STEPHEN V. WILSON, District Judge.
On March 8, 2013, Plaintiff Jennifer Houston ("Plaintiff) commenced this action against Defendants Medtronic, Inc., and Medtronic Sofamor Danek USA, Inc. (collectively, "Defendants"). Plaintiff alleges that she suffered harmful side effects after undergoing lumbar surgery in which her surgeon used Defendants' product, the Infuse Device, in an off-label manner. (Dkt. 1 ("Compl.") ¶¶ 1-13). Now before
Medtronic Sofamor Danek, USA, Inc. ("MSD"), a division of Medtronic, Inc., manufactures a medical device known as the InFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device ("Infuse Device"). (See Def. Req. Judicial Not. ("RJN"), Ex. B ("PMA")).
Defendants' Infuse Device consists of two sub-components: (1) a metallic cylindrical cage ("LT-Cage™"); (2) the InFUSE™ Bone Graft, which is comprised of a liquid protein (rhBMP-2), and a collagen sponge carrier for the protein, both of which are placed inside the cage. (Compl. ¶¶ 55-56). The LT-Cage maintains the spacing between vertebrae and temporarily stabilizes the diseased region of the spine, whereas the liquid protein binds with the sponge to stimulate bone growth. (Id. ¶¶ 57-58).
The Infuse Device is a Class III device under the Federal Food, Drug, and Cosmetic Act of 1938 ("FDCA"), as amended by the Medical Device Amendments of 1976 ("MDA"), a classification reserved for devices that pose the greatest risk of death or complications. (Compl. ¶ 64). For that reason, Defendants were required to obtain premarket approval ("PMA") from the FDA before it could sell or distribute the subject device. (Id. ¶ 65). Accordingly, Defendants filed a PMA application in 2001, submitting extensive clinical data and nonclinical studies to shore up the subject device's safety and efficacy. (Id.).
On July 2, 2002, the FDA granted premarket approval for the Infuse Device for spinal fusion procedures to treat degenerative disc disease. (RJN, Ex. A at 1). The FDA's approval letter stated that the Infuse Device may only be implanted (1) from the anterior (front) abdomen, and (2) placed within lumbar spine levels L4 through SI. (Compl. ¶¶ 72-73); (RJN, Ex. B at 1). In addition, the FDA approved labeling emphasizes that the InFUSE™ Bone Graft must not be used without the LTCage. (Compl. ¶ 74); (RJN, Ex. G at l).
In October 2008, Plaintiff underwent a posterior-approach lumbar fusion at levels L4-L5-S1. Her physician performed the surgery using the Infuse Device in the following off-label manner: the device was implanted by means of a posterior, not anterior, approach, and an LTCage was not used. (Compl. ¶ 248).
Plaintiff alleges that prior to her surgery, Defendants did not inform her of any risks attendant to the use of the Infuse Device in the lumbar spine, nor did Defendants adequately inform Plaintiffs surgeon of the true incidence of uncontrolled bone growth resulting from the use of the device in off-label procedures, or of other risks or dangers or complications associated with the off-label use of the device. (Id, ¶¶ 37-38, 249, 254). Plaintiff further alleges that Defendants affirmatively engaged in a lengthy campaign of off-label promotion of the Infuse Device to physicians and spine patients, including Plaintiff and her physician, while "minimizing, concealing, and/or downplaying" the increased safety risks associated with off-label use of the subject device. (Id, ¶¶ 11, 23). In reality, however, Plaintiff asserts that Defendants knew, or had reason to know, at least a year prior to her surgery, of the "true risks and dangers to spine patients of off-label use of Infuse," including uncontrolled bone growth. (Id. ¶¶ 30-32).
After her surgery, Plaintiff developed uncontrolled bone growth and resulting nerve compression near where the Infuse Device (in reality, only the InFUSE™ Bone Graft) was implanted. (Compl. ¶ 251). Plaintiff now suffers from bone overgrowth with nerve compression, chronic pain and radiculitis, and emotional distress and mental anguish. (Id, ¶ 256).
Based on the foregoing allegations, Plaintiff advances six causes of action against Defendants: (1) fraudulent misrepresentation and fraud in the inducement (Compl. ¶¶ 265-78); (2) strict products liability — failure to warn (id. ¶¶ 280-97); (3) strict products liability — design defect (id. ¶¶ 299-307); (4) strict products liability — misrepresentation (id. ¶¶ 309-21); (5) products liability — negligence (id. ¶¶ 323-37); and (6) breach of express warranty (id. ¶¶ 339-48).
A motion to dismiss under Rule 12(b)(6) challenges the legal sufficiency of the claims stated in the complaint. Fed. R. Civ. Proc. 12(b)(6). Dismissal is proper where there is a "`lack of a cognizable legal theory'" or "`the absence of sufficient facts alleged under a cognizable legal theory.'" Conservation Force v. Salazar, 646 F.3d 1240, 1242 (9th Cir.2011) (quoting Balistreri v. Pacifica Police Dept., 901 F.2d 696, 699 (9th Cir.1990)). 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, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). This determination has two steps.
First, the court may "begin by identifying pleadings that, because they are no more than conclusions, are not entitled to the assumption of truth." Id. at 679, 129 S.Ct. 1937. A complaint that offers mere "labels and conclusions" or "a formulaic recitation of the elements of a cause of action will not do." Id. (internal quotation marks omitted). "Nor does a complaint suffice if it tenders `naked assertion[s]' devoid of `further factual enhancement.'" Id. (internal quotation marks omitted). Moreover, "[t]he court need not ... accept as true allegations that contradict matters properly subject to judicial notice or by exhibit. Nor is the court required to accept as true allegations that are merely conclusory, unwarranted deductions of fact, or unreasonable inferences." Sprewell v. Golden State Warriors, 266 F.3d 979, 988 (9th Cir.2001) (internal citation omitted). However, well-pleaded factual "[allegations in the complaint, together with reasonable inferences therefrom, are assumed to be true for purposes of the motion." Odom v. Microsoft Corp., 486 F.3d 541, 545 (9th Cir.2007).
Second, the court must address whether the well-pleaded facts, and reasonable inferences therefrom, give rise to a plausible claim for relief.
Claims for fraud must overcome the heightened pleading requirements of Rule 9(b). Fed.R.Civ.P. 9(b). Rule 9(b) provides that, "[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake." Fed.R.Civ.P. 9(b). When pleading fraud, a complaint must "be `specific enough to give defendants notice of
Defendants argue that Plaintiffs state law claims are expressly preempted by the MDA, 21 U.S.C. § 360k(a), or in the alternative, impliedly preempted by 21 U.S.C. § 337(a). Defendants further argue that Plaintiffs strict liability design defect claim, breach of warranty claim, and fraudbased claims must be dismissed on independent grounds. Before addressing these arguments, the Court briefly reviews the relevant legal framework under the MDA.
Before 1976, states were left to regulate the entry of new medical devices. Perez v. Nidek Co., Ltd., 711 F.3d 1109, 1117 (9th Cir.2013). In 1976, Congress enacted the MDA, which "swept back some state obligations and imposed a regime of detailed federal oversight" of medical devices. Riegel v. Medtronic, Inc., 552 U.S. 312, 316, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008).
The MDA established a "rigorous process" of premarket approval for new Class III devices, such as the subject device in this case. Riegel, 552 U.S. at 316-17, 128 S.Ct. 999. To obtain premarket approval ("PMA"), a manufacturer must submit detailed studies and investigations of the device's safety and effectiveness, and a full description of the device's components and how it may be used. Id. at 318, 128 S.Ct. 999.
Id. After completing its review, the FDA may grant or deny premarket approval. 21 U.S.C. § 360e(d).
The MDA contains an express preemption provision that provides, with an exception not applicable here, that:
21 U.S.C. § 360k(a).
In Riegel, the Supreme Court applied a two-step analysis to determine whether the MDA expressly preempts a state law claim within the meaning of § 360k(a). First, a court must determine whether the FDA has established requirements applicable to the particular medical device at issue. 552 U.S. at 321, 128 S.Ct. 999. If so, a court must determine whether the state law claims are based on state requirements that are "different from, or in addition to" the federal requirements, and relate to safety and effectiveness. Id. at 321-22,128 S.Ct. 999.
State "requirements" include the state's common-law legal duties. Riegel, 552 U.S. at 324-25, 128 S.Ct. 999 ("State tort law... disrupts the federal scheme no less than state regulatory law to the same effect."). However, the Supreme Court has made clear 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." Riegel, 552 U.S. at 330, 128 S.Ct. 999; see also Stengel v. Medtronic, Inc., 704 F.3d 1224, 1228 (9th Cir.2013) (en banc) ("[T]he MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty under the MDA.").
The Eleventh Circuit also has shed light on the meaning of parallel requirements:
Wolicki-Gables v. Arrow Int'l, Inc., 634 F.3d 1296, 1300 (11th Cir.2011) (quoting McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir.2005)) (emphasis in original).
"To properly plead parallel claims that survive preemption, a plaintiff must allege facts (1) showing an alleged violation of FDA regulations or requirements related to [the device], and (2) establishing a causal nexus between the alleged injury and the violation." Erickson v. Boston Scientific Corp., 846 F.Supp.2d 1085, 1092 (C.D.Cal.2011) (internal quotation marks omitted); see also Simmons v. Boston Scientific Corp., No. CV 12-7962, 2013 WL 1207421, at *4 (C.D.Cal. Mar. 25, 2013) ("[A] plaintiff must allege that the defendant violated a particular federal specification referring to the device at issue, or identify specific PMA requirements that have been violated." (internal citations and quotation marks omitted)).
Thus, in Stengel, an en banc panel of the Ninth Circuit held that the plaintiffs' proposed negligence claim for failure to report adverse events to the FDA was not preempted "insofar as the state-law duty parallels a federal-law duty under the MDA." 704 F.3d at 1233. As the court explained, FDA regulations required the manufacturer to file an adverse event report with the FDA if it learned of information "reasonably suggesting]" that its device "[m]ay have caused or contributed to a death or serious injury." 21 C.F.R.
The MDA also provides that all actions to enforce FDA requirements "shall be by and in the name of the United States." 21 U.S.C. § 337(a). The Supreme Court interpreted § 337(a) in Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001), and concluded that the provision "leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions." Id, at 349 n. 4, 121 S.Ct. 1012. In Buckman, "the plaintiffs asserted a state law fraud claim based on purported misrepresentations made to the FDA during the premarket approval process for the medical device at issue." Stengel, 704 F.3d at 1235 (citing Buckman, 531 U.S. at 343, 121 S.Ct. 1012). "The Supreme Court held that this claim was impliedly preempted because it sought to enforce an exclusively federal requirement and was not grounded in traditional state tort law." Id. (citing Buckman, 531 U.S. at 352-53, 121 S.Ct. 1012). Permitting such a result, the Buckman court reasoned, would interfere "with the federal statutory scheme, which `amply empowers the FDA to punish and deter fraud against the Administration.'" 531 U.S. at 348, 121 S.Ct. 1012. Thus, a state law claim is impliedly preempted where it "exist[s] solely by virtue" of federal requirements. Id. at 353, 121 S.Ct. 1012.
Riley v. Cordis Corp., 625 F.Supp.2d 769, 776-77 (D.Minn.2009) (internal quotations and citations omitted) (emphasis added).
The Court begins by addressing Defendants' contention that Plaintiffs claims are expressly preempted. The first prong of the Riegel test — whether the FDA has established requirements for the subject device — is clearly met. In Riegel, the Supreme
Likewise here, the Infuse Device, also a Class III device, has been subjected to the same "rigorous" premarket approval regime described above. The subject device was approved by the FDA on July 2, 2002, and received supplemental review and approval thereafter. As Riegel concluded, such premarket approval imposes federal requirements that are specific to the device and which constitute "federal safety review." Id. at 322-23, 128 S.Ct. 999. Thus, specific federal requirements apply to the Infuse Device.
Plaintiff objects that the first step of Riegel is not met because the "particular medical device" at issue here is only the InFUSE™ Bone Graft used alone in her surgery. Plaintiff argues that the PMA process for the Infuse Device only establishes federal requirements for the InFSE™ Bone Graft used in conjunction with the LT-Cage™ but not the InFUSE™ Bone Graft used alone. Therefore, in Plaintiffs view, no federal requirements apply to the particular medical device that is the object of her lawsuit.
This argument misses the mark. Section 360k(a) broadly preempts any state requirement "with respect to" a particular device, as long as the state requirement is (1) "different from, or in addition to" any federal requirement "applicable ... to the device," and (2) relates to the "safety or effectiveness of the device or to any other matter included in a requirement applicable to the device." Here, Plaintiff's state law claims are bottomed, inter alia, on (1) Defendants' alleged misrepresentations while promoting off-label uses of the Infuse Device, and (2) Defendants' failure to warn of the risks of off-label uses of the Infuse Device, a device which Plaintiff implicitly concedes is subject to federal strictures. Thus, even though Plaintiff was not implanted with the Infuse Device in an approved manner, her state claims are oriented "with respect to" the off-label promotion and use of a device that is covered by federal requirements. This suffices to bring her state law claims within the ambit of express preemption under Riegel.
Having resolved the first step, the Court turns to the central inquiry: whether Plaintiff's state law claims are based on "any requirement" of California law that is "different from, or additional to" federal requirements applicable to the Infuse Device, and that "relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device." § 360k(a). It is undisputed that safety and effectiveness are the prime concerns of Plaintiffs claims, so the key issue is whether California's laws impose duties different from or additional to the federal ones. Because Plaintiffs state law claims proceed on distinct legal theories, the Court addresses them separately.
Plaintiff's failure to warn claim asserts generally that Defendants failed to warn Plaintiff and her physicians of the dangers of using the Infuse Device in an off-label manner. (Compl. ¶ 280). Plaintiff further 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 LTCage and placed posteriorly or laterally in a lumbar spine fusion surgery," and "failed to provide the level of information that an ordinary physician or consumer would expect." (Compl. ¶¶ 284-85).
The Court concludes that Plaintiff's strict products liability failure to warn claim is expressly preempted by the MDA. 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. See Stengel, 704 F.3d at 1234 (Watford, J., concurring) (citing 21 C.F.R. § 814.39(d)). In either case, Plaintiff aims to foist upon Defendants labeling or warning requirements "in addition to" what federal law requires. Therefore, the claim is expressly preempted.
Plaintiff's design defect claim alleges that the Infuse Device was "defectively designed at the time that it left the Defendants' control" because "the design was unsafe when used in the manner promoted by Defendants," and because "the risks of danger in the design outweigh the benefits of the design." (Compl. ¶¶ 299-301). In other words, this claim attacks "the risk/benefit analysis that led the FDA to approve an inherently dangerous Class III device. Such claims are expressly preempted by § 360k." Bryant v. Medtronic, Inc., 623 F.3d 1200, 1206 (8th Cir. 2010); Mitchell v. Collagen Corp., 126 F.3d 902, 913-14 (7th Cir.1997), cert. denied, 523 U.S. 1020, 118 S.Ct. 1300, 140 L.Ed.2d 467 (1998) (strict liability claim that product
Plaintiff's negligence claim asserts that Defendants breached their duties to Plaintiff in four respects: (1) improper promotion and marketing of the Infuse Device to physicians, including for off-label uses; (2) failure to warn physicians and Plaintiff of dangers associated with off-label uses of the Infuse Device; (3) failure to exercise reasonable care by not complying with federal law and regulations applicable to the sale and marketing of the Infuse Device; and (4) failing to exercise reasonable care to prevent the subject device from creating an unreasonable risk of harm to Plaintiff. (Compl. ¶ 329).
First, any negligence claim based solely on illegal off-label promotion is impliedly preempted under Buckman and § 337(a). Like the "fraud on the FDA" claim in Buckman, the instant claim that Defendants engaged in illegal off-label marketing of the Infuse Device "exist[s] solely by virtue" of federal regulations, and is not rooted in any traditional state tort law. Permitting this claim to proceed would essentially allow a private litigant to attempt to enforce the FDCA. Such a claim is impliedly preempted under Buckman. Cf. Perez, 711 F.3d at 1119-20 (fraud by omission claim impliedly preempted because premised on defendant's non-disclosure concerning scope of FDA's premarket approval).
Second, to the extent Plaintiff's negligence claim is premised on a failure to warn or dangerous design (Grounds 2 and 4), the claim is expressly preempted for the same reasons that the preceding strict products liability claims are preempted: these claims proceed on the theory that state law required Defendants to issue warnings about the risks of off-label uses, or make cost-benefit decisions about the device design, "different from" or "in addition to" what applicable federal requirements demand.
Third, to the extent Plaintiff anchors her negligence claim in some other violation of federal law, Plaintiff has not alleged sufficient facts to establish a parallel claim that avoids express preemption. Plaintiff "cannot simply incant the magic words `[Defendant] violated FDA regulations' in order to avoid preemption." Wolicki-Gables v. Arrow Int'l, Inc., 634 F.3d 1296, 1301 (11th Cir.2011). Rather, Plaintiff must allege facts to substantiate that Defendants violated a particular federal requirement applicable to the subject device. Simmons, 2013 WL 1207421, at *4. The vague allegation that Defendants violated federal law is "insufficient to overcome the preemptive reach of § 360k(a)." Caplinger v. Medtronic, Inc., 921 F.Supp.2d 1206, 1224 (W.D.Okla.2013).
Accordingly, Plaintiff's negligence claim must be dismissed.
Plaintiff's claims for fraudulent misrepresentation and fraud in the inducement alleges that "Defendants fraudulently and intentionally misrepresented material and important health and safety product risk information from [sic] Plaintiff and Plaintiffs physicians." (Compl. ¶ 265). Plaintiff further alleges the following grounds for this claim:
(Id. ¶ 267).
Similarly, Plaintiff's claim for strict products liability/misrepresentation alleges that "[i]n the course of marketing Infuse, the MEDTRONIC Defendants made untrue representations of material facts and omitted material information to Plaintiff, Plaintiffs physicians, and the public at large. The MEDTRONIC Defendants sponsored biased medical trials, reports, and articles that wrongfully and inaccurately claimed that the dangers inherent to off-label use of Infuse did not exist or were significantly less than the actual dangers." (Id. ¶ 310). In short, the gravamen of Plaintiffs allegations is that Defendants, in the course of promoting off-label uses of the Infuse Device, fraudulently omitted or misrepresented material facts to Plaintiff and her physician, and that Plaintiff and her physician would not have decided to proceed with the off-label use of the Infuse Device had they known such material facts.
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.
Although the Court has concluded that Plaintiffs fraud-based claims are not susceptible to preemption, these claims must nevertheless be dismissed because Plaintiff has not plead them with the particularity required by Rule 9(b). Plaintiff has alleged generally that Defendants misrepresented the safety of the Infuse Device to physicians and patients. But the Complaint fails to allege the specific contents of those representations, when and where Defendants allegedly made them, and to whom they were made. Nor has Plaintiff alleged which parts of the misrepresentations were misleading, and why they are false. Accordingly, the claim must be dismissed.
Plaintiff 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." (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. ¶ 341).
The Court concludes that Plaintiffs breach of express warranty claim is not expressly preempted because it would not impose any requirement different from or in addition to what federal law demands.
Although the express warranty claim is not federally preempted, Plaintiff has not alleged sufficient facts for the claim to survive dismissal under Rule 8. Under California law, to state a claim for breach of express warranty, Plaintiff must allege that the seller: "(1) made an affirmation of fact or promise or provided a description of its goods; (2) the promise or description formed the basis of the bargain; (3) the express warranty was breached; and (4) the breach caused injury to the plaintiff." Keegan v. Am. Honda Motor Co., Inc., 838 F.Supp.2d 929, 949 (C.D.Cal.2012) (internal citation and quotation marks omitted). Plaintiff has alleged no facts demonstrating that Defendants made any affirmations specifically to Plaintiff or her physician so as to form the basis of the bargain.
Moreover, to state a claim for breach of express warranty, a buyer must plead that notice of the alleged breach was provided to the seller within a reasonable time after discovery of the breach. See Alvarez v. Chevron Corp., 656 F.3d 925, 932 (9th Cir.2011) (internal citations omitted). Thus, Plaintiffs claim fails for the additional reason that she has failed to allege that she gave any notice of the alleged breach to Defendants within a reasonable time after discovering the breach and prior to filing suit. The claim therefore must be dismissed.
For the foregoing reasons, the motion to dismiss the Complaint (Dkt. 16) is GRANTED with leave to amend.
IT IS SO ORDERED.
