Judicial Notice of FDA Website Documents Can Be a Powerful Lever in a Medical Device Manufacturer’s Motion to Dismiss


A motion to dismiss can be a powerful tool in the hands of medical device companies to eliminate cases that should be dismissed from the outset on preemption grounds, before engaging in costly discovery.  Oftentimes, however, sufficient information may not be pled in a complaint to support the motion for early dismissal.  Requesting that a court take judicial notice of public documents posted on the Food & Drug Administration’s (FDA) website is one way to get some of that important information, such as labeling and approval letters, before the court for consideration.

The U.S. District Court for the District of Arizona’s recent opinion in Poll v. Stryker Sustainability Solutions, Inc., No. Civ. 13-440, demonstrates the positive impact of judicial notice of FDA website documents at the motion to dismiss stage.  In Poll, the plaintiff, Jeffrey Poll, filed a complaint against Stryker Sustainability Solutions, Inc., and others, alleging that he was injured by their Cormet Cup and Cormet Head (Cormet System), a Class III medical device under the Federal Food, Drug and Cosmetic Act of 1938 (FDCA).

Defendants filed a motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6), arguing that the original complaint was preempted by § 360k of the Medical Device Amendments to the FDCA, as interpreted in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  In the motion, defendants attached and referred to the Cormet System approval letter, Summary of Safety and Effectiveness, labeling and instructions for use, and supplemental PMA approvals.  The plaintiff opposed the motion, arguing that the defendants converted their motion to dismiss into one for summary judgment by citing and relying on materials and facts outside of the complaint.

The court determined that it was appropriate to take judicial notice of the challenged documents because they were available on the FDA’s website.  In rendering its decision, the court relied on case law finding that, where the authenticity of a website or the accuracy of the information on the website is not disputed, it is appropriate to take judicial notice of information displayed publically on government websites.

Important documents such as approval letters, labeling, and supplemental approval letters for a drug or medical device are often critical to the success of a motion to dismiss based on preemption.  When deciding whether to make such a motion, counsel should consider whether such documents are publically available on governmental websites such as the FDA’s.  If so, cases such as Poll can help assure those documents are considered by the court in the context of a dispositive motion as early in the case as possible, thereby foreclosing the need for extensive discovery. 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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