This post is from the non-Dechert side of the blog.

Before we get to today’s case, we fondly tip our hat to the Westminster Kennel Club Dog Show, held (and televised) last week.  Regular readers know how much we love this annual event and also may recall that our “heart breed” is the Standard Poodle.  (We actually had a probable future family member competing – “Joel,” a gorgeous grand champion white standard shown in cords.) Ultimately, the purple Best in Show Rosette was awarded to Trumpet the Bloodhound, marking the first time that breed has taken the top honor at Westminster.  By all accounts, Trumpet is a spectacular representative of his venerable breed, and we are excited about his historic win.

We also are happy about the result in today’s case, Africano v. Atrium Med. Corp., 2022 U.S. Dist. LEXIS 100428 (N.D. Ill. June 6, 2022), in which the court denied the plaintiff’s motion for new trial and affirmed multiple helpful rulings on the admissibility and inadmissibility of FDA-related evidence.  We have blogged about Africano three times before.  The plaintiff asserted claims for failure to warn and manufacturing defect, alleging that the defendant’s allegedly unsterile hernia mesh injured him when it was implanted in him to repair his inguinal hernia.  At trial, as we reported, the jury found for the defendant on both claims.

The plaintiff moved for a new trial pursuant to Fed. R. Civ. P. 59, arguing that the trial court erred in excluding several pieces of evidence.  First, the plaintiff argued that the court should have admitted evidence of a government complaint and consent decree against the defendant.  The consent decree shut down one of the defendant’s manufacturing plants until the defendant came into compliance with certain FDCA manufacturing regulations.  Before trial, the court granted the defendant’s motion in limine to exclude both documents, holding that “both constituted inadmissible hearsay; that the complaint did not fall under the public records exception to hearsay; that the consent decree did not constitute non-hearsay evidence as a statement of a party opponent; and that [Fed R. Evid.] 408 also rendered the consent decree inadmissible to the extent [that the plaintiff] offered it to prove the truth of the matters contained therein.”  Africano, 2022 U.S. Dist. LEXIS 100428 at *4-5 (citation omitted).

On the eve of trial, the plaintiff moved for reconsideration of the exclusion of the FDA complaint, arguing that it intended “to use the complaint for the non-hearsay purpose of impeaching [the defendant’s] argument” that it had cured deficiencies in its sterilization process.  The court denied the motion, finding that the complaint did not address the sterilization process in question but “broadly alleged regulatory violations that were not facially related to the” sterilization process,   id. at *5, so could not be used be used for impeachment as the plaintiff described.  The court also found that the complaint was inadmissible under Rules 401 and 403 because it related to an inspection that postdated the manufacture of the plaintiff’s hernia mesh, so “the risk of prejudice and confusion outweighed the complaint’s limited probative value.”  Id. at *6 (citation omitted).

In his motion for a new trial, the plaintiff argued that the complaint was not hearsay because the plaintiff “would not have offered it to prove that the [sterilization process] was not adequate, only that the FDA had not found that it was.”  Id. at *7 (citation omitted).  The court held:

This argument, as Defendant points out, is pure sophistry.  The only relevance of the FDA’s view of a process being inadequate is to show that the process actually is inadequate.  Plaintiff therefore sought to admit the complaint for the truth of the matters purportedly asserted therein – that Defendant’s sterilization validation was inadequate.  This runs headlong into the rule against hearsay.

Id., at *7-8.   Moreover, contrary to the plaintiff’s argument that the complaint was relevant because it suggested that the defendant’s validation of its sterilization process was not adequate, the court reiterated that the complaint “did not say anything about whether the sterilization validation was inadequate.”  Rather, it alleged “broad regulatory violations that, on their face, [did] not specifically related to the sterilization validation process that concerned” the plaintiff’s hernia mesh product.  Id. at *8.   Finally, the complaint did not qualify for the public records exception to the hearsay rule because it contained “mere allegations, not factual findings.”  Id. 

The plaintiff also argued that the court erred in excluding two observations from an FDA Warning Letter the defendant received.  The court had allowed the plaintiff to introduce the first page of the warning letter and the first of six observations, which, it found, was relevant to the case because it addressed the adequacy of the defendant’s validation of its sterilization process.  In his motion for a new trial, the plaintiff challenged the exclusion of the second and third observations.  Observation 2 concerned a different mesh than the mesh implanted in the plaintiff, and Observation 3 concerned foreign material, including hair, found in the defendant’s sterile medical devices.  The court found that the plaintiff had not met his burden of showing that these incidents “occurred under substantially similar circumstances [to] those at issue in this case;” thus, he “failed to show the probative value of these other incidents.”  Id. at *11 (citation omitted).   As such, “the potential for these unrelated incidents to confuse and mislead the jury substantially outweighed their probative value.”  Id.

The court also rejected the plaintiff’s argument that the court’s exclusion of Observations 2 and 3 “prevented the jury from considering the entirety” of the defendant’s failure to “address basic contamination prevention.”  Id. (internal punctuation and citation omitted).   To the contrary, the court emphasized, the jury was permitted to see the unredacted first page of the warning letter, which set forth the defendant’s failure to conform to the relevant regulatory requirements.  Finally, the court rejected the plaintiff’s argument that the exclusion of Observations 2 and 3 impaired his ability to cross-examine the defendant’s experts, emphasizing, again, that the excluded observations concerned observations “having nothing to do with the sterilization procedures relating to the . . . mesh product” at issue in the case.   The court concluded,

After considering [Plaintiff’s] arguments, this Court determines a new trial is unwarranted.   Plaintiff has not demonstrated that any of this Court’s evidentiary decisions constitutes error, much less the kind of error that had a substantial and injurious effect on the jury’s verdict.  Accordingly, this Court denies Plaintiff’s motion for a new trial.

Id. at *15 (citation omitted).   We really like this opinion.   Complicated evidentiary issues like these are a quagmire, and it is too easy for courts to punt tough threshold admissibility questions in favor of juries’ “weight of the evidence” assessments.   We agree with the court’s pretrial rulings and applaud its refusal to reconsider them.

We’ll talk to you soon, hopefully with poodle news to share.  In the meantime, stay safe out there.