Friday, August 19, 2022
HomeHealth LawRegulatory Witnesses - One thing Else To Watch

Regulatory Witnesses – One thing Else To Watch


An attention-grabbing difficulty not too long ago arose (however was not resolved) in In re: Proton-Pump Inhibitor Merchandise Legal responsibility Litigation, 2022 WL 2188038 (D.N.J. June 17, 2022) (“PPI”).  The flexibility of an FDA skilled witness to testify was challenged below 18 U.S.C. §207, a federal battle of curiosity statute.  Now we have by no means seen that statute invoked in reference to an ex-FDA witness earlier than, and apparently neither has anybody else, because the opinion observes that “the actual fact sample introduced right here is one thing of an unprecedented difficulty.”  Id. at *4 (quotation and citation marks omitted).  So we thought we’d alert our readers.

The issue is that any social gathering, on both facet of the “v.,” would favor to have (funds allowing) probably the most expertly skilled witness doable.  In PPI such a witness had been retained by one of many defendants, however the identical factor likewise might have arisen in reference to a plaintiff-side skilled.  The witness at difficulty was anticipated to “provide[] opinions concerning the regulatory necessities and proceedings with respect to” one of many medication at difficulty within the litigation, which had been taken by a specific plaintiff.  2022 WL 2188038, at *1.  The witness was very skilled, certainly, on this matter:

As a Group Chief and the Division Director of FDA’s Division of Nonprescription Medical Analysis [the witness] “was intimately concerned with proton-pump inhibitors and the FDA’s approval of [the drug in question] for over-the-counter use” and “oversaw the labeling of those medication, the adequacy of the warnings, and any modifications to the labels.”

Id. (quoting the witness’ report).  It wasn’t precisely the identical drug, but it surely was shut – the OTC model of a prescription drug at difficulty within the litigation.

That’s the place §207 is available in.  It prohibits: (1) any former “officer or worker … of the chief department of america” – together with the FDA – from (2) “knowingly mak[ing], with the intent to affect, any communication to or look earlier than any … courtroom,” about one thing (3) “through which the individual participated personally and considerably as such officer or worker,” and which (4) “concerned a particular social gathering or particular events on the time of such participation.”  Id. §207(a)(1)(A-C).

The witness had, whereas working on the FDA, supervised proceedings involving the identical molecule that was at difficulty in PPI and had been engaged by one of many events.  The skilled’s report established “that the overview for [OTC] approval included the overview of security knowledge associated to the prescription model of the drug.”  Id. at *2.  Was the witness disabled by §207 from testifying about FDA regulation of a associated drug?

Neither the events nor the Particular Grasp have recognized any instances making use of Part 207 to a former FDA worker who proposes to testify in a product legal responsibility lawsuit concerning a prescription drug with the identical energetic ingredient and indications as a later-approved OTC pharmaceutical product that the worker reviewed whereas at FDA.

PPI, 2022 WL 2188038, at *2.

There have been, nevertheless rules – which made clear that the statute applies to skilled testimony.  “[W]right here the bar of part 207(a)(1) applies, a former worker could not function an skilled witness.”  5 C.F.R. §2641.301(f)(2).  Certainly, one of many examples in these rules entails an FDA official, however was not significantly on-point.  Id. §2641.201(h)(2), instance 5.  That was as a result of:

[A]pproval of a specific drug and its labeling − whether or not a prescription drug or an OTC model of that drug after consideration of security and regulatory knowledge concerning the prescription model − is just not the promulgation of a rule of basic software.  Slightly it’s a particular continuing affecting authorized rights of recognized events.

PPI, 2022 WL 2188038, at *5.  Nonetheless, the worth of those rules was questionable.  Id. at *4 (“it’s not clear that [these] rules deciphering prison battle of curiosity statutes are entitled to deference”).

PPI additionally rejected an argument for the statute’s per se inapplicability in “personal civil litigation through which FDA is just not a celebration,” discovering the statutory language “sufficiently broad to embody the circumstances at difficulty” – subsequent “skilled” testimony involving a drug that the witness had overseen whereas on the FDA.  2022 WL 2188038, at *3.  The connection between a prescription drug and its OTC successor was likewise “sufficiently interrelated to represent the identical ‘explicit matter.’”  Id.

PPI, whereas flagging this novel difficulty, didn’t resolve it.  Slightly, as a result of the FDA’s place on the query was “unknown” – and the Company “could also be unaware” of the scenario altogether, the choice proposed that the FDA be contacted and that the movement to disqualify the witness be postponed pending receipt of the FDA’s place.  Id. at *5.

That’s the place issues stand (so far as we all know).  The end result is unsure, and the potential for disqualification exists for an FDA (or different federal authorities) skilled proffered by both facet.  So our function on this submit is solely to flag the problem.  It’s doable – given federal battle of curiosity rules – for an skilled to be so intimately concerned with a specific regulatory difficulty that s/he could also be precluded altogether from testifying about it.  So watch out on the market.

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