United States District Court, D. Arizona
For John Arvizu, Josephine Arvizu, Plaintiffs: Adam T Funk, Margaret M Branch, Turner Williamson Branch, LEAD ATTORNEYS, Branch Law Firm, Albuquerque, NM; Marlene J Goldenberg, Stuart Goldenberg, LEAD ATTORNEY, Goldenberg Law PLLC, Minneapolis, MN; Serena C Montague, LEAD ATTORNEY, Begam & Marks PA, Phoenix, AZ.
For Medtronic Incorporated, Medtronic Sofamor Danek USA Incorporated, Defendants: Kathleen Kelly Kahn, Stephen M Bressler, LEAD ATTORNEYS, Lewis Roca Rothgerber LLP - Phoenix Office, Phoenix, AZ; Michael Kevin Brown, LEAD ATTORNEY, Mildred Segura, Reed Smith LLP - Los Angeles, CA, Los Angeles, CA.
David G. Campbell, United States District Judge.
Defendants Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. have filed a motion to dismiss pursuant to Rule 12(b)(6). Doc. 20. The motion is fully briefed. The Court will grant the motion in part and deny it in part.
Defendants produce the " Infuse Device," which is the Class III medical device at issue in this case. Doc. 20 at 4. The Infuse Device consists of a " metallic spinal fusion cage," known as the LT-Cage, a " bone graft substitute which consists of liquid rhBMP-2" (" Bone Protein" ), and " an absorbable collagen sponge (ACS) which holds the protein and then is placed inside the cage."  Doc. 1, ¶ 57. The Infuse Device was initially approved by the Food and Drug Administration (" FDA" ) via its Premarket Approval (" PMA" ) process on July 2, 2002. Id., ¶ 64. The
approval was " for one limited and very specific spinal fusion procedure with the LT-Cage." Id. Plaintiffs John and Josephine Arvizu allege that " [t]here are numerous lumbar and cervical spine procedures for which [the Infuse Device] was not initially approved and for which it has never subsequently been approved." Doc. 1, ¶ 78. Plaintiffs allege that, despite the limited purpose for which the Infuse Device was approved, Defendants " engaged in a multi-faceted campaign to promote off-label uses of [the Infuse Device]," which included having sales representatives present in operating rooms to assist physicians during surgery, distributing false or misleading medical literature, referring physicians to paid patients, using distributors to purchase gifts for physicians, using paid physician consultants to promote off-label uses at conferences and meetings, and " playing an active role in the writing and editing of nearly all published medical literature on [the Infuse Device] from at least 2001 through 2006." Doc. 1, ¶ 158.
Some of the off-label uses allegedly promoted by Defendants used only the bone protein component of the Infuse Device. Plaintiffs allege that Defendants sold the bone protein and the LT-Cage separately despite the fact that the FDA approval for the Infuse Device required them to be used together. Id., ¶ ¶ 76. Plaintiffs contend that the FDA had concerns about off-label uses of the Infuse Device because some studies showed that " uncontrolled bone growth developed in a number of patients" ( id., ¶ 81), which resulted in these other uses not receiving FDA approval.
Plaintiffs allege that Mr. Arvizu's physician used the Infuse Device in an " off-label" manner. They specifically allege that Mr. Arvizu " underwent a transforaminal lumber interbody fusion at L5-S1[.]" Doc. 1, ¶ 299. Plaintiffs further allege that Defendants, " through their sales representatives and paid Key Opinion Leaders, directly and indirectly promoted, trained and encouraged Plaintiff's surgeon to engage in the off-label procedure of utilizing a transforaminal approach without the required LT Cage." Id., ¶ 300.
Plaintiffs brought this action on April 15, 2014, asserting claims for fraudulent misrepresentation and fraud in the inducement, failure to warn, design defect, misrepresentation, negligence, breach of express warranty, violation of Arizona's Consumer Protection Statutes, loss of consortium, and punitive damages. See Doc. 1, ¶ ¶ 305 -420. Defendants argue that these claims are expressly preempted by section 360k of the Medical Devices Amendments (" MDA" ) to the Federal Food, Drug, and Cosmetic Act (" FDCA" ), and the holding in Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). Doc. 20 at 2. They also contend that Plaintiffs' claims are impliedly preempted by Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). Doc. 20 at 2.
II. Legal Framework.
A. Rule 12(b)(6).
When analyzing a complaint for failure to state a claim to relief under Rule 12(b)(6), the well-pled factual allegations are taken as true and construed in the light most favorable to the nonmoving party. Cousins v. Lockyer, 568 F.3d 1063, 1067 (9th Cir. 2009). Legal conclusions couched as factual allegations are not entitled to the assumption of truth, Ashcroft v. Iqbal, 556 U.S. 662, 680, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009), and therefore are insufficient to defeat a motion to dismiss for failure to state a claim, In re Cutera Sec. Litig., 610 F.3d 1103, 1108 (9th Cir.
To avoid a Rule 12(b)(6) dismissal, the complaint must plead enough facts to state a claim to relief that is plausible on its face. Bell A. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). This plausibility standard " is not akin to a 'probability requirement,' but it asks for more than a sheer possibility that a defendant has acted unlawfully." Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 556). " [W]here the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct, the complaint has alleged B but it has not 'show[n]' B 'that the pleader is entitled to relief.'" Id. at 679 (quoting Fed.R.Civ.P. 8(a)(2)).
B. Rule 9(b).
Rule 9(b) requires that a plaintiff " state with particularity the circumstances constituting fraud or mistake." Fed.R.Civ.P. 9(b). Rule 9(b) has been interpreted by the Ninth Circuit to require the pleader to " state the time, place, and specific content of the false representations as well as the identities of the parties to the misrepresentation." Schreiber Distrib. Co. v. Serv-Well Furniture Co., 806 F.2d 1393, 1401 (9th Cir. 1986). The plaintiff must also " set forth . . . an explanation as to why the disputed statement was untrue or misleading when made." Yourish v. Cal. Amplifier, 191 F.3d 983, 993 (9th Cir. 1999); see also Vess v. Ciba-Geigy Corp. USA, 317 F.3d 1097, 1103 (9th Cir. 2003) (" Averments of fraud must be accompanied by the who, what, when, where, and how of the misconduct charged." ).
C. Federal Preemption.
1. Express and Implied Preemption.
Section 360k of the MDA includes this preemption clause:
Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
21 U.S.C. § 360k.
In Riegel, the Supreme Court outlined a two-part test to determine whether state law claims are expressly preempted under § 360k: (1) whether the federal government established " requirements" applicable to the device in question, and, if so, (2) whether the state common law claims are based on state law requirements " that are different from, or in addition to the federal ones" and " relate to safety and effectiveness." 552 U.S. at 321-22 (citing § 360k(a)); see also Hawkins, 2014 WL 346622, at *3 (quoting Riegel ).
In Buckman, the court held that claims that a device manufacturer had made fraudulent representations to the FDA were " inherently federal in nature" because the ...