534 F.Supp.3d 152
D. Mass.2021Background
- Plaintiffs Jill and Douglas Ducat sued Ethicon, Inc. after Jill had a Gynecare Gynemesh PS Prolene (vaginal mesh) implanted in 2003; the mesh later eroded, migrated, and caused chronic vaginal bleeding, pain, and multiple surgical interventions.
- Plaintiffs allege negligent design (Count I), breach of the implied warranty of merchantability (Count II), and loss of consortium (Count III); they disclaim any manufacturing-defect theory.
- Defendant removed the action to federal court and moved for judgment on the pleadings under Rule 12(c).
- The parties dispute whether Plaintiffs pleaded sufficient facts about the mesh’s defect and, centrally, whether Plaintiffs must plead a safer alternative design under Massachusetts law.
- The court accepted Plaintiffs’ factual allegations that the mesh eroded and caused injury but held Plaintiffs failed to plead the existence of a technologically feasible, practical alternative design as required by controlling Massachusetts law.
- The court dismissed Counts I and II for failure to plead an alternative design but granted Plaintiffs 21 days’ leave to amend; the loss-of-consortium claim rises or falls with the amended substantive tort claim.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Plaintiffs pleaded a valid negligent-design claim | The mesh’s erosion, migration, and resulting surgeries show the product was defectively designed and caused injury | Complaint does not identify how the design was unsafe or any safer alternative design | Court: Plaintiffs plausibly pleaded injury and causation but failed to allege a feasible/practical alternative design; negligent-design claim dismissed with leave to amend |
| Whether implied warranty claim survives | Warranty claim follows from defect/injury caused by mesh | Warranty claim fails for same reason as design-negligence (no pleaded alternative design) | Court: Warranty claim dismissed for failure to plead a safer alternative design; leave to amend granted |
| Whether loss-of-consortium claim survives | Loss of consortium arises from Jill’s injuries | Depends on survival of underlying tort claim | Court: Derivative claim contingent on amended substantive claims; dismissed if underlying claim not repleaded successfully |
Key Cases Cited
- Evans v. Lorillard Tobacco Co., 465 Mass. 411 (Mass. 2013) (SJC adopts risk-utility test and states plaintiff must prove a technologically feasible, practical alternative design to establish a prima facie defect)
- Back v. Wickes Corp., 375 Mass. 633 (Mass. 1978) (articulates multi-factor balancing test for design defect)
- Smith v. Ariens, 375 Mass. 620 (Mass. 1978) (upholds design-defect verdict without evidence of alternative design in circumstances within ordinary juror knowledge)
- Uloth v. City Tank Corp., 376 Mass. 874 (Mass. 1978) (holding that proof of a feasible modification can establish a design-defect case but not necessarily required in every case)
- Osorio v. One World Techs., 659 F.3d 81 (1st Cir. 2011) (observes Smith may allow a design-defect finding without proof of an alternative design)
- Tersigni v. Wyeth, 817 F.3d 364 (1st Cir. 2016) (interprets Massachusetts law to require proof of a reasonable alternative design)
- Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (U.S. 2007) (pleading must state a plausible entitlement to relief)