McDonald v. Ethicon, Inc., 2:12-cv-01366

Background

MDL No. 2327 involves thousands of transvaginal mesh cases; this memorandum addresses a Daubert motion to exclude the opinions of Elaine Duncan, M.D., a medical device regulatory/engineering consultant offered by Ethicon to rebut plaintiffs’ experts on regulatory compliance and risk management.
Plaintiffs moved to exclude Dr. Duncan’s testimony; briefing completed and the court considered the motion as part of coordinated MDL Daubert practice.
The court follows Rule 702 and Daubert gatekeeping but cautions parties against relying solely on prior MDL Daubert rulings; each expert and record are assessed on their own merits.
The court granted in part and reserved in part the motion: it excluded testimony about the FDA 510(k) clearance process and certain FDA regulatory compliance opinions, reserved rulings on testimony about design controls/risk-management standards and clinical/marketing practices, and barred legal-conclusion/state-of-mind testimony.
The opinion explains the court’s general evidentiary approach in the MDL: frequent exclusion of 510(k)-related evidence for low probative value and high risk of juror confusion, selective reservation for state-law-dependent issues, and preference for live testimony where necessary.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Admissibility of Elaine Duncan’s expert testimony	Duncan’s opinions are unreliable for rebutting plaintiffs’ experts and should be excluded	Duncan is qualified as a regulatory/engineering consultant and may rebut regulatory/risk-management opinions	GRANTED in part and RESERVED in part — address specific categories below rather than blanket exclusion
Testimony about FDA 510(k) clearance, labeling, and adverse-event reporting	Such testimony is relevant to defendants’ compliance and thus should be admitted	Defendant contends FDA/regulatory testimony is probative of design and safety processes	EXCLUDED — 510(k) process and related FDA compliance opinions are of negligible probative value and risk juror confusion
Testimony about design controls, risk-management and international standards	Plaintiffs argue such standards show defective design process and should be excluded if irrelevant	Defendants assert these standards are relevant to how Ethicon managed risk and designed products	RESERVED — court will evaluate specific standards’ applicability in context of state law and at hearing or trial
Experts offering legal conclusions, state of mind, or parroting corporate documents	Plaintiffs seek to bar experts from stating legal conclusions or serving as conduits for corporate facts	Defendants may rely on experts to explain technical document review and opinions	EXCLUDED/BARRED as to legal conclusions and state-of-mind testimony; experts may explain basis for opinions but cannot usurp jury or repeat corporate facts as mere conduits

Key Cases Cited

Daubert v. Merrell Dow Pharm., 509 U.S. 579 (1993) (sets Rule 702 admissibility framework for expert testimony)
Kumho Tire Co. v. Carmichael, 525 U.S. 137 (1999) (Daubert principles apply to all expert testimony, not only scientific)
Cooper v. Smith & Nephew, Inc., 259 F.3d 194 (4th Cir. 2001) (discusses Daubert factors and district court discretion)
In re Phenylpropanolamine Prods. Liab. Litig., 460 F.3d 1217 (9th Cir. 2006) (MDL courts must respect individuality of cases when gatekeeping expert evidence)
In re C. R. Bard, Inc., 810 F.3d 913 (4th Cir. 2016) (upholding exclusion of 510(k)-related evidence as having low probative value and high potential for prejudice)
United States v. McIver, 470 F.3d 550 (4th Cir. 2006) (expert testimony that states legal standard or draws legal conclusions is generally inadmissible)