United States: One From Out Of Left Field

Last Updated: July 26 2019
Article by James Beck

Occasionally we feature court decisions that have nothing to do with prescription medical products. Dalgic v. Misericordia University, 2019 WL 2867236 (M.D. Pa. July 3, 2019), is such a case. Dalgic involved cross-motions for summary judgment in litigation about an alleged bureaucratic screw up that prevented the plaintiff (an overseas student) from remaining in the United States while finishing certain graduate studies. The relevant regulations (the numbers are irrelevant) produced this situation:

[A] student must submit his or her [additional studies] application within 30 days of the date the [college] enters the . . . recommendation into the [relevant governmental database]. However, the student cannot submit the application until 90 days before his or her graduation date. In other words, the earliest the [college] can submit the . . . recommendation is 120 days before the student's graduation.

Id. at *1 (with jargon explained). The plaintiff claimed that the defendant college negligently submitted its recommendation too soon, meaning that he could not apply in a timely fashion, and as a result could not qualify for the program.

So what?

How do you go about proving compliance with a complicated governmental program? Why, with an expert witness of course! That's what the defendant did, but the court was having none of it.

And that's where Dalgic becomes relevant to what we do in prescription medical product-land – because our opponents (often forcing us to follow suit) routinely attempt to use similar regulatory experts to make claims about what the Food, Drug & Cosmetic Act ("FDCA") requires.

In Dalgic, "[t]he parties' cross-motions implicate, in large part, the federal regulations pertaining to the [federal program's] application process." Id. at *7. The defendant "submitted an expert report authored by . . . an attorney practicing immigration law for over twenty-five years." Id. at *9. The attorney did what attorneys (and regulatory experts) do – spouted all kinds of legal conclusions, based primarily on his own interpretation of the relevant legal framework. Id. at *9-10. He also opined about what the author (a government employee) of a critical email about the relevant processes must have meant, given the relevant regulatory background. Id. at *9.

The court tossed him.

First, as to expert's interpretation of the email, the email itself was hearsay, and the expert's "opinions" were simply a dodge to introduce and rely upon otherwise inadmissible evidence. Id. at *12. How many times have we seen experts used to put inadmissible hearsay before a jury? More than we can count, so any decision disapproving of the practice is valuable. The bases for exclusion were:

  • No expert was needed. The "email (if it were admissible) could be easily read and comprehended without expert assistance." Indeed the expert referenced the email's "plain meaning." Id. at *11 (citations and quotation marks omitted).
  • The opinion was ipse dixit. "[T]here does not appear to be any discernible methodology applied by [the expert] in offering his opinion." Id. at *12. This is usually the case when the object of the opinion is simply to launder otherwise inadmissible hearsay into evidence. "[T]he expert may not, however, simply transmit that hearsay to the jury." Id. (citation and quotation marks omitted).
  • The opinion was simply a ruse to rely on hearsay. "Rule 703 was not intended to abolish the hearsay rule and to allow a witness, under the guise of giving expert testimony, to in effect become the mouthpiece of the [hearsay] witnesses on whose statements or opinions the expert purports to base his opinion." Id. (citation and quotation marks omitted).

The lawyer-expert's opinions on the regulatory scheme were also inadmissible, because they were exactly what they purported to be – expert opinions on issues of law:

[An expert's] understanding of the applicable federal regulations is also not a subject for which expert testimony is proper. Indeed, the meaning of federal regulations is not a question of fact, to be resolved by the jury after a battle of experts. It is a question of law, to be resolved by the court. . . . The only legal expert in a federal courtroom is the judge. . . . An expert should not be permitted to express an opinion that is merely an interpretation of federal statutes or regulations, as that is the sole province of the court. . . . Thus, [the expert's] opinion as to the meaning of [the pertinent regulation] and his interpretation of the phrase [in the regulation] is not admissible.

Id. (numerous citations and quotation marks omitted). Everything stated in Dalgic would be equally applicable to a plaintiff-side oath-helper posing as an "FDA expert" in a prescription medical product case.

And there's more. "Relatedly, [the expert's] opinion improperly states legal conclusions drawn by applying the law to the facts," which is also a no-no. Id. at *13 (citation and quotation marks omitted).

[An] expert may not state his or her opinion as to legal standards nor may he or she state legal conclusions drawn by applying the law to the facts. [O]pinion testimony that states a legal standard or draws a legal conclusion by applying law to the facts is generally inadmissible." In particular, [the expert] opines that [the college's conduct] "was not the proximate cause" of [the] injuries. This is not proper expert testimony.

Id. (more citations and quotation marks omitted). "Proximate cause is a question of law for the court to answer[, and] 'substantial cause' is a legal term of art that courts commonly hold cannot be the subject of expert testimony. Id. (citations and quotation marks omitted). Plaintiffs' experts also do that all the time in prescription medical product cases, finding "violations" where the FDA has not and opining on substantial factor causation.

Secondarily, the discussion of the "sham affidavit" doctrine in Dalgic is also relevant to what we do. "Sham affidavits" are something we've discussed elsewhere:

A sham affidavit is a contradictory affidavit that indicates only that the affiant cannot maintain a consistent story or is willing to offer a statement solely for the purpose of defeating summary judgment. A sham affidavit cannot raise a genuine issue of fact because it is merely a variance from earlier deposition testimony, and therefore no reasonable jury could rely on it to find for the nonmovant. Therefore, if it is clear that an affidavit is offered solely for the purpose of defeating summary judgment, it is proper for the trial judge to conclude that no reasonable jury could accord that affidavit evidentiary weight and that summary judgment is appropriate.

Id. at *14 (quoting Jiminez v. All American Rathskeller, Inc., 503 F.3d 247, 253 (3d Cir. 2007)). Most notably, Dalgic confirms that "a 'sham affidavit' need not directly contradict the earlier deposition testimony if there are other reasons to doubt its veracity, such as its inclusion of 'eleventh-hour revelations' that could have easily been discovered earlier." Id. at *15 (citation and quotation marks omitted).

The sham affidavit in Dalgic was indeed "an eleventh-hour revelation[] that could have easily been discovered earlier," since it involved facts that had already been litigated. Id. Moreover, it contained statements that contradicted the witness' prior "I don't recall" deposition testimony. Id. The timing "leads to the conclusion that the Affidavit was written in an attempt to provide factual support for the assumptions made by [the college's] expert that lack record support." Id. So out it went, as well.

Ultimately, the expert's opinions were unvarnished and unsupported legal conclusions – similar to those defense counsel in prescription medical product liability litigation encounter on a daily basis:

Virtually all of [the expert's] testimony whether factual or legal opinion was classic ipse dixit, i.e., I say it is so, so it is so. His legal opinion had no legal authority and his factual opinions were simply just that. There was no methodology except to say that the way it was, was the way he said it was. . . . [The expert] would have one believe that this entire [regulatory] process was whimsical. The requirements set forth in the Code of Federal Regulations were either meaningless or could be "interpreted" to mean the opposite of what they say. . . . I have rarely seen testimony so tortured and so tailored to the need of the client when the evidence was plainly contrary to the position advanced in the testimony.

In sum, [the expert's] testimony was and would be unhelpful to the fact finder. Moreover, the legal opinions were inappropriate.

Dalgic, 2019 WL 2867236, at *16.

With the Supreme Court's recent decision in Albrecht that preemption decisions, and their accompanying regulatory complexities, are legal issues for judges, and not factual questions for juries, we look forward to more decisions in the prescription medical product area excluding purported FDA regulatory experts for the same reasons that produced Dalgic – opinions on legal questions, opinions pushing inadmissible hearsay, opinions without any support, and opinions that "torture" and "tailor" the FDCA scheme "to the needs of the client."

This article is presented for informational purposes only and is not intended to constitute legal advice.

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