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Much of the Camp Lejeune litigation is rapidly becoming, in military parlance, FUBAR.  Even prominent plaintiff-side lawyers have started calling out the avalanche of fraudulent claims that MDL-style solicitation has been generating.  Congress permitted liability, so now the United States itself is being targeted by the same litigation practices that plague MDL defendants.

But the United States has some advantages that other litigants lack (besides the ability literally to print money).  Anybody who might attempt to obtain similar discovery from the FDA in a prescription medical product case, take note.

In In Re: Camp Lejeune Water Litigation, 2023 WL 8791671 (E.D.N.C. Dec. 19, 2023), the plaintiffs sought “to compel production of a draft Cancer Incidence Study (CIS)” from a federal agency before it had been published.  Id. at *1.  Instead, they received a judicial Alpha Charlie.  That’s because of something called the “deliberative privilege.”

Basically, the Camp Lejeune litigation is about allegations (often overblown) of exposure to carcinogenic substances.  Thus, an official study “to determine whether residential workplace exposures to the drinking water contaminants at Camp Lejeune are associated with increased risks of specific cancers,” id., is likely to be a big deal in this litigation and could well be fatal to many of the bogus claims now being filed.  That best explains why the Camp Lejeune plaintiffs wanted to jump the gun and demanded access before the study was finished.

It also explains why the plaintiffs’ motion to compel was forcefully denied.  Prior to the study’s intended public release, documents and information concerning the study were protected from civil discovery by the government’s deliberative process privilege – and if this federal agency enjoys that privilege, then the FDA probably does, too.  Lejeune described the deliberative process privilege:

The privilege “rests on the obvious realization that officials will not communicate candidly among themselves if each remark is a potential item of discovery and front page news, and its object is to enhance the quality of agency decisions by protecting open and frank discussion among those who make them within the Government.”

Lejeune, 2023 WL 8791671, at *2 (quoting Dep’t of the Interior v. Klamath Water Users Protective Assn., 532 U.S. 1, 8-9 (2001)) (internal quotations omitted).  Even “purely factual information” is protected when “inextricably intertwined with deliberative material.”  Id. (citation and quotation marks omitted).

Lejeune held that all the documents that plaintiffs sought were privileged.  They were “deliberative” because not only were they required by law, but the law demanded that such studies “‘shall be reported or adopted only after appropriate peer review.’” Id. at *3 (quoting statute).  Peer review in this instance requires “multiple reviews” and approval from not one, but two, government agencies.  Id.  Everything plaintiffs were seeking had been “prepared to help the agency formulate its position, specifically, to publish” a hypothetical final CIS.  Id. (citation and quotation marks omitted).  That included the study data itself:

[T]he data and analytical files are part of the deliberative review and intertwined with the Cancer Incidence Study’s analysis.  Release of the data would reveal much of the agency’s deliberation about the study findings. The collection and management of this data is also intertwined in the ATSDR study authors’ preliminary analysis and draft conclusions.

Lejeune, 2023 WL 8791671, at *4 (citation and quotation marks omitted).  The data, and the government’s analysis of it, were “inextricably intertwined.”  Id.

The privilege also applied because all the documents were “predecisional” – the study had not yet passed the government’s review.  Id.  The study was “undergoing [agency] review currently,” and its contents could “change substantially before the review is complete.”  Id.  That could well be precisely why plaintiffs were trying to interfere with the process, but that is also precisely the sort of extraneous influence that the deliberative process privilege was intended to prevent.  “The privilege is about preserving the deliberative process itself.”  Id. at *2.

The deliberative process privilege is qualified, but in Lejeune the information at issue fully qualified.  The information was “plainly relevant,” but “Plaintiffs have access to multiple other studies linking exposure to the toxic chemicals . . . with various diseases and health effects.”  Id. at *5.  The plaintiffs desire to look over the scientists’ shoulders “weighs heavily in favor” of the privilege.  Id.

[R]eleasing the non-final CIS would suppress the routine scientific review process and have a chilling effect on deliberations.  That scientific review is mandated by statute and involves multiple independent experts . . . to protect the scientific process and integrity of the study to be published.

Id. (citations and quotation marks omitted).  Given that “tens of thousands of individuals may be implicated by” the CIS, the pressure that premature release could create is cause for “[c]oncern for the integrity of the scientific review process.”  Id. at *5-6.  In addition, “compelling production of an incomplete CIS subject to change” could result in “public confusion” – likely generated by plaintiffs’ reacting loudly to anything they didn’t like – and could “undermine the public’s trust in and credibility.”  Id. at *6.

For all these reasons, the Camp Lejeune plaintiffs’ motion to compel premature release of information relating to the cancer study was rejected. 

The same privilege should protect the FDA from similar impositions.  While occasionally defendants also need information from the FDA, See, e.g., In re Phenylpropanolamine, MDL NO. 1407, slip op. (W.D. Wash. Nov. 12 2003), as a practical matter only plaintiffs would be likely to do so abusively.  Defendants:  (1) must consider their ongoing relationship with the agency that regulates them, (2) rarely seek to overturn FDA actions in product liability litigation, and (3) mostly want backward-looking regulatory history information available through the Freedom of Information Act.