United States District Court, D. Arizona
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[Copyrighted Material Omitted]
For Debra Martin, Patrick Martin, Plaintiffs: Adam T Funk, Turner Williamson Branch, LEAD ATTORNEYS, Margaret M Branch, Branch Law Firm, Albuquerque, NM; Deborah S Kerr, LEAD ATTORNEY, Goldberg & Osborne, Phoenix, AZ; Marlene J Goldenberg, Stuart L Goldenberg, LEAD ATTORNEYS, Goldenberg Law PLLC, Minneapolis, MN.
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, Reed Smith LLP, Los Angeles, CA.
H. Russel Holland, United States District Judge.
Motion to Dismiss
Defendants move to dismiss plaintiffs' complaint. This motion is opposed. Oral argument was requested but is not deemed necessary.
Plaintiffs are Debra and Patrick Martin. Defendants are Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc.
Defendants are alleged to have " researched, developed, manufactured, marketed, promoted, advertised, sold and distributed" a medical device known as the Infuse® Bone Graft device. The Infuse device " consists of (1) a metallic spinal fusion cage (the LT-Cage[TM]); (2) the bone graft substitute which consists of liquid rhBMP-2 (derived from Chinese hamster cells);  and (3) an absorbable collagen sponge (ACS) which holds the protein and is then placed inside the cage." 
The Infuse device is considered a Class III medical device  and thus in order to market the device, defendants had to obtain Premarket Approval (PMA) from the Federal Drug Agency (FDA). " Premarket approval is a 'rigorous' process."
Riegel, 552 U.S. at 317 (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 477, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996)). " The FDA spends an average of 1,200 hours reviewing each application and grants premarket approval only if it finds there is a reasonable assurance of the device's safety and effectiveness." Id. at 318 (internal citations omitted). " The agency must 'weig[h] any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.'" Id. (quoting 21 U.S.C. § 360c(a)(2)(C)). As part of the PMA process, the manufacturer " must include copies of all proposed labeling for the device," which must include, among other things, " information for use...."  " The FDA evaluates safety and effectiveness under the conditions of use set forth on the label and must determine that the proposed labeling is neither false nor misleading[.]"
Riegel, 552 U.S. at 318 (internal citations omitted).
" On July 2, 2002, the FDA approved Infuse® to treat degenerative disc disease, but only by means of one specific procedure, namely, anterior lumbar interbody fusion (ALIF) surgeries on a single level between L4 and S1."  Plaintiffs allege that " [t]here are numerous lumbar and cervical spine procedures for which Infuse® was not initially approved and for which it has never subsequently been approved."  Use of a medical device in a manner not consistent with the FDA-approved label is known as " off-label" use.
Although physicians may independently decide to use a device off-label, plaintiffs allege that " medical device companies are prohibited by federal law from promoting off-label uses for their medical devices or from paying doctors inducements or kickbacks to promote off-label uses[.]" Yet, according to plaintiffs' allegations, this is exactly what defendants did. Plaintiffs allege that defendants
[i]n order to drive sales of Infuse® , ... engaged in a multi-faceted campaign  to promote off-label uses of Infuse® that consisted of the following techniques:
a. Utilizing its sales representatives to promote off-label uses of Infuse® by having the representa tives be present in operating rooms during surgery to assist physicians, distribute the false and misleading medical literature that was written and/or edited by [defendants], make recommendations concerning dosing, and refer physicians to [defendants'] paid physicians;
b. Utilizing its distributors to purchase gifts for physicians and facilities with the aim of inducing those parties to use Infuse® off-label;
c. Utilizing " Opinion Leaders" and other paid physician consultants to promote off-label uses of Infuse® at conferences, in VIP meetings, hands-on demonstrations, and by having these paid physicians serve as resources for other physicians seeking more information on off-label uses of Infuse® ; and
d. Playing an active role in the writing and editing of nearly all published medical literature on Infuse® from at least 2001 through 2006.
Plaintiffs further allege that defendants engaged in this off-label promotion even though defendants knew that the off-label uses they were promoting were dangerous and likely to cause side effects, " such as severe uncontrolled or ectopic bone growth, severe inflammatory reaction, adverse back and leg pain events, radiculitis, retrograde ejaculation in men, urinary retention, bone resorption, and implant displacement."  Plaintiffs allege that defendants engaged in the off-label promotion of the Infuse device because it was profitable for them to do so.
" On July 14, 2010," plaintiff Debra Martin " underwent a posterolateral lumbar interbody fusion at L4-5 and L5-S1. To achieve fusion, [Debra's] surgeon performed an off-label procedure by utilizing a posterolateral approach, as well as by failing to use the required LT-Cage[TM]."  Plaintiffs allege that defendants, " through their sales representatives and paid Key Opinion Leaders, directly and indirectly promoted, trained, and encouraged [Debra's] surgeon to engage in the off-label procedure of utilizing a posterolateral approach without the required LT-Cages[TM]."  Plaintiffs allege that in August 2013, Debra " was diagnosed with bony overgrowth at L5-S1. A CT-scan also revealed the formation of a cyst near the cage, which had become displaced. As a result, [Debra] has required extensive medical treatment." 
On February 27, 2014, plaintiffs commenced this action. Plaintiff Debra Martin asserts the following state law claims against defendants: 1) fraudulent misrepresentation/fraud in the inducement, 2)
strict products liability - failure to warn, 3) strict products liability - design defect, 4) strict products liability - misrepresentation, 5) product liability -negligence, 6) breach of express warranty, and 7) violation of Arizona's Consumer Protection statutes. Debra's claims are based on her contention that defendants " should not have violated federal law by falsely and misleadingly promoting and marketing new designs and uses for a product that were never considered or approved by the FDA."  Patrick Martin asserts a loss of consortium claim.
Defendants now move to dismiss plaintiffs' claims.
Defendants move to dismiss pursuant to Rules 9(b) and 12(b)(6), Federal Rules of Civil Procedure. " Rule 12(b)(6) authorizes courts to dismiss a complaint for 'failure to state a claim upon which relief can be granted.'" In re Rigel Pharmaceuticals, Inc. Securities Litig., 697 F.3d 869, 875 (9th Cir. 2012) (quoting Fed.R.Civ.P. 12(b)(6)). " To avoid dismissal, the complaint must provide 'more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.'" Id. (quoting Bell A. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). " '[A] plaintiff must 'allege sufficient factual matter ... to state a claim to relief that is plausible on its face.'" OSU Student Alliance v. Ray, 699 F.3d 1053, 1061 (9th Cir. 2012) (quoting Pinnacle Armor, Inc. v. United States, 648 F.3d 708, 721 (9th Cir. 2011)). " In evaluating a Rule 12(b)(6) motion, the court accepts the complaint's well-pleaded factual allegations as true and draws all reasonable inferences in the light most favorable to the plaintiff." Adams v. U.S. Forest Srvc., 671 F.3d 1138, 1142-43 (9th Cir. 2012). " Rule 9(b) provides that '[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.'" United States ex rel. Cafasso v. General Dynamics C4 Systems, Inc., 637 F.3d 1047, 1054-55 (9th Cir. 2011) (quoting Fed.R.Civ.P. 9(b)). " To satisfy Rule 9(b), a pleading must identify 'the who, what, when, where, and how of the misconduct charged,'" as well as " 'what is false or misleading about [the purportedly fraudulent] statement, and why it is false.'" Id. at 1055 (quoting Ebeid ex rel. United States v. Lungwitz, 616 F.3d 993, 998 (9th Cir. 2010)).
Defendants argue that plaintiffs' claims must be dismissed because they are preempted. The FDA regulates medical devices pursuant to the Medical Device Amendments of 1976 (MDA). The MDA contains an express preemption clause that provides:
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(a). " A state law claim will be expressly preempted by Section 360k(a) when 1) there are federal requirements applicable to the medical device and 2) the state law claim seeks to impose requirements  that relate to safety and
effectiveness of the device that are 'different from, or in addition to' those federal requirements." Hawkins v. Medtronic, Inc., Case No. 1:13-CV-00499 AWI SKO, 2014 WL 346622, at *3 (E.D. Cal. Jan. ...