NEEDREPLACE, No. Civ. S–12–3052 LKK/KJN.

CourtNew York District Court
Writing for the CourtLAWRENCE K. KARLTON
Citation7 F.Supp.3d 1043
PartiesPaul HERRON, Jr., Plaintiff, v. SMITH & NEPHEW, INC.; Does 1 to 60, inclusive, Defendants.
Docket NumberNo. Civ. S–12–3052 LKK/KJN.
Decision Date24 March 2014

7 F.Supp.3d 1043

Paul HERRON, Jr., Plaintiff,
SMITH & NEPHEW, INC.; Does 1 to 60, inclusive, Defendants.

No. Civ. S–12–3052 LKK/KJN.

United States District Court, E.D. California.

Signed March 21, 2014
Filed March 24, 2014

Motion granted.

[7 F.Supp.3d 1045]

R. Parker White, Poswall White & Cutler, Sacramento, CA, for Plaintiff.

David O'Quinn, PHV, Irwin Fritchie Urquhart & Moore LLC, New Orleans, LA, John W. Shaw, Litsa Georgantopoulos, Morris Polich & Purdy LLP, Los Angeles, CA, for Defendants.


LAWRENCE K. KARLTON, Senior District Judge.

Defendant moves to dismiss the amended complaint, asserting that it is preempted by federal law, and that it fails to state a claim. For the reasons that follow, the amended complaint will be dismissed with leave to amend.


Defendant, Smith & Nephew, Inc., is the manufacturer of the Birmingham Hip Resurfacing System (“BHR System”), a medical device.1 FAC ¶ 6. Defendant sought pre-market approval (“PMA”) of the device, which was granted, with conditions, on May 9, 2006. FAC ¶ 8. See Approval Letter (ECF No. 29–3), Exhibit A to the Declaration of Litsa Georgantopoulous in support of Defendant's motion to dismiss.2 “Pre–Market Approval” is part of a federal regulatory process created by the Medical Device Amendments of 1976 (“MDA”), 21 U.S.C. § 360c et seq. 3

The Approval Letter states that “[f]ailure to comply with any postapproval requirement constitutes a ground for withdrawal of approval of a PMA,” and that “[c]ommercial distribution of a device that is not in compliance with these conditions is a violation” of the federal Food, Drug, and Cosmetic Act. Approval Letter at 7.

On July 11, 2009, plaintiff underwent surgery to replace a BHR System. FAC ¶ 10. Unbeknownst to plaintiff at the time, the BHR System leaks metal ions into the tissues, causing various types of serious injury. FAC ¶ 14. As a result, plaintiff suffered pain and symptoms of cobalt poisoning.4 Id. On May 10, 2012,

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plaintiff's BHR System was removed, and he was told that the device had failed. FAC ¶ 12. On June 1, 2012, a component of the BHR System (the “acetabular component”) was subject to a market recall. FAC ¶ 13.

On June 20, 2012, plaintiff filed a complaint in state court alleging that defendant was strictly liable for the BHR System, under a “Product Liability” cause of action. ECF No. 1 at 15–16 (original complaint). Defendant answered, asserting, among other things, that the complaint was preempted by the Medical Device Amendments of 1976 (“MDA”) to the Federal Drug and Cosmetic Act (the “Act”), 21 U.S.C. § 321 et seq., and federal regulations. Id., at 59–60.

Defendant removed the action to this court on December 19, 2012. Id., at 1. After defendant moved to dismiss the case based upon federal preemption, plaintiff amended his complaint. The amended complaint contains two common-law claims. The first claim alleges “Negligence,” asserting that the device was designed or manufactured in violation of the MDA and its implementing regulations. The second claim alleges “Strict Products Liability,” asserting, in addition to the negligence claims, that the device was “defective” and “unreasonably dangerous” when it entered the stream of commerce, due to defendant's alleged failures to comply with the MDA and regulations.

Defendant now moves to dismiss the amended complaint based upon preemption, and failure to state a claim.

A. Dismissal.

A dismissal motion under Fed.R.Civ.P. 12(b)(6) challenges a complaint's compliance with the federal pleading requirements. Under Fed.R.Civ.P. 8(a)(2), a pleading must contain a “short and plain statement of the claim showing that the pleader is entitled to relief.” The complaint must give the defendant “ ‘fair notice of what the ... claim is and the grounds upon which it rests.’ ” Bell Atlantic v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (quoting Conley v. Gibson, 355 U.S. 41, 47, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957)).

To meet this requirement, the complaint must be supported by factual allegations. Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). Moreover, this court “must accept as true all of the factual allegations contained in the complaint.” Erickson v. Pardus, 551 U.S. 89, 94, 127 S.Ct. 2197, 167 L.Ed.2d 1081 (2007).5

“While legal conclusions can provide the framework of a complaint,” neither legal conclusions nor conclusory statements are themselves sufficient, and such statements are not entitled to a presumption of truth. Iqbal, 556 U.S. at 679, 129 S.Ct. 1937. Iqbal and Twombly therefore prescribe a two-step process for evaluation of motions to dismiss. The court first identifies the nonconclusory factual allegations, and then determines whether these allegations, taken as true and construed in the light most favorable to the plaintiff, “plausibly give rise to an entitlement to relief.” Iqbal, 556 U.S. at 679, 129 S.Ct. 1937.

[7 F.Supp.3d 1047]

“Plausibility,” as it is used in Twombly and Iqbal, does not refer to the likelihood that a pleader will succeed in proving the allegations. Instead, it refers to whether the nonconclusory factual allegations, when assumed to be true, “allow[ ] the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” 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 a defendant has acted unlawfully.” Id. (quoting Twombly, 550 U.S. at 557, 127 S.Ct. 1955).6 A complaint may fail to show a right to relief either by lacking a cognizable legal theory or by lacking sufficient facts alleged under a cognizable legal theory. Balistreri v. Pacifica Police Dep't, 901 F.2d 696, 699 (9th Cir.1990).

B. Preemption.

“There is a presumption against federal preemption of state laws that operate in traditional state domains.” Stengel v. Medtronic Inc., 704 F.3d 1224, 1227 (9th Cir.2013) ( en banc).7 Preemption of fields traditionally occupied by the States will not be found “unless that was the clear and manifest purpose of Congress.” Id. (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 485, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996)). Parties seeking to invalidate a state law claim based on preemption “bear the considerable burden of overcoming ‘the starting presumption that Congress does not intend to supplant state law.’ ” Id. (quoting De Buono v. NYSA–ILA Med. & Clinical Servs. Fund, 520 U.S. 806, 814, 117 S.Ct. 1747, 138 L.Ed.2d 21 (1997)).

A. The Law

This lawsuit arises from the injuries allegedly caused by a BHR System, a Class III medical device.8 The Medical Device Amendments (“MDA”) to the Food, Drug and Cosmetic Act (“FDCA”) “divides medical devices into three classes according to user risk.” Stengel, 704 F.3d at 1226. Class III medical devices pose the greatest risk, and are subject to a rigorous “pre-market approval [“PMA”] process” of the Food and Drug Administration (“FDA”). Id.

The PMA process results in a denial, an approval or an approval “with conditions

[7 F.Supp.3d 1048]

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, 128 S.Ct. 999, 169 L.Ed.2d 892 (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 adverse event files,” and “submit specified followup.” 21 C.F.R. §§ 814.84(a) (must comply with Part 803 reporting requirements); 803.1(a) (general statement of reporting requirements).

B. MDA Preemption.

The Medical Devices Amendments contain an explicit preemption clause which prohibits the States from establishing or continuing 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). However, the FDA regulations provide that the MDA “does not preempt State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the act.” 21 C.F.R. § 808.1(d)(2).

1. The Claims That Are Subject to Preemption.

The Supreme Court has established a two-step framework for determining whether a state law claim is subject to preemption by the MDA.9 First, has the federal government “established requirements applicable to” the medical device? This first step is plainly met by the PMA process here, as pre-market approval “imposes ‘requirements' under the MDA,” and they are “specific to individual devices.” Riegel, 552 U.S. at 322–23, 128 S.Ct. 999. The PMA Approval Letter in this case plainly and specifically refers to the BHR System:

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) for the Birmingham Hip Resurfacing (BHR) System.... [¶] We are pleased to inform you that the PMA is approved.
Approval Letter at 4.

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