490 F.Supp.3d 430
D. Mass.2020Background
- In 1999 Taupier received a Reconix ePTFE mesh patch manufactured by Davol to repair a left inguinal hernia.
- In 2017 Taupier developed a recurrent abscess, was diagnosed with perforated sigmoid diverticulitis and a probable mesh infection, and underwent removal of the mesh and sigmoid resection.
- Taupier alleges the mesh migrated/deteriorated, perforated his large intestine, and had design defects (harbored bacteria, shrank 30–50%, depolymerized/stress‑cracked and flaked) and that he was not warned of known risks.
- Claims in the First Amended Complaint: breach of express warranty; breach of implied warranties (merchantability and fitness for a particular purpose); negligence (design and failure to warn); and strict liability/failure to warn.
- Davol moved to dismiss under Fed. R. Civ. P. 12(b)(6); the court granted the motion in part and denied it in part.
Issues
| Issue | Taupier's Argument | Davol's Argument | Held |
|---|---|---|---|
| Breach of express warranty | Davol expressly warranted mesh was fit and not injurious; Taupier relied on that | Complaint fails to identify specific warranty terms or plaintiff's reliance | Dismissed |
| Breach of implied warranty (merchantability) — design defect | Mesh design (ePTFE) was unreasonably dangerous (bacterial colonization, shrinkage, depolymerization) and caused injury | Comment k/"unavoidably unsafe" doctrine bars such claims for implanted medical products | Survived (claim for implied warranty based on design defect allowed) |
| Breach of implied warranty (fitness for particular purpose) | Mesh was not fit for a particular purpose (beyond ordinary use) | No allegation of a special, non‑ordinary purpose or reliance on seller's skill | Dismissed |
| Negligent design | Davol failed to exercise reasonable care in choosing/designing ePTFE; caused injury | Allegations lack specificity and causation | Survived (negligent design claim sufficiently pled) |
| Negligent failure to warn | Davol failed to warn of non‑obvious risks to physician/patient | Learned intermediary rule and complaint lacks specific allegations about warnings given or omitted | Dismissed |
| Strict liability for failure to warn (breach of warranty warning theory) | Inadequate warnings were a substantial factor in causing injury | Overlaps with negligent failure to warn; complaint allegations conclusory | Dismissed |
Key Cases Cited
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (pleading must state a plausible claim)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (courts draw reasonable inferences and disregard bare conclusions)
- Haglund v. Philip Morris Inc., 847 N.E.2d 315 (Mass. 2006) (implied warranty of merchantability as functional equivalent of strict liability; factors for design defect)
- Vassallo v. Baxter Healthcare Corp., 696 N.E.2d 909 (Mass. 1998) (discusses Restatement §402A/comment k in Massachusetts jurisprudence)
- Commonwealth v. Johnson Insulation, 682 N.E.2d 1323 (Mass. 1997) (Massachusetts does not recognize strict products liability)
- Evans v. Lorillard Tobacco Co., 990 N.E.2d 997 (Mass. 2013) (risk‑utility balancing test for design defect)
- Back v. Wickes Corp., 378 N.E.2d 964 (Mass. 1978) (ordinary purposes and consumer expectations in design defect/warranty claims)
- Garside v. Osco Drug, Inc., 976 F.2d 77 (1st Cir. 1992) (learned intermediary doctrine and burden‑shifting for failure‑to‑warn claims)
- Mut. Pharm. Co. v. Bartlett, 570 U.S. 472 (2013) (discussion of comment k and case‑by‑case treatment of unavoidably unsafe products)