United States District Court, D. Delaware
[Copyrighted Material Omitted]
Jeffrey M. Gentilotti, Esquire and Robin M. Grogan, Esquire of Bifferato Gentilotti LLC, Wilmington, Delaware, Counsel for Plaintiff. Of Aaron J. Freiwald, Esquire and Glenn A. Ellis, Esquire of Layser & Freiwald, P.C.
M. Duncan Grant, Esquire and James H.S. Levine, Esquire of Pepper Hamilton LLP, Wilmington, Delaware, Counsel for Defendants. Of Murray S. Levin, Esquire and Sean P. Fahey, Esquire of Pepper Hamilton LLP and Daniel L. Ring, Esquire and Andrew E. Tauber, Esquire of Mayer Brown LLP.
Sue L. Robinson, District Judge.
On May 11, 2012, plaintiff Eileen Scanlon (" plaintiff" ) filed this action in the Court of Common Pleas of Philadelphia County, Pennsylvania. On June 7, 2012, defendants Medtronic Sofamor Danek USA, Inc. and Medtronic, Inc. (collectively " defendants" ) removed this action to the United States District Court for the Eastern District of Pennsylvania. (D.I. 1) On July 5, 2012, plaintiff filed an amended complaint alleging violations of Delaware law. (D.I. 8) Defendants moved to dismiss the amended complaint. (D.I. 13) The court took the motion to dismiss under advisement and granted plaintiff leave to file a second amended complaint by December 13, 2012. (D.I. 23) Plaintiff moved for discovery on December 13, 2012 and separately filed a second amended complaint on December 17, 2012. (D.I. 24; D.I. 25) On January 3, 2013, defendants moved to dismiss the second amended complaint. (D.I. 28) On January 11, 2013, the court determined that diversity jurisdiction was proper, but that the United States District Court for the District of Delaware was the proper venue. The court ordered the action transferred and the outstanding motions were denied without prejudice for reconsideration by the transferee court. (D.I. 31)
After transfer to this court, on April 3, 2013, the court denied plaintiff's request for limited discovery and ordered briefing on defendants' arguments regarding dismissal for failure to state a claim. Currently before the court is defendants' motion to dismiss for failure to state a claim. (D.I. 43) The court has jurisdiction over these matters pursuant to 28 U.S.C. § § 1332(a)(1) and 1332(c)(1). Venue is proper under 28 U.S.C. § 1391(b).
II. STANDARD OF REVIEW
A motion filed under Federal Rule of Civil Procedure 12(b)(6) tests the sufficiency of a complaint's factual allegations. Bell A. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007); Kost v. Kozakiewicz, 1 F.3d 176, 183 (3d Cir. 1993). A complaint must contain " a short and plain statement of the claim showing that the pleader is entitled to relief, in order to give the defendant fair notice of what the . . . claim is and the grounds upon which it rests." Twombly, 550 U.S. at 545 (internal quotation marks omitted) (interpreting Fed.R.Civ.P. 8(a)). Consistent with the Supreme Court's rulings in Twombly and Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009), the Third Circuit requires a two-part analysis when reviewing a Rule 12(b)(6) motion.
Edwards v. A.H. Cornell & Son, Inc., 610 F.3d 217, 219 (3d Cir. 2010); Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir. 2009). First, a court should separate the factual and legal elements of a claim, accepting the facts and disregarding the legal conclusions. Fowler, 578 F.3d. at 210-11. Second, a court should determine whether the remaining well-pled facts sufficiently show that the plaintiff " has a 'plausible claim for relief.'" Id. at 211 (quoting Iqbal, 556 U.S. at 679). As part of the analysis, a court must accept all well-pleaded factual allegations in the complaint as true, and view them in the light most favorable to the plaintiff. See Erickson v. Pardus, 551 U.S. 89, 94, 127 S.Ct. 2197, 167 L.Ed.2d 1081 (2007); Christopher v. Harbury, 536 U.S. 403, 406, 122 S.Ct. 2179, 153 L.Ed.2d 413 (2002); Phillips v. Cnty. of Allegheny, 515 F.3d 224, 231 (3d Cir. 2008). In this regard, a court may consider the pleadings, public record, orders, exhibits attached to the complaint, and documents incorporated into the complaint by reference. Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308, 322, 127 S.Ct. 2499, 168 L.Ed.2d 179 (2007); Oshiver v. Levin, Fishbein, Sedran & Berman, 38 F.3d 1380, 1384-85 n.2 (3d Cir. 1994).
The court's determination is not whether the non-moving party " will ultimately prevail" but whether that party is " entitled to offer evidence to support the claims." United States ex rel. Wilkins v. United Health Grp., Inc., 659 F.3d 295, 302 (3d Cir. 2011). This " does not impose a probability requirement at the pleading stage," but instead " simply calls for enough facts to raise a reasonable expectation that discovery will reveal evidence of [the necessary element]." Phillips, 515 F.3d at 234 (quoting Twombly, 550 U.S. at 556). The court's analysis is a context-specific task requiring the court " to draw on its judicial experience and common sense." Iqbal, 556 U.S. at 663-64.
A. Statutory and Regulatory Framework
The Federal Food, Drug, and Cosmetic Act, 52 Stat. 1040, as amended, 21 U.S.C. § 301 et seq., has long required approval by the Food and Drug Administration (" FDA" ) for the introduction of new drugs into the market. The introduction of new medical devices was left largely for the states to oversee. Riegel v. Medtronic, Inc., 552 U.S. 312, 315, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). As more complex medical devices entered the marketplace, Congress passed the Medical Device Amendments of 1976 (" MDA" ), 21 U.S.C. § 360c et seq., " which swept back some state obligations and imposed a regime of detailed federal oversight." Riegel, 552 U.S. at 316.
The MDA divides medical devices into three classes and provides varying levels of oversight for each, according to the risks they present. Class III devices, defined as such because they are " purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or . . . present a potential ...