## Facts

- Carolyn Lewis and other plaintiffs sued Ethicon, Inc. in the Ethicon pelvic mesh multidistrict litigation, alleging they were injured by an Ethicon pelvic mesh product used to treat urinary incontinence.
- Plaintiffs’ theory of the case was that the product’s design and related conduct caused them harm.
- Before trial, Lewis filed a motion in limine targeting a recently published position statement from the American Urogynecologic Society (AUGS).
- The AUGS statement included favorable assessments of the product category, including that it represented the “standard of care” and was “safe and effective.”
- Lewis argued the AUGS statements were out-of-court assertions being offered to prove the truth of those assertions and therefore were inadmissible hearsay.
- Ethicon sought to use the AUGS statement at trial to support its defense themes about accepted medical practice and the product’s safety and performance.

## Issues

1. Whether statements in an AUGS position statement that pelvic mesh slings are the “standard of care” and “safe and effective” were inadmissible hearsay when offered as substantive proof of those propositions.

## Decision

- The court granted Lewis’s motion in limine to exclude the AUGS position-statement statements as substantive evidence because they were hearsay when offered to prove that the product was, in fact, standard of care and safe and effective.
- The court declined to allow Ethicon to use the position statement as a backdoor means of presenting an authoritative-seeming endorsement to the jury without a witness subject to cross-examination.
- The court’s ruling left open only the limited, rule-based ways such materials may be used at trial (such as use in connection with expert testimony if the requirements for a recognized hearsay exception are satisfied), rather than admitting the statement itself for its truth.

## Legal Principles

- Under Federal Rule of Evidence 801(c), an out-of-court statement offered to prove the truth of what it asserts is hearsay and is inadmissible unless an exception applies.
- A professional association’s “position statement” does not become admissible merely because it is published by a recognized medical group; the proponent still must establish a valid nonhearsay purpose or a hearsay exception.
- The “learned treatise” exception in Rule 803(18) is limited: it generally permits statements from a reliable authority to be used in examination of an expert and read to the jury, but it does not permit the treatise itself to be received as an exhibit, and it requires an adequate foundation that the source is a reliable authority.
- On motions in limine, the court may exclude categories of evidence that would invite the jury to accept third-party conclusions for their truth without testing them through live testimony and cross-examination, and it may manage the manner in which technical publications are referenced at trial to prevent confusion or unfair prejudice under Rule 403.

## Conclusion

Lewis held that Ethicon could not present an AUGS position statement to the jury as substantive proof that pelvic mesh slings were the standard of care or were safe and effective, because those assertions were hearsay; any use of such materials had to fit within the narrow limits of the Federal Rules of Evidence rather than serving as an untested endorsement.


Lewis v. Ethicon, Inc. (In re Ethicon, Inc., Pelvic Repair System Products Liability Litigation), No. 2:12-MD-02327, 2014 U.S. Dist. LEXIS 14971 (2014)