Commercial Litigation and Arbitration

Judicial Notice of Internet Evidence — Materials on FDA Website, Both Those Generated by FDA and Non-FDA Studies Required to Be Submitted to FDA

Caton v. Stryker Sustainability Solutions, Inc., 2015 U.S. Dist. LEXIS 181033 (C.D. Cal. May 12, 2015):

Proceedings (In Chambers): Order GRANTING IN PART and DENYING IN PART Motion to Dismiss

Before the Court is Defendants Corin Group PLC and Corin USA Limited's (collectively, "Corin Defendants") motion to dismiss the Second Amended Complaint ("SAC"). Dkt. # 45. Defendants Stryker Sustainability Solutions, Inc.; Stryker Sales Corporation; Stryker Corporation; and Howmedica Osteonics Corp. d/b/a Stryker Orthopaedics (erroneously sued as Howmedica Osteonics Corporation) (collectively, "Stryker Defendants") join in the motion. Dkt. # 46. The Court finds this matter appropriate for decision without oral argument. See Fed. R. Civ. P. 78(b); L.R. 7-15. After considering the arguments in the moving, opposing, and reply papers, the Court GRANTS IN PART and DENIES IN PART the motion to dismiss.

I. Background

Plaintiff Bruce Caton ("Plaintiff") brings a lawsuit against Corin Defendants and Stryker Defendants (collectively, "Defendants"). See SAC ¶¶ 1-10.

The Corin Defendants "entered into a 10-year marketing and distribution agreement with the Stryker [*2]  Defendants to market and sell the Cormet System ["Cormet"]." SAC ¶ 21. The Cormet is an artificial hip prosthesis designed such that there is metal-on-metal contact between the ball at the top of the femur and the acetabulum at the base of the pelvis. Id. ¶¶ 16-20.

The Cormet and certain other medical devices require Premarket Approval ("PMA"). PMA is the Federal Drug Administration's ("FDA") "process of scientific and regulatory review to evaluate the safety and effectiveness" of these medical devices under the Food, Drug, and Cosmetics Act "in order to obtain marketing clearance." Id. ¶ 22. The Corin Defendants received PMA for the Cormet on July 3, 2007. Id. ¶ 25.

The FDA issued a PMA for the Cormet in the form of an approval order ("Approval Order"). Id. The Approval Order and FDA regulation 21 C.F.R. § 814.84 required Defendants to (1) provide the FDA with unpublished reports of data from any clinical investigations or nonclinical laboratory studies involving the Cormet or related devices; (2) provide the FDA with reports in the scientific literature concerning the Cormet; and (3) report adverse reactions "attributable to the [Cormet] that had not been addressed by the [Cormet's] labeling or had [*3]  been addressed by the [Cormet's] labeling but [were] occurring with unexpected severity or frequency[.]" Id. ¶¶ 23-25; 21 C.F.R. §§ 814.82(a)(9), 814.84. In addition, Defendants were required to comply with 21 C.F.R. § 814.80, which states that "a device may not be manufactured, packaged, stored, labeled, distributed, or advertised in a manner that is inconsistent with any conditions to approval specified in the PMA approval order for the device." SAC ¶ 27; 21 C.F.R. § 814.80. Finally, pursuant to 21 C.F.R. § 820.90, the FDA required Defendants to "establish and maintain procedures to identify, document, evaluate, segregate, and dispose of" products if they did not conform to FDA requirements. SAC ¶ 32.

Plaintiff alleges that Defendants knew of problems associated with the use of certain manufacturing techniques, including double heat treatment. Id. ¶ 58. Plaintiff also asserts that Defendants became aware of clinical investigations and studies that revealed problems with the Cormet, including studies indicating the development of cobalt poisoning in patients and the development of pseudo tumors around the devices. Id. ¶ 28. Plaintiff alleges that Defendants did not report these issues to the FDA despite being required to do so. Id. ¶ 37.

Further, Plaintiff contends [*4]  that Defendants violated regulations by failing to report European studies finding high failure rates and revisions for patients implanted with the Cormet. Id. Plaintiff alleges that Defendants did not report this information to the FDA despite being required to do so. Id. ¶ 30. Plaintiff lists five of these sources: (1) a 2011 Annual Report released by the National Joint Registry of England and Wales (the "2011 Report"); (2) a 2008 study by the Royal College of Surgeons (the "2008 Study"); (3) a 2009 study by Hip International (the "2009 Study"); (4) the 2007 study by the Journal of Orthopaedic Surgical (the "2007 Study"); and (5) the 2008 report by the Journal of Bone and Joint Surgery reporting on a 2000 study investigating the Cormet (the "Journal of Bone and Joint Surgery Report"). Id. ¶ 29. Plaintiff also lists three different risks that Defendants knew about but failed to report: (1) the deterioration of the Cormet's surfaces due to double heat treatment; (2) the development of cobalt poisoning in patients; and (3) the development of pseudo tumors around the Cormet devices. Id. ¶¶ 28, 58.

Plaintiff had a Cormet hip prosthesis implanted on January 4, 2011. Id. ¶ 36. On March 29, [*5]  2013, Plaintiff's physician determined that he was suffering from abnormally high metal ion levels in his blood. Id. ¶ 38. Plaintiff underwent a revision surgery on September 3, 2013. Id. ¶ 40. This surgery confirmed that Plaintiff's Cormet prosthesis had failed. Id.

In April 2014, Plaintiff filed this lawsuit against the Stryker Defendants. See Dkt. # 1. On September 12, 2014, the Court granted a motion to dismiss filed by the Stryker Defendants and gave Plaintiff leave to file an amended Complaint. See Dkt. # 17, September 12, 2014 Order ("Order Dismissing Compl."). Plaintiff filed the First Amended Complaint ("FAC") on October 10, 2014 asserting the same claims previously brought against the Stryker Defendants. See Dkt. # 19; FAC ¶¶ 34-55. On December 19, 2014, the Court granted a motion to dismiss the FAC filed by the Stryker Defendants. See Dkt. # 29, December 19, 2014 Order ("Order Dismissing FAC"). Plaintiff filed the operative Second Amended Complaint ("SAC") on February 2, 2015 and added the Corin Defendants to the lawsuit. See Dkt. # 36. The Corin Defendants, joined by the Stryker Defendants, now move to dismiss the SAC pursuant to Federal Rule of Civil Procedure 12(b)(6). See Dkts. # 45-46.

II. Legal Standard

A motion [*6]  to dismiss under Rule 12(b)(6) tests whether the complaint "contain[s] sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face.'" See Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). When deciding a Rule 12(b)(6) motion, the court must accept the facts pleaded in the complaint as true, and construe them in the light most favorable to the plaintiff. Faulkner v. ADT Sec. Servs., Inc., 706 F.3d 1017, 1019 (9th Cir. 2013); Cousins v. Lockyer, 568 F.3d 1063, 1067-68 (9th Cir. 2009). The court, however, is not required to accept "legal conclusions . . . cast in the form of factual allegations." W. Mining Council v. Watt, 643 F.2d 618, 624 (9th Cir. 1981); see Iqbal, 556 U.S. at 678; Twombly, 550 U.S. at 555.

The court may properly consider exhibits attached to the complaint. Manzarek v. St. Paul Fire & Marine Ins. Co., 519 F.3d 1025, 1030-31 (9th Cir. 2008); Amfac Mortg. Corp. v. Az. Mall of Tempe, Inc., 583 F.2d 426, 429-30 (9th Cir. 1978). The court may also consider documents that have been judicially noticed. Lee v. City of L.A., 250 F.3d 668, 688-89 (9th Cir. 2001), overruled on other grounds, Galbraith v. Cnty. of Santa Clara, 307 F.3d 1119, 1125-26 (9th Cir. 2002).

After accepting all non-conclusory allegations as true and drawing all reasonable inferences in favor of the plaintiff, the court must determine whether the complaint alleges a plausible claim to relief. See Iqbal, 556 U.S. at 679-80. "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. . . . 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." Id. at 678 (citing Twombly, 550 U.S. at 556); see [*7]  Moss v. U.S. Secret Serv., 572 F.3d 962, 969 (9th Cir. 2009).

III. Discussion

A. Request for Judicial Notice

As a threshold matter, the Court considers Defendants' request for judicial notice. The Court may take judicial notice of and consider facts that are "not subject to reasonable dispute because [they]...can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned." See Fed. R. Evid. 201(b)(2). Under the incorporation by reference doctrine, Courts may also consider documents "whose contents are alleged in a complaint and whose authenticity no party questions, but which are not physically attached to the [plaintiff's] pleadings." Branch v. Tunnell, 14 F.3d 449, 454 (9th Cir.1994).

Defendants request that the Court take judicial notice of seven exhibits. Exhibits One, Two and Three are documents taken from the FDA's website: (1) Cormet's PMA Approval Letter from the FDA ("Approval Letter"); (2) the Cormet's Labelling ("Labelling"); and (3) the Summary of Safety and Effectiveness of the Cormet ("SSE"), a publicly available report summarizing the information that the Corin Defendants submitted to the FDA that the FDA considered when evaluating the risks and effectiveness associated with the Cormet. Mot. 5:25-6:6, Ex. 1-3; 21 U.S.C. § 360j(h)(2)(explaining the SSE requirements). However, Plaintiff [*8]  opposes taking judicial notice of Exhibits 1 through 3. Plaintiff does not dispute the documents' authenticity, instead arguing that these documents should not be considered because they are "available through complicated URL addresses" and that considering the documents would convert the motion to dismiss into a motion for summary judgment. Opp. 11:14-26.

The Court grants Defendants' request as to Exhibits 1-3 as these documents are publicly accessible on the FDA website and their authenticity is "not subject to reasonable dispute." Fed. R. Evid. 201(b). Courts regularly consider publicly available information on the FDA's website. See In Re Amgen Inc. Sec. Litig., 544 F.Supp.2d 1009, 1023 (C.D. Cal. 2008) (taking judicial notice of two pharmaceutical labels available on the FDA's website); Erickson v. Boston Scientific Corp., 846 F.Supp.2d 1085, 1089 (C.D. Cal. 2011) (taking judicial notice of FDA PMAs available on the Federal Register or on the FDA's online database); Funk v. Stryker Corp., 631 F.3d 777, 783 (5th Cir. 2011) (holding that "the district court did not err in taking judicial notice of the PMA" for the purposes of defendant Stryker Corporation's motion to dismiss a claim regarding the Trident artificial hip replacement).

Defendants also ask that the Court take judicial notice of several of the studies that Plaintiff references in, but does not attach to, the SAC. Mot., 17 n.6. Defendants [*9]  attach the following documents to their motion: (1) the 2011 Report; (2) the Journal of Bone and Joint Surgery Report; and (3) the 2009 Study. Id., Ex. 4-5, 6, 8. Plaintiff does not dispute the authenticity of these reports but opposes their consideration, arguing that the fact that the documents are readily available on the FDA's website is irrelevant in adjudicating a motion to dismiss and that he "dispute[s] how, when, why, and by whom the information came to exist on the FDA's website." Opp. 17:12-25.

Plaintiff's argument misses the mark. The relevance of a document is not the primary concern here; what matters is whether the document is "capable of accurate and ready determination" and "not subject to reasonable dispute." Fed. R. Evid. 201(b). Under such a framework, publicly available reports such as these are judicially noticeable. Regardless, the Court takes judicial notice of these reports under the incorporation by reference doctrine because Plaintiff mentions the reports in the SAC and does not dispute their authenticity. Though Plaintiff disputes how the reports came to be on the FDA website, he does not challenge the content of the reports.

Accordingly, the Court grants Defendants' requests for judicial [*10]  notice.


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