In re C.R. Bard, Inc.
948 F. Supp. 2d 589
S.D.W. Va2013Background
- Four bellwether MDLs involve transvaginal Avaulta mesh for pelvic organ prolapse and stress urinary incontinence; claims include negligence, strict liability, warranties, loss of consortium, and punitive damages.
- Bard moves to exclude or limit testimony of multiple experts across all four cases; plaintiffs respond with various Daubert challenges and competing methodologies.
- Zolnoun, Altenhofen, Loving/Carroll, and Shull are the primary excluded/limited experts in the court’s initial ruling; several treating-physician opinions and other experts were partially allowed or denied.
- The court applies Daubert and Rule 702 standards, emphasizing reliability, relevance, and fit, and discusses differential diagnosis as a reliability benchmark.
- The court also addresses issues related to treating physicians under Rule 26(a)(2)(B)/(2)(C), and grants reconsideration on specific issues relating to El-Ghannam and Klosterhalfen.
- Final orders grant in part and deny in part Bard’s Daubert motions across the four cases, and grant in part and deny in part the plaintiffs’ motion for reconsideration.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of Zolnoun's causation opinions | Zolnoun offers general and specific causation linking Avaulta to pain; Daubert allows reliable causation. | Zolnoun's opinions are ipse dixit without reliable testing or methodology. | Zolnoun's general and specific causation opinions excluded. |
| Admissibility of Altenhofen's complication-rate and related opinions | Complication-rate comparison to literature is probative and relevant. | Rate calculations lack reliable methodology and are inconsistent. | Altenhofen's complication-rate opinions excluded; remaining opinions on IFUs/training excluded as outside expertise. |
| Admissibility of Loving and Carroll as damages/relationship experts | Experts will quantify impact on body image, intimacy, and life quality. | Testimony is unnecessary for jurors, not properly applied to facts, or relies on inadmissible hearsay. | Relationship Experts' opinions excluded in part; portions applying to case facts or directly tied to plaintiffs' damages denied; other parts excluded as not applied to facts. |
| Admissibility of Shull's opinions on knowledge and warnings | Dr. Shull provides expert views on warnings, safety concerns, and corporate conduct. | Shull lacks expertise in warnings/labeling and on Bard's knowledge; results are not predictive for jury. | Shull's opinions on Bard's knowledge/state of mind/corporate conduct excluded; warnings-related opinions excluded; some areas related to product design also excluded. |
| Treating physicians' expert testimony and Rule 26 disclosures | Treating physicians may testify as to treatment-based opinions without Rule 26(B) reports if within scope. | Treating physicians may still be experts requiring disclosure; some causation must be treated as treating testimony. | Treating physicians' testimony allowed for treatment-based causation/factual opinions; opinions outside the course of treatment/extra opinions excluded; Rule 26 reporting addressed and deemed substantial justification or harmless in certain respects. |
Key Cases Cited
- United States v. Crisp, 324 F.3d 261 (4th Cir. 2003) (Daubert factors guide reliability/flexibly applied)
- Westberry v. Gislaved Gummi AB, 178 F.3d 257 (4th Cir. 1999) (flexible Daubert inquiry focused on methodology, not conclusions)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (U.S. 1999) (Daubert factors may be pertinent or not depending on issue and expert)
- Maryland Casualty Co. v. Therm-O-Disc, Inc., 137 F.3d 780 (4th Cir. 1998) (trial court must preliminarily assess reliability and relevance)
- Cooper v. Smith & Nephew, Inc., 259 F.3d 194 (4th Cir. 2001) (gatekeeper role; testing reliability and cross-examination)