United States District Court, N.D. California
ORDER GRANTING DEFENDANT'S MOTION TO DISMISS
JEFFREY S. WHITE, District Judge.
Now before the Court is the motion to dismiss filed by Defendant Mentor Worldwide LLC ("Defendant"). The Court finds that this matter is appropriate for disposition without oral argument and is deemed submitted. See N.D. Cal. Civ. L.R. 7-1(b). Accordingly, the hearing set for June 6, 2014 is hereby VACATED. Having carefully reviewed the parties' papers, considered their arguments and the relevant legal authority, the Court hereby grants Defendant's motion to dismiss.
Plaintiff Edna Malonzo ("Plaintiff") brings state-law claims based on injuries she sustained when the saline breast implants, manufactured by Defendant, leaked and caused a mycobacterial infection. (Compl., ¶ 4.) Plaintiff alleges that before she had the product surgically implanted, Defendant new that its product was extremely dangerous and unsafe and that Defendant failed to take appropriate action to cure the defects or to warn the users of this product or their physicians. ( Id., ¶ 8.) Plaintiff asserts claims for strict product liability, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, res ipsa loquitor, and fraud. Defendant argues that all of Plaintiff's claims are preempted by Section 360k of the Medical Device Amendments ("MDA") to the Food, Drug and Cosmetic Act ("FDCA"). Plaintiff, in her opposition, does not offer any argument that her claims as currently pled are not preempted. Instead, Plaintiff merely seeks leave to amend. The Court will address additional facts as necessary in the remainder of this Order.
A. Applicable Legal Standards.
A motion to dismiss is proper under Federal Rule of Civil Procedure 12(b)(6) where the pleadings fail to state a claim upon which relief can be granted. The Court construes the allegations in the complaint in the light most favorable to the non-moving party and all material allegations in the complaint are taken to be true. Sanders v. Kennedy, 794 F.2d 478, 481 (9th Cir. 1986). However, even under the liberal pleading standard of Rule 8(a)(2), "a plaintiff's obligation to provide the grounds' of his entitle[ment] to relief' requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007) (citing Papasan v. Allain, 478 U.S. 265, 286 (1986)).
Pursuant to Twombly, a plaintiff must not merely allege conduct that is conceivable but must instead allege "enough facts to state a claim to relief that is plausible on its face." Id. at 570. "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (citing Twombly, 550 U.S. at 556). "The plausibility standard is not akin to a probability requirement, but it asks for more than a sheer possibility that a defendant has acted unlawfully.... When 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) (internal quotation marks omitted). If the allegations are insufficient to state a claim, a court should grant leave to amend, unless amendment would be futile. See, e.g., Reddy v. Litton Indus., Inc., 912 F.2d 291, 296 (9th Cir. 1990); Cook, Perkiss & Liehe, Inc. v. N. Cal. Collection Serv., Inc., 911 F.2d 242, 246-47 (9th Cir. 1990).
Where, as here, a plaintiff pleads a claim for fraud, he must also satisfy the requirements of Rule 9(b). Under Rule 9(b), claimants must allege with particularity the circumstances constituting fraud. Moore v. Kayport Package Exp., Inc., 885 F.2d 531, 540 (9th Cir. 1989). The claimant satisfies the heightened particularity requirement if the allegations in his complaint "identif[y] the circumstances constituting fraud so that a defendant can prepare an adequate answer from the allegations." Id. Averments of fraud must be accompanied by "the who, what, when, where, and how" of the misconduct charged. Vess v. Ciba-Geigy Corp. USA, 317 F.3d 1097, 1106 (9th Cir. 2003).
B. Defendant's Motion.
This lawsuit arises from the injuries allegedly caused by saline breast implants, a Class III medical device. MDA "divides medical devices into three classes according to user risk." Stengel v. Medtronic Inc., 704 F.3d 1224, 1226 (9th Cir. 2013). Class III medical devices pose the greatest risk, and are subject to a rigorous "pre-market approval ["PMA"] process" of the Federal Drug Administration ("FDA"). Id.
The PMA process results in a denial, an approval or an approval "with conditions on distribution, marketing or sale." Id. The PMA process includes a "risk-benefit assessment of the device." Id. Thus, the FDA may "approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives." Riegel v. Medtronic, Inc., 552 U.S. 312, 318 (2008).
Even after pre-market approval is granted, there are post-approval statutory and regulatory requirements the manufacturer must satisfy, in addition to any post-approval conditions the FDA imposes on the specific device subject to the PMA. In general, the manufacturer must refrain from manufacturing, packaging, storing, labeling, distributing or advertising the medical device "in a manner that is inconsistent with any conditions to approval specified in the PMA approval order for the device." 21 C.F.R. § 814.80. In addition, the manufacturer must report deaths and serious injuries that the device "has or may have caused or contributed to" and certain device malfunctions, and it "must establish and maintain ...