While updating the preemption chapter of his drug and device product liability treatise, Bexis came across a proposition he had not thought about in a long time.  In two opinions in the Birmingham Hip (“BHR”) MDL, the court, under the aegis of Fed. R. Evid. 702, excluded expert testimony because it solely concerned a preempted topic, and was therefore irrelevant:

It is “the district judge’s responsibility . . . to ensur[e] that an expert’s testimony both rests on a reliable foundation and is relevant to the task at hand.”  Relevant evidence is of course that which helps the trier of fact to understand the evidence or determine a fact in issue.  Testimony that relates only to claims that are preempted is not relevant to the remaining claims.

In re Smith & Nephew Birmingham Hip Resurfacing Hip Implant Products Liability Litigation, 2023 WL 6794318, at *2 (D. Md. Oct. 12, 2023) (quoting Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579, 597 (1993)), other citations and quotation marks omitted).  As a result, p-side expert opinions concerning failure to recall, adequacy of PMA submissions, and inadequate warnings were excluded.  Id. at *6, 13-14.

An earlier BHR decision reached largely the same conclusion, excluding expert testimony “that relates to the PMA approval process” because “[t]he claims to which such testimony might be relevant are expressly or impliedly preempted by federal law.”  In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, 2021 WL 781682, at *5 (D. Md. March 1, 2021).  In addition:

[A]ny claim that [defendant] had a duty to communicate information to patients or the medical community should be preempted as an attempt to impose requirements that add to or differ from federal regulations.  Accordingly, the court will exclude the challenged testimony relating to Dear Doctor letters and other communications to the medical community or patients.

Id. at *8.  Further, since only parallel claims were left in the MDL, “[t]o the extent that any expert testimony seeks to rely exclusively on state law duties that are not pinned to federal requirements, they are irrelevant to the remaining claims in this case.“  Id. at *9.

That caused us to look for other decisions that had mixed preemption and the admissibility of expert testimony under Rule 702, and sure enough, they were out there if one looked hard enough.  In In re Baycol Products Litigation, 532 F. Supp.2d 1029 (D. Minn. 2007), one of the plaintiffs’ experts purported to offer opinions “that criticize [defendant’s] submissions to the FDA and the FDA’s approval of [the drug].“  Id. at 1052.  That, of course, is a no-no under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  The testimony was excluded for that reason.  “[T]o the extent [the expert’s] testimony is offered only to show that the FDA was misled, or that information was intentionally concealed from the FDA, the testimony must be excluded.”  Id. at 1053.  We note that a number of courts have excluded various kinds of fraud-on-the-FDA evidence on Buckman grounds (see our post here), but Baycol seems to be the only such decision that focused specifically on expert testimony.

Another ruling excluding expert testimony for preemption reasons occurred in the Lipitor MDL:

[The expert] opines that the [particular study’s] data did not establish efficacy of [the drug]. . . .  As explained above, any claims that the [drug’s] label was misleading based on [that study] are pre-empted.  Therefore, this testimony is irrelevant.  To the extent that it has any marginal relevance, it would be confusing and misleading to the jury to hear testimony on the allegedly misleading nature of the . . . label’s description of [the study] when such allegations cannot be the basis of Plaintiff’s claims.

In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 185 F. Supp.3d 761, 783 (D.S.C. 2016).

The same result occurred in Lowery v. Sanofi-Aventis LLC, 2021 WL 872620 (N.D. Ala. March 9, 2021), involving an injectable premarket approved medical device subject to extensive preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  The expert claimed that the defendant “should have conducted additional testing” in the course of manufacturing the device.  2021 WL 872620, at *21.  Preemption precluded those opinions from being admissible.  The “opinion that Defendant should have implemented different testing methods that are not compelled by a federal law goes, at best, to a theory of liability that is preempted and, for that reason, cannot be an issue put to the jury at trial.”  Id. (citing Daubert).

We also found a number of analogous decisions.  Preemption has led to expert exclusion in several railroad cases.  In Campbell v. Union Pacific Railroad Co., 616 S.W.3d 451 (Mo. App. 2020), expert opinions that railroad crossing safety equipment was inadequate were rejected.  “[O]pinions concerning the safety of the crossing and allegedly optimal warning devices have no bearing on the . . . preemption inquiry.  If a crossing is equipped with federally funded warning devices, a railroad does not have an additional duty to erect other warning devices.”  Id. at 475.  In Joiner v. National Railroad Passenger Corp., 2008 WL 11506272, at *3 (S.D. Miss. March 25, 2008), expert testimony by the plaintiff’s expert “that the subject crossing was ‘ultrahazardous [wa]s not relevant, reliable, or admissible under F.R.E. 702” because it attacked “the adequacy of the warning devices in place at the subject crossing,” which was preempted.  Id. at *3.  See Rasmusen v. White, 970 F. Supp.2d 807, 816 (N.D. Ill. 2013) (expert opinion about a train’s “excessive speed” precluded due to preemption because the expert was demanding a speed less than the applicable federal speed limit).

Finally, in a maritime personal injury case, expert testimony about certain regulations was excluded because those regulations were preempted in the maritime context.

The Court will grant Defendant’s motion and exclude [the] expert testimony in this case.  It is undisputed in this litigation that the [ship] is a Coast Guard-inspected vessel, and that the OSHA regulations [the expert] relies on as the bases for his opinion . .   are completely preempted in this case.  Those OSHA regulations therefore are irrelevant to the claims and defenses in this case.

Al Qari v. American Steamship Co., 2023 WL 5014782, at *5 (E.D. Mich. Aug. 7, 2023).

Given the above, defendants have a solid legal basis for including preemption (where factually appropriate) in their Daubert/Rule 702 motions as a basis for challenging expert testimony as irrelevant.  It’s one situation where defendants may decide to deviate from our general “Don’t say Daubert” admonition (since the reference to “relevance” is from Daubert rather than the rule).