Funke v. Sorin Grp. USA, Inc.

• Decision Date: 24 November 2015
• Docket Number: Case No.: SACV 15–01182–CJC(ASx)
• Citation: 147 F.Supp.3d 1017
• Parties: Kenneth Funke, Plaintiff, v. Sorin Group USA, Inc. and Does 1–10, inclusive, Defendants.
• Court: U.S. District Court — Central District of California

147 F.Supp.3d 1017

Kenneth Funke, Plaintiff,

v.Sorin Group USA, Inc. and Does 1–10, inclusive, Defendants.

Case No.: SACV 15–01182–CJC(ASx)

United States District Court, C.D. California, Southern Division.

Signed November 24, 2015

Matthew Ramon Lopez, Ramon R. Lopez, Troy A. Brenes, Lopez McHugh LLP, Newport Beach, CA, for Plaintiff.

Matthew L. Marshall, Wendi J. Frisch, Morris Polich and Purdy LLP, Los Angeles, CA, for Defendants.

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 Mitroflow 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 Negligent Misrepresentation, and seeks punitive damages under California Civil Code § 3294. (Compl.¶¶ 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. (Compl.¶ 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. (Compl.¶ 24–25.)

The Valve consists of a single piece of bovine pericardium sewn into a plastic frame and covered with polyester fabric. (Compl.¶ 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.” (Compl.¶ 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.” (Compl.¶ 26.) After the operation, the Valve removed from Mr. Funke was sent to Sorin for investigation into the reason for the failure. (Compl.¶ 27.) Sorin 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 factual 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 plaintiff's 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 conclusory, 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 on 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., 552 U.S. 312, 321–22, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). Under the Riegel framework, courts must first determine whether the FDA has established requirements applicable to the device at issue. Courts must then determine whether the plaintiff's claims are based on state requirements regarding the device that are “different from, or in addition to” the federal requirements, and that relate to safety and effectiveness. Id. If so, the MDA expressly preempts the plaintiff's claims.

The MDA does not, however, prohibit states from providing remedies for state law claims premised on violations of FDA regulations. Id. at 330, 128 S.Ct. 999. The state duties in that situation are “parallel” to the federal duties, and claims based on the parallel state duties are not preempted. Id. ; Stengel v. Medtronic Inc., 704 F.3d 1224, 1228 (9th Cir.2013) (en banc) (“[T]he MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty under the MDA.”). These parallel state law requirements can be established by either statute or common law. Riegel, 552 U.S. at 324–25, 128 S.Ct. 999.

The MDA also impliedly preempts certain claims that are based solely on violations of federal requirements themselves: it prohibits suits by private litigants to enforce the provisions of the Act, instead requiring that all such actions “shall be by and in the name of the United States.” 21 U.S.C. § 337(a). In Buckman Co. v. Plaintiffs' Legal Committee, the Supreme Court interpreted this provision as impliedly preempting claims seeking to enforce an exclusively federal requirement not also grounded in state law. 531 U.S. 341, 352–53, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) ; see Stengel, 704 F.3d at 1229–30. Together, express preemption and implied preemption leave only a “narrow gap” through which the plaintiff's claims must fit in order to survive. Perez v. Nidek Co., Ltd., 711 F.3d 1109, 1120 (9th Cir.2013).

The threshold prong of Riegel —whether the FDA has established requirements for the device in question—is plainly met here. Because it is classified as a Class III Medical Device under the PMA, the Valve underwent the Premarket Approval (“PMA”) process through which the FDA imposes specific requirements regarding its safety and effectiveness. (Dkt. 10–1, Def.'s Ex. A, FDA's Premarket Approval Summary, PMA No. P060038, for the Mitroflow Tissue Valve, October 23, 2007.)¹ In addition, the Valve is subject to continuing regulation by the FDA in areas such as its manufacturing process. (Id. ) This is sufficient to establish Riegel 's threshold prong. Riegel, 552 U.S. at 322, 128 S.Ct. 999 (“Premarket approval ... imposes ‘requirements' under the MDA.”). The second prong of Riegel, whether Plaintiff's claims are based on any requirement of state law that is “different from, or in addition to” federal requirements and relate to safety and effectiveness, must be addressed separately for each of Mr. Funke's claims.

A. Strict Liability—Failure to Warn

Mr. Funke's state law claim for failure to warn is expressly preempted to the extent it is based on...