Loustaunau v. Ethicon, Inc.
2:17-cv-07596
E.D. La.Aug 24, 2016Background
- Multidistrict litigation in the Southern District of West Virginia (MDL No. 2327) consolidating thousands of transvaginal mesh cases; court handles Daubert challenges centrally under PTO No. 217.
- Ethicon moved to limit the testimony of Prof. Dr. Uwe Klinge, a hernia surgeon and expert for plaintiffs, raising multiple challenges to his opinions about mesh products (Prolene, Prolene Soft, PVDF, Prolift+M, sutures, porosity, degradation).
- The court emphasizes its gatekeeper role under Rule 702/Daubert and warns parties against recycling prior MDL rulings instead of addressing the current record; reserves some rulings for live testimony at trial when necessary.
- On specific product-design and scientific-opinion topics, the court assesses whether Klinge is qualified and whether his methods/opinions are reliable and relevant to the cases identified.
- The court also addresses recurring evidentiary themes in the MDL: exclusion of testimony about FDA 510(k) clearance and caution about testimony that offers legal conclusions, state of mind, or merely parrots corporate documents.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| PVDF as safer alternative | Klinge may testify PVDF is a safer mesh alternative | Ethicon argues PVDF not FDA-cleared so opinion unreliable | Denied: FDA clearance status does not make opinion unreliable |
| Prolene degradation, fraying, particle loss (general) | Klinge can opine on degradation and particle loss as general causation evidence | Ethicon says testimony is irrelevant or not tied to specific clinical outcomes | Denied: testimony admissible; expert need not tie every link to specific case |
| Prolene Soft degradation/fraying | Klinge may rely on SUI mesh studies; plaintiffs say opinions apply to Prolene Soft used for POP | Ethicon says pore/weight differences between Prolene and Prolene Soft undermine reliability | Reserved: court will decide after further probing at trial; cannot exclude now |
| Prolift+M testimony | Plaintiffs will not elicit Klinge on Prolift+M | Ethicon sought exclusion | Denied as moot per plaintiffs’ concession |
| Prolene sutures and FDA approval | Klinge can use Ethicon studies about sutures to support opinions | Ethicon argues FDA approval preempts or invalidates such testimony | Denied: court finds no authority that FDA approval preempts expert opinions; impeachment with FDA approval not permitted here |
| Effective porosity/design alternatives | Klinge may testify about porosity and pore size relevance | Ethicon contends testimony is speculative absent a proven safer design | Denied: relevance accepted; expert need not prove a complete safer alternative |
| FDA 510(k), labeling, reporting, and regulatory compliance testimony | Plaintiffs seek to introduce regulatory evidence to support causation/design claims | Ethicon seeks to admit/explore FDA submissions and compliance | Partly granted/partly reserved: 510(k)-related testimony and FDA labeling/reporting evidence excluded; broader design-control and foreign standards testimony reserved for trial/contextual review |
Key Cases Cited
- Daubert v. Merrell Dow Pharm., 509 U.S. 579 (gatekeeping standard for expert admissibility)
- Kumho Tire Co. v. Carmichael, 525 U.S. 137 (Daubert reliability inquiry applies to all expert testimony)
- Cooper v. Smith & Nephew, Inc., 259 F.3d 194 (4th Cir.) (non-exclusive Daubert reliability factors)
- Huskey v. Ethicon, Inc., 29 F. Supp. 3d 691 (S.D. W. Va.) (general causation opinions can be helpful even if not case-specific)
- In re Phenylpropanolamine Prods. Liab. Litig., 460 F.3d 1217 (9th Cir.) (MDL judges must respect individuality of cases)
- United States v. McIver, 470 F.3d 550 (4th Cir.) (experts may not state legal conclusions)