A Winning Strategy: Using Publicly Available FDA Documents in a 12(b)(6) Motion to Dismiss is Advantageous

In Poll v. Stryker Sustainability Solutions, Inc., et al., the U.S. District Court for the District of Arizona notably held that courts may take judicial notice of documents on the FDA’s website when considering a motion to dismiss. 2014 U.S. Dist. LEXIS 6309 (D. Az. Jan. 17, 2014). Plaintiff Jeffrey Poll brought strict liability, breach of express warranty, implied warranty, negligent failure to warn, products liability failure to warn, and products liability defective design claims against Defendants[1] alleging injuries and damages arising out of the use of a hip resurfacing device consisting of the Cormet Cup and Cormet Head (the “Cormet System”), a Class III medical device under the FDCA.

In his Complaint, Plaintiff did not cite to the FDA documents -- the Cormet System approval letter, the Summary of Safety and Effectiveness, the labeling and instructions for use, and the Cormet System supplemental PMA approvals -- even though they were available to the public.  However, when Defendants filed their Motion to Dismiss, they attached these documents. Plaintiff argued that Defendants’ Motion to Dismiss was converted into a Motion for Summary Judgment because it contained cites to, and relied on, materials and facts outside of the Complaint and not yet adduced in discovery. 

A court may take judicial notice of matters of public record and consider them without converting a Rule 12 motion into one for summary judgment. In its analysis, the court cited to a significant number of cases holding that where the authenticity of a website or the accuracy of the information displayed on the website is not disputed, it is appropriate for courts to take judicial notice of information displayed publicly on government websites.  The court went on to find it appropriate to take judicial notice of the FDA documents and, therefore, Defendants’ Motion to Dismiss was not deemed converted into a summary judgment motion. 

Plaintiff argued that he should be allowed to engage in discovery in an effort to find information to respond to the FDA documents. In his Motion for Rule 56(d) Relief he argued that the Supreme Court has interpreted FRCP 56(d) to require discovery where the nonmoving party has not had the opportunity to discover information that is essential to its opposition. However, the court reiterated that because judicial notice is appropriate, the Motion to Dismiss was not converted to a Motion for Summary Judgment, and therefore R. 56(d) was not relevant to the pending motion.  On this basis, the court denied Plaintiff’s motion for relief. 

In addition to the noteworthy discussion of the use of publicly available documents, Poll provides a succinct discussion of preemption principles and pleading requirements:

Plaintiff’s strict liability, breach of warranty and defective design claims were preempted under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). Plaintiff’s strict liability and defective design claims would constitute the imposition of requirements in addition to those mandated by the FDA. Plaintiff’s warranty claims were not based on statements made to the FDA, but rather on alleged warranties/statements made to Plaintiff and medical personnel. The alleged warranties did not go beyond the conclusions made by the FDA and were therefore preempted. 

Plaintiff’s failure to warn claims survived the preemption argument. Plaintiff claimed there were European studies that revealed problems with the Cormet System and that Defendants knew but did not report these problems to the FDA. Relying on Twombly and Iqbal, the court held that these claims were not adequately pled. The Complaint did not specify what studies or what problems were at issue.  Since the claims sounded in fraud, Plaintiff should have pled them with some level of specificity. In sum, Plaintiff’s allegations were conclusory, and the non-conclusory “factual content” did not plausibly suggest a claim entitling Plaintiff to relief. The court dismissed Plaintiff’s claims with leave to amend as to his failure to warn and breach of warranty claims.