Urogynecology Expert WitnessesUnited States District Judge Joseph R. Goodwin was asked to decide Plaintiff’s Motion to Exclude or Otherwise Limit the Opinions and Testimony of the Defense’s Expert in Multidistrict Litigation concerning the use of transvaginal surgical mesh to treat pelvic organ prolapse (“POP”) and stress urinary incontinence (“SUI”).

In the seven MDLs, there are more than 16,000 cases currently pending, approximately 10,000 of which are in this MDL.

Judge Goodwin wrote the “[b]efore plunging into the heart of the Motion, a few preliminary matters need[ed] to be addressed.”

Goodwin said he was compelled to comment on the parties’ misuse of his previous Daubert rulings on several of the experts offered in this case.

The parties have, for the most part, structured their Daubert arguments as a response to these prior rulings, rather than an autonomous challenge to or defense of expert testimony based on its reliability and relevance. In other words, the parties have comparatively examined expert testimony and have largely overlooked Daubert‘s core considerations for assessing expert testimony.

Although he recognized the tendency of his prior evidentiary determinations to influence subsequent motions practice, counsels’ expectations that the Goodwin aligned with these previous rulings when faced with a different record were misplaced, he said—especially when an expert has issued new reports and given additional deposition testimony.

Judge Goodwin went on to opine:

In the course of examining a multitude of these very similar cases involving the same fields of expertise, I have faced irreconcilably divergent expert testimony offered by witnesses with impeccable credentials, suggesting, to me, an unreasonable risk of unreliability. The danger—and to my jaded eye, the near certainty—of the admission of “junk science” looms large in this mass litigation.

The judge noted that the parties regularly presented out-of-context statements, after-the-fact rationalizations of expert testimony, and incomplete deposition transcripts. This, combined with the above-described practice of recycling expert testimony, objections, and the court’s prior rulings, created “the perfect storm of obfuscation,” Goodwin concluded.

Plaintiff claimed the urogynecologist wasn’t qualified to offer expert testimony about product warnings, which included expert testimony about the adequacy of the relevant Instructions for Use (“IFU”). According to the plaintiff, the doctor wasn’t an expert in the development of warning labels and thus wasn’t qualified to offer expert testimony about warnings. The judge acknowledged that, although an expert who is a urogynecologist may testify about the specific risks of implanting mesh and whether those risks appeared on the relevant IFU, the same expert must possess “additional expertise” to offer expert testimony about what information should or should not be included in an IFU. Here, the urogynecologist didn’t have additional expertise to offer expert testimony about what an IFU should or should not include. This, his expert testimony about these matters was excluded and Plaintiff’s Motion was granted on this point.

As to the expert testimony about the adequacy of the IFU, Defendant claimed its expert was qualified to testify about whether certain risks were commonly known in the medical community. In Judge Goodwin’s view, this wasn’t the subject of the plaintiff’s motion. The plaintiff’s motion focused on whether the expert was qualified to offer expert testimony about what should be included in or what may be excluded from an IFU. As a result, the judge offered no opinion on whether the expert could testify about whether certain risks were common knowledge. However, an expert can’t testify about whether any risks should have been included in an IFU unless he or she possesses additional expertise—expertise Defendant’s expert didn’t possess.

Plaintiff also sought to exclude the urogynecologist’s testimony as it related to mesh properties, including degradation, cytotoxicity, pore-size and weight, and laser-cut mesh versus mechanically cut mesh. Plaintiff argued that the expert lacked the qualifications to offer these opinions and that he failed to provide a reliable basis for his opinions.

As to qualifications, Plaintiff argued that the urogynecologist wasn’t an expert on designing mesh devices and, therefore, couldn’t opine on the material properties of the devices. However, Judge Goodwin found that this didn’t render him unqualified to opine on mechanical properties. The urogynecologist was a board-certified urologist specializing in pelvic floor medicine and reconstructive surgery and performed nearly 500 surgeries a year to treat POP and SUI. This extensive clinical experience qualifies him to opine on mesh’s reaction to and effect on the human body, the judge said. As a result, Plaintiff’s motion on this matter was denied.

Judge Goodwin explained that he has repeatedly excluded evidence regarding the FDA’s section 510(k) clearance process in these MDLs, and would continue to do so in these cases—a position that has been affirmed by the Fourth Circuit. Because the section 510(k) clearance process doesn’t speak directly to safety and efficacy, it’s of negligible probative value, the judge held. Delving into complex and lengthy testimony about regulatory compliance could “inflate the perceived importance of compliance” and lead jurors “to erroneously conclude that regulatory compliance proved safety.”

Thus, expert testimony related to the section 510(k) process, including subsequent enforcement actions and discussion of the information Ethicon did or did not submit in its section 510(k) application, was excluded. For the same reasons, opinions about Defendant’s compliance with or violation of the FDA’s labeling and adverse event reporting regulations were excluded. In addition to representing inappropriate legal conclusions, such testimony wasn’t helpful to the jury in determining the facts at issue in these cases and runs the risk of misleading the jury and confusing the issues. Thus, the judge held that insofar as the motion challenged the FDA-related testimony discussed here, it was granted.

The court denied in part, granted in part, and reserved in part the Plaintiff’s Motion to Exclude or Otherwise Limit the Opinions and Testimony of Defense Expert.


In re Ethicon Inc.,  2018 U.S. Dist. LEXIS 121735 (S.D. W.V. July 19, 2018)