United States District Court, D. Arizona
Decided: March 5, 2015.
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Kathryn Marie Jones, Plaintiff, Pro se, Phoenix, AZ.
For Medtronic, Defendant: 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.
Honorable Steven P. Logan, United States District Judge.
Before the Court is Defendant Medtronic's Motion to Dismiss (Doc. 17). The motion is fully briefed ( see Doc. 30, 32), and for the reasons that follow, will be granted.
On January 28, 2014, Plaintiff Kathryn Marie Jones filed a Complaint (Doc. 1-2) in the Maricopa County Superior Court, and the action was removed to federal court on February 26, 2014 (Doc. 1). In the complaint, Plaintiff brings seven causes of action against Defendant for: (1) fraud in the inducement (Count I); (2) actual fraud (Count II); (3) constructive fraud (Count III); (4) willful negligence and gross negligence (Count IV); (5) design defect (Count V); (6) negligence per se (Count VI); and (7) punitive damages (Count VII). (Doc. 1-2.)
At the heart of the complaint is Plaintiff's claim that Defendant is liable for actively promoting the off-label use of its FDA-approved devices. Plaintiff alleges that Defendant is in the business of selling, manufacturing, and distributing medical devices. ( Id. at 3.) Specifically, Defendant is alleged to have manufactured, marketed, promoted, advertised, sold, and distributed " Infuse Bone Graft, Infuse Bone Graft/LT Cage Lumbar Tapered Fusion Devices, Capstone Spinal System Cages, Clydesdale Spinal System Cages, PEEK Intervertebral Cages, Cannulated Screws, Longitude Set Screws, Rods, the METRx system, and any and all other Medtronic devices, products, and therapies implanted in or used upon the body of Plaintiff Kathryn Marie Jones." ( Id. at 3.) Plaintiff further alleges that it is " possible" that her surgeons used the CD Horizon Longitude System during her surgeries. ( Id. at 36.)
On October 26, 2010, Plaintiff's first surgery was a direct lateral anterior interbody fusion during which she alleges her lumbar discs were removed and the Infuse Bone Graft and autogenous bone were implanted in Clydesdale Spinal System Cages (" Clydesdale cage." ) ( Id. at 8.) Plaintiff's second surgery, that same afternoon, was a right transforaminal lumbar interbody fusion, to repair a fractured vertebra and damaged nerve root. After the repairs, Plaintiff alleges she was implanted with the Infuse Bone Graft and autogenous bone in a Capstone Spinal System Cage (" Capstone Cage." ) On October 27, 2010, she underwent a posterior lumbar interbody fusion surgery during which she alleges that the Infuse Bone Graft was implanted without cages. ( Id. at 8-9.) Plaintiff claims her surgeries were unsuccessful and she suffers severe, permanent, disabling injuries as a result. ( Id. at 4.)
Defendant moves to dismiss Plaintiff's claims because they are: (1) expressly preempted by Section 360k of the Medical Device Amendments (" MDA" ) and the holding in Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008); (2) impliedly preempted by Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001); (3) and otherwise fail to state a
claim for relief. Additionally, Defendant argues that Plaintiff's fraud claims fail to comply with Rule 9(b).
In response, Plaintiff urges the Court to adopt the holding in Ramirez v. Medtronic, Inc., 961 F.Supp.2d 977, 985-87 (D. Ariz. 2013), mot. for reconsideration denied (Oct. 24, 2013), which held that if a manufacturer promotes off-label usage of its medical devices, it is creating a new use for the device that is not covered by the MDA and preemption is defeated. Plaintiff further argues that her claims against Class II medical devices are not preempted.
II. Legal Standards
A. Rule 12(b)(6)
A complaint may be dismissed under Rule 12(b)(6) of the Federal Rules of Civil Procedure for failure to state a claim upon which relief can be granted if the complaint fails to state: (1) a cognizable legal theory; or (2) sufficient facts under a cognizable legal theory. Balistreri v. Pacifica Police Dep't, 901 F.2d 696, 699 (9th Cir. 1990). To survive a motion to dismiss, a complaint must contain " a short and plain statement of the claim showing that the pleader is entitled to relief" such that the defendant is given " fair notice of what the . . . claim is and the grounds upon which it rests." Bell A. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (quoting Fed.R.Civ.P. 8(a)(2); Conley v. Gibson, 355 U.S. 41, 47, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957)).
A complaint must " 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 Twombly, 550 U.S. at 570). Facial plausibility requires the plaintiff to plead " factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. " Where a complaint pleads facts that are 'merely consistent with' a defendant's liability, it 'stops short of the line between possibility and plausibility of entitlement to relief.'" Id. (quoting Twombly, 550 U.S. at 557). Although a complaint " does not need detailed factual allegations," a plaintiff must " raise a right to relief above the speculative level." Twombly, 550 U.S. at 555. This requires " more than labels and conclusions, and a formulaic recitation of the elements of a cause of action." Id.
In reviewing a complaint for failure to state a claim, the Court must " accept as true all well-pleaded allegations of material fact, and construe them in the light most favorable to the non-moving party." Daniels-Hall v. Nat'l Educ. Ass'n, 629 F.3d 992, 998 (9th Cir. 2010); see also Cousins v. Lockyer, 568 F.3d 1063, 1067 (9th Cir. 2009). In comparison, " allegations that are merely conclusory, unwarranted deductions of fact, or unreasonable inferences" are not entitled to the assumption of truth, Daniels-Hall, 629 F.3d at 998, and " 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. 2010) (internal citation and quotation omitted).
Although a court may not consider matters outside the pleadings in ruling on a Rule 12(b) motion, a document is not considered " outside" the complaint if it is attached to the complaint and its authenticity is not questioned. Cooper v. Pickett, 137 F.3d 616, 622 (9th Cir. 1997). See also Knievel v. ESPN, 393 F.3d 1068, 1076 (9th Cir. 2005) (a court may consider documents " whose contents are alleged in a complaint and whose authenticity no party questions, but which are not physically attached to the plaintiff's pleading." ) (quotations and
brackets omitted). The Court may also consider undisputed " matters of public record" that are judicially noticed. See Lee v. City of Los Angeles, 250 F.3d 668, 689 (9th Cir. 2001); Fed.R.Evid. 201(b).
B. Rule 9(b)
Fraud claims are subject to Rule 9(b) of the Federal Rules of Civil Procedure, which requires that a plaintiff " state with particularity the circumstances constituting fraud or mistake." Fed.R.Civ.P. 9(b). Rule 9(b) requires that the pleader " 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. Rule 15
Rule 15(a) of the Federal Rules of Civil Procedure provides that leave to amend should be freely granted " when justice so requires." Fed.R.Civ.P. 15(a)(2). " The power to grant leave to amend . . . is entrusted to the discretion of the district court, which 'determines the propriety of a motion to amend by ascertaining the presence of any of four factors: bad faith, undue delay, prejudice to the opposing party, and/or futility.'" Serra v. Lappin, 600 F.3d 1191, 1200 (9th Cir. 2010) (quoting William O. Gilley Enters. v. A. Richfield Co., 588 F.3d 659, 669 n.8 (9th Cir. 2009)). See also Foman v. Davis, 371 U.S. 178, 182, 83 S.Ct. 227, 9 L.Ed.2d 222 (1962); Saul v. United States, 928 F.2d 829, 843 (9th Cir. 1991) (district courts properly deny leave to amend if the proposed amendment would be futile or the amended complaint would be subject to dismissal). When dismissing for failure to state a claim, " a district court should grant leave to amend even if no request to amend the pleading was made, unless it determines that the pleading could not possibly be cured by the allegation of other facts." Lopez v. Smith, 203 F.3d 1122, 1130 (9th Cir. 2000) (quoting Doe v. United States, 58 F.3d 494, 497 (9th Cir. 1995)). See also Carrico v. City & Cnty. of San Francisco, 656 F.3d 1002, 1008 (9th Cir. 2011) (" It is properly denied, however, if amendment would be futile." ).
III. Medical Device Amendments
1. Approval Process
Congress enacted the Medical Device Amendments (" MDA" ) to the Federal Food, Drug and Cosmetic Act (" FDCA" ) and authorized the Food and Drug Administration (" FDA" ) to regulate the safety and effectiveness of medical devices. The MDA establishes different levels of oversight for medical devices, depending upon the risks they present. Riegel v. Medtronic, Inc., 552 U.S. 312, 316, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008).
Class I devices are the safest products and receive the lowest level of oversight, consisting of " general controls" such as labeling requirements. Id.
Class II devices are those " that are potentially more harmful." Medtronic, Inc. v. Lohr, 518 U.S. 470, 477, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). Class II devices
are approved through the 510(k) process, a limited form of review. Id., 518 U.S. at 478. Class II devices are subject to " general controls" and to " special controls," such as performance standards and post-market surveillance measures. Riegel, 552 U.S. at 316-17.
Class III devices receive the most federal oversight, and are subject to a pre-market approval process. Id. at 317-18. The FDA grants pre-market approval (" PMA" ) " only if it finds there is a 'reasonable assurance' of the device's 'safety and effectiveness' . . . after weigh[ing] any probable benefit to health from the use of the device against any probable risk of injury or illness from such use." Id. at 318 (quoting § § 360e(d) & 360c(a)(2)(C)). The FDA must weigh the risks and benefits before granting PMA. Once a device receives PMA, the manufacturer must obtain FDA approval before making any changes in design specification, manufacturing processes, labeling, or other feature that would affect the device's safety or effectiveness. Id. at 319 (citing § 360e(d)(6)(A)(i)). " If the applicant wishes to make such a change, it must submit, and the FDA must approve, an application for supplemental pre-market approval, to be evaluated under the largely the same criteria as an initial application." Id. (citing § 360e(d)(6); 21 C.F.R. § 814.39(c)). After PMA, the manufacturer is required to ...