ORDER GRANTING DEFENDANTS MEDTRONIC, INC. AND MED-TRONIC SOFAMOR DANEK USA, INC.’S MOTION TO DISMISS PLAINTIFF’S COMPLAINT PURSUANT TO FED. R. CIV. P. 12(B)(6)
I. INTRODUCTION
On December 16, 2013, Plaintiff Karla Beavers-Gabriel (“Plaintiff’) filed this action against Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. (collectively, “Medtronic” or “Defendants”), asserting state law claims based on injuries she sustained after undergoing spinal surgery in which her surgeon used Defendants’ Infuse® Bone Graft (the “Infuse Device” or “Infuse®”), a Class III prescription medical device, in an off-label manner not approved by the Food and Drug Administration (“FDA”).
Currently before the court is Defendants’ Motion to Dismiss, in which they argue that Plaintiffs claims are expressly preempted by the Medical Device Amendments (“MDA”) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 360k(a), impliedly preempted by the “no private right of action clause” of the FDCA, 21 U.S.C. § 337(a), and in any event fail to assert plausible claims for relief or comply with Federal Rule of Civil Procedure 9(b). Based on the following, the court finds that Plaintiffs claims are preempted in part and otherwise fail to assert a plausible claim for relief and/or comply with Rule 9(b). The court therefore GRANTS Defendants’ Motion to Dis
II. BACKGROUND
A. Factual Background
To properly frame the issues presented in Defendant’s Motion to Dismiss, the court provides the following factual background based on the allegations of the Complaint, the judicially-noticed facts,
1. FDA Approval and Oversight of Class III Medical Devices
Class III medical devices such as the Infuse Device are regulated by the FDA pursuant to the Medical Device Amendments of 1976 (the “MDA”) of the FDCA. Riegel v. Medtronic, Inc.,
Class III medical devices are subjected to a “rigorous regime” of premarket approval (“PMA”). Id. To obtain PMA, a manufacturer must submit a multi-volume application outlining, among other things, all studies and investigations of the device’s safety and effectiveness that have been published or should reasonably be known to the applicant; a “full statement” of the device’s “components, ingredients, and properties and of the principle or principles of operation;” “a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device;” samples or device components required by the FDA; and a specimen of the proposed labeling. Id. at 318,
FDA approval of a Class III medical device does not end oversight — “[o]nce a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.” Id. at 319 (citing 21 U.S.C. § 360e(d)(6)(A)(i)). As a result, “[i]f the applicant wishes to make such a change, it must submit, and the FDA must approve, an application for supplemental premarket approval, to be evaluated under largely the same criteria as an initial application.” Id. (citing 21 U.S.C. § 360e(d)(6); 21 C.F.R. § 814.39(c)). The manufacturer also has continuing reporting duties to the FDA of any new studies of the device or incidents of adverse affects, and “[t]he FDA has the power to withdraw premarket approval based on newly reported data or existing information and must withdraw approval if it determines that a device is unsafe or ineffective under the conditions in its labeling.” Id. at 319-20,
2. FDA Approval of the Infuse Device
On July 2, 2002, the FDA approved the Infuse Device “to treat degenerative disk disease, but only by means on one specific procedure, namely, anterior lumbar inter-body fusion (“ALIF”) surgeries on a single level between L4 and SI.” Doc. No. 1, Compl. ¶ 74; see also Doc. No. 15-1, Defs.’ Ex. A.
The Infuse Device consists of (1) a metallic cylindrical spacer used to keep the two vertebrae in place and to direct the development of new bone growth (the “LT-Cage”); and (2) the Bone Graft Component, which includes a collagen sponge that acts as a carrier and scaffold for the active ingredient, rhBMP-2 protein, which promotes bone growth. Id. ¶ 72. The labeling for the Infuse Device, as approved by the FDA, provides: “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.” Id. ¶ 75; see also Doc. No. 15-7, Defs.’ Ex. G at 1.
The labeling further warns against using the Infuse Device in spinal surgeries beyond what is approved by the FDA:
The safety and effectiveness of the InFUSE Bone Graft component with other spinal implants, implanted at locations other than the lower lumbar spine, or used in surgical techniques other than anterior open or anterior laparoscopic approaches have not been established. When degenerative disc disease was treated by a posterior lumber interbody fusion procedure with cylindrical threaded cages, posterior bone formation was observed in some instances.
Doc. No. 15-7, Defs.’ Ex. G at 4. An earlier Medtronic trial using rhBMP-2 in a posterior lumbar interbody fusion was halted in
3. Off-Label Use of the Infuse Device
Although the Infuse Device is approved only for the ALIF procedure and by using both of its components together, Medtronic sells the Bone Graft Component separately from the LT-Cage, and physicians may use FDA-approved medical devices “in any way they see fit” so long as the patient is fully informed of the off-label use. Id. ¶¶ 76, 79. Off-label uses of the Infuse Device account for 85 to 90 percent of all spine surgeries using the Infuse Device, id. ¶ 133, even though these off-label uses have resulted in many more reported adverse events than on-label uses. Id. ¶ 110. Adverse effects include severe uncontrolled or ectopic bone growth, severe inflammatory reaction, adverse back and leg pain events, radiculits, retrograde ejaculation in men, urinary retention, bone resorption, and implant displacement. Id. ¶ 115.
The Complaint asserts that Medtronic, aware of the heightened risks of off-label uses, nonetheless engaged in an aggressive campaign to promote off-label uses of the Infuse Device. For example, Medtronic funded studies which failed to accurately describe the adverse side effects of off-label uses, id. ¶¶ 115, 143, and ensured that adverse side effects were under-reported by writing and editing the published medical literature. Id. ¶¶ 153(d), 189-90, 253-54. The Complaint further asserts that Medtronic (1) used its sales representatives to promote off-label uses by assisting physicians during surgery, distributing false and misleading medical literature that was written and/or edited by Med-tronic, recommending dosages, and referring physicians to paid Medtronic physicians; (2) used its distributors to purchase gifts for physicians and facilities to induce them to use the Infuse Device off-label; (3) and 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. Id. ¶ 153.
4. Plaintiff’s Surgery
On April 17, 2008, Plaintiff underwent a transforaminal lumbar interbody fusion and posterolateral fusion at L5-S1 in Honolulu, Hawaii. Id. ¶ 299. To achieve this fusion, Plaintiffs surgeon used the Infuse Device in an off-Jabel manner by using a transforaminal and posterolateral approach as well as by placing rhBMP-2 both inside and outside of non-LT-Cages. Id. The Complaint asserts that Plaintiffs surgeon was encouraged to engage in this off-label procedure by Medtronic’s sales representatives and paid key opinion leaders. Id. ¶ 300. After the surgery, Plaintiff was diagnosed with heterotopic bone growth, secondary to rhBMP-2 at the right neuroforamen of the SI nerve root, requiring extensive medical treatment and additional surgery, and causing significant injuries to Plaintiff. Id. ¶¶ 301-02.
B. Procedural History
Plaintiffs December 16, 2013 Complaint, containing 414 paragraphs, alleges
On February 4, 2014, Defendants filed their Motion to Dismiss. Doc. No. 14. On March 13, 2014, the parties stipulated to dismissal of Count 7 of the Complaint for Breach of Hawaii’s Consumer Protection Statutes. Doc. No. 21. On March 14, 2014, Plaintiff filed her Opposition, Doc. No. 22, and Defendants filed their Reply on March 24, 2014. Doc. Nos. 26, 28.
III. STANDARDS OF REVIEW
A. Rule 12(b)(6): Failure to State a Claim
Federal Rule of Civil Procedure 12(b)(6) permits a motion to dismiss a claim for “failure to state a claim upon which relief can be granted[.]”
“To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’ ” Ashcroft v. Iqbal,
Rather, “[a] claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal,
B. Federal Rule of Civil Procedure 9(b)
Federal Rule of Civil Procedure 9(b) requires that “[i]n all averments of fraud or mistake, the circumstances constituting fraud or mistake shall be stated with particularity.” “Rule 9(b) requires particular
In their pleadings, Plaintiffs must include the time, place, and nature of the alleged fraud; “mere conclusory allegations of fraud are insufficient” to satisfy this requirement. Id. at 1548 (citation and quotation signals omitted). However, “[mjalice, intent, knowledge, and other condition of mind of a person may be averred generally.” Fed.R.Civ.P. 9(b); see also In re GlenFed, Inc. Sec. Litig.,
A motion to dismiss for failure to plead with particularity is the functional equivalent of a motion to dismiss under Fed. R.Civ.P. 12(b)(6). Vess v. Ciba-Geigy Corp. USA,
IV. ANALYSIS
Defendants argue that Plaintiffs state law claims are expressly preempted and/or impliedly preempted, and in any event fail to assert plausible claims for relief and/or comply with Rule 9(b). The court first outlines the basic principles of express and implied preemption, addresses the parties’ preemption arguments that apply to all claims, and then addresses each of the claims in this action.
A. Express and Implied Preemption 1. Framework
The MDA outlines two different forms of preemption-express preemption and implied preemption.
The express preemption provision of the MDA provides, in relevant part:
[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.
21 U.S.C. § 360k(a); see also 21 C.F.R. § 808.1(d) (implementing regulation). The implied preemption statute, 21 U.S.C. § 337(a), states in relevant part: “[A]ll 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).
Three Supreme Court cases address MDA preemption—Medtronic, Inc. v. Lohr,
Riegel clarified the contours of express preemption. Unlike in Lohr, Riegel held that claims alleging that a catheter was defective when inflated to a higher pressure than recommended were preempted because they were based on violations of state law despite compliance with the MDA, and would therefore allow state law to impose a more stringent safety requirement than federal law. Riegel,
Riegel outlined that a state-law claim is expressly preempted by the MDA where (1) the FDA has established requirements applicable to the particular medical device at issue; and (2) the state common law claims seek to impose requirements that are “different from, or in addition to” the federal requirements, and that relate to safety and effectiveness.
Finally, Buckman determined that implied preemption applied where the plaintiffs asserted state-law negligence claims against a consulting company that
Notwithstanding the fact that [Lohr] did not squarely address the question of implied pre-emption, it is clear that the [Lohr] claims arose from the manufacturer’s alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements. See518 U.S. at 481 ,116 S.Ct. 2240 . In the present case, however, the fraud claims exist solely by virtue of the FDCA disclosure requirements. Thus, although [Lohr] can be read to allow certain state-law causes of actions that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim.
Id. at 352-53,
Together, express preemption and implied preemption identify a “‘narrow gap’ through which a state-law claim must fit to escape preemption.” Perez,
2. The Parties’ General Preemption Arguments
This court is hardly the first to address preemption as applied to off-label use of Infuse Device — the allegations in the Complaint mirror those asserted in other actions, and numerous courts have already addressed the issues presented in the parties’ briefing. The caselaw provides fertile ground for both parties’ arguments— courts have taken differing views in applying Lohr, Buckman, and Riegel to determine whether a plaintiffs claims for off-label use of the Infuse Device are preempted. Although most of the preemption arguments are best addressed in terms of particular claims, the court first addresses those arguments raising more general questions as to whether claims based on off-label promotion of a medical device can be preempted.
a. First step of Riegel
Riegel’s first step in applying express preemption is to determine whether the FDA has established requirements applicable to the Infuse Device. This step appears to be plainly met — the Infuse Device is a Class III medical device approved by the FDA. Plaintiff nonetheless argues that this step is not met in this case because the only “requirements” the FDA established were for the Infuse Device when both components are used in a single-level ALIF procedure, and the FDA established no requirements where only a component
Plaintiff fails to cite any authority that supports this proposition,
b. Second step of Riegel
The second step of Riegel requires the court to determine whether the state-law claims seek to impose requirements that are “different from, or in addition to” the federal requirements. In theory, the federal “requirements” should be easy enough to determine — they are defined by the MDA, FDCA, and the implementing regulations. But courts have struggled in
i Ojf-label promotion of the Infuse Device
Contrary to Defendants’ argument, there are ample “requirements” in both the FDCA and its regulations establishing that off-label promotion is prohibited. In particular, the FDCA makes unlawful “[t]he introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.” 21 U.S.C. §§ 331(a), 333. The FDCA defines that an article may be “misbranded” where “the labeling or advertising is misleading,” and such finding is determined by considering, among other things, “representations made or suggested by statement, word, design, device, or any combination thereof.” 21 U.S.C. § 321(n) (emphasis added). Thus, the FDCA prohibits a manufacturer from engaging in misleading advertising regarding Class III medical devices, because such advertising is a form of misbranding.
The FDCA regulations further define that a manufacturer cannot engage in advertising off-label uses. In particular, the FDCA regulations provide that “[a] device may not be manufactured, packaged, stored, labeled, distributed, or advertised in a manner that is inconsistent with any conditions to approval specified in the PMA approval order for the device.” 21 C.F.R. § 814.80 (emphasis added). The PMA approval letter for the Infuse Device provides that the Infuse Device “is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L4-S1,” and the “Bone Graft/LT-Cage devices are to be implanted via an anterior open or an anterior laparoscopic approach.” Doc. No. 15-2, Defs.’ Ex. B. The approved labeling
In sum, the FDCA prohibits “misbrand-ing” of medical devices, which includes either misleading labeling or misleading advertising of the medical device, and 21 C.F.R. § 814.80 prohibits Defendants from advertising the Infuse Device for uses beyond what is provided in the PMA approval. Given these federal “requirements,” the court finds that a claim based on off-label promotion survives express preemption. See, e.g., Eidson,
ii. Ramirez
Plaintiff argues that the court should follow Ramirez, which read Riegel narrowly to determine that the second step for express preemption — that the state common law claims seek to impose requirements that are “different from, or in addition to” the federal requirements — is not met where the Infuse Device is used in an off-label manner. Ramirez started with the premise that “the FDA reviewed Infuse’s safety and effectiveness only for the uses Medtronic specified in its PMA application, and the regulations are premised on that review.”
Ramirez has been rejected — for good reason — by numerous courts.
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,
The court agrees with this reasoning and rejects Ramirez to the extent it suggests that the preemption analysis does not apply to claims based on off-label promotion. The court now addresses each of Plaintiffs claims.
B. Plaintiffs Claims
1. Fraudulent Misrepresentation and Fraud in the Inducement (Count I)
The Complaint asserts that Med-tronic fraudulently concealed and misrepresented (1) the health and safety hazards associated with off-label use of the Infuse Device, (2) its practice of promoting and marketing the practice of using the Infuse Device in off-label manners, and (3) information about the known comparative risks and benefits of the off-label use of the Infuse Device and other alternate treatments. Doc. No. 1, Compl. ¶ 309. The Complaint further asserts that Medtronic intended to cause Plaintiff and Plaintiffs physicians to rely on Defendants’ concealment and misrepresentations, that Plaintiff and Plaintiffs physicians were justified in relying on Medtronic’s actions and would not have decided to use the Infuse Device in an off-label manner had they known of the safety risks, and that Plaintiff was injured as a result of Medtronic’s fraudulent concealment and/or misrepresentations. Id. ¶¶ 307-15.
Reading these allegations in context of the entire Complaint, this claim appears to be based on misrepresentations and omissions (1) contained in the labeling of the Infuse Device, and/or (2) made in promoting off-label use of the Infuse Device. See, e.g., Eidson,
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. In sum, federal law forbids device manufacturers to promote any off-label uses, and certainly prohibits false or misleading off-label promotion. Against this backdrop, Plaintiffs fraud claims are parallel or “genuinely equivalent” to federal law because there is no likelihood that Defendants could be held liable under state law without having violated the federal law.
In opposition, Defendants argue that Plaintiffs claims, to the extent based on a concealment theory (as opposed to an affirmative misrepresentation), are preempted pursuant to Perez. In Perez, the plaintiff alleged that the manufacturer was aware that its device was being used in an off-label manner and should have affirmatively provided certain warnings about the off-label nature of that use.
Perez is distinguishable. As described above, although claims directed to the labeling and warnings provided with the In
The court finds, however, that Plaintiffs claim must still be dismissed for failure to comply with the particularity requirements of Rule 9(b). The Complaint certainly details (in voluminous fashion) the numerous alleged omissions and misrepresentations made by Defendants, including, for example, that they (1) funded studies which failed to accurately describe the adverse side effects of off-label uses, Doc. No. 1, Compl. ¶¶ 115, 143, (2) ensured that adverse side effects were under-reported by writing and editing the published medical literature, id. ¶¶ 153(d), 189-90, 253-54; 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. Id. ¶ 153. The Complaint identifies the dates of many of these alleged bad acts, and describes as much as possible the individuals responsible for these actions. Id. ¶¶ 112-283.
Missing from the Complaint, however, is the connection between Defendants’ alleged misdeeds and Plaintiff and Plaintiffs physicians — i.e., that Plaintiff and Plaintiffs physicians relied on these misrepresentations. See Shoppe v. Gucci Am., Inc.,
The court therefore GRANTS Defendants’ Motion to Dismiss Count I, with leave for Plaintiff to assert a fraud claim based on Defendants’ off-label promotion of the Infuse Device.
2. Strict Products Liability — Failure to Warn (Count II)
The Complaint alleges that Med-tronic failed to warn Plaintiff and her physicians of the dangers of using the Infuse Device in an off-label manner. Doc. No. 1, Compl. ¶ 322. In particular, the Complaint alleges that “the warnings accompanying the Infuse® product did not adequately warn Plaintiff and Plaintiffs physicians ... of the dangers associated with Infuse® when used without an LT-CageTM and placed transforaminally or posterolaterally in a lumbar spine fusion surgery,” and “failed to provide the
This claim is expressly preempted. As Houston I explains, “for Plaintiff to prevail, a jury would have to find either that Defendants were required to include warnings beyond those in the FDA-approved label for the Infuse Device, or that Defendants were obligated to issue post-sale warnings about potential adverse effects of using the Infuse Device in an off-label manner. While FDA regulations permit Defendants to issue such post-sale warnings, those regulations do not require such warnings.”
In opposition, Plaintiff argues that this claim runs parallel to the federal prohibition on off-label promotion because Med-tronic unilaterally changed the “intended use” of the Infuse Device by promoting off-label uses and then failed to notify the FDA or provide any warnings for this new “intended use.” Doc. No. 22, Pl.’s Opp’n at 28; see also 21 C.F.R. § 801.4 (explaining that an “intended use” of a medical device refers “to the objective intent of the persons legally responsible for the labeling of devices”). Plaintiff asserts that Defendants’ actions therefore simultaneously violate the FDA’s prohibition of misbranding devices, 21 U.S.C. § 352, and the state law duty to warn. Id.
This argument was adopted in Alton, which determined that a failure to warn claim was not preempted to the extent the claim was parallel to the requirement that Medtronic update its label where it has adopted a new intended use for the Infuse Device. See
Avoiding state law liability would require providing additional warnings not required by the FDCA. Likewise, a finding that Defendants created a new intended use of the INFUSE® device giving rise to a duty to provide adequate directions in the product label would require making changes to the INFUSE® label that has been approved by the FDA. As such, a parallel claim could not be based on the federal requirement that Defendants provide adequate directions because doing so would require Defendants to make changes to the FDA-approved label based on a state law requirement. Such a claim cannot survive express preemption.
The court therefore GRANTS Defendants’ Motion to Dismiss Count II of the Complaint, with leave for Plaintiff to amend as to a failure to warn theory based on Defendants’ alleged failure to submit reports of adverse events to the FDA. The parties have not briefed, and the court expresses no opinion at this time, as to whether such claim would survive a preemption analysis.
3. Strict Products Liability-Design Defect (Count III)
The Complaint alleges that the Infuse Device “was defectively designed because the design was unsafe when used in the manner promoted by Defendants and/or in a manner reasonably foreseeable by Defendants,” and that the Infuse Device “failed to perform as safely as an ordinary consumer would expect when used, as it was promoted by the MED-TRONIC Defendants for use off-label without an LT-CageTM and placement transforaminally and posterolaterally in lumber spine fusion surgeries.” Doc. No.
1, Compl. ¶ 340. The Complaint further asserts that the Infuse Device “was defectively designed because the risks of danger in the design outweigh the benefits of the design,” and that an alternative design would have resulted or avoided the foreseeable risks of harm. Id. ¶¶ 341-43.
The court joins the majority of courts finding that this claim is expressly preempted — to prevail on this claim, Plaintiffs would need to establish that the Infuse Device should have been designed in a manner different than that approved by the FDA. See, e.g., Houston I,
The court therefore GRANTS Defendants’ Motion to Dismiss Count III of the Complaint without leave to amend.
4. Products Liability — Negligence (Count V)
The Complaint alleges that Defendants had an affirmative duty to fully and adequately warn Plaintiff and Plaintiffs physicians of the true health and safety risks related to the off-label use of the Infuse Device, and to disclose their practices of improperly promoting to physicians off-label uses of the Infuse Device. Doc. No. 1, Compl. ¶ 369. The Complaint further alleges that Defendants breached this duty by (1) improperly promoting the Infuse Device for off-label uses; (2) failing to warn of the dangers of off-label uses;
As explained above, this claim is expressly preempted to the extent it 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, because such claim would seek to impose labeling and design requirements different, or in addition to, the FDA requirements. See also Hawkins,
To the extent this claim is based on the theory that Defendants were negligent in promoting the Infuse Device for off-label uses, it is not expressly preempted, but is barred by implied preemption. As described above for Plaintiffs fraud and strict liability/misrepresentation claims, this claim is not expressly preempted because it is based on a violation of federal law banning off-label promotion. See also Hawkins,
Finally, to the extent Plaintiff bases this claim on Defendant’s failure to report adverse events to the FDA, the court recognizes that some courts have found that such a claim may survive preemption. See, e.g., Eidson,
The court therefore GRANTS Defendants’ Motion to Dismiss Count V of the Complaint, with leave for Plaintiff to assert a negligence claim based on the failure to report adverse events to the FDA.
5. Breach of Express Wairanty (Count VI)
Count VI alleges that Defendants “utilized journal articles, advertising media, sales representatives/consultants and paid Key Opinion Leaders to urge the use, purchase, and utilization of the off-label use of Infuse® Bone Graft and expressly warranted to physicians and other members of the general public and medical community that such off-label uses, including uses in lumbar fusion procedures, were safe and effective.” Doc. No. 1, Compl. ¶ 339. Plaintiff further alleges that “her treating surgeon relied on Defendants’ express warranty representations regarding the safety and efficacy of off-label use of Infuse®, but such off-label uses, including uses in lumbar fusion procedures, were not effective, safe, and proper for the use as warranted in that Infuse® was dangerous when put to these promoted uses.” Id. ¶ 384.
The court finds that this claim survives both express preemption and implied preemption. As Houston I persuasively explains, express preemption does not apply:
[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.
The court finds, however, that Plaintiff has failed to allege 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 include any facts suggesting that
The court therefore GRANTS Defendant’s Motion to Dismiss Count YI, with leave for Plaintiff to assert a breach of warranty claim based on alleged false warranties made beyond the federally-approved labeling of the Infuse Device.
6. Punitive Damages (Count VIII)
Defendants argue that Plaintiff’s punitive damages claim must be dismissed where none of the other claims asserts a plausible basis for relief. Doc. No. 14-1, Defs.’ Mot. at 31-32. The court agrees— punitive damages is a remedy, and not a substantive claim for relief. Punitive damages may be realleged in an amended complaint as a remedy sought by Plaintiff.
Y. CONCLUSION
For the foregoing reasons, the court GRANTS Defendants’ Motion to Dismiss, with leave for Plaintiff to amend (1) Count I to assert a fraud claim based on Defendants’ off-label promotion; (2) Count II to assert a strict liability — failure to warn claim based on Defendants’ alleged failure to submit reports of adverse events to the FDA; (3) Count V to assert a negligence claim based on the failure to report adverse events to the FDA; and (4) Count VI to assert a breach of warranty claim based on alleged false warranties made beyond the federally-approved labeling of the Infuse Device.
IT IS SO ORDERED.
Notes
. Both parties submitted Requests for Judicial Notice. See Doc. Nos. 15, 23. Defendants request the court to take judicial notice of certain public documents available on the FDA's public website regarding premarket approval of the Infuse Device. The court grants Defendants’ request — matters of public record such as records and reports of administrative bodies are proper subjects of judicial notice. See Eidson v. Medtronic, Inc.,
Plaintiff requests the court to take judicial notice of the Staff Report on Medtronic's Influence on Infuse Clinical Studies, which was prepared by the Staff of the Committee on Finance for the United States Senate, and is publicly available online (Plaintiff also submits two exhibits without requesting that the court take judicial notice, which the court ignores for the purposes of the Motion to Dismiss). Doc. No. 23. Defendants object to the extent Plaintiff submits the Report to establish the assertions and opinions provided in the Report, and not merely the fact of its existence. Doc. No. 28, Defs.' Obj. To the extent Plaintiff submits her Exhibit 1 for the validity of its contents, they are not the proper subject for judicial notice. See, e.g., Ramirez v. Medtronic, Inc.,
. The FDA has subsequently approved forty-seven supplements to the PMA for the Infuse Device (neither party argues that these supplements address the use of the Infuse Device at issue in this action). See Doc. No. 15-1, Defs.’ Ex. A.
. The Complaint further outlines that Med-tronic has been criticized for its off-label promotion of the Infuse Device, and as a result has been investigated and the subject of two whistleblower actions. See Doc. No. 1, Compl. ¶¶ 125-27, 255-60, 284-98.
. After filing the Reply, Defendants filed various Notices of Supplemental Authority. Doc. Nos. 29, 30.
. Although Plaintiff cites to Ramirez v. Medtronic,
. See also, e.g., Hawkins v. Medtronic, Inc.,
. Without citing any specific holding, Plaintiffs also argue that the court should generally follow Alton v. Medtronic, Inc.,
. See, e.g., Scovil v. Medtronic, Inc.,
. This claim appears to be based on off-label promotion generally; the Complaint does not assert that Defendants were negligent in making a particular statement to Plaintiff or Plaintiff's physicians.