Source: http://fl.findacase.com/research/wfrmDocViewer.aspx/xq/fac.20180327_0001042.MFL.htm/qx
Timestamp: 2019-04-25 12:37:38+00:00

Document:
FindACase | Romer v. Stryker Corp.
STRYKER CORPORATION, CORIN GROUP, PLC, and CORIN USA LIMITED, Defendants.
JOHK E. STEELE, UNITED STATES DISTRICT JUDGE.
This matter comes before the Court on defendants Corin Group, PLC and Corin USA Limited's Motion to Dismiss (Doc. #3) filed on January 18, 2018. Plaintiffs filed a Response in Opposition (Doc. #20) on March 5, 2018. For the reasons set forth below, the Motion is granted in part with leave to amend Counts III-V.
The Cormet System is a Class III medical device that receives the highest level of federal oversight under the current premarket approval (PMA) process allowed under the Medical Device Amendments of 1976 (MDA). (Doc. #2, ¶ 14.) As a Class III medical device, the Cormet System requires premarket approval from the Food and Drug Administration (FDA) before it can be made commercially available. The FDA gave this approval for the Cormet System on July 3, 2007, but set conditions, namely that the manufacture of each Cormet System must adhere to “Approved Design Standards” in order to ensure the device is able to withstand the stresses of ordinary use without releasing dangerous levels of metal into the body.
On December 6, 2017, plaintiffs initiated this action in state court, seeking to recover damages from defendants based on five theories of products liability under Florida law: negligence per se, manufacturing defects (Count I); negligence per se, improper quality control testing procedures (Count II); strict liability, failure to warn (Count III); strict liability, malfunction theory (Count IV); negligence (Count V). Plaintiff Holly Romer also brings a claim for loss of consortium (Count VI).
After removal, the Corin defendants (hereinafter “defendants”) moved to dismiss, arguing that the FDA device regulations preempt plaintiffs' state law claims, relying on Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). Under Riegel, the MDA preempts state law requirements that are “in addition to, or different from” federal requirements for Class III medical devices that undergo the PMA process. Thus, defendants argue that all of plaintiffs' claims must be dismissed because they are expressly preempted by, or are derivative of, the MDA pursuant to Riegel, and plaintiffs fail to properly allege any parallel state law claims.
Under Federal Rule of Civil Procedure 8(a)(2), a Complaint must contain a “short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2). This obligation “requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (citation omitted). To survive dismissal, the factual allegations must be “plausible” and “must be enough to raise a right to relief above the speculative level.” Id. at 555. See also Edwards v. Prime Inc., 602 F.3d 1276, 1291 (11th Cir. 2010). This requires “more than an unadorned, the-defendant-unlawfully-harmed-me accusation.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (citations omitted).
In deciding a Rule 12(b)(6) motion to dismiss, the Court must accept all factual allegations in a complaint as true and take them in the light most favorable to plaintiff, Erickson v. Pardus, 551 U.S. 89 (2007), but “[l]egal conclusions without adequate factual support are entitled to no assumption of truth.” Mamani v. Berzain, 654 F.3d 1148, 1153 (11th Cir. 2011) (citations omitted). “Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.” Iqbal, 556 U.S. at 678. “Factual allegations that are merely consistent with a defendant's liability fall short of being facially plausible.” Chaparro v. Carnival Corp., 693 F.3d 1333, 1337 (11th Cir. 2012) (internal citations omitted). Thus, the Court engages in a two-step approach: “When there are well-pleaded factual allegations, a court should assume their veracity and then determine whether they plausibly give rise to an entitlement to relief.” Iqbal, 556 U.S. at 679.
The Eleventh Circuit has recently provided guidance on Federal Preemption Law in the context of the MDA. See Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017) (discussing metal-on-metal hip replacements such as the one at issue here); Godelia v. Zoll Services, Inc., 881 F.3d 1309 (11th Cir. 2018). The MDA established the federal regulatory regime for medical devices. 21 U.S.C. § 360c et seq. “Any company wanting to sell a metal-on-metal hip replacement system is required to undergo the FDA's ‘premarket approval process.'” Mink, 860 F.3d at 1325 (citing 21 C.F.R. § 814.1). This is a rigorous process that evaluates a medical device's safety and effectiveness. Id.
The MDA includes an express preemption provision (§ 360k) for Class III medical devices, which protect manufacturers from civil liability to the extent that they comply with federal law. Section 360k states: “no State ... may establish ... any requirement which is (1) different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety and effectiveness of the device ...” 21 U.S.C. § 360k(a). In Riegel, the Supreme Court held that the MDA preempted state law products liability restrictions, including common law requirements, which were in addition to or different from federal regulations used to evaluate Class III medical devices that underwent the PMA process. 552 U.S. 312 (2008).

References: v. 
 v. 
 v. 
 v. 
 v. 
 v. 
 v. 
 v. 
 v. 
 v. 
 § 360
 § 814
 § 360