ORDER GRANTING DEFENDANTS’ MOTION TO DISMISS (Doc. 61)
This civil action is before the Court upon Defendants’ motion to dismiss the Omnibus Complaint filed August 28, 2015 (Doc. 61). The Omnibus Complaint (Doc. 54) consolidates the claims from five cases brought against Defendants. See 4/20/15 Minute Entry and Notation Order. Plaintiffs filed a response to the motion to dismiss on October 26, 2015 (Doc. 63), and Defendants filed a reply on December 15, 2015 (Doc. 65).
I. BACKGROUND
Defendants Medtronic, Inc. and Med-tronic Sofamor Danek, USA, Inc. (hereinafter referred to collectively as the singular “Medtronic”) are medical device manufacturers. Medtronic manufactures many products, but the product at the center of this case is called Infuse. Infuse is used to stimulate bone growth in spinal fusion surgeries.
Infuse, like all medical devices sold in the United States, is regulated by the Food and Drug Administration (FDA), which draws its regulatory authority in this area from the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA). 21 U.S.C. § 360c et seq. Under the MDA, different types of devices receive different levels of FDA scrutiny. Devices that “support[] or sustain[] human life” or “present[ ] a potential unreasonable risk...of injury” are designated “Class III” devices. 21 U.S.C.
“Premarket Approval is a ‘rigorous’ process.” Riegel v. Medtronic, Inc.,
“Once 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. § 360e(d)(6)(A)(i).” Id. A manufacturer which wishes to make such changes “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. § 360e(d)(6); 21 CFR § 814.39(c).” Id.
Infuse is one component of a medical device that was granted PMA by the FDA in 2002. The device itself consists of a collagen carrier sponge soaked with liquid protein rhBMP-2 (this is the portion of the device referred to by the parties and by this Order as “Infuse”) and a metallic cage, the LT-Cage. (Doc. 54, at 86-87). The protein-soaked sponge is placed inside the LT-Cage which is inserted into the patient’s spine. (Id., at 87). The premarket approval specifies that the FDA-approved Infuse device consists of all component parts which must be used together. (Id. at 92). The Infuse device was approved only for use in a single-level fusion in the L4-S1 region of the lumbar spine via the Anterior Lumbar Interbody Fusion procedure and in combination with the LT-Cage. (Id. at 92-93). Use of the device in a manner not approved by the FDA is considered an “off-label” use. (Id. at 92). Nevertheless, medical practitioners are not prohibited from using a legally marketed device like Infuse in a manner that has not been approved by the FDA. See 21 U.S.C. § 396; Buckman,
Plaintiffs in this case are several hundred former patients of Dr. Atiq Durrani, M.D., an orthopedic surgeon operating in the Cincinnati area (in the past). The Omnibus Complaint alleges that Dr. Durrani either directly performed or ordered surgeries utilizing Infuse on Plaintiffs. The Complaint further alleges that each surgery was done using Infuse in a manner that was “off-label,” meaning that Infuse was not used in the specific manner for which the FDA gave PMA to the device. Specifically, Plaintiffs allege that they were subjected to the following off-label uses of Infuse:
[s]ome of the Omnibus Plaintiffs were implanted with Infuse® without the LT-Cage. Some were subjected to a posteri- or surgical approach. Others had Infuse® implanted in multiple levels of the spine. And some Omnibus Plaintiffs had Infuse® implanted in their cervical or thoracic spines.
(Doc. 63, at 9-10). Plaintiffs further allege that, as a result of off-label use of Infuse, each Plaintiff has suffered injury.
The Omnibus Complaint raises the following claims against Medtronic on behalf of all Plaintiffs:
(1) fraudulent concealment, misrepresentation and fraud in the inducement;
(2) strict products liability (failure to warn);
(3) strict products liability (design defect);
(4) strict products liability (misrepresentation);
(5) products liability (negligence); and
(6) breach of express and implied warranties.
II. STANDARD OF REVIEW
A motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6) operates to test the sufficiency of the complaint and permits dismissal of a complaint for “failure to state a claim upon which relief can be granted.” To show grounds for relief, Fed. R. Civ. P. 8(a) requires that the complaint contain a “short and plain statement of the claim showing that the pleader is entitled to relief.”
While Rule 8 of the Federal Rules of Civil Procedure “does not require ‘detailed factual allegations,’.. .it demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation.” Ashcroft v. Iqbal,
Accordingly, “[t]o 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.’ ” Iqbal,
III. ARGUMENT
A. Pleading Standards
An important issue argued by both parties, and relevant to all of Plaintiffs claims, is with what specificity these claims must be pleaded.
Generally, pleadings are governed by Rule 8 of the Federal Rules of Civil Procedure, which states in relevant part:
A pleading that states a claim for relief must contain:
(1) a short and plain statement of the grounds for the court’s jurisdiction, unless the court already has jurisdiction and the claim needs no new jurisdictional support;
(2) a short and plaint statement of the claim showing that the pleader is entitled to relief; and
(3) a demand for the relief sought, which may include relief in the alternative or different types of relief.
Fed. R. Civ. P. 8(a).
As previously stated above, Federal Rule of Civil Procedure 8 “demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation.” Iqbal,
Conclusory allegations that the defendant violated FDA regulations in the manufacture, labeling, or marketing of the premarket approved medical device are insufficient to state a parallel state-law claim and thereby avoid preemption under § 360k(a).” Ali v. Allergan USA, Inc.,2012 WL 3692396 , at *6 (E.D.Va. 2012). Thus, “Plaintiffs cannot simply incant the magic words ‘Medtronic violated FDA regulations’ in order to avoid preemption.” In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig.,592 F.Supp.2d 1147 , 1158 (D.Minn.2009), aff'd sub nom. Bryant v. Medtronic, Inc.,623 F.3d 1200 (8th Cir.2010); accord, e.g., Caplinger I,921 F.Supp.2d at 1224 . Rather, “to avoid preemption, Plaintiff must sufficiently allege a ‘parallel’ claim in accordance with general pleading standards.” Franklin v. Medtronic, Inc.,2010 WL 2543579 , at *8 (D.Colo.2010), report and recommendation adopted,2010 WL 2543570 (D.Colo. 2010). “To state a ‘parallel’ claim” that escapes preemption under § 360k(a), “a plaintiff must allege ... the violation of a specific federal requirement.” Millman v. Medtronic,2015 WL 778779 , at *4 n. 2 (D.N.J. Feb 24, 2015) (emphasis added); accord, e.g., Wolicki-Gables v. Arrow Int'l Inc.,634 F.3d 1296 , 1300-01 (11th Cir.2011). Moreover, “ ‘[t]o properly allege parallel claims, the complaint must set forth facts’ ” that, if true, would establish the predicate federal violation. Franklin,2010 WL 2543579 , at *8 (quoting Parker v. Stryker Corp.,584 F.Supp.2d 1298 , 1301 (D.Colo.2008)) (emphasis by court).
(Doc. 65, at 36-37).
Plaintiffs admit that, for several of the claims in the Omnibus Complaint, Plaintiffs did not plead specific federal laws nor regulations that were allegedly violated. {See Doc. 63, at 28). However, Plaintiffs argue that the specific circumstances behind a medical device products liability case merit a more permissive review of a Complaint’s Rule 8 compliance. Thus, Plaintiffs argue that:
.The better reasoned analysis regarding the specificity required in the context of a design defect claim (or any other claim) and MDA preemption is that a plaintiff need not identify the precise defect or the specific federal regulatory requirements that were alleged violated in order to comply with Rule 8. Waltenburg v. St. Jude Medical, Inc.,33 F.Supp.3d 818 , 827 (W.D.Ky.2014). The Walternberg [sic] Court relied upon the following quote from the Court of Appeals for the Seventh Circuit in Bausch v. Stryker Corp.,630 F.3d at 560 (7th Cir.2010):
Defendants object that the original complaint does not specify the precise defect or the specific federal regulatory requirements that were allegedly violated. Although the complaint would be stronger with such detail, we do not believe the absence of those details shows a failure to comply with Rule 8 of the Federal Rules of CivilProcedure or can support a dismissal under Rule 12(b)(6). Id.
The Seventh Circuit based its decision in part on the fact that “in the context of Class III medical devices, much of the critical information is kept confidential as a matter of federal law [and] there is no public access to complete versions of [the FDA’s premarket approval] documents.” Id. Thus, the Bausch Court reasoned that “[i]f plaintiffs must allege that the defendant violated a particular FDA-approved specification before discovery, then it is difficult to appreciate how any plaintiff will ever be able to defeat a Rule 12(b)(6) motion.” Id. at 561. See also Garross v. Medtronic, Inc.,77 F.Supp.3d 809 , 817 (E.D. Wis. 2015).
(Id. at 28 fn. 8).
Several courts have disagreed with Bausch’s holding that particularity was not required in a products liability pleading involving FDA Class III medical devices. See, e.g., Bertini v. Smith & Nephew, Inc.,
Plaintiffs seem to contend that their complaint should be allowed to proceed because they can’t get to the facts that would support their causes of action without discovery (doc. 8, “it is impossible for Plaintiff to be certain how the [medical device] injured her because there has not yet been discovery”). Unfortunately for Plaintiffs, discovery cannot be used as a fishing expedition to uncover the facts necessary to support the causes of action presented in the complaint, “even when the information needed to establish a claim... is solely within the purview of the defendant or a third party.” New Albany Tractor, Inc., v. Louisville Tractor, Inc.,650 F.3d 1046 , 1051 (6th Cir.2011). Plaintiffs “may not use the discovery process to obtain facts after filing suit.” Id. Absent factual support from which the Court may plausibly infer negligence, Count One fails to meet the pleading standard set forth by the Supreme Court in Iqbal and Twom-bly and must therefore be dismissed.
Anderson v. Boston Scientific Corp.,
Furthermore, even were the Court to apply the lowered pleading standard from Bausch, several of Plaintiffs’ claims would still be deficient because they are not adequately pleaded even under that standard. Here, “unlike [the plaintiffs in Bausch], Plaintiffs simply do not allege—or provide any factual support for an allegation of— violations of federal law” with respect to several of their claims. Id. at *4 fn. 1 (dismissing a products liability claim as insufficiently pleaded to be a parallel claim allowed by the MDA).
B. Plaintiffs’ State Law Claims and Causes of Action Are Preempted by Federal Law
1. Express Preemption
The MDA’s preemption clause, 21 U.S.C. § 360k(a), prohibits the use of state
Although preemption of state-law tort claims may leave some injured individuals “without.. .judicial recourse,” Congress determined that the loss to those comparatively few individuals was outweighed by the benefit to the far greater number “who would suffer without new medical devices if juries were allowed to apply the tort law of 50 states to all innovations.” Riegel,
However, not all state law claims involving medical devices are preempted by the MDA. The Supreme Court has explicitly held that “[njothing in [21 U.S.C.] § 360k denies [a state] the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements.” Medtronic, Inc. v. Lohr,
Accordingly, 21 U.S.C. § 360k(a) creates a two-step test for determining whether state-law claims are preempted. See, e.g., Wolicki-Gables v. Arrow Int’l, Inc.,
a. Established Federal Requirements
Plaintiffs argue that their state-law claims are not preempted because the FDA has not established any requirements for Infuse as it was used on the Plaintiffs in this case. This claim is without merit.
The crux of Plaintiffs’ argument is that the product that was used on each of the Plaintiffs, Infuse, was only one component of the medical device that received PMA
The device that received PMA approval from the FDA was a combination device consisting of two components—the Infuse® bone protein and the LT-Cage. The LT-Cage™ is an intervertebral spacer cage that must be used in combination with the bone protein. The FDA’s 2002 approval of Medtronic’s PMA for this device was expressly restricted to the use of both components together: “These components must be used as a system. The InFuse™ Bone Graft component must not be used without the LT-CAGE™ Lumbar Tapered Fusion Component.” These are not merely requirements the FDA is imposing on an approved device. This is the FDA’s definition of the device it approved.
(Doc. 63, at 19 (emphasis in original)).
Plaintiffs’ argument that the FDA has not established federal requirements for Infuse’s rhBMP-2 component when used without the LT-Cage component is incorrect. Premarket approval extends to all components of an approved device, even when a physician uses the components separately. Thus, nearly every court to consider this issue in an Infuse case has held that “premarket approval is as controlling of the individual components... as it is to the device as a whole.” Hawkins v. Medtronic, Inc.,
Plaintiffs cite two cases to support the proposition that § 360k(a) does not impose FDA requirements on the individual components of an approved medical device.
The first case, Samet v. Procter & Gamble Co.,
Plaintiffs’ other cited case, Purchase v. Advanced Bionics, LLC,
Several courts throughout the country have examined this exact issue and have held that “the FDA established specific federal requirements for the Infuse Device, even when the Infuse Protein is used alone.” Angeles v. Medtronic, Inc.,
Indeed, Plaintiffs’ assertion that pre-market approval of the Infuse device does not extend to the device’s constituent components cannot be reconciled with the FDCA, which explicitly defines “[t]he term ‘device’ ” to “includ[e] any component” of a device. 21 U.S.C. § 321(h) (emphasis added). See also Angeles,
The FDA’s granting of PMA to the Infuse protein and LT-Cage medical device concomitantly established federal requirements on Infuse alone.
b. Parallel Claims
■ As the FDA’s granting of PMA to the Infuse medical device created federal requirements applicable to the device, Plaintiffs state law claims can survive only if the requirements imposed by the state laws are parallel to those imposed by the FDA. Any state-law requirement imposed on FDA-regulated medical devices that is “different from, or in addition to” FDA requirements is expressly preempted and cannot support a Complaint. 21 U.S.C. § 360k(a).
1) Failure to Warn
Plaintiffs’ Omnibus Complaint alleges that Medtronic is liable for Plaintiffs’ injuries due to Plaintiffs’ failure to warn of the dangers of Infuse. Specifically, the Complaint states:
At all relevant times, Defendants misrepresented the safety of Infuse® to physicians and spine patients, including to Plaintiffs and Dr. Durrani, and recklessly, willfully, or intentionally failed to inform each Plaintiff and Dr. Durrani of the significant dangers to patients resulting from the off-label use of Infuse®. Any warnings Defendants may have issued concerning the dangers of off-label uses of Infuse® or regarding the specific risks of those uses were insufficient in light of Defendants’ contradictory prior, contemporaneous, and continuing illegal promotional efforts and promotion of Infuse® for non-FDA-approved off-label uses in the spine and Defendants’ contemporaneous efforts to hide or downplay the true risks and dangers of the off-label uses of Infuse®.
(Doc. 54, at 82).
Plaintiffs’ failure to warn claims are expressly preempted by 21 U.S.C. § 360k(a).
Plaintiffs argue that “the failure to warn claim is premised upon Medtronic’s failure to file adverse-event reports with the FDA.” (Doc. 63, at 26). The FDA requires that all manufacturers or importers of medical devices “shall report[] whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices.. .may have caused or contributed to a death or serious injury.” 21 U.S.C. § 360i(a)(l). Plaintiffs claim that Ohio’s duty to warn extends to third parties, which in this case would include the FDA. Ohio’s imposition of a duty to warn would therefore be a parallel requirement as it pertains to warning the FDA, because federal law already requires that a device manufacturer do so in the form of adverse-event reports.
Plaintiffs’ argument is without merit. Although federal law requires device manufacturers to report certain adverse events to the FDA, there is no state-law duty to report adverse events to the FDA. And the federal duty to report certain information to the FDA is not “identical” (Lohr,
Adverse-event reports are not warnings. Although the FDA “may disclose” adverse-event reports, it is not required to do so. 21 C.F.R. § 803.9(a) (emphasis added). Thus, adverse-event reports, unlike the warnings on a device label, “are not automatically made public.” Pinsonneault,
Furthermore, adverse-event reports do not necessarily result in labeling changes and cannot be used by a manufacturer to unilaterally change the label. Labeling changes require FDA approval (see 21 C.F.R. § 814.39), and the FDA may not approve a safety-related labeling change absent “valid scientific evidence” (id. § 814.20(b)(3)(vi)), a category that specifically excludes “[i]solated case reports” and “reports lacking sufficient details to permit scientific evaluation” (id. § 860.7(c)(2)). Because adverse-event reports are anecdotal and “do[ ] not necessarily reflect a conclusion by.. .FDA.. .that the device ... caused or contributed to the reportable event” (FDA, Manufacturer and User Facility Device Experience Database, http://www.fda.gov/MedicalDevices /Devi-ceRegulationandGuidance/PostmarketRe-quirements/ReportingAdverseEvents/ucml 27891.htm), adverse-event reports are not by themselves sufficient grounds for a labeling change. Given that adverse-event reports are regulatory submissions, not warnings, that must be submitted to the FDA, not to patients or their physicians,
Moreover, because the FDCA does not require that a manufacturer furnish adverse-event reports directly to physicians, any state-law requirement that a manufacturer do so is “different from, or in addition to, any requirement applicable under the FDCA and its implementing regulations, and is pre-empted.” Pinsonneault,
There is, conversely, no state-law requirement that medical-device manufacturers submit adverse-event reports to the FDA. Plaintiffs’ Omnibus Complaint does not identify any Ohio (or other state) authority that “recognize[s] a state common-law failure-to-warn claim based on a failure to properly issue reports to a federal agency, such as the FDA.” Pinsonneault,
Plaintiff has provided the Court with cases in other circuits in which state-law failure-to-warn claims against medical device manufacturers were permitted to proceed based on the theory that the defendants’ failure to provide adverse-event reports to the FDA was a violation of parallel state and federal requirements on manufacturers. See Stengel v. Medtronic Inc.,
Accordingly, Plaintiffs’ failure to warn claims are expressly preempted under 21 U.S.C. § 360k(a) and are therefore dismissed.
2) Design Defect Claim
Plaintiffs have also raised a design defect claim against Defendants. Specifically, the Omnibus Complaint alleges:
Defendants’ Infuse® device was defectively designed at the time that it left their control and was placed into the stream of commerce. The device reached each Plaintiff without a substantial change in the condition in which it was sold.
Defendants’ 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 them. The Infuse® product failed to perform assafely as an ordinary consumer would expect when used, as it was promoted by Defendants and their agent, Dr. Durra-ni, for an off-label manner in spine surgeries.
Defendants’ Infuse® device was defectively designed because the risks of danger in the design outweigh the benefits of the design.
The Infuse® product was designed in a way that caused users to suffer injuries including, but not limited to, pain and weakness in limbs, radiculitis, ectopic bone formation, osteolysis, and poorer global outcomes than equally-effective, alternative designs and treatments. The foreseeable risks of harm posed by using the Infuse® product in a manner promoted by Defendants and their agent, Dr. Durrani, could have been reduced or avoided by adopting a reasonably alternative design. Defendants did not adopt a design that would have rendered the Infuse® product reasonably safe.
(Doc. 51, at 802-03).
Plaintiffs design defect claim is expressly preempted by 21 U.S.C. § 360k(a). Notably, the Omnibus Complaint does not allege, even in a conclusory fashion, that the design of the Infuse device Plaintiffs received was anything other than the design approved by the FDA through the PMA process. Thus, “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.” Beavers-Gabriel,
However, the Supreme Court’s decision in Riegel—which held that § 360k(a) preempts “claims of strict liability.. .and negligence in the design” of a device (
Plaintiffs’ response argues that, although there were no specific allegations that Defendants manufactured Infuse contrary to FDA specifications in the Complaint, the design defect claim should still be allowed to proceed. The response lists several statutes, unmentioned in the Omnibus Complaint, that “may have been violated by Medtronic.” (Doc. 63, at 28-30). However, many of these statutes are irrelevant, and several of them are statutes regulating manufacturing defects rather than design defects. Even read in the manner most possibly favorable to Plaintiffs, the Omnibus Complaint cannot be said to allege manufacturing defects (i.e., that the Infuse used in Plaintiffs’ surgeries was not produced according to FDA specifications); only design defects (i.e., that the process for manufacturing Infuse that was approved by the FDA is faulty) are properly alleged. However, allowing a design defect claim to proceed would be tantamount to holding that a medical device design that
Accordingly, Plaintiffs’ design defect claims are preempted and therefore warrant dismissal.
3) Breach of Express Warranty
Count Six of Plaintiffs’ Omnibus Complaint alleges that Medtronic breached purported express warranties with respect to the “effectiveness [and] safety” of the Infuse device and the “absence of complications” associated with its use. (Doc. 54, at 810-11). For Plaintiffs to prevail on this claim, a jury would need to find that Infuse “was not safe and effective” as labeled. Gavin,
That the purported warranty at issue in this case allegedly encompassed off-label uses is immaterial. When the FDA determined that Infuse is safe and effective as labeled, it knew that medical devices often are—and that Infuse in particular likely would be (cf. Doc. 54, at 74-75)—used in an off-label manner. See United States v. Caronia,
Furthermore, Plaintiffs’ breach of express warranty claim fails to articulate in any fashion what the express warranty made by Defendants was and how that express warranty could be enforced by Ohio law in a parallel fashion to federal law so as to avoid preemption. Plaintiffs’ response cites Hawkins v. Medtronic, Inc.,
This argument is without merit for two reasons. First, as explained in Part III.A, supra, this Court rejects the reduced pleading standard for products liability cases involving FDA Class III medical devices articulated in cases such as Bausch. Second, Plaintiffs’ express warranty claim in this case fails to meet even the more lax standard articulated by the court in Hawkins, as it is absolutely not “clear from the allegations that [the plaintiffl’s claim is in fact premised upon the theory that Defendant violated federal law.” Id.
Accordingly, Plaintiffs’ claim of breach of express warranty is preempted by 21 U.S.C. § 360k(a) and therefore warrants dismissal.
2. Implied Preemption
Defendants’ motion to dismiss also argues that “[e]ven if Plaintiffs had stated a parallel claim that escapes express preemption under [21 U.S.C.] § 360k(a), any such claim predicated on alleged off-label promotion or an alleged failure to submit adverse-event reports to the FDA would be impliedly preempted[.]” (Doc. 61, at 63 (quoting Cales,
In enacting the FDCA, Congress not only declined to create a private cause of action, but also affirmatively required that any action to enforce the FDCA “shall' be by and in the name of the United States” (21 U.S.C. § 337(a)), thereby mandating that the FDCA and its implementing regulations be “enforced exclusively by the Federal Government.” Buckman,
Consequently, through 21 U.S.C. § 337(a), Congress impliedly preempted any private action seeking to enforce duties created by the FDCA and its implementing regulations. As the Sixth Circuit has explained, any claim that relies on the FDCA or its implementing regulations “ ‘[a]s a critical element’ ” is barred by § 337(a). Marsh v. Genentech, Inc.,
Indeed, § 337(a) forbids private plaintiffs from asserting any “state claim [that] would not exist if the FDCA did not exist,” or any claim for which “ ‘the existence of
a. Claims Based on a Failure to Submit Adverse-Event
Reports to the FDA are Impliedly Preempted The Sixth Circuit has squarely held that claims premised on an alleged “failure to submit reports to the FDA” are impliedly preempted by § 337(a), as interpreted by Buckman, because any such claim would be an impermissible attempt to enforce exclusively federal requirements with no counterpart in state law. Marsh,
As Buckman teaches, “the relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law.”
Plaintiffs failure to warn claim, negligence claim, and products liability (misrepresentation) claim all rely upon Defendants’ alleged failure to report adverse events to the FDA. Therefore, these claims are all impliedly preempted and warrant dismissal.
b. Claims Based on “Off-label Promotion” are Impliedly Preempted
“[T]here is no state-law duty to abstain from off-label promotion.” Thorn,
Claims predicated on off-label promotion are thus “impliedly preempted under Buckman and § 337(a),” Caplinger,
Plaintiffs’ failure to warn, design defect, negligence, and breach of implied warranty claims all rely on Defendants’ alleged off-label promotion of Infuse. Accordingly, those claims are impliedly preempted and warrant dismissal.
C. Alternative Grounds for Dismissing Plaintiffs’ Liability Claims
In addition to arguments based on preemption by the MDA, Defendants also advance several alternative arguments as to why Plaintiffs’ product liability claims should fail. As this Court has held Plaintiffs’ product liability claims to be preempted, the Court need not rule upon these arguments. However, in the interest of completeness, the Court will address certain additional grounds for dismissal of Plaintiffs’ claims.
1) Ohio Product Liability Act
Defendant claims that Plaintiffs product liability claims are preempted by the Ohio Product Liability Act (OPLA). Ohio Rev. Code Ann. §§ 2307.71 et seq. The OPLA established in Ohio a comprehensive statutory scheme governing product liability claims. As part of this scheme, the Act expressly states that it is intended “to abrogate all common-law product liability claims or causes of action.” O.R.C. § 2307.71(B). Therefore, any product liability claim not brought under the OPLA would be subject to dismissal.
Plaintiffs did not adequately plead their claims under the OPLA. The OPLA is cited only once in the Omnibus Complaint, in the section establishing jurisdiction:
The Ohio Product Liability Act (R.C. §§ 2307.71, et. seq.) does not impose requirements that are different from or in addition to those imposed by the federal Food and Drug Administration (hereafter the “FDA”), the Medical Device Amendments and Combination Drug and Device Amendments, the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301, et seq., and the regulations promulgated thereunder at 21 CFR § 800, et seq. or elsewhere.
(Doc. 54, at 73). There is no citation to, or even mention of, the Act in any of the sections of the Omnibus Complaint outlining the claims against Defendants. These claims are all clearly pleaded as common-law causes of action arising from the design, production, or marketing of Infuse, or the warnings associated with Infuse, or the alleged failure of the Infuse device to conform to purported representations or warranties. These claims are therefore preempted by the OPLA.
Plaintiffs argue that the fact that their Omnibus Complaint failed to plead any claim under the OPLA is immaterial, citing the Seventh Circuit in Bausch for the proposition that a relaxed pleading standard is required in products liability cases involving medical devices. (Doc. 63, at 26). However, as explained in Part III.A, supra, this Court finds that Plaintiffs’ complaint must be held to the traditional pleading standards of Rule 8 of the Federal Rules of Civil Procedure. Plaintiffs’ failure to identify any specific statutory basis for their claims will not save them from dismissal.
Accordingly, Plaintiffs’ products liability claims are abrogated by the Ohio Product Liability Act.
2) Comment K to Section 402A of the Restatement (Second) of Torts
Ohio has adopted Section 402A of the Restatement (Second) of Torts, according to White v. Wyeth Labs., Inc.,
(1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if
(a) .the seller is engaged in the business of selling such a product, and
(b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.
(2) The rule stated in subsection (1) applies although
(a) the seller has exercised all possible care in the preparation and sale of his product, and
(b) the user or consumer has not bought the product from or entered into any contractual relation with the seller.”
However, Comment K to Section 402A provides an exemption to strict liability of manufacturers for injuries caused by defective' products for “unavoidably unsafe” products. Specifically, the comment provides:
“Unavoidably unsafe products. There are some products, which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidably high degree of risk which they involve. Such a product, properly prepared, and accompanied byproper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.” (Emphasis sic.) 2 Restatement of the Law 2d, Torts, supra, at 353-354.
White,
Plaintiffs argue that “the determination as to whether any particular medical device is ‘unavoidably unsafe’ is necessarily made on a case by case basis,” and that dismissal at this stage based on the Restatement is therefore inappropriate. (Doc. 63, at 36). Defendants argues in response that Infuse’s classification by the FDA as a Class III medical device inherently means that it is unavoidably unsafe and that Comment K’s prohibition of strict liability claims therefore applies. (Doc. 65, at 49-50).
Defendant’s argument is well taken. Class III devices such as Infuse are, as relevant here, defined as devices that are “for a use which is of substantial importance in preventing impairment of human health, or.. ,present[] a potential unreasonable risk of illness or injury.” 21 U.S.C. § 360c(a)(l)(C)(ii). That Infuse in particular “presents a potential unreasonable risk of illness or injury” is evidenced by the fact that the FDA has both: (1) designated Infuse a “restricted device” given “its potentiality for harmful effect” (id. § 360j(e); Mem. Ex. 1 at 1 (designating Infuse a restricted device pursuant to 21 U.S.C. § 360e(d)(l)(B)(ii)) and (2) categorically determined that the less stringent regulatory controls applicable to Class II devices “are insufficient to provide reasonable assurance of safety and effectiveness for an intervertebral body fusion device when it contains a therapeutic biologic grafting material,” as Infuse does. See Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device, 72 Fed. Reg. 32,170, 32,171 (June 12, 2007); see also 21 C.F.R. § 888.3080(b)(2) (classifying “inter-vertebral body fusion devices that include any therapeutic biologic (e.g., bone mor-phogenic protein)” as Class III devices).
Plaintiffs suggest that it would be “inappropriate to determine at this juncture whether, for the Infuse device, ‘there existed no alternative design which would have as effectively accomplished the same purpose or result with less risk,’ such that the device can necessarily be said to be ‘unavoidably unsafe’ under Comment k.” (Doc. 63, at 37 (quoting White,
Plaintiffs also contend that Comment K does not apply to Infuse because the warnings that Medtronic provided were purportedly inadequate. Opp. 37 (“[Pjroper warnings were not properly given.”). But this argument also runs headlong into the device’s receipt of premarket approval and the FDA’s conclusive determination that the warnings contained in the Infuse label are adequate. See Riegel,
Accordingly, Plaintiffs’ strict liability claims are barred by Ohio’s adoption of Section 402A of the Restatement (Second) of Torts due to' the fact that Infuse is an “unavoidably unsafe product.”
3) Medtronic expressly disclaimed all warranties
Defendants’ motion to dismiss argues that Plaintiffs’ claims for breach of express and implied warranties must fail because the FDA-approved labeling for Infuse states that “[n]o warranties, express or implied are made” and that “[i]mplied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.” (Doc. 61-2, at 4). Defendant argues that this explicit disclaimer of warranties defeats Plaintiffs’ warranty claims.
Plaintiffs do not argue that Defendant did not disclaim all warranties. Instead, Plaintiffs’ response argues that “[Medtronic] may or may not have disclaimed warranties. However, since this subject was not mentioned within the Complaint, the topic of disclaimers is not proper in the context of a motion to dismiss.” (Doc. 63, at 33).
Plaintiffs’ argument is not well taken. This Court may take judicial notice of Infuse’s receipt of PMA from the FDA, including the device’s FDA-mandated warning label which includes the warranty disclaimers. See, e.g., Chapman v. Abbott Labs.,
Plaintiffs also argue that, even if Defendants disclaimed all warranties, an express warranty from Defendants overrides any warranty disclaimer. (Doc. 63, at 33 (citing Scovil v. Medtronic, Inc.,
Accordingly, Defendants’ explicit disclaimer of all warranties defeats Plaintiffs’ breach of express and implied warranty claims.
Unlike Plaintiffs’ other claims, the fraud claims in the Omnibus Complaint are not implicated by any preemption analysis. While the other claims all would require some finding that either the Infuse product itself or the Infuse labeling imposed by the FDA were legally deficient in some way, Plaintiffs’ fraud claim is solely related to actions allegedly taken by Defendants— i.e., affirmative misrepresentations about the safety or effectiveness of Infuse and its off-label use—wholly separate from their manufacturing or labeling of Infuse.
Plaintiffs’ fraud claims are subject to the heightened pleading standard outlined in Federal Rule of Civil Procedure 9. That rule states in relevant part:
(b) Fraud or Mistake; Conditions of Mind. In alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake. Malice, intent, knowledge, and other conditions of a person’s mind may be alleged generally.
Fed. R. Civ. P. 9(b). The Sixth Circuit has held that Rule 9(b) specifically requires a claim of fraud to “allege the time, place, and content of the alleged misrepresentations on which he or she relied; the fraudulent scheme; the fraudulent intent of the defendants; and the injury resulting from the fraud.” Sanderson v. HCA-The Healthcare Co. et al.,
Defendants have identified several portions of Plaintiffs’ fraud claim that fail to meet the Rule 9(b) pleading standard. The most glaring flaw in Plaintiffs’ fraud claim is that it simultaneously alleges two contradictory sets of facts. On the one hand, Plaintiffs allege that they were defrauded by Dr. Durrani—who Plaintiffs allege was acting as an agent for Medtronic—when he allegedly misled Plaintiffs concerning the safety of Infuse. On this theory, “Dr. Dur-rani was an Opinion Leader for Defendants” (Doc. 54, at 127) and as such had purportedly “known...for many years” that “off-label use of Infuse in the spine frequently causes serious adverse events” (Id. at 94), yet not only “concealed] these risks from the Plaintiffs” (Id. at 163) but also “fraudulently and intentionally misrepresented” them to Plaintiffs (Id. at 793). On the other hand, Plaintiffs allege that Medtronic “misrepresented the safety of Infuse to... Dr. Durrani.” Id. at 82. On this theory, under which Medtronic supposedly “did not adequately inform... Dr. Durrani.. .of the true incidence of dangerous side effects resulting from the use of Infuse in off-label surgeries or... in any surgery, whether off-label or otherwise” (Id. at 163), Dr. Durrani was purportedly “justified in relying.. .on Defendants’ concealment of information and misrepresentations about the safety risks related to Infuse in deciding to make off-label use of Infuse for spine surgery” (Id. at 797). Thus, Plaintiffs allege that Dr. Durrani simultaneously had and did not have knowledge of the true facts regarding the safety of Infuse.
The inconsistent factual statements of the Omnibus Complaint are not saved by the Federal Rules of Civil Procedure’s allowance of alternative pleading. While Rule 8(d)(3) allows inconsistent claims—a plaintiff may, for example, bring claims for both intentional and unintentional torts, even where recovery on both would impossible—it does not allow what Plaintiffs are attempting to do here—namely, to make “clashing factual assertions.. .in the context of the same claim.” Nat’l W. Life Ins. Co. v. Merrill Lynch, Pierce, Fenner & Smith, Inc.,
Accordingly, Plaintiffs’ claim of fraudulent concealment, misrepresentation and fraud in the inducement warrants dismissal.
IV. CONCLUSION
Ultimately, with the exception of Plaintiffs’ fraud-based claims, all of the claims raised in the Omnibus Complaint represent an attempt to use state law to violate the regulatory monopoly on medical devices which was granted to the FDA via 21 U.S.C. § 360(k). This Court therefore finds, as have many of the other courts across the country that have considered these exact issues, that product liability claims of this nature cannot survive a motion to dismiss. Plaintiffs’ fraud claims independently fail for failing to meet the heightened pleading standard of Rule 9 of the Federal Rules of Civil Procedure.
Accordingly, IT IS ORDERED as follows:
1) Defendants’ motion to dismiss (Doc. 61) is GRANTED;
2) The Clerk shall enter judgment in each of the consolidated cases accordingly, whereupon those cases are TERMINATED on the docket of this Court.
Notes
. Accord, e.g., Hafer v. Medtronic, Inc.,
. Accord, e.g., Bertini v. Smith & Nephew, Inc.,
. Accord, e.g., Byrnes v. Small,
. Accord, e.g., Kemp v. Medtronic, Inc.,
. See also Hafer, 99 F.Supp.3d at 856-57 ("A plaintiff cannot bring a state-law claim that is in substance a claim to enforce the FDCA.”); Arnold v. Alphatec Spine, Inc.,
. Accord Cupek,
. See also Gavin,
. Accord Hafer, 99 F.Supp.3d at 856-57 (given 21 U.S.C. § 337(a), "[a]ny claim based solely on off-label promotion would.. .be impliedly preempted”); Blankenship,
. See also Gross,