Poll v. Stryker Sustainability Solutions, Inc., 2014 U.S. Dist. LEXIS 6309 (D. Az. Jan. 17, 2014), is a pretty good preemption decision but, more important, another decision holding that courts may take judicial notice of documents on the FDA website as part of a motion to dismiss. The case involved a hip resurfacing system, a Class III medical device. So here comes Riegel preemption. Plaintiff’s strict liability, warranty and design defect claims were all preempted. Id. at *14-16. The road was rougher for plaintiff’s failure to warn claim, but things landed in the right place – or close to it. The court accepted plaintiff’s allegations that manufacturing techniques in one of the company’s European facilities and problems raised by unnamed European studies should have been disclosed to the FDA. Id. at *12-14. It seems to us that, in the least, Buckman preemption should have ended these claims. Beyond that, we’re not aware of any common law claim for failure to warn the FDA, another reason to dismiss these claims. No matter, though. The court TwIqballed these claims because plaintiff failed to identify the alleged European studies or the particular problems that weren’t reported to the FDA. Id. at *20.
What we like most about this decision, though, is its treatment of documents from the FDA website. The court held that they are properly considered on a motion to dismiss even though plaintiff chose not to cite or quote them in his complaint. We are seeing more and more of this. In Poll, the documents were the initial and subsequent FDA approval letters, the label, and the Summary of Safety and Effectiveness. Id. at *5. All of these documents were publicly available, meaning that they were available to plaintiff before he drafted his complaint. Their authenticity was not in dispute, as they almost never are. So the court should be able to – and did – take judicial notice of them. In doing so, the court provided a helpful string cite – mostly under 9th Circuit law – on why:
[T]he Ninth Circuit has determined that, where the authenticity of a website or the accuracy of the information displayed on the website is not disputed, it is appropriate to take judicial notice of information displayed publicly on government websites. See Daniels-Hall v. National Educ. Ass'n, 629 F.3d 992, 998-99 (9th Cir. 2010) (taking judicial notice of information on websites of school districts) (citingFed. R. Evid. 201 (allowing a court to take judicial notice of a fact "not subject to reasonable dispute in that it is . . . capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned"); Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308, 322, 127 S. Ct. 2499, 168 L. Ed. 2d 179 (2007) (noting that courts ruling on 12(b)(6) motions to dismiss may take into consideration "matters of which a court may take judicial notice"); In re Amgen Inc. Sec. Litig., 544 F.Supp.2d 1009, 1023-24 (C.D. Cal. 2008) (taking judicial notice of drug labels taken from the FDA's website); County of Santa Clara v. Astra USA, Inc., 401 F.Supp.2d 1022, 1024 (N.D. Cal. 2005) (taking judicial notice of information posted on a Department of Health and Human Services web site)); see also Erickson v. Boston Scientific Corp., 846 F. Supp. 2d 1085, 1089 (C.D. Cal. 2011) (taking judicial notice of PMA approval documents). The Cormet System approval letter, the Cormet System Summary of Safety and Effectiveness, the Cormet System labeling and instructions for use, and the Cormet System supplemental PMA approvals are available on the FDA's website. The Court finds it is appropriate to take judicial notice of these documents.
Id. at *5-7. We believe the court gets this right.
Plaintiff argued, as you would expect, that if the court allowed use of these documents, the motion to dismiss should be denied so that plaintiff could move forward to discovery in the hope of finding information to respond to these documents. But that’s really just the plaintiff asking for a remedy to a problem he created. The documents had always been available to him. He in fact likely had a duty to consider them before filing his complaint. And, after doing so, he could have used them in his complaint. Frankly, complaining about publicly available documents and asking to keep them out seems odd for a plaintiff. When it’s a TwIqbal motion, we hear the opposite. Plaintiffs argue that not enough information is public, they need more, and so they should proceed to discovery. In fact, the Poll plaintiff made this precise argument to combat the TwIqbal portion of the defense’s motion. It seems that no matter the question, the response is the same: we need discovery.
Such publicly available information from self-authenticating documents on the precise topics about which plaintiff is making allegations should be fair game on a motion to dismiss. Now, what they say may affect the outcome of the motion. The information could establish that plaintiff’s claims should not be preempted, or in the least cast doubt on preemption. If they did, however, we bet they’d already be in the complaint. The documents in Poll apparently didn’t cast doubt on preemption. So, after determining that it could consider them, the court dismissed all plaintiffs’ claims.
This is another case to keep in mind next time you see a complaint whose allegations don’t stand up against public information. There’s no reason to be frustrated. Make your motion, and bring them in.