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An interesting issue recently arose (but was not resolved) in In re: Proton-Pump Inhibitor Products Liability Litigation, 2022 WL 2188038 (D.N.J. June 17, 2022) (“PPI”).  The ability of an FDA expert witness to testify was challenged under 18 U.S.C. §207, a federal conflict of interest statute.  We have never seen that statute invoked in connection with an ex-FDA witness before, and apparently neither has anyone else, since the opinion observes that “the fact pattern presented here is something of an unprecedented issue.”  Id. at *4 (citation and quotation marks omitted).  So we thought we’d alert our readers.

The problem is that any party, on either side of the “v.,” would prefer to have (budget permitting) the most expertly expert witness possible.  In PPI such a witness had been retained by one of the defendants, but the same thing likewise could have arisen in connection with a plaintiff-side expert.  The witness at issue was expected to “offer[] opinions regarding the regulatory requirements and proceedings with respect to” one of the drugs at issue in the litigation, which had been taken by a particular plaintiff.  2022 WL 2188038, at *1.  The witness was very expert, indeed, on this topic:

As a Team Leader and the Division Director of FDA’s Division of Nonprescription Clinical Evaluation [the witness] “was intimately involved with proton-pump inhibitors and the FDA’s approval of [the drug in question] for over-the-counter use” and “oversaw the labeling of these drugs, the adequacy of the warnings, and any changes to the labels.”

Id. (quoting the witness’ report).  It wasn’t exactly the same drug, but it was close – the OTC version of a prescription drug at issue in the litigation.

That’s where §207 comes in.  It prohibits: (1) any former “officer or employee … of the executive branch of the United States” – including the FDA – from (2) “knowingly mak[ing], with the intent to influence, any communication to or appearance before any … court,” about something (3) “in which the person participated personally and substantially as such officer or employee,” and which (4) “involved a specific party or specific parties at the time of such participation.”  Id. §207(a)(1)(A-C).

The witness had, while working at the FDA, supervised proceedings involving the same molecule that was at issue in PPI and had been engaged by one of the parties.  The expert’s report established “that the review for [OTC] approval included the review of safety data related to the prescription version of the drug.”  Id. at *2.  Was the witness disabled by §207 from testifying about FDA regulation of a related drug?

Neither the parties nor the Special Master have identified any cases applying Section 207 to a former FDA employee who proposes to testify in a product liability lawsuit regarding a prescription drug with the same active ingredient and indications as a later-approved OTC pharmaceutical product that the employee reviewed while at FDA.

PPI, 2022 WL 2188038, at *2.

There were, however regulations – which made clear that the statute applies to expert testimony.  “[W]here the bar of section 207(a)(1) applies, a former employee may not serve as an expert witness.”  5 C.F.R. §2641.301(f)(2).  Indeed, one of the examples in these regulations involves an FDA official, but was not particularly on-point.  Id. §2641.201(h)(2), example 5.  That was because:

[A]pproval of a particular drug and its labeling − whether a prescription drug or an OTC version of that drug after consideration of safety and regulatory data regarding the prescription version − is not the promulgation of a rule of general application.  Rather it is a specific proceeding affecting legal rights of identified parties.

PPI, 2022 WL 2188038, at *5.  However, the value of these regulations was questionable.  Id. at *4 (“it is not clear that [these] regulations interpreting criminal conflict of interest statutes are entitled to deference”).

PPI also rejected an argument for the statute’s per se inapplicability in “private civil litigation in which FDA is not a party,” finding the statutory language “sufficiently broad to encompass the circumstances at issue” – subsequent “expert” testimony involving a drug that the witness had overseen while at the FDA.  2022 WL 2188038, at *3.  The relationship between a prescription drug and its OTC successor was likewise “sufficiently interrelated to constitute the same ‘particular matter.’”  Id.

PPI, while flagging this novel issue, did not resolve it.  Rather, because the FDA’s position on the question was “unknown” – and the Agency “may be unaware” of the situation altogether, the decision proposed that the FDA be contacted and that the motion to disqualify the witness be postponed pending receipt of the FDA’s position.  Id. at *5.

That’s where things stand (as far as we know).  The outcome is uncertain, and the potential for disqualification exists for an FDA (or other federal government) expert proffered by either side.  So our purpose in this post is simply to flag the issue.  It is possible – given federal conflict of interest regulations – for an expert to be so intimately involved with a particular regulatory issue that s/he may be precluded altogether from testifying about it.  So be careful out there.