United States District Court, W.D. Washington, Seattle
MARY JO HERRNANDEZ and LUIS A. HERRNANDEZ, Plaintiffs,
STRYKER CORPORATION, a foreign corporation, et al., Defendants.
ORDER GRANTING DEFENDANTS' MOTION TO DISMISS PLAINTIFFS' FIRST AMENDED COMPLAINT
RICARDO S. MARTINEZ, District Judge.
This matter comes before the Court on Defendants' Motion to Dismiss Plaintiff's First Amended Complaint under Federal Rules of Civil Procedure 12(b)(6). Dkt. #14. Defendants argue that Plaintiffs' claims are explicitly preempted from suit by the United States Supreme Court's decision in Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999 (2008). Id. Defendants further argue that Plaintiffs' claims independently fail under an implied preemption analysis. Id. Finally, Defendants argue that Plaintiffs have failed to adequately plead sufficient facts to meet the appropriate notice pleading standard. Id. Plaintiffs argue that their claims may proceed because they are "parallel claims, " and therefore allowed under Riegel, and that they have pled sufficient facts to meet the applicable pleading standard. Dkt. #16. For the reasons set forth below, this Court disagrees with Plaintiffs and GRANTS Defendants' motion to dismiss.
This matter involves product liability allegations related to a hip replacement. On March 28, 2005, Plaintiff Mary Jo Herrnandez underwent a primary right total hip replacement, receiving the Stryker Trident acetabulum and Secur-Fit stem with a ceramic-on-ceramic bearing surface. Dkt. #10 at ¶ 3.6. After the surgery, she experienced increasing pain, which ultimately became disabling in December of 2011. Id. at ¶ ¶ 3.7-3.9. As a result, the hip system was removed on February 27, 2012. Id. at ¶ 3.10. Plaintiff's orthopedic surgeon determined that the device had failed. Id.
On March 21, 2014, Plaintiffs filed suit in King County Superior Court. Dkt. #4. Ms. Herrnandez seeks compensation for her injuries allegedly sustained as a result of the implantation, and later removal, of the Trident system. See Dkts. #4 and #10 at ¶ 3.5. Mr. Herrnandez brings a derivative loss of consortium claim. Id. Plaintiffs allege six state law causes of action, including: 1) strict liability in tort; 2) negligence; 3) breach of express and implied warranties; 4) failure to warn; 5) products liability; and 6) failure to monitor. Dkt. #10 at ¶ ¶ 4.1-4.52. Defendants have removed the case to this Court on the basis of diversity jurisdiction, and now move to dismiss the case in its entirety. Dkt. #1.
A. Standard of Review Under 12(b)(6)
On a motion to dismiss for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6), all allegations of material fact must be accepted as true and construed in the light most favorable to the nonmoving party. Cahill v. Liberty Mut. Ins. Co., 80 F.3d 336, 337-38 (9th Cir. 1996). However, the court is not required to accept as true a "legal conclusion couched as a factual allegation." Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007)). The Complaint "must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face." Id. at 678. This requirement is met when the plaintiff "pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. Absent facial plausibility, Plaintiffs' claims must be dismissed. Twombly, 550 U.S. at 570.
The Court generally may not consider material beyond the pleadings in ruling on a motion to dismiss. Lee v. City of Los Angeles, 250 F.3d 668, 688 (9th Cir. 2001). However, where documents are referenced extensively in the Complaint, form the basis of Plaintiff's claim, or are subject to judicial notice, the Court may consider those documents in the context of a motion to dismiss. United States v. Ritchie, 342 F.3d 903, 908-09 (9th Cir. 2003). Defendants have sought judicial notice of a number of documents outside of the First Amended Complaint, to which Plaintiffs have not objected. See Dkts. #15 and #16. Accordingly, the Court has taken judicial notice of and considers herein the following documents: 1) Trident System PMA Approval Order and Letters, Summary of Safety and Effectiveness Data, and Labeling (Dkt. #15, Exs. 1 and 2); and 2) two FDA Warning Letters (Dkt. #15, Exs. 3 and 4 1 at 6-8).
B. Applicable Regulatory Framework
While the Food, Drug and Cosmetic Act ("FDCA") has long required approval by the U.S. Food and Drug Administration ("FDA") of new drugs prior to their introduction into the market, oversight of the introduction of new medical devices was historically left largely to the states. Riegel v. Medtronic, Inc., 552 U.S. 312, 315, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). However, the development of medical devices using new technology - such as "kidney dialysis units, artificial heart valves, and heart pacemakers" - prompted concern among policymakers and the public "about the increasingly severe injuries that resulted from the failure of such devices." Medtronic, Inc. v. Lohr, 518 U.S. 470, 475-76, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). In response, Congress enacted the Medical Device Amendments ("MDA") to the FDCA, 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 classifies medical devices into three categories based upon the "risks they present." Id. Medical devices in Class III receive the greatest federal oversight. Id. at 317. "In general, a device is assigned to Class III if it cannot be established that a less stringent classification would provide reasonable assurance of safety and effectiveness, and the device is 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 presents a potential unreasonable risk of illness or injury.'" Id. (quoting 21 U.S.C. § 360c(a)(1)(C)(ii)). New Class III devices must undergo a rigorous premarket approval ("PMA") process. Riegel, 552 U.S. at 317. Only a small percentage of new Class III devices (roughly 1% in 2005) are approved annually by the FDA through the PMA process. Id.
Once the FDA has approved a medical device for sale under the PMA process, the MDA prohibits the manufacturer from making "changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness" without filing a supplementary premarket approval application and obtaining permission from the FDA to make such changes. Id. at 319 (citing 21 U.S.C. § 360e(d)(6)(A)(i)); 21 C.F.R. § 814.39(a). Furthermore, following approval, the manufacturer must report to the FDA any adverse results it has become aware of in patients using the medical device. Riegel, 552 U.S. at 319 (citing 21 U.S.C. § 360i). "The FDA has the power to withdraw premarket approval based on newly reported data or existing information and must withdraw approval if it determines that a device is unsafe or ineffective under the conditions in its labeling." Id. at 319-20 (citing 21 U.S.C. §§ 360e(e)(1); 360h(e)).
Medical device manufacturers in general must comply with the FDA's current good manufacturing practice requirements ("CGMPs"), which set forth a "quality system regulation" and "govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use." 21 C.F.R. § 820.1(a)(1). The CGMPs serve "to ensure that finished devices will be safe and effective and otherwise in compliance with the [FDCA]." Id. "They do not specifically address the design, production and marketing requirements for each and every type of medical device. The CGMP requirements, therefore, leave it up to the manufacturer to institute a quality control ...