We’ve gleefully detailed the plaintiffs’ utter failure in the Zostavax MDL to establish causation. Now, the Gardasil MDL likewise seems well on the way to a place on the list (along with Bone Screw, Aredia/Zometa, Taxotere, and Zantac) of MDLs that plaintiffs’ counsel wish they’d given a miss. Maybe plaintiffs will learn not to seek vaccine-related MDLs. Not long ago we discussed an excellent Gardasil preemption decision. Today’s post is about In re Gardasil Products Liability Litigation, 2025 WL 1782576 (W.D.N.C. Feb. 20, 2025), an interesting Fed. R. Evid. 702 decision that was actually decided a few weeks before the preemption decision, but only recently appeared on Westlaw/Lexis.
The issue in this Gardasil opinion – since it preceded the merits ruling on preemption – dealt with experts and preemption, something we speculated about shortly after Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019), but that has not received a lot of judicial attention since. Now that the Supreme Court has declared preemption to be a question of law for courts, not juries, to decide, what if any role can expert witnesses (particularly FDA experts) play? We commented in 2019:
Instead of juries hearing dueling testimony of plaintiff and defense FDA experts on whether some arcane CGMP was violated in some possibly causal fashion, judges should decide such issues, since the Albrecht Court has unanimously concluded that judges are “better equipped to evaluate” the intricacies of the FDA’s regulatory scheme. Purported FDA experts . . . regularly violate the limitation that expert witness should not offer conclusions of law, so confining them to testifying to judges rather than juries is more in keeping with the proper roles of expert witnesses generally.
Only a couple of cases have addressed this expert issue directly following Albrecht. The first happened right away. Delfino v. Medtronic, Inc., 2019 WL 2415049 (Minn. App. June 10, 2019), was an unpublished decision holding that, because “expert opinion as to a legal matter is generally inadmissible” in deciding preemption after Albrecht, a trial court “did not abuse its discretion by prohibiting [plaintiff’s expert] from opining on a legal question.” Id. at *12. The other is In re Zofran (Ondansetron) Products Liability Litigation., 57 F.4th 327 (1st Cir. 2023), which held:
[T]he question of whether the studies constitute newly acquired information [i]s a question of law. Expert testimony on questions of law is rarely admissible because such testimony cannot properly assist the trier of fact. To that end, [plaintiffs’ expert’s] opinion is likely inadmissible. Although experts can opine on the underlying factual questions, including providing interpretations of pharmaceutical studies, they provide little, if any, relevant assistance when they opine on the ultimate legal question of whether something is “newly acquired information.”
Id. at 340 (citations and quotation marks omitted).
The Gardasil opinion had more to say along these lines. It addressed dueling Rule 702 (don’t say Daubert) motions filed against both sides’ regulatory “experts.” Most of the discussion focused on the plaintiff’s expert. He had plenty of credentials. 2025 WL 1782576, at *2-3. However, since the issue was preemption, his opinions concerned what was ultimately a question of law.
[H]is general expertise does not allow the Court to consider all of [plaintiffs’ expert’s] opinions, and the Court must limit [his] testimony. . . . Plaintiffs ask the Court to rely on [their expert’s] testimony that [defendant] met the governing regulatory test to unilaterally include additional warnings on the Gardasil label as to [Postural Orthostatic Tachycardia Syndrome] POTS and [Primary Ovarian Insufficiency] POI. While that opinion is of course generally relevant to the Court’s ruling on preemption, the Court finds [his] opinion on the ultimate issues of regulatory authority is outside the scope of proper expert testimony because he is opining on questions of law.
Id. at *3.
Generally, “[e]xpert testimony on questions of law is rarely admissible because such testimony cannot properly assist the trier of fact.” Id. (quoting Zofran and collecting cases). Further, “[t]he issue of whether Plaintiffs’ state law failure to warn claims are preempted by federal law is a question of law, which must be determined solely by the Court.” Id. (citing Albrecht). Thus, plaintiff’s regulatory expert cannot “go[] beyond presenting evidence of the alleged ‘newly acquired information’ for the Court to itself consider.” Id. To the extent that the expert “offer[ed] his own interpretation as to whether the data was sufficient to meet the governing standard,” that legal opinion was excluded. Id. It went “to the heart of what the Court must decide and will be barred.” Id. However, “factual information” about “evidence and data that he contends [defendant] should have considered” could “assist” the court and would be considered. Id. At that point, testifying to facts rather than opinions, he would not really be acting as an expert at all.
Plaintiffs’ regulatory expert had his wings clipped in another respect as well. He had zero medical background, and thus “opinions on whether patient case studies, symptoms, etc., reflect a ‘causal association’” between the product and POTS/POI were entirely beyond his competence to give. 2025 WL 1782576, at *4. He was “not qualified to offer opinions as to ‘causal association’ at the patient level” because that subject was “indistinguishable from ‘medical causation.’” Id. Gardasil offers a useful collection of cases (which all appear to be courtesy of the aforementioned Aredia/Zometa litigation) for the proposition that FDA regulatory experts “are prohibited from testifying as to causal association/medical causation.” Id. (citing Jones v. Novartis Pharmaceuticals Corp., 235 F. Supp.3d 1244, 1257 (N.D. Ala. 2017), aff’d in pertinent part, 720 Fed. Appx. 1006 (11th Cir. 2018); Earp v. Novartis Pharmaceuticals Corp., 2013 WL 4854488, at *4 (E.D.N.C. Sept. 11, 2013); Guenther v. Novartis Pharmaceuticals Corp., 2013 WL 1278089, at *3 (M.D. Fla. March 28, 2013)).
In the absence of any competent POTS/POI diagnosis in the materials he reviewed, plaintiff’s expert had no expertise to make such diagnoses on his own, which he purported to do several times. 2025 WL 1782576, at *4. The expert “admit[ted] he is not qualified to makes these diagnoses, which underscore[d] his inability to differentiate causal association from medical causation.” Id. He “neither provided a proper foundation for linking various symptoms to POTS and POI, nor identified or applied an accepted method of analysis in reaching his diagnosing conclusions.” Id. at *4 n.4. That he would even try to get away with such incompetent and threadbare opinions also underscores the weakness of plaintiffs’ factual position – something that no doubt contributed to the defense win on preemption a few weeks later.
In sum, while the expert’s discussion of the underlying “evidence and data which he contends [defendant] could have used to support a decision to give warnings . . . about POTS and POI,” was admissible:
the Court cannot consider his opinion on the ultimate legal question of whether [defendant] had “newly acquired information” (i.e. whether or not [it] could have legally given the proposed warnings) or his opinions on whether any patient or study participant had POTS or POI (i.e. patient level causation) because they are outside the scope of proper expert testimony.
Id. at 9. Since p-side regulatory experts do these kind of things all the time, Gardasil is a useful addition to the defense armamentarium.
And what about the defense regulatory expert? While the court held that, generally, the same standards would apply to both sides, id. at *5 (“strictly limit its consideration in the same way”), the opinion does not suggest that the defense expert in fact committed any of the sins that the opinion detailed (with record citations) about the plaintiffs’ expert. Plaintiffs’ argument that the defense expert should be excluded altogether because “he most often testifies for defendants” received the back of the judicial hand in a footnote stating that “it is of little surprise to the Court that the Parties have each selected experts who most often . . . testify for” the same side. Id. at *5 n.6.
Thus, with regulatory experts in preemption situations, the court would “only consider the factual evidence and data that [the expert] contends should be evaluated,” and not any legal opinions on what did, or did not meet pertinent regulatory standards.” Id. FDA issues can be complicated, and courts can use that kind of help, so we can live with that.