiffs’ claims which are based on defendants’ off-label promotion of the Infuse device. It is possible that some or all of plaintiffs’ claims are preempted.
Defendants argue, however, that the Second Circuit recently rejected a similar argument in United States v. Caronia,
Defendants’ reliance on Caronia is misplaced because Caronia held that the misbranding provisions of the FDCA did not prohibit “truthful off-label promotion of FDA-approved prescription drugs.” Caronia,
Defendants next make a general argument that plaintiffs have not alleged parallel state law claims because there is no state law duty to abstain from off-label promotion. See Hawkins,
“[T]o avoid being impliedly preempted under Buckman, a claim must rely[ ] on traditional state tort law which had predated the federal enactments in question[]. In other words, the conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law— and that would give rise to liability under state law even if the FDCA had never been enacted. If the defendant’s conduct is not of this type, then the plaintiff is effectively suing for a violation of the FDCA (no matter how the plaintiff labels the claim), and the plaintiffs claim is thus impliedly preempted under Buckman.”
Id. at 1214-15 (quoting Riley v. Cordis Corp.,
This general argument fails because there is a state law duty to refrain from making misrepresentations, and this duty or requirement predates the FDCA. See Jennings v. Lee,
Because defendants’ general preemption arguments fail, it is possible that all or some -of plaintiffs’ claims are parallel claims. In order to determine whether plaintiffs have stated any parallel claims that would survive defendants’ motion to dismiss, the court must apply the preemption analysis to each of plaintiffs’ claims.
Fraud claims
In the first cause of action in plaintiffs’ complaint, Debra alleges that defendants fraudulently concealed and misrepresented 1) the health and safety problems associated with the off-label use of the Infuse device, 2) their practice of promoting the off-label use of the Infuse device, and 3) the “known comparative risks and benefits of the use of’ the Infuse device.
To the extent that Debra’s fraud claims are based on allegations that defendants made misrepresentations and omissions in the labeling of the Infuse device, “the court joins the majority of courts finding that such claims are expressly preempted.” Beavers-Gabriel,
To the extent that Debra’s fraud claims are based on allegations “that [defendants made misrepresentations and omissions in promoting off-label use of the Infuse Device — the court joins those courts determining that such claim is neither expressly preempted nor impliedly preempted.” Id. at 1037,
“Leaving aside Rule 9(b) for the moment, the Court concludes that Plaintiffs fraud-based claims could escape both express and implied preemption. As an initial matter, Plaintiffs fraudulent advertising claims are not impliedly preempted under Buckman because they are moored in traditional state common law that exists independently from the FDCA. With respect to express preemption, Plaintiffs claim that Defendants made fraudulent statements to promote off-label uses of the Infuse Device lies ‘parallel’ to federal requirements. First, although federal law permits Defendants to engage in advertising beyond the subject device’s label, it requires that such representations not be false or misleading. Second, federal regulations prohibit device manufacturers from promoting off-label uses of medical devices. Against this backdrop, Plaintiffs fraud claims are parallel or ‘genuinely equivalent’ to federal law[.]”
Id. (quoting Houston I,
But Debra’s fraud claims based on the off-label promotion allegations must still be dismissed as these claims have not been pled with the requisite particularity. Debra has certainly alleged who made misrepresentations about the Infuse device and when and where those misrepresentations were made. But, she has not alleged which misrepresentations were relied on by her and her surgeon. Instead she generally alleges that “[defendants through their sales representatives and paid Key Opinion Leaders, directly and indirectly promoted, trained, and encouraged [Debra’s] surgeon to engage in the off-label procedure of utilizing a posterolateral approach without the required LT-Cag-esTM.”
[t]he Complaint certainly details (in voluminous fashion) the numerous alleged omissions and misrepresentations madé by Defendants, including, for example, that they (1) funded studies which failed to accurately describe the adverse side effects of off-label uses, (2) ensured that adverse side effects were under-reported by writing and editing the published medical literature, and (3) used “opinion leaders” and other paid physician consultants to promote off-label uses of the Infuse Device at conferences, VIP meetings, demonstrations, and to serve as resources for other physicians seeking information on off-label uses. The Complaint identifies the dates of many of these alleged bad acts, and describes as much as possible the individuals responsible for these actions.
Missing from the Complaint, however, is the connection between Defendants’ alleged misdeeds and Plaintiff and Plaintiffs physicians — i.e., that Plaintiff and Plaintiff’s physicians relied on these misrepresentations. Although the Complaint generally asserts that “Plaintiff and Plaintiffs physicians ... [relied] on MEDTRONIC’S concealment of information and misrepresentations about the safety risks related to Infuse® in deciding to use Infuse® in an off-label manner,” the Complaint fails to identify what particular misrepresentations and/or concealments were made to Plaintiff and Plaintiffs physicians (as opposed to the medical field generally), who made those particular representations and/or omissions, and when those events occurred.
Beavers-Gabriel,
In sum, Debra’s fraud claims (the first, fourth and seven causes of action) are dismissed. But, Debra is given leave to amend as to her fraud claims which are based on allegations that defendants made misrepresentations while promoting the off-label use of the Infuse device.
Strict liability-failure to warn
In the second cause of action in plaintiffs’ complaint, Debra alleges that defendants had a duty to warn her and her physicians about the dangers of using the
First, Debra argues that this claim runs parallеl to the federal prohibition on off-label promotion. She cites to Riley v. Cordis Corporation,
[i]t seems possible ... that Riley could plead a narrow failure-to-warn claim that would escape preemption. Specifically, if Riley pleaded that (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, then Riley’s claim might survive.
Id. at 783. Debra contends that she has alleged such a claim. She argues that when the FDA approved the Infuse device, that approval pertained only to the device if it contained all three parts and that defendants unilaterally changed the intended use of that device by actively promoting the use of the bone protein alone. Or in other words, Debra argues that defendants were manufacturing, marketing, selling, and promoting an unregulаted application of the bone protein, which violates both federal law and state law. See 21 U.S.C. § 352(a) (prohibition on mis-branding); A.R.S. §§ 12-681-12-689 (product liability statutes).
This court joins the majority of other courts which have held that failure-to-warn claims “based on off-label promotion of Infuse are expressly preempted.” Eidson II, — F.Supp.3d at -,
Debra also contends that her failure to warn claim is cognizable under Stengel v. Medtronic Inc.,
[t]he new claim in the Stengels’ proposed аmended complaint alleges that, 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 “[t]he Stengels’ proposed new claim under Arizona law, insofar as the state-law duty parallels a federal-law duty under the MDA, is not preempted.” Id. at 1233. The court 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, givеn 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. (internal citations and quotation marks omitted).
Debra argues that similarly here she has alleged a state-law failure to warn claim that runs parallel to defendants’ violations of the FDCA’s requirements to submit reports of adverse events and include those events in their labeling. Debra contends that her failure-to-warn allegations are similar to those in Stengel because after the 2002 PNIA approval of the Infuse device, defendants failed to report certain adverse events to the FDA.
Courts have held that failure-to-warn claims “based on failure to report adverse events to the FDA escape[ ] both express and implied preemption.” Eidson II, —
Strict products liability — design defect
In the third cause of action in plaintiffs’ complaint, Debra alleges that the Infuse device’s design was defective because “the design was unsafe when used in the manner promoted by [defendants ....”
fact that Medtronic is alleged to have actively promoted the use of Infuse outside of the prescribed federal approval process has opened up state lаw 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,
The weight of authority is, however, to the contrary. See Dunbar v. Medtronic, Inc., Case No. CV 14-01529-RGK (AJWx),
Negligence
In the fifth cause of action in plaintiffs’ complaint, Debra alleges that defendants had a duty to fully and adequately warn others about the health and safety risks related to the off-label use of the Infuse device and to disclose their practice of improperly promoting off-label uses of the Infuse device.
To the extent that Debra’s negligence claim “is based on a failure to provide warnings on the labeling of the Infuse Device, or based on any negligence in the design and manufacture of the Infuse Device,” the claim is expressly preempted “because such claim would seek to impose labeling and design requirements different, or in addition to, the FDA requirements.” Beavers-Gabriel,
“To the extent” that Debra’s negligence claim “is based on the theory that
To the extent that Debra’s negligence claim is based on a failure to comply with federal law, she has failed to state a plausible claim because she did “not specify what federal laws were violated” so the court cannot “determine whether [she] is asserting a parallel state law claim.” Beavers-Gabriel,
In sum, Debra’s negligence claims are dismissed. Although Debra does not raise this argument, it is possible that she could amend her negligence claim to state a' plausible parallel state law claim. Courts have held that “a negligence allegation predicated on Medtronic’s failure to submit adverse-event reports to the FDA after the FDA granted the Infuse device pre-market approval” survive preemption. Schouest,
Breach of express warranty
In the sixth cause of action in plaintiffs’ complaint, Debra alleges that defendants made express warranties regarding the safety and efficacy of off-label uses of the Infuse device.
However, in Beavers-Gabriel,
“[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 fеderal 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.”
Id. (quoting Houston I, 957 F.Supp.2d at 1180-81). The court also determined that implied preemption does not apply because a “breach of warranty claim is well-recognized under Hawaii law and requires a plaintiff to establish ‘that (1) Defendants made' an affirmation of fact or promise regarding the product, (2) that statement became part of the basis of the bargain, and (3) the product failed to perform according to the statement.’” Id. (quoting Stoebner Motors, Inc. v. Automobili Lamborghini S.P.A.,
But even if Debra’s breach of express warranty claim is not preempted, it must still be dismissed because she has not
allege[d] sufficient facts to assert a plausible breach of warranty claim. Although the Complaint details Medtronic’s alleged representations regarding off-label use of the Infuse Device, it fails to inсlude any facts suggesting that those representations became the ‘basis of the bargain’ for [Debra] and her physicians. Indeed, the Complaint fails to describe what specific warranties Med-tronic made to [Debra] and/or her physicians.
Id.; see also, Houston I,
Loss of consortium claim
The parties do not expressly address Patrick Martin’s loss of consortium claim which is asserted in the eighth cause of action in plaintiffs’ complaint. “Loss of consortium is a derivative claim, so it cannot exist unless ‘all elements of the underlying cause [are] proven.’ ” Tavilla v. City of Phoenix, Case No. 1 CA-CV 10-0429,
Conclusion
Defendants’ Motion for Leave to File Supplemental Briefing
Notes
. Docket No. 13.
. Docket No. 15.
. Complaint for Damages at 3, ¶ 1 & 6, ¶ 22, Docket No. 1.
. Plaintiffs refer to this component as the "bone protein” in their response to the instant motion.
. Complaint for Damages at 13, II 57, Docket No. 1.
. "In general, a device is assigned to Class III if it cannot be established that a less stringent classification would provide reasonable assurance of safety and effectiveness, and the device is ‘purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health,’ or 'presents a potential unreasonable risk of illness or injury.’ ” Riegel v. Medtronic, Inc.,
.Complaint for Damages at 16, ¶ 68, Docket No. 1.
. Id. at 17, ¶ 74. The initial PMA has been supplemented and the FDA has approved the use of the Infuse device at the L4-S1 to L2-S1 level, has approved alternative cage components, and has approved the use of the bone protein alone (without the cage component) for certain oral maxillofacial surgeries and to repair tibial fractures. Id. at 17, n. 1; Exhibits B, D, E & F, Request for Judicial Notice, Docket No. 14. (Defendants have requested that the court take judicial notice of numerous PMA documents. Plaintiffs do not oppose this request and because these documents are publically available and/or official FDA documents, the court may take judicial notice of these documents without converting this Rule 12(b)(6) motion into a motion for summary judgment. Lee v. City of Los Angeles,
. Complaint for Damages at 18, ¶ 78, Docket No. 1. Defendants contend that the FDA does not approve "uses” of a medical device through the PMA process but rather that the FDA approves the device itself and the labeling for the device. See Nightingale Home Healthcare, Inc. v. Anodyne Therapy, LLC, Case No. 1:06-cv-1435-SEB-JMS,
. Complaint for Damages at 19, ¶ 79, Docket No. 1. It has been estimated that by 2011, "at least 85% of InFuse use [was] off-label.” Staff Report on Medtronic's Influence on Infuse Clinical Studies at 3, Exhibit B, Memorandum in Opposition to Defendants' Motion to Dismiss, Docket No. 15.
. The editor-in-chief of The Spine Journal referred to this as a “carnival-like promotion” in that "[m]arket boosters adverted that the BMP-2 product went beyond all other medical innovations.” Response to Long-Awaited YODA Report on Controversial Spinal Fusion Product, Exhibit A at 1, Memorandum in Opposition to Defendants' Motion to Dismiss, Docket No. 15.
. Complaint for Damages at 39-40, ¶ 158, Docket No. 1.
. Id. at 28-32, ¶¶ 112-123.
. Id. at 35-36, ¶¶ 136-140 (alleging, for example, that defendants sold $4 billion worth of Infuse devices between 2002 and 2011).
. Id. at 80, ¶ 299.
. Plaintiffs allege that Key Opinion Leaders “were paid physician promoters[.]” Id. at 4, ¶ 6.
. Id. at 80, ¶ 300.
. This allegation is inconsistent with plaintiffs’ allegation that Debra's surgeon did not use the LT-CageTM.
. Complaint for Damages at ¶ 301, Docket No. 1.
. Plaintiffs' Response at 3, Docket No. 15 (emphasis omitted).
. "State 'requirements’ include the state’s common law legal dutiеs.” Eidson v. Med
. Plaintiffs suggest that Buckman only applies to fraud-on-the-FDA claims because that was the claim at issue in that case, but Buck-man cannot be read that narrowly. See e.g., Perez v. Nidek Co.,
. Section 337(a) states in relevant part that "all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.” 21 U.S.C. § 337(a).
. In their opposition, plaintiffs cite to numerous state court decisions that they contend have also rejected defendants’ preemption arguments. Plaintiffs' citation to these decisions was unhelpful because in large part the courts’ reasoning was not clear as the decisions were made on the record or in conclusory written orders.
. Memorandum in Opposition to Defendants' Motion to Dismiss at 6, Docket No. 15.
. Complaint for Damages at 37, ¶ 144, Docket No. 1.
. Id. at ¶¶ 143, 145.
. Complaint for Damages at 82, ¶ 308, Docket No. 1.
. Id. at 88, ¶ 353.
. Id. at 93, ¶ 391.
. Id. at 94, ¶ 397.
. Complaint for Damages at 80, ¶ 300, Docket No. 1.
. Complaint for Damages at 84-85, ¶¶ 320-327, Docket No. 1.
. Complaint for Damages at 38, ¶ 148, Docket No. 1 (alleging that defendants violated the FDCA "by failing to account for adverse events and update its labeling, directions for use, and advertising to address the adverse events resulting from ... off-label uses”).
. Complaint for Damages at 86, ¶ 339, Docket No. 1.
. Complaint for Damages at 90, ¶ 368, Docket No. 1.
. Id. at 90-91, ¶ 371.
. Complaint for Damages at 92, ¶ 381, Docket No. 1.
. Docket No. 24.
. Docket No. 13.