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Chione v. Medtronic, Inc.

United States District Court, S.D. California

May 7, 2015

MEDTRONIC, INC., ET AL., Defendants.


CYNTHIA BASHANT, District Judge.

On or about February 5, 2014, Plaintiffs Jeffrey Chione and Deanna Chione (collectively "Plaintiffs") commenced this action against Medtronic, Inc., Medtronic USA, Inc., and Medtronic Sofamor Danek USA, Inc. (collectively "Medtronic" or "Defendants") in San Diego Superior Court alleging negligence, strict liability, breach of express and implied warranty, fraud, negligence per se, and loss of consortium. Defendants removed this action to federal court on April 25, 2014 based on diversity of citizenship under 28 U.S.C. § 1441(b). Defendants now move to dismiss this action under Rule 12(b)(6) of the Federal Rules of Civil Procedure. Plaintiffs oppose. (ECF No. 11 ("Opp.").)

The Court heard oral argument on the motion on May 4, 2015. For the following reasons, the Court GRANTS Defendants' motion to dismiss with leave to amend. (ECF No. 6.)


This is a products liability action arising out of Defendants' alleged illegal and off-label[1] promotion of INFUSE Bone Graft ("Infuse"), a medical device manufactured by Defendants. (ECF No. 1-1 ("Compl.") at ¶¶ 1, 8.) Infuse is a surgically implanted medical device containing a genetically engineered protein designed to stimulate bone growth. (Id. at ¶ 8.)

On January 12, 2001, Defendants submitted Infuse to the Federal Drug Administration ("FDA") for premarket approval. (Id. at ¶ 24.) During the approval process, the FDA Advisory Committee expressed concern about the potential for off-label use of Infuse. (Id. at ¶¶ 26, 33.) Nonetheless, on July 2, 2002, the FDA approved Infuse under expedited review. (Id. at ¶¶ 24, 25.) Despite numerous studies showing that off-label use of Infuse can lead to "serious, even adverse, events, " Plaintiffs claim Medtronic then proceeded to actively promote off-label use, concealing the dangers and its surreptitious effort to promote such off-label use. (Id. at ¶¶ 36-44.)

On April 24, 2007, May 22, 2007, and September 9, 2008, Dr. Eric Korsh performed various back surgeries on Mr. Chione using Infuse. (Id. at ¶¶ 45, 49). Dr. Korsh used Infuse in an off-label manner. (Id. at ¶ 50.) He used Infuse in cervical fusion procedures and a posterior procedure. (Id. at ¶¶ 45-49.) Neither of these procedures has been approved by the FDA. (Id. at ¶ 50). Plaintiff alleges Defendants "directly and indirectly promoted, trained and encouraged Dr. Korsh to use" Infuse in this manner. (Id. at ¶ 51).

Dr. Korsh never informed Mr. Chione (1) that he was using Infuse in an off-label manner, (2) that use of Infuse in a posterior procedure had never been tested or approved by the FDA, (3) that an Infuse "clinical trial utilizing the posterior procedures had been halted due to the serious adverse events that had been experienced, " (4) that use of Infuse "could result in unwanted bone growth and migration of the bone to sensitive nerve areas exacerbating her [sic] pain, " and (5) of available alternative methods of surgery. (Id. at ¶ 52.)

Plaintiffs allege six causes of action: (1) Negligence-largely based on Defendants' failure to warn doctors, the medical community, and the general public of the dangers of the off-label use of Infuse; (2) Strict liability-based on Defendants' promotion of the off-label use of Infuse, impliedly representing such use was safe when Defendants knew it was not; (3) Breach of express and implied warranty-based on Defendants' representations to doctors and members of the public that off-label use was safe and effective; (4) Fraud-based primarily on allegations that Defendants provided inaccurate or misleading information to the medical community which was material to the surgeon's decision to treatment of Plaintiff; (5) Negligence per se-claiming a violation of federal statutes and regulations; and (6) Loss of consortium on behalf of Mr. Chione's spouse, Deanna Chione.

Defendants move to dismiss on the grounds that Plaintiffs' claims are barred by the statute of limitations, both expressly and impliedly preempted by the federal Medical Device Amendments of 1976 ("MDA"), and that Plaintiffs' fraud claims lack particularity.


A. Rule 12(b)(6)

A motion to dismiss pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure tests the legal sufficiency of the claims asserted in the complaint. Fed.R.Civ.P. 12(b)(6); Navarro v. Block, 250 F.3d 729, 732 (9th Cir. 2001). The court must accept all allegations of material fact pleaded in the complaint as true and must construe them and draw all reasonable inferences from them in favor of the nonmoving party. Cahill v. Liberty Mut. Ins. Co., 80 F.3d 336, 337-38 (9th Cir. 1996). To avoid a Rule 12(b)(6) dismissal, a complaint need not contain detailed factual allegations; rather, it must plead "enough facts to state a claim to relief that is plausible on its face." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). "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). "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. at 678 (quoting Twombly, 550 U.S. at 557) (internal quotations omitted).

"[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." Twombly, 550 U.S. at 555 (quoting Papasan v. Allain, 478 U.S. 265, 286 (1986) (alteration in original). A court need not accept "legal conclusions" as true. Iqbal, 556 U.S. at 678. Despite the deference the court must pay to the plaintiff's allegations, it is not proper for the court to assume that "the [plaintiff] can prove facts that [he or she] has not alleged or that defendants have violated ...

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