236 F. Supp. 3d 940
S.D.W. Va2017Background
- Consolidated trial over injuries allegedly caused by Ethicon TVT (transvaginal mesh) devices; court requested briefing on what qualifies as an "alternative, feasible design" under West Virginia law.
- Parties submitted simultaneous briefs and responses; final pretrial conference held February 22, 2017.
- West Virginia law permits multiple products-liability theories (strict liability, negligence, warranty) to go to the jury when supported by evidence.
- Dispute whether alternative designs may include surgical procedures or different products (e.g., polypropylene sutures) and whether alternative design is required for negligence or the malfunction theory.
- Court evaluated federal and state authorities (including Fourth and Fifth Circuit decisions) and West Virginia Pattern Jury Instructions (PJI) to define legal standards for design-defect proof.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| May multiple product-liability theories be submitted? | Plaintiffs: may pursue strict liability, negligence, warranty together. | Defendants: no election required only after evidence. | Plaintiffs may present one or more theories; only theories supported by trial evidence go to jury. |
| Is an alternative surgical procedure an "alternative, feasible design"? | Plaintiffs: alternative procedures (e.g., non-mesh surgery) show feasible alternatives. | Defendants: procedure-based critiques are essentially medical-malpractice/therapy-choice arguments. | Alternative surgical procedures are not alternative, feasible designs as a matter of law. |
| Is a polypropylene suture an alternative, feasible design to TVT mesh? | Plaintiffs: suture is functionally similar and thus an alternative design. | Defendants: suture is a different device with different FDA history and function. | Polypropylene suture is not an alternative, feasible design for TVT as a matter of law. |
| Is an alternative, feasible design required for negligence and/or malfunction theory? | Plaintiffs: malfunction and negligence theories may proceed without alternative-design proof. | Defendants: risk-utility test applies to both negligence and strict liability, so alternative design should be required across theories. | Alternative-design proof is not required for negligence. Alternative-design proof is not required under the malfunction theory; whether a comparable product/design is feasible is a jury question once identified. |
Key Cases Cited
- Ilosky v. Michelin Tire Corp., 307 S.E.2d 603 (W. Va. 1983) (West Virginia permits multiple product-liability theories without pretrial election)
- Talley v. Danek Med., Inc., 179 F.3d 154 (4th Cir. 1999) (distinguishing product defect from medical-judgment claims; procedures are not design alternatives)
- Anderson v. Chrysler Corp., 403 S.E.2d 189 (W. Va. 1991) (malfunction theory allows circumstantial proof that a product malfunctioned absent a reasonable secondary cause)
- Bennett v. ASCO Servs., Inc., 621 S.E.2d 710 (W. Va. 2005) (applying malfunction theory and requiring evidence product failed to perform intended function)
- Morningstar v. Black & Decker Mfg. Co., 253 S.E.2d 666 (W. Va. 1979) (contrasting strict liability focus on product condition with negligence focus on manufacturer conduct)
- Theriot v. Danek Med., Inc., 168 F.3d 253 (5th Cir. 1999) (procedure-based alternatives attack medical treatment choice, not product design)