A Primer on the Admissibility of FDA Warning Letters

By Goodwin, Paige S.; Jacobs, Kevin T. | Defense Counsel Journal, April 2013 | Go to article overview

A Primer on the Admissibility of FDA Warning Letters


Goodwin, Paige S., Jacobs, Kevin T., Defense Counsel Journal


Whether Food and Drug Administration ("FDA") warning letters sent to manufacturers are admissible to show a regulatory violation on the part of the manufacturer is a hotbed issue in many lawsuits involving pharmaceutical products and medical devices. Plaintiffs' counsel vehemently fight for the ability to wave a warning letter before the jury to demonstrate an official, governmental pronouncement of the danger of a drug or device and the bad conduct of the corporate defendant. And, for obvious reasons, manufacturers wrestle to prevent jurors from seeing such letters.

But because FDA warning letters are undisputedly hearsay, plaintiffs must get creative when arguing that warning letters should come into evidence. A favorite tool for obtaining admission of FDA warning letters is Federal Rule of Evidence 803(8), which provides a hearsay exception for public records. Although a seemingly obvious choice on its face, Rule 803(8) is not a proper means for admission because FDA warning letters are tentative conclusions that do not embody a final agency decision. This was recently confirmed when the FDA itself explained before the U.S. Supreme Court in Holistic Candlers & Consumers Association v. FDA that warning letters do "not mark the consummation of FDA's decision-making process," are "not based on a formal and complete administrative record," are merely "tentative," and "do not constitute final agency action." (1)

In the wake of Holistic Candlers, are FDA warning letters ever admissible and, if so, under what circumstances? This article discusses how federal courts have treated FDA warning letters, including the host of possible evidentiary rules that proponents of the admissibility of warning letters may rely on to obtain their admission, and how the Holistic Candlers decision will likely reinforce the majority precedent that, although warning letters may, under certain circumstances, be admissible for other purposes, the letters are not admissible to show a regulatory violation.

1. The FDA's Position on Warning Letters: FDA Procedures Manual and Holistic Candlers

FDA warning letters are issued by employees at FDA centers and district offices advising drug and device manufacturers about alleged regulatory infractions and providing the manufacturer an opportunity to respond and take voluntary corrective action. According to FDA's Regulatory Procedures Manual, warning letters are "the agency's principal means of achieving prompt, voluntary compliance with the [FDCA]." (2) The Regulatory Procedures Manual makes clear that warning letters are "informal and advisory" and that they "do[] not commit FDA to taking enforcement action." (3) Indeed, FDA discounts such letters as a basis upon which it can be sued. (4) Unlike formal FDA advisory opinions, FDA warning letters are merely the judgment of particular agency employees and "do[] not necessarily represent the formal position of FDA, and do[] not bind or otherwise obligate or commit the agency to the views expressed." (5)

Although the FDA Procedures Manual and regulations strongly indicate that FDA warning letters are not final agency action, the issue recently received further clarification in Holistic Candlers & Consumers Association v. FDA. In that case, the plaintiffs--sellers and advocates of the use of "ear candles"--sued FDA under the Administrative Procedure Act after receiving five warning letters requesting that the plaintiffs take corrective action and threatening potential enforcement action. (6) The district court dismissed the plaintiffs' complaint on the ground that FDA warning letters do not constitute "final agency action" subject to judicial review under the Administrative Procedure Act. (7) After the court of appeals affirmed the district court's decision, the plaintiffs petitioned for writ of certiorari to the U.S. Supreme Court. Although the Supreme Court denied certiorari, (8) FDA's briefing on certiorari provides further evidence of the agency's characterization of warning letters. …

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