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Bausch v. Stryker Corp.

December 9, 2008


The opinion of the court was delivered by: Samuel Der-yeghiayan, District Judge


This matter is before the court on Defendant Howmedica Osteonics Corp.'s ("Howmedica") motion to dismiss. This matter is also before the court on Defendant Stryker Ireland, LTD.'s ("Stryker Ireland") motion to dismiss. For the reasons stated below, we grant Howmedica's motion to dismiss. We also grant Stryker Ireland's motion to dismiss.


Plaintiff Margaret J. Bausch ("Bausch") alleges that on March 21, 2007, she underwent a right total hip replacement surgery during which a surgeon implanted in her a Trident Brand Ceramic on Ceramic Hip Replacement System ("Trident"). According to Bausch, the Trident was designed, manufactured, and sold by Defendants. Bausch alleges that the Trident used in her surgery was defective rendering it unreasonably dangerous. Specifically, Bausch alleges that the Trident contained a component known as the Trident Hemispherical Acetabular Shell, which was recalled by Defendants in January 2008. Bausch further alleges that Defendants had notice of defects in the Trident prior to her surgery and that the United States Food and Drug Administration ("FDA") had issued a letter to Defendants advising them that certain manufacturing methods relating to the Trident were not in conformity with industry, regulatory standards, and Defendants' specifications. Bausch claims that the defect in her Trident caused her to have an unstable right hip, pain, suffering, disability, loss of normal life, the need for revision surgery, delayed care for her other hip, and medical and other expenses.

Bausch brought the instant action and includes in her complaint strict liability in tort claims (Count I) and negligence claims (Count II). Howmedica and Stryker Ireland have moved separately to dismiss all claims pursuant to Federal Rule of Civil Procedure 12(b)(6).


In ruling on a motion to dismiss brought pursuant to Rule 12(b)(6), the court must draw all reasonable inferences that favor the plaintiff, construe the allegations of the complaint in the light most favorable to the plaintiff, and accept as true all well-pleaded facts and allegations in the complaint. Thompson v. Ill. Dep't of Prof'l Regulation, 300 F.3d 750, 753 (7th Cir. 2002); Perkins v. Silverstein, 939 F.2d 463, 466 (7th Cir. 1991). In order to withstand a motion to dismiss, a complaint must allege the "operative facts" upon which each claim is based. Kyle v. Morton High Sch., 144 F.3d 448, 454-55 (7th Cir. 1998); Lucien v. Preiner, 967 F.2d 1166, 1168 (7th Cir. 1992). A plaintiff is required to include allegations in the complaint that "plausibly suggest that the plaintiff has a right to relief, raising that possibility above a 'speculative level' " and "if they do not, the plaintiff pleads itself out of court."

E.E. O.C. v. Concentra Health Services, Inc., 496 F.3d 773, 776 (7th Cir. 2007)(quoting in part Bell Atl. Corp. v. Twombly, 127 S.Ct. 1955, 1965 (2007)). Under the current notice pleading standard in federal courts a plaintiff need not "plead facts that, if true, establish each element of a 'cause of action. . . .'" See Sanjuan v. Amer. Bd. of Psychiatry & Neurology, Inc., 40 F.3d 247, 251 (7th Cir. 1994)(stating that "[a]t this stage the plaintiff receives the benefit of imagination, so long as the hypotheses are consistent with the complaint" and that "[m]atching facts against legal elements comes later"). The plaintiff need not allege all of the facts involved in the claim and can plead conclusions. Higgs v. Carver, 286 F.3d 437, 439 (7th Cir. 2002); Kyle, 144 F.3d at 455. However, any conclusions pled must "'provide the defendant with at least minimal notice of the claim,'" Kyle, 144 F.3d at 455 (quoting Jackson v. Marion County, 66 F.3d 151, 153-54 (7th Cir. 1995)), and the plaintiff cannot satisfy federal pleading requirements merely "by attaching bare legal conclusions to narrated facts which fail to outline the bases of [his] claims."

Perkins, 939 F.2d at 466-67. The Seventh Circuit has explained that "[o]ne pleads a 'claim for relief' by briefly describing the events." Sanjuan, 40 F.3d at 251; Nance v. Vieregge, 147 F.3d 589, 590 (7th Cir. 1998)(stating that "[p]laintiffs need not plead facts or legal theories; it is enough to set out a claim for relief").


Howmedica and Stryker Ireland separately move to dismiss the instant action arguing that, based on the allegations in Bausch's complaint, Bausch can prove no set of facts that would support her claims for relief. Howmedica and Stryker Ireland argue that both of Bausch's state common law claims are preempted by the Medical Device Amendments ("MDA") of 1976, 21 U.S.C. § 360k, to the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq. The enactment of the MDA in 1976, established a new "regulatory regime" whereby the preapproval of medical devices into the market would be almost exclusively monitored by the FDA. Riegel v. Medtronic, Inc., 128 S.Ct. 999, 1003 (2008). The MDA contains a preemption clause that provides, with certain exceptions, that "no 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). Howmedica and Stryker Ireland argue in their motions to dismiss that Bausch's claims are predicated upon state common law theories of strict liability and negligence which are considered to be regulations that are "different from, or in addition to" established federal regulations and are, therefore, preempted under the MDA. 21 U.S.C. § 360k(a).

Under the Supremacy Clause of the Constitution, "the Laws of the United States . . . shall be the supreme Law of the Land . . . the Constitution or Laws of any State to the Contrary notwithstanding." U.S. Const. art. VI. The doctrine of preemption arises out of the Supremacy Clause. Chambers v. Osteonics Corp., 109 F.3d 1243, 1246 (7th Cir. 1997)(stating that "[p]ursuant to this authority [in the Supremacy Clause], Congress may preempt state law"). Courts have recognized three different forms of preemption: express preemption, field preemption, and conflict preemption. Aux Sable Liquid Products v. Murphy, 526 F.3d 1028, (7th Cir. 2008). The instant case presents a situation where "a statutory provision [] expressly preempts state law." Medtronic, Inc. v. Lohr, 518 U.S. 470, 484 (7th Cir. 1996).

I. Supreme Court Decision in Riegel

The United States Supreme Court recently addressed the issue of preemption under the MDA in Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008), and found that common law claims relating to medical devices are expressly preempted by the MDA when "the Federal Government has established requirements applicable to" the device, and when the claims "are based upon [state] requirements with respect to the device that are 'different from, or in addition to' the federal ones, and that relate to safety and effectiveness." Id. at 1006 (quoting in part 21 U.S.C. ยง 360k(a)). In Riegel, the plaintiffs brought strict liability, negligence, and other ...

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