Lawyers like to grouse about their lot in life. We complain about stress and the things that most contribute to such stress: hard work and unpleasant people. But if you labor long enough in this profession, you end up running into many excellent folks. By “excellent,” we mean brilliant and generous.  We’ve long deployed a taxonomy of personalities, parking them in four (duh) quadrants.  Those quadrants are defined by combinations of binaries re intelligence (smart or dumb) and affability (nice or nasty).  We’re happy to say that 40 years of legal practice have brought us into contact with many individuals in that upper left quadrant of smart and nice.

Dan Troy is one of the really impressive people in our profession.  We have known him as a partner at a top-flight firm, General Counsel of both the FDA and a preeminent life sciences company, and a leading expert in the field of healthcare.  Many years ago we were on a panel with Troy at a bench and bar conference. We were given the assignment of making a plaintiff presentation arguing against application of an FDA Preamble that had been developed on Troy’s watch and that seemed to favor preemption.  We wore the part like a method actor, brutally mischaracterizing the facts and law, and ending by decrying the Preamble as a “Trojan horse” that had been smuggled in to harm consumers.  It was a cheap joke. It was stupid and unkind. Like we told you, we were pretending to be a plaintiff lawyer.  As we strode back to our seat, Troy muttered, “I didn’t even write the darned thing.” But he was a good sport.  

Today’s case, United States ex rel. Siegel v. Novo Nordisk, Inc., 2025 WL 1932532 (W.D. Wash. July 14, 2025), sees Troy in his current role as a healthcare regulatory expert. He was proffered as an expert by the defendant pharmaceutical company in a False Claims Act (FCA) case.  Off label promotion is the caricatured villain of the piece. As with most FCA cases, it does not appear that the defendant said or did anything “false.” To help make that rather important point, the defendant proffered expert opinions from Troy regarding the relevant regulatory backdrop.  The plaintiff moved to exclude those expert opinions.  

The court initially tells us that the plaintiff did “not challenge Troy’s credentials or expertise.” That makes sense. We do not see how any plaintiff could mount such a challenge. Good luck finding an expert who knows as much about FDA regulation as Troy does. Compare his profile to that of the avaricious mediocrities typically enlisted, force-fed, and overpaid by the plaintiff bar. Rather than quibble with Troy’s bona fides, the plaintiff argued that “his Report reads like a legal brief,” and sought to exclude “the admissibility of his proffered legal conclusions, that [the defendant’s] conduct could be consistent with the First Amendment and FDA guidance,” and that its distribution of free samples “can be consistent with FDA regulations.”

 The court agreed with the defense that “the bulk of Troy’s testimony will assist the jury and is admissible.” An expert’s opinion “is not objectionable simply because it embraces an ultimate issue to be decided by the trier of fact.” The issue was the extent to which the proffered opinions would go too far and amount to instructing the jury on the law. (When we think of all the times over the years when courts permitted plaintiff experts to do exactly that, well … Sing, Muse, of the rage of defense DDL hacks!)

Here is how the court called balls and strikes as to whether Troy’s expert regulatory opinions could come in or must be excluded: While Troy was not permitted to testify about off-label promotion being First Amendment protected, which is a legal conclusion, he was permitted to tell the jury about the complexity of the relevant FDCA regulatory scheme.  He was also permitted to testify about how medical studies are used in pharmaceutical marketing, with reference to relevant FDA regulations and guidance for reprint use.  He was also permitted to testify about how off-label use can become the medical standard of care.  This testimony is “not unlike an expert physician specialist explaining to a jury the standard of care for a particular procedure by describing the procedure’s steps and then explaining, through reference to medical records, what steps the allegedly negligent physician took.” 

Troy was also permitted to rebut any claim of negative inference from the defendant refusing an FDA request to conduct a Phase III study, and he could explain alternative ways to establish safety and effectiveness.  He was also permitted to rebut attacks on the defendant’s provision of free samples and “describe how the FDA regulates this activity, and under what conditions free samples can meet [regulatory] safe harbor requirements, and what the record demonstrates about [the defendant’s] distribution of free samples.” All that being said, the court held that Troy could not offer legal conclusions about the defendant’s compliance with those regulations.  

To our eyes, the court worked hard to draw the right lines.  There is little cause for complaint. We believe to a reasonable degree of defense-hack certainty that Troy will provide testimony that is accurate and helpful, and the jury and justice will benefit.