A primer on the admissibility of FDA warning letters.

AuthorGoodwin, Paige S.

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. (9) Citing to its Regulatory Procedures Manual, FDA argued that warning letters:

[Do] not mark the consummation of FDA's decisionmaking process. As FDA has explained, warning letters give 'firms an opportunity to take voluntary and prompt corrective action before [FDA] initiates an enforcement action.' An enforcement action--typically a seizure or an injunction--is not inevitable, and indeed, most warning letters do not result in enforcement action. (10) Indeed, consistent with FDA's Procedures Manual, regulatory authority, and FDA's briefing in Holistic Candlers, myriad court decisions agree that FDA warning letters are not "final agency actions." Most courts considering the issue, including the Ninth, Tenth, and District of Columbia Circuits, have concluded that warning letters do not "constitute a final decision by the FDA." (11) Courts also agree that because warning letters--and similar records of other agencies--merely contain "conclusions by subordinate officials of the FDA," they "do not commit the FDA to enforcement action," and they do not constitute a "final" or "formal" agency determination. (12) How FDA and the courts characterize FDA warning letters is critical to whether such letters which are hearsay--are nonetheless admissible under a hearsay exception, particularly the "public records" exception at Federal Rule of Evidence 803(8) and the "residual exception" of Rule 807.

  1. Federal Rule of Evidence 803(8): Hearsay Exception for "Public Records"

    Rule 803(8) provides a hearsay exception for:

    [A] record or statement of a public office if: (A) it sets out: (i) the office's activities; (ii) a matter observed while under a legal duty to report ...; or (iii) in a civil case or against the government in a criminal case, factual findings from a legally authorized investigation. (13) A further requirement of Rule 803(8) is that "neither the source of information nor other circumstances indicate a lack of trustworthiness." (14)

    Athough the text of Rule 803(8) makes no distinction between "preliminary" and "tentative" material and material reflecting the final position or conclusion of a public office or agency, it is widely acknowledged that clause (iii) of Rule 803(8) "does not include evaluations, tentative conclusions or opinions." (15) Rather, an additional requirement of "finality" is often inferred in the rule. (16) Implicit in Rule 803(8)(iii) is "the proposition that what is to be admitted under clause [iii] is the 'factual finding' of an office or an agency.... If it is to be the finding of an office or agency, it follows that the exception does not embrace everything that might be set down in writing by someone working for a public office or agency." (17)

    A few court decisions shed light on the application of Rule 803(8)(A)(iii)--and its near-identical predecessor, Rule 803(8)(c)--in the context of non-final government documents. In City of New York v. Pullman Inc., the Second Circuit excluded an interim staff report prepared by an employee of the Urban Mass Transit Administration CUMTA"), a federal agency under the Department of Transportation. (18) The court noted that "[b]y its own terms, the UMTA report was not the final report or finding of a government agency within the meaning of the Rule, but was an 'interim' staff report in the form of a recommendation to the Administrator." (19) Because the report was not a final embodiment of the UMTA's findings, the court held that "the report did not satisfy the express requirement of the Rule that the...

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