Funke v. Sorin Group USA, Inc.

147 F. Supp. 3d 1017, 2015 U.S. Dist. LEXIS 162473, 2015 WL 7747011
CourtDistrict Court, C.D. California
DecidedNovember 24, 2015
DocketCase No.: SACV 15-01182-CJC(ASx)
StatusPublished
Cited by5 cases

This text of 147 F. Supp. 3d 1017 (Funke v. Sorin Group USA, Inc.) is published on Counsel Stack Legal Research, covering District Court, C.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Funke v. Sorin Group USA, Inc., 147 F. Supp. 3d 1017, 2015 U.S. Dist. LEXIS 162473, 2015 WL 7747011 (C.D. Cal. 2015).

Opinion

ORDER GRANTING DEFENDANTS’ MOTION TO DISMISS

CORMAC J. CARNEY, UNITED STATES DISTRICT JUDGE

I. INTRODUCTION

In his Complaint, plaintiff Kevin Funke alleges that he sustained injuries as a result of product defects in the Sorin Mitro-flow Tissue Valve (the “Valve”), a medical device designed and manufactured by defendant Sorin Group USA, Inc. (“Sorin”). Mr. Funke alleges causes of action against Sorin for Negligence; Strict Products Liability — Failure to Warn; Strict Products Liability-Manufacturing Defect; and Nég-ligent Misrepresentation, and seeks punitive damages under California Civil Code § 3294. (CompLU 30-68.) Sorin has moved to dismiss all of Mr, Funke’s causes of action on the basis that each is preempted by federal law. For the reasons discussed below,-the Court DISMISSES Mr. Funke’s complaint and grants him leave to amend.

II. BACKGROUND

The following facts from Mr. Funke’s Complaint are accepted as true for the purposes of-this Motion to Dismiss. Mr. Funke underwent aortic valve replacement surgery on July 9, 2008. (ComplJ 23.) A Mitroflow Tissue Value, manufactured by Sorin, was installed during the operation. (Id.) Mr. Funke was told to expect that the Valve would last at least ten years before needing to be replaced, but about five years after the Valve was installed, it failed and Mr. Funke was diagnosed with an aortic murmur. (ComplJ 24-25.)

The Valve consists of a single piece of bovine pericardium sewn into a plastic frame and covered with polyester fabric. (ComplJ 9.) Mr. Funke asserts that Sorin was aware of a large number of reported events where the Valve failed within five years of placement, and was “aware that this was being contributed to by manufacturing processes and design issues relating to the .cross stitches at the stent post and the darcon [sic] fabric, leading to abrasion, rubbing, fatigue damage, and ultimately device failure.” (ComplJ 19.) Mr. Funke’s Valve in particular was found to have “structural valve deterioration with calcification at the commissure posts as well as some degree of erosion on the leaflets.” (ComplJ 26.) After the operation, the Valve removed from Mr. Funke was sent to Sorin for investigation into the reason for the failure. (ComplJ 27.) So-rin has ignored Mr. Funke’s requests for information concerning the results of that investigation. (Id.)

III.LEGAL STANDARD

A motion to dismiss for failure to state a claim challenges the legal sufficiency of the claims stated in the complaint. Conservation Force v. Salazar, 646 F.3d 1240, 1241-42 (9th Cir.2011). To sufficiently state a claim to relief and survive a Rule 12(b)(6) motion, the pleading “does not need detailed factual allegations,” but the “[f]actual allegations must be enough to raise a right to relief above the speculative level.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L,Ed.2d 929 (2007). Mere “labels and conclusions” or a “formulaic recitation of the elements of a cause of action will not do.” Id, Rather, the complaint must contain sufficient factu[1022]*1022al matter, accepted as true, to 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). The Supreme Court has been careful to note that the “plausibility” requirement “does not impose a probability requirement at the pleading stage; it simply calls for enough facts to raise a reasonable expectation that discovery will reveal evidence” supporting the plaintiffs legal claims. Twombly, 550 U.S. at 556, 127 S.Ct. 1955; see also Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 (“The plausibility standard is not akin to a 'probability requirement,’ but it asks for more than a sheer possibility that defendant has acted unlawfully.”).

In light of Twombly and Iqbal, the Ninth Circuit summarized the governing standard as follows: “In sum, for a complaint to survive a motion to dismiss, the nonconclusory factual content, and reasonable inferences from that content, must be plausibly suggestive of a claim entitling the plaintiff to'relief.” Moss v. U.S. Secret Serv., 572 F.3d 962, 969 (9th Cir.2009). Apart from factual insufficiency, a complaint is also subject to dismissal under Rule 12(b)(6) where it lacks a cognizable legal theory, Balistreri v. Pacifica Police Dept., 901 F.2d 696, 699 (9th Cir.1988), or where the allegations on their face “show that relief is- barred” as a matter of law. See Jones v. Bock, 549 U.S. 199, 215, 127 S.Ct. 910, 166 L.Ed.2d 798 (2007) (finding dismissal appropriate when the statute of limitations prevents relief).

In deciding whether to grant a motion to dismiss, courts must accept as true all well-pleaded factual allegations in the pleading under attack. Iqbal, 556 U.S. at 678-79, 129 S.Ct. 1937. A court is not, however, “required to accept as true allegations that are merely conelusory, unwarranted deductions of fact, or unreasonable inferences.” Sprewell v. Golden State Warriors, 266 F.3d 979, 988 (9th Cir.2001). The court’s plausibility analysis is. a “context-specific task,” and it calls on the court to rely on its experience and to exercise common sense. Iqbal, 556 U.S. at 678, 129 S.Ct. 1937.

When ruling bn a motion to dismiss, a court must normally convert a Rule 12(b)(6) motion into one for summary judgment under Rule 56 if the court considers evidence outside of the pleadings. United States v. Ritchie, 342 F.3d 903, 907 (9th Cir.2003). However, a court may consider certain materials, such as documents attached to the complaint, documents incorporated by reference in the complaint, or matters of judicial notice, without converting the motion to dismiss into a motion for summary judgment. Id. at 908.

IV.-' ANALYSIS

Sorin moves to dismiss on the ground that Mr. Funke’s state law claims are preempted by the Medical Device Amendment (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”). The MDA contains an express preemption provision:

[N]o 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). The Supreme Court set, the framework for analyzing express preemption under the MDA in Riegel v. Medtronic, Inc.,

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Bluebook (online)
147 F. Supp. 3d 1017, 2015 U.S. Dist. LEXIS 162473, 2015 WL 7747011, Counsel Stack Legal Research, https://law.counselstack.com/opinion/funke-v-sorin-group-usa-inc-cacd-2015.