Adams v. Boston Scientific Corp.
177 F. Supp. 3d 959
S.D.W. Va2016Background
- Ms. Julie Adams received a Pinnacle transvaginal mesh implant manufactured by Boston Scientific (BSC) on June 30, 2011 in Texas and alleges multiple post‑implant complications. Mr. Adams asserts loss of consortium.
- Plaintiffs filed in the MDL for Boston Scientific pelvic mesh cases; the court applies Texas law (implant and parties located in Texas).
- Plaintiffs pleaded strict liability (design, manufacturing, failure to warn), negligence (design, manufacturing), breach of express and implied warranties, and punitive damages; Mr. Adams asserted loss of consortium.
- BSC moved for summary judgment on multiple claims; plaintiffs conceded strict liability manufacturing defect and negligent manufacturing, and the court granted judgment on those counts.
- Court denied summary judgment as to strict liability design defect, negligent design, and loss of consortium; failure to warn claims also survive because BSC did not move on them.
- Court granted summary judgment for BSC on breach of express and implied warranty claims due to plaintiffs’ failure to provide pre‑suit notice under Texas Business & Commerce Code § 2.607.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Applicability of Texas statutory presumption tied to federal regulation (Tex. Civ. Prac. & Rem. Code § 82.008) | Section 82.008 bars liability if device complied with federal standards or had premarket approval | Pinnacle had 510(k) clearance; BSC argued that triggers presumptions of nonliability | Court: 510(k) is not a federal safety standard or FDA "approval"; § 82.008(a) and (c) inapplicable; no statutory presumption |
| Strict liability — design defect (unreasonably dangerous; safer alternative) | Design defect: Pinnacle was unreasonably dangerous and a safer alternative existed | BSC: claim barred by Restatement §402A comment k (unavoidably unsafe) or other defenses | Court: Rejected categorical application of comment k here; genuine fact issues remain — summary judgment denied |
| Negligence — negligent design and manufacturing | Plaintiffs assert negligent design and manufacturing caused injuries | BSC argued lack of evidentiary/legal support; plaintiffs conceded negligent manufacturing | Court: negligent manufacturing conceded but negligent design survives; summary judgment denied on negligent design |
| Breach of express and implied warranties (merchantability, fitness) | Plaintiffs claim warranties were breached by the device's defects | BSC argued plaintiffs failed to provide required pre‑suit notice under Tex. Bus. & Com. Code § 2.607 | Court: No evidence of pre‑suit notice; warranty claims dismissed on summary judgment |
| Loss of consortium (derivative claim) | Mr. Adams’ claim derives from Ms. Adams’ surviving tort claims | BSC: derivative and should be dismissed if primary claims fail | Court: Because design defect and failure to warn survive, loss of consortium survives; summary judgment denied |
Key Cases Cited
- Anderson v. Liberty Lobby, 477 U.S. 242 (summary judgment standard and "scintilla" rule)
- Celotex Corp. v. Catrett, 477 U.S. 317 (summary judgment burden on nonmoving party)
- Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574 (drawing inferences for summary judgment)
- McKisson v. Sales Affiliates, Inc., 416 S.W.2d 787 (Tex. 1967) (Texas adoption of strict products liability under Restatement §402A)
- Timpte Indus., Inc. v. Gish, 286 S.W.3d 306 (Tex. 2009) (Texas design‑defect elements and jury allocation)
- Am. Tobacco Co. v. Grinnell, 951 S.W.2d 420 (Tex. 1997) (risk‑utility factors for design defect)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (510(k) clearance focuses on equivalence, not safety)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (distinguishing 510(k) clearance from premarket approval)