ORDER
This cause comes before the Court upon the Motion to Dismiss filed by Defendants Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. (collectively, “Medtronic”) (Doc. 32). Plaintiffs Lori Byrnes and Matthew Byrnes (collectively, “Plaintiffs”) responded in opposition to the Motion (Doc. 36). Medtronic replied in further support of its Motion (Doc. 39). On November 20, 2014, the Court held oral argument on the Motion. Doc. 57. Both sides Submitted a number of supplemental authorities (Docs. 43, 46-51, 53, 61-62, 64-65, 71). The Court, having considered the parties’ submissions and the oral argument, and being fully advised in the premises, .will now GRANT the Motion to Dismiss.
I. STATEMENT OF FACTS
This action arises over the injuries аllegedly caused to Lori Byrnes by the bone graft device Infuse, which was implanted in Ms. Byrnes in an off-label manner during a spinal fusion surgery. The Com
Infuse is a bio-engineered bone graft device that was designed, manufactured, and marketed by Medtronic for use in spinal fusion surgeries. Id. ¶ 2. It consists of three parts: (1) a metallic spinal fusion cage (the* “LT-Cage”); (2) the bone graft substitute; and (3) a sponge-like carrier or scaffold for the bpne graft substitute that is placed inside the fusion cage. Id. ¶ 56. The fusion cage serves to maintain spacing and temporarily stabilize the diseased region of the spine. Id. ¶ 57. The bone graft component serves to form the bone that will permanently stabilize the treated portion of the spine. Id. The sponge serves to bind the bone graft substitute, and resorbs over time. Id. ¶ 58. As the sponge dissolves, the bone graft substitute stimulates the production of new bone. Id.
Infuse is a Class III medical device. Id. ¶ 65. Accordingly, before Medtronic could market Infuse, it was required to submit a Premarket Approval Application (“PMA”) for approval by the U.S. Food and Drug Administration (“FDA”). Id. ¶ 65. As presented in the PMA, Infuse consists of both the LT-Cage and the bone graft component. Id. ¶ 71. In July 2002, the FDA approved Infuse for a certain spinal fusion procedure, id. ¶ 63, specifically, the anteri- or lumbar interbody fusion procedure, which involves a single-level fusion and is performed by approaching the spine from the front through an incision in the abdomen, id. ¶ 72. The approved label indicates that Infuse’s components must be used as a system, and that the bone graft component must not be used without the LT-Cage. Id. 174.
Infuse has never been approved by the FDA for use in any other parts of the body or any other type of procedure (other than two non-spinal uses), id. ¶ 76, due to thе number of adverse events resulting from the use of the bone graft substitute in off-label applications, id. ¶ 80. For example, in a trial examining the application of the. bone graft substitute to posterior lumbar interbody fixation, a number of patients developed uncontrolled bone growth. Id. Further, the FDA admonished Medtronic to guard against the off-label use of Infuse. Id. ¶¶ 84-86.
Despite being aware of the FDA’s concerns regarding the off-label use of Infuse, Medtronic nevertheless sold the LT-Cage and the bone graft component separately. Id. ¶ 75. Moreover, not only did Medtronic intentionally conceal from the general public, the dangers of the off-label use of Infuse, id. ¶¶ 114-15, it actively promoted the off-label use of Infuse through its sales representatives and spine surgeon consultants, id. ¶ 132-38.
In October 2006, Dr. John Small performed a surgery on Ms. Byrnes using Infuse in an off-label manner. Id. ¶ 248. Specifically, Dr. Small implanted Infuse by means of a posterior approach lumbar fusion, and did not use the requisite LT-Cage. Id. Ms. Byrne subsequently suffered and reported increasingly severe pain. Id. ¶ 250. Imaging studies ultimately revealed that Ms. Byrnes had developed uncontrolled bone growth and
In the Complaint, Ms. Byrnes asserts, inter alia, that Medtronic is liable for: (1) fraudulent misrepresentation and fraud in the inducement (First Cause of Action) (2) strict products liability — failure to warn (Second Cause of Action); (3) strict products liability — design defect (Third Cause of Action); (4) strict products liability— misrepresentation (Fourth Cause of Action); (5) products liability — negligence (Fifth Cause of Action); and (6) breach of express warranty (Sixth Cause of Action). Id. ¶¶ 264-348. Ms. Byrnes’ husband, Matthew Byrnes, also asserts' against Medtoonic a claim for loss of consortium (Ninth Cause of Action). Id. ¶¶ 378-79.
Medtronic now moves to dismiss the Causes of Action asserted against it, arguing that they are preempted by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. (“FDCA”). Specificаlly, Medtronic argues that all of Ms. Byrnes’ claims, with the possible exception of those alleging affirmative fraud, are either expressly preempted by the Medical Device Amendments to the FDCA (“MDA”), or impliedly preempted by 21 U.S.C. § 337(a). Medtronic also argues that, to the extent Ms. Byrnes’ claims are premised on affirmative fraud, they must be dismissed because they have not been pleaded with requisite particularity. Med-tronic finally argues that Mr. Byrnes’ loss of consortium claim, as well as Plaintiffs’ request for punitive damages, must fail because all of Ms. Byrnes’ claims fail.
II. LEGAL STANDARD
To survive a motion to dismiss, a pleading must include а “short and plain statement of the claim showing that the pleader is entitled to relief.” Ashcroft v. Iqbal,
III. DISCUSSION
A. Statutory Framework of the Medical Device Amendments
The regulation of medical devices entering the market is governed by the FDCA, which provides that the enforcement of violations “shall be by and in the name of the United States.” 21 U.S.C. § 337(a). In 1976, Congress passed the MDA, which amended the FDCA and imposed a regime of detailed federal oversight. See 21 U.S.C. § 360c et seq. The new regulatory regime separated medical devices into three classes based on the risks they pose to thе public. Id.; Riegel v. Medtronic, Inc.,
1. Premarket Approval
All Class III devices, such as the Infuse product, must undergо the “rigorous” PMA process administered by the FDA. Medtronic, Inc. v. Lohr,
Even after PMA approval is granted, manufacturers are forbidden to make changes in design specifications, manufacturing processes, labeling, or any other attribute that would affect safety or effectiveness, without FDA permission. Id. (citing 21 U.S.C. § 360e(d)(6)(A)(i)). If a manufacturer wishes to make such a change to a device, it must submit an application for supplemental PMA, which is evaluated under identical criteria as the initial application. Id. (citing 21 U.S.C. § 360e(d)(6)). Moreover, after PMA, manufacturers are subject to reporting requirements. Id. (citing 21 U.S.C. § 360i). These include the obligation to inform the FDA of new clinical investigations or scientific studies, 21 C.F.R. § 814.84(b)(2), and to report incidents where the device may have caused or contributed to death or serious injury, 21 C.F.R. § 803.50(a). Riegel,
2. . Preemption under the FDCA Framework
Prior to the statutory enactment of the MDA, the introduction of new medical devices was left largely for the states to supervise as they saw fit. Riegel,
[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). In Riegel, the Supreme Court suggested that the MDA’s preemption of certain state obligations in favor of more detailed federal oversight was justified because of the harm that would be caúsed by stifling innovation in medical devices if “juries were allowed to apply the tort law of 50 States to all innovations.”
Accordingly, ,“[t]he MDA expressly pre-empts [] state requirements different from, or in addition to, any requirement applicable ... to the device under federal law.” Wolicki-Gables v. Arrow Int'l, Inc.,
“In order for a state requirement to be parallel to a federal requirement, and thus not. expressly preempted under § 360k(a), the plaintiff must show that the requirements are ‘genuinely equivalent.’ State and federal requirements' are not genuinely equivalent if a manufacturer could be held liable under the state law without having violated the federal law.”
In Riegel, the Supreme Court established a two-prong test for determining whether a state claim is expressly preempted by the MDA: (i) determine whether the federal government has established requirements applicable to the medical device; and (2) if so, determine whether the state law claims are based upon requirements with respect to the device that are different from, or in addition to, the federal ones, and that relate to safety and effectiveness.
In addition to express preemption-under the MDA, the FDCA also impliedly preempts suits by private litigants “for noncompliance, with the medical device provisions.” See Buckman,
Riegel and Buckman creаte a narrow gap through which a plaintiffs state-law claim must fit if it is to escape express or implied preemption. The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman).
In re Medtronic, Inc., Sprint Fidelis Leads Prod. Liab. Litig.,
B. Application of Preemption Analysis
Infuse was approved through the PMA process. Compl." ¶ 65. Therefore, for purposes of evaluating express preemption, the first prong of the Riegel test is automatically satisfied. See Riegel,
C. Claim-by-Claim Analysis
1. Fraudulent Misrepresentation and Fraud in the Inducement (First Cause of Action)
Medtronic argues that the First Cause of Action is expressly and impliedly preempted to the extent that it is premised on any failure-to-warn theory. The Court agrees. First, to the extent that the claim is based on Medtronic’s failure to warn the, medical community of the dangers associated with the off-label usé of Infuse, including any purported inadequacies in the warnings and labels accompanying Infuse, it is expressly preempted. Critically, Plaintiffs have not identified any federal requirement to inform the public or to update warning labels regarding the dangers of off-label use. Accord McClelland v. Medtronic, Inc.,
Second, to the extent that the claim is based on Medtronic’s failure to report adverse events to the FDA, it is impliedly preempted. Although federal law requires medical devicе manufacturers to file adverse event reports whenever the device “may have caused or contributed to a death or serious injury,” 21 U.S.C. § 360i(a)(l); 21 C.F.R. § 803.50(a), Plaintiffs have failed to identify any Florida state law duty to report to the FDA. Accordingly, such a claim is impliedly preempted, as it is merely “[an] attempt to recast a claim for violation of the FDCA as a state-law negligence claim.” McClelland,
It is unclear whether Medtronic believes that this claim is preempted even to the extent that it is premised on the affirmative misrepresentations it allegedly made to promote the off-label use of Infuse. See Doc. 32 at 11 (arguing that “[Plaintiffs’] claims are — with the possible exception of claims predicated on certain alleged affirmative misrepresentations—
The Court nevertheless agrees that this Cause of Action must be dismissed in its entirety, because, to the extent it relies on affirmative falsehoods and is not preempted, Plaintiffs have failed to plead fraud with the requisite particularity. See Fed.R.Civ.P. 9(b) (“a party must state with particularity the circumstances constituting fraud or mistake”). Indeed, Plaintiffs only allege in a vague and con-clusory manner that Medtronic “fraudulently concealed and misrepresented” the dangers of the off-label use of Infuse, Compl. ¶¶ 265-67, but fail to identify with particularity any misrepresentations and/or concealments that were actually relied upon by Dr. Small, or how those misrepresentations and/or concealments proximately caused Ms. Byrnes’ injuries. The Court, however, will afford Plaintiffs an opportunity to amend the claim to conform to the heightened pleading requirements of claims for fraud.
2. Failure to Warn (Second Cause of Action)
For the reasons discussed in Section III.C.l, supra, Ms. Byrnes’ failure to warn claim is preempted. Further, because this claim does not entail any affirmative falsehoods, it is preempted in its entirety. The Court, therefore, will dismiss this claim with prejudice.
3. Design Defect Claim (Third Cause of Action)
Medtronic argues that Ms. Byrnes’ design defect claim is expressly preempted. The Court agrees. The Third Cause of Action alleges that Infuse was defectively designed because “the risks of danger in the design outweigh the benefits of the design,” and that “[t]he foreseeable risks of harm ... could have been reduced or avoided by adopting a reasonably [sic] alternative design.” Compl. ¶¶ 301, 303. Accordingly, to prevail on this claim, Ms. Byrnes necessarily would have to prove that Medtronic should have employed a design different from the one approved by the FDA — -the consequence of which would be to impose requirements that are “different from, or in addition to” the federal requirements.
Plaintiffs contend that the design defect claim is not preempted because they are not arguing that the Infuse device should
To the extent Plaintiffs rely on Ramirez v. Medtronic Inc.,
Accordingly, the Court finds that the Third Cause of Action is expressly preempted, and will dismiss it with prejudice.
A Misrepresentation (Fourth Cause of Action)
Medtronic argues that Ms. Byrnes’ strict products liability claim for misrepresentation is preempted, and that even if it is not, it must be dismissed pursuant to comment k to Section 402A of the Restatements (Second) of Torts.
Nevertheless, for the reasons discussed in Section III.C.l, supra, to the extent this claim is not preempted, it has been inadequately pleaded. Accordingly, the Court will dismiss the Fourth Cause of Action, but will also grant Plaintiffs leave to amend.
5. Negligence (Fifth Cause of Action)
Ms. Byrnes’ negligence claim appears to be premisеd on several theories: (1) Med-tronic’s promotion and marketing of Infuse for off-label use; (2) Medtronic’s failure to warn physicians and Ms. Byrnes of the dangers of the off-label use of Infuse; (3) Medtronic’s failure to comply with federal law and regulations; and (4) Medtronic’s failure to exercise reasonable care to prevent Infuse from creating an unreasonable risk of harm to Ms. Byrnes and other consumers. Compl. ¶ 329. Each of these grounds, as alleged, is preempted. First, to the extent the negligence claim is premised on a failure-to-warn theory (grounds 2 and 4), it is expressly preempted. See Section III.C.l, supra. Second, to the extent that the claim is premised on the mere fact that Medtronic engaged in off-label promotion (ground 1), it is impliedly preempted, because Plaintiffs have not identified any state law duty to refrain from truthful off-label promotion and have not alleged any affirmative misrepresentations. See supra note 2. Finally, to the extent that the claim is premised on Med-tronic’s failure to comply with federal law and regulations (ground 3), it is impliedly preempted. See Section III.C.l, supra.
Although this claim, as pleaded, is preempted, the Court will give Plaintiffs an opportunity to amend to assert a claim that falls in the narrow gap through which a plaintiffs stаte-law claim must fit if it is to escape express or implied preemption. Accordingly, the Court will dismiss this claim, but without prejudice.
6. Breach of Express Warranty Claim (Sixth Cause of Action)
Medtronic argues that Ms. Byrnes’ breach of express warranty claim is preempted because to prevail on that claim, Plaintiffs must prove that Infuse was not safe and effective as labeled. And, according to Medtronic, such a finding would impose requirements different from or in addition to those imposed by the FDA.
The Court disagrees. As the Complaint makes clear, Ms. Byrnes’ breach of warranty claim is premised on voluntary, - affirmative (but false) warranty statements made by Medtrоnic, aside from any FDA-approved label or warning, to promote the off-label use of Infuse. See, e.g., Compl. ¶ 339. And, as Plaintiffs note, “[flederal law already requires Medtronic to ensure that any warranty statements it voluntarily makes are truthful, accurate, not misleading, and consistent with applicable federal and state law.” Brady,
The Court declines to follow the cases cited by Medtronic, because they are not binding, and because they fail to convincingly address why such a state law requirement would be different from, or in addition to, the federal requirements. For example, the court in Gavin v. Medtronic, Inc., Case No. 12-cv-851,
Although the Court finds that the breach of express warranty claim is not preempted, the Court nevertheless agrеes with Medtronic that this Cause of Action must be dismissed because Plaintiffs’ allegations are insufficient. Indeed, Plaintiffs have failed to allege specifically what affirmations of fact were made by Medtronic to Dr. Small, or how those express warranties proximately caused Ms. Byrnes’ injury. See Compl. ¶¶ 339, 342 (with regard to the alleged express warranties, asserting only that Medtronic made them to unspecified “physicians and other members of the general public and medical community”; and, with regard to causation, alleging only that “Defendants thus breached their express warranty which was a direct and proximate cause of Plaintiffs injuries and damages.”); Fla. Stat. § 672.313(l)(a) (“Express warranties by the seller are created as follows: Any affirmation of fact or promise made by the seller to the buyer which relates to the goods and becomes part of the basis of the bargain ....”) (emphasis added).
The Court will therefore dismiss this Cause of Action, but will also grant Plaintiffs leave to amend to cure any defects in the pleadings.
7. Loss of Consortium (Ninth Cause of Action)
Because all of Ms. Byrnes’ Causes of Action have now been dismissed, see also Doc. 55, the Court must also dismiss Mr. Byrnes’ claim for loss of consortium. See Gates v. Foley,
8. Punitive Damages
As is clear from the above discussion, all of Plaintiffs’ substantive causes of actions must be dismissed. Accordingly, Plaintiffs’ claim for punitive damages must also
IV. CONCLUSION
Many courts have addressed issues that are nearly-identical, if not identical, to the ones currently before this Court. Many have reached conclusions that differ in a multitude of ways, and cannot be reconciled easily, if at all. Having conducted an exhaustive review of those opinions and the reasoning behind them, the Court has applied the general principle that claims premised on voluntary, affirmative falsehoods are not preempted. Accord Buccelli v. Mayer, Case No.2014-CA-1667, Order on Motion to Dismiss of Defendants Medtronic, Inc. and Medtronic Sofamore Danek USA, Inc.,
Accordingly, it is hereby ORDERED:
1. Medtronic’s Motion to Dismiss (Doc. 32) is GRANTED.
2. Plaintiffs’ Second and Third Causes of Action are DISMISSED with prejudice.
3. Plaintiffs’ First, Fourth, Fifth, Sixth, and Ninth Causes of Action are DISMISSED without prejudice.
4. Plaintiffs’ request for punitive damages is DISMISSED without prejudice
5.Plaintiffs are granted leave to file an Amended Complaint within fourteen (14) days from the date of this Order which cures the deficiencies identified in this Order.
Notes
. The following statement of facts is derived from the Complaint (Doc. 2), the allegations of which the Court must accept as true in ruling on a motion to dismiss. See Linder v. Portocarrero,
. The Court emphasizes that its ruling applies only to untruthful off-label promotion, because that is what has been alleged in this case, see Doc. 36 at 9 ("As Plaintiffs have alleged throughout their Complaint, MED-TRONIC aggressively promoted untruthful off-label use of Infuse”); 12 ("the case at hand revolves around fraudulent (and untruthful) off-label promotion by MEDTRONIC”). To the extent that Plaintiffs are suggesting that a claim premised on truthful off-label promotion is not preempted, see Doc. 36 at 10, the Court disagrees. Such a claim would be impliedly preempted because, even if off-label promotion were prohibited under the FDCA, Plaintiffs have failed to identify a state law duty to refrain from off-label promotion, see Schouest,
. Because these are the only grounds for dismissal advanced by Medtronic and briefed by the parties, the Court assumes, without deciding, that such a claim is otherwise cognizable under Florida law.
. To the extent Medtronic argues that this claim fails because Infuse's FDA-approved label expressly disclaims any warranties, see Doc. 32 at 34, the Court rejects this argument as a basis for dismissal. In ruling on a motion to dismiss, a court must accept all the allegations of the complaint as true, and draw all reasonable inferences in favor of the non-moving party. Accordingly, this argument is premature.