YOUR COMPANY RECEIVED AN FDA Warning Letter years ago. You responded and everything seemed settled. Now your company has been sued about the drug or medical device that was the subject of the letter. Is that old Warning Letter going to come back to haunt you in court?

More than five hundred FDA Warning Letters have been issued to various food, drug, and device manufacturers in 2012 alone.¹ Their substance ranges from regulatory clearance and approval, to proposed findings of promotional and misleading labeling and advertising, to adulterated and misbranded products, to a host of other issues under the Federal Food, Drug, and Cosmetic Act. Frankly, while warning and other untitled letters are routinely issued by the FDA, they do not bring good news to their recipients. Perhaps it is for this reason that Warning Letters sometimes find themselves in court — as the supposed basis for the action itself or as key evidence for one of the parties. In either instance, however, one question must be addressed: Is the use of the Warning Letter proper?

In July 2012, the FDA released an updated Regulatory Procedures Manual in which the agency defined and established uniform guidance and procedures for FDA Warning Letters and Untitled Letters.² At the outset of its chapter on Advisory Actions, the FDA defines Warning Letters as “the agency’s principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act (the Act).”³ The FDA proceeds to explain that such letters are “informal and advisory” and do “not commit FDA to taking enforcement action.”⁴ Instead, while the letters “communicate the agency’s position on a matter […] FDA does not consider Warning Letters to be final agency action on which it can be sued.”⁵ In other words, FDA Warning Letters do not constitute a determination of rights by the agency from which legal consequences arise.

This Regulatory Procedures Manual, notably, was released just six months after the U.S. Court of Appeals for the D.C. Circuit upheld the dismissal of an action against the FDA brought by manufacturers of “ear candles”⁶ under the Administrative Procedures Act.⁷ In Holistic Candlers, the plaintiff-appellant manufacturers sued the FDA alleging, among other things, that Warning Letters issued by the agency violated the manufacturers’ First Amendment rights and were contrary to the Act.⁸ The Warning Letters at issue advised the manufacturers that they had failed to obtain the proper approval or clearance prior to marketing the devices, that the FDA had received a number of adverse event reports related to the devices, and that the manufacturers should therefore cease marketing, promoting, or distributing the devices.⁹ Although the manufacturers claimed the letters espoused the “FDA’s determination that ear candles are, per se, unapproved medical devices [that] cannot be sold in the United States,”¹⁰ the Court of Appeals disagreed, finding that “the Warning Letters do not constitute final agency action.”¹¹ This finding was markedly unaffected by either the presence of a Consumer Update against ear candles on the FDA’s website or by the individual statements of agency officials that the “FDA would never approve” ear candles.¹² The rationale for the opinion was as follows:

As a general matter, two conditions must be satisfied for agency action to be ‘final’: First, the action must mark the consummation of the agency’s decision-making process — it must not be of a merely tentative or interlocutory nature. And second, the action must be one by which rights or obligations have been determined or from which legal consequences will flow […]. FDA’s Warning Letters fail to satisfy either condition: they neither mark the consummation of the agency’s decision-making process nor determine the appellants’ legal rights or obligations.¹³

Chapter 4 of the FDA’s July 2012 Regulatory Procedures Manual, for all intents and purposes, adopts and memorializes the opinion of the D.C. Circuit as the position of the FDA. In fact, in September 2012, the FDA cited the Manual repeatedly in response to a Petition for Writ of Certiorari filed by the manufacturer plaintiffs in Holistic Candlers. The FDA reiterated the following to the United States Supreme Court:

[T]he warning letters here did not mark the consummation of FDA’s decision-making process. […] Relatedly, the Warning Letters were not based on a formal and complete administrative record. At this stage, FDA’s statement that Petitioners violated the FDCA was not ‘final and binding’ on the agency or petitioners but rather remained ‘tentative and interlocutory’ in nature.¹⁴

These recent representations of the FDA — both in the Regulatory Procedures Manual and to the Supreme Court — solidify the FDA’s position that Warning Letters to product manufacturers, alone, or in combination with other informal agency communications, are not final agency action. As a result, they do not subject the agency to judicial review.

An interesting corollary to this position, however, concerns the admissibility of FDA Warning Letters and similar communications in product liability trials against drug or device manufacturers. On their face, written FDA warnings and communications are hearsay, inadmissible to prove the truth of the warnings themselves. Nevertheless, Federal Courts routinely apply Rule 803(8) of the Federal Rules of Evidence to determine whether governmental reports such as FDA Warning Letters should be excepted from the hearsay rule in civil actions. Under that rule, courts may admit documents or reports that contain “factual findings resulting from an investigation made pursuant to authority granted by law, unless the sources of information or other circumstances indicate lack of trustworthiness.”¹⁵

An important commonality exists between this evidentiary inquiry and the position taken by the FDA in Holistic Candlers and its Regulatory Procedures Manual. In a nutshell, both connote a requirement of finality before FDA Warning Letters may be used against a party substantively. On one hand, Warning Letters do not constitute “final agency action” sufficient to institute an action directly against the FDA. On the other, the “informal and advisory” nature of Warning Letters, which do “not commit FDA to taking enforcement action,”¹⁶ arguably do not constitute final governmental findings with sufficient trustworthiness to be admissible under Rule 803(8)(c).

This latter rationale has supported a number of federal evidentiary opinions on governmental reports that predate both the Holistic Candlers litigation and the July 2012 Regulatory Procedures Manual.¹⁷ For instance, in Toole v. McClintock, the Eleventh Circuit Court of Appeals reversed the Florida District Court and granted a new trial to the defendant manufacturer because the trial court improperly admitted a report containing the FDA’s proposed findings on silicone breast implants under Rule 803(8)(c).¹⁸ The Toole court first noted that “the FDA report contains no findings specifically about the […] implants at issue in this case, but rather proposes findings about implants generally.”¹⁹ Furthermore:

The FDA report is not the kind of trustworthy report described in Rule 803. By its own terms, the FDA report contained only ‘proposed’ findings. The report invited public comment and forecasted the issuance of a “final” document after more study. Rule 803 makes no exception for tentative or interim reports subject to revision and review. […] The tentative and secondhand nature of the findings in the FDA report should have kept it out of evidence.²⁰

Similarly, in Appleby v. Glaxo Wellcome, Inc., the U.S. District Court for the District of New Jersey rejected the plaintiffs’ claim that “Dear Healthcare Professional” letters issued by the FDA concerning risks of the drug Lotronex® fell within the hearsay exception for public records and reports under Rule 803(8)(c). The Appleby court explained that the rule “typically does not apply to render hearsay admissible where the findings are merely proposed, tentative, or ‘secondhand.’”²¹ This common element of finality — or the lack thereof — has been the deciding factor for numerous other courts in deciding whether to admit government writings of any nature under the public report’s exception to the hearsay rule.²² These courts have specifically emphasized the “interim or inconclusive nature of the reports”²³ and have focused largely on whether the reports reflected the “final determination” of the authoring agency.²⁴

The FDA’s now-express categorization of Warning Letters as “tentative and interlocutory in nature”²⁵ substantially bolsters the argument that Warning Letters do not fall within the hearsay exception of Rule 803(8)(c), and as such are not admissible for substantive purposes at trial. The parallel between the FDA’s declaration that Warning Letters “do not mark the consummation of FDA’s decision-making process” and Rule 803’s exclusion of interim or inconclusive reports is evident. More importantly, however, that parallel may provide manufacturer defendants with new or stronger ground on which to stand when seeking the exclusion or opposing the admission of Warning Letters into evidence at trial. The same ammunition may also apply to FDA Web-based safety alerts, Dear Doctor letters, and other similar, informal public health notifications, none of which possess the prerequisite finality discussed above. This is not to suggest that plaintiffs will be prevented from using documents like these for the non-hearsay purpose of demonstrating notice or state-of-mind. Nevertheless, any substantive use of FDA Warning Letters by a party to try to prove the truth of the warnings themselves arguably should be limited heavily — if not prohibited altogether — absent some other indication of a final determination of rights by the FDA. Therefore, your litigation team should not assume that letter is admissible, and a motion to exclude it might be in order.

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[1] See <http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/default.htm?Page=50>.

[2] FDA, Regulatory Procedures Manual, 4-1 (July 2012).

[3] FDA, Regulatory Procedures Manual, 4-2 (July 2012).

[4] Id.

[5] FDA, Regulatory Procedures Manual, 4-2 – 4-3 (July 2012).

[6] Ear candles are hollow cones made of fabric, soaked in beeswax or paraffin, which are placed into the ear and set on fire with an open flame. They are marketed as a holistic treatment for a number of conditions, including sinus congestion, ear infection, and sleep disorders.

[7] Holistic Candlers & Consumers Ass’n v. FDA, 664 F.3d 940 (D.C. Cir. 2012).

[8] Holistic Candlers, 664 F.3d at 942.

[9] Id.

[10] Id. at 943.

[11] Id. at 942.

[12] Id. at 945.

[13] Id. at 943.

[14] Br. of Respondents, Holistic Candlers & Consumers Assn. v. FDA, 2012 WL 3991471, *10, No. 11-1454 (Sept. 11, 2012).

[15] Fed. R. Evid. 803(8)(c).

[16] FDA, Regulatory Procedures Manual, 4-2 – 4-3 (July 2012).

[17] See, e.g., In Re Cessna 208 Series Aircraft Prod. Liab. Litig., 2009 U.S. Dist. LEXIS 78504, Case No. 05-md-1721 (D. Kan. Sept. 1, 2009); Appleby v. Glaxo Wellcome, Inc., 2005 U.S. Dist. LEXIS 32875, Civil No. 04-0062 (D. N.J. Dec. 13, 2005); Toole v. McClintock, 999 F.2d 1430 (11th Cir. 1993), and City of New York v. Pullman, Inc., 662 F.2d 910 (2d Cir. 1981).

[18] Toole v. McClintock, 999 F.2d 1430 (11th Cir. 1993).

[19] Toole, 999 F.2d at 1434.

[20] Id. at 1434-35.

[21] Appleby v. Glaxo Wellcome, Inc., 2005 U.S. Dist. LEXIS 32875, Civil No. 04-0062 (D. N.J. Dec. 13, 2005).

[22] See, e.g., United Air Lines Inc. v. Austin Travel Corp., 867 F.2d 737 (2d Cir. 1989); Koonce v. Quaker Safety Prods. & Mfg. Co., 798 F.2d 700 (5th Cir. 1986); Plemer v. Parsons-Gilbane, 713 F.2d 1127 (5th Cir. 1983); City of New York v. Pullman, Inc., 662 F.2d 910 (2d Cir. 1981); In Re Cessna 208 Series Aircraft Prod. Liab. Litig., 2009 U.S. Dist. LEXIS 78504, Case No. 05-md-1721 (D. Kan. Sept. 1, 2009); Gentile v. County of Suffolk, 129 F.R.D. 435 (E.D.N.Y. 1990).

[23] United Air Lines, 867 F.2d at 743.

[24] In Re Cessna 208 Series Aircraft Prod. Liab. Litig., 2009 U.S. Dist. LEXIS 78504, *22.

[25] Holistic Candlers, 2012 WL 3991471 at *10.

Finis