In a recent post, we discussed a decision that, among other things, excluded an FDA expert’s “opinion” that the defendant’s medical device was “adulterated” and/or “misbranded.”  In Robinson v. Ethicon, Inc., 2022 WL 614919 (S.D. Tex. March 2, 2022), the court held that the expert “cannot take the final step of opining that the product was ‘misbranded’ or ‘adulterated,’ as these are impermissible legal conclusions.”  Id. at *6.  We think that this is a fact pattern that recurs with sufficient frequency that it would be worthwhile to collect other precedent to the same effect.

The first case was easy.  Robinson cited In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation, 2021 WL 3286439 (S.D. Ohio Aug. 1, 2021), which held that “no expert . . . may offer legal opinions, such as that the [defendant’s device] was ‘misbranded.’”  Id. at *8.  However, that trail stopped there, as Davol cited general appellate precedent precluding expert opinions on questions of law.  Id.  We’re not going there, because a comprehensive collection of such cases already exists in §10.06 of Bexis’ book.  Here, we’re focusing on expert opinions misusing these FDA terms of art.  And we found another decision from that same MDL to the same effect.  See In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation, 2021 WL 3617152, at *2 (S.D. Ohio Aug. 16, 2021) (identical language; adding that “experts may not offer other legal opinions, such as the meaning of the statutory or regulatory scheme surrounding medical devices”).

So we ran a search.  High on the list was Tsao v. Ferring Pharmaceuticals, Inc., 2018 WL 3649714 (S.D. Tex. April 19, 2018).  A lot of the discussion in Tsao was case specific because the purported expert opinions at issue were among the most ridiculous we’ve ever seen – directly contrary to the controlling FDA regulations applicable to the particular drug.  Id. at *12-13.  However, Tsao also recognized the general proposition that experts throwing around FDA terms like “misbranding” and “adulteration” were spouting inadmissible conclusions of law:

Finally, [the expert’s] opinions that the [the drug] was “misbranded” or “adulterated” are inadmissible legal conclusions.  The Federal Rules of Evidence do not permit an expert to render conclusions of law, because such testimony cannot properly assist the jury in understanding the evidence or determining a fact in issue.  Rather, expert testimony couched as legal conclusion merely tells the jury which result to reach.  The court must remain vigilant against the admission of legal conclusions to uphold its own function in charging the jury regarding the applicable law. . . .  [The expert’s] opinions that [the drug] was adulterated, misbranded, or false and misleading under the FDA regulations should be excluded as inadmissible legal conclusions.

Id. at *13 (citations and quotation marks omitted).

In Sadler v. Advanced Bionics, LLC, 2013 WL 1385376 (W.D. Ky. April 3, 2013), the defendant successfully moved to preclude the other side’s expert from letting loose a litany of legal conclusions, including that the device at issue was “adulterated”:

Defendant moves the Court to preclude [the expert] from rendering improper legal conclusions by testifying that the devices were “adulterated” and “defective,” or that Defendant acted “unconscionably,” “recklessly,” or “illegally”. . . .  To the extent [he] proposes to testify using these terms in a way that expresses a purely legal conclusion or a personal opinion beyond the proper scope of expert testimony, such testimony is inadmissible.  Consistent with the Court’s contemporaneous and prior rulings on this issue, [he] shall not use terms such as “adulterated,” “defective,” “unconscionably,” “recklessly,” or “illegally” at trial.

Id. at *6.

The same issue arose in In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2015 WL 5145546 (N.D. Ill. Aug. 31, 2015), and produced the same result:

[T]he court declines to permit [plaintiffs’ expert] to offer an opinion that the [devices] are “adulterated” and “misbranded” under the FDA regulations.  Legal opinions by experts are inadmissible. . . .  [N]ot even the FDA may declare unilaterally that a label is false or misleading and thus that a drug is misbranded; it must proceed to court for a judicial determination in an enforcement action.

Id. at *18 (citations and quotation marks omitted).

Similar expert testimony has also been offered, and repeatedly rejected, in pelvic mesh cases.  See Tyree v. Boston Scientific Corp., 54 F. Supp.3d 501, 543 (S.D.W. Va. 2014) (pelvic mesh case; excluding expert’s assertion that the “devices misbranded as a result of failure to furnish information requested” by the FDA); Foster v. Ethicon, Inc., 2021 WL 4476642, at *8 (D.S.D. Sept. 30, 2021) (expert “opinions on misbranding” would not “assist the jury in deciding a fact in issue”); Sanchez v. Boston Scientific Corp., 2014 WL 4851989, at *36 (S.D.W. Va. Sept. 29, 2014) (“misbranding” opinion excluded; “testimony on whether or not [defendant] complied with the FDCA would constitute an impermissible legal conclusion rather than an expert opinion”); In re Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation, 2014 WL 186872, at *19 (S.D.W. Va. Jan. 15, 2014) (expert’s “misbranding” opinions excluded as “not helpful to the jury and they will confuse and mislead the jury”).  See Eghnayem v. Boston Scientific Corp., 57 F. Supp. 3d 658, 694 (S.D.W. Va. 2014) (following Sanchez); Hall v. Boston Scientific Corp., 2015 WL 868907, at *29 (S.D.W. Va. Feb. 27, 2015) (same).

Finally, we came across several opinions excluding expert opinion on “adulteration” and/or “misbranding” in other circumstances.  United States v. Caputo, 374 F. Supp.2d 632, 646 (N.D. Ill. 2005) (in criminal misbranding/adulteration case, expert could “not testify about whether Defendants met their obligations under the [FDCA]”); Mause v. Global Household Brands, Inc., 2003 WL 22416000, at *4 (E.D. Pa. Oct. 20, 2003) (purported expert precluded from “offering an opinion if a product was misbranded” because “[i]t is for the Court, and not an expert, to decide whether the law is violated”); United Phosphorus, Ltd. v. Midland Fumigant, Inc., 173 F.R.D. 675, 687-88 (D. Kan. 1997) (excluding expert “misbranding” opinions in FIFRA pesticide case).