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Spellman v. Smith & Nephew, Inc.

United States District Court, D. Arizona

September 24, 2016

Lori Spellman, Plaintiff,
Smith & Nephew, Inc., Defendant.




         At docket 16, defendant Smith & Nephew, Inc. (“S&N”) moves pursuant to Federal Rule of Civil Procedure 12(b)(6) for an order dismissing the complaint of plaintiff Lori Spellman (“Spellman”). Spellman opposes at docket 21. S&N replies at docket 22. Oral argument was requested but would not assist the court.


         Spellman's complaint alleges she was injured by the Birmingham Hip Resurfacing (“BHR”) system, a metal-on-metal hip resurfacing prosthesis manufactured by S&N that was implanted in her hips in 2009 and 2010. In 2014 Spellman “underwent revision of her right hip due to right hip pain.”[1] Her doctor informed her that the BHR system implanted in her right hip was defective and was causing her to suffer pain and “an adverse metal reaction.”[2] Spellman alleges that the BHR system installed in her left hip failed as well, causing her to undergo a second revision surgery.

         Spellman brings two Arizona-common-law causes-of-action against S&N: strict liability and negligence. She alleges that S&N is liable for “designing and/or manufacturing” the BHR systems in violation of the Federal Food, Drug, and Cosmetic Act” (“FDCA”)[3] and related federal regulations.[4] Specifically, Spellman alleges the following ten regulatory violations:

(1) failure to accurately establish the in vivo life expectancy of the BHR;
(2) failure to validate the anticipated wear of the acetabular cup prior to its release into commercial distribution;
(3) failure to establish and maintain appropriate reliability assurance testing to validate the BHR design both before and after its entry into the marketplace;
(4) failure to conduct adequate bio-compatibility studies to determine the BHR's latent propensity to effuse metallic contaminants into the human blood and tissue;
(5) failure to identify the component discrepancy;
(6) failure to capture the component discrepancy or defect during their “Final Acceptance Activities;”
(7) failure to establish and maintain procedures for implementing corrective and preventative action in response to, inter alia, complaints regarding the BHR, returned BHR, and other quality problems associated with the BHR;
(8) failure to appropriately respond to adverse incident reports that strongly indicated the acetabular component was “Malfunctioning [as defined in 21 C.F.R. 803.3], ” or otherwise not responding to its “Design Objection Intent;”
(9) failure to complete device investigations on returned BHR and components, including the acetabular component; and
(10) continuing to inject BHR into the stream of interstate commerce when it knew, or should have known, that the acetabular component was “Malfunctioning [as defined in 21 C.F.R. 803.3]” or otherwise not responding to its “Design Objective Intent.”

         S&N moves for dismissal under Rule 12(b)(6), arguing that Spellman has not pleaded specific, plausible facts showing that her state law claims are not preempted by federal law.


         Rule 12(b)(6) tests the legal sufficiency of a plaintiff's claims. In reviewing such a motion, “[a]ll allegations of material fact in the complaint are taken as true and construed in the light most favorable to the nonmoving party.”[5] To be assumed true, the allegations, “may not simply recite the elements of a cause of action, but must contain sufficient allegations of underlying facts to give fair notice and to enable the opposing party to defend itself effectively.”[6] Dismissal for failure to state a claim can be based on either “the lack of a cognizable legal theory or the absence of sufficient facts alleged under a cognizable legal theory.”[7] “Conclusory allegations of law . . . are insufficient to defeat a motion to dismiss.”[8]

         To avoid dismissal, a plaintiff must plead facts sufficient to “‘state a claim to relief that is plausible on its face.'”[9] “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.”[10] “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.”[11] “Where a complaint pleads facts that are ‘merely consistent with' a defendant's liability, it ‘stops short of the line between possibility and plausibility of entitlement to relief.'”[12] “In sum, for a complaint to survive a motion to dismiss, the non-conclusory ‘factual content, ' and reasonable inferences from that content, must be plausibly suggestive of a claim entitling the plaintiff to relief.”[13]


         A. Federal Preemption

         1. Express preemption

         When Congress passed the Medical Device Amendments (“MDA”)[14] to the FDCA, it “imposed a regime of detailed federal oversight” from the Food and Drug Administration (“FDA”) over the introduction of new medical devices into the market.[15] The MDA contains the following clause that ...

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