Anastasi v. Wright Medical Technology, Inc.
16 F. Supp. 3d 1032
E.D. Mo.2014Background
- Plaintiff Lois Annette Anastasi sues Wright Medical for injuries from the Wright Medical Hip Implant with Conserve Cup (eight counts; plaintiff concedes dismissal of VII and VIII).
- Defendants move to dismiss Counts I (design defect) and VI (fraudulent misrepresentation) under Rule 12(b)(6).
- Implant date: Jan 11, 2012; surgery in Texas; post-operative metallosis, infection, pain, and implant loosening; explant on May 1, 2013.
- The Conserve Cup is a Class III device; FDA premarket approval was obtained via 510(k) rather than full PMA; FDA approval does not imply safety or effectiveness.
- Plaintiff alleges concealment and misrepresentation about safety and durability; defendants allegedly marketed the device as safe and durable while knowing of risks.
- Court applies Texas choice-of-law and discusses Rule 12(b)(6) standards and the potential applicability of Comment k to design defects.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Comment k bars strict-liability design defect claim | Comment k applies to drugs, not medical devices; not to bar design defect here. | Comment k should apply nationwide to bar design defect claims for medical devices. | Count I denied; Comment k premature for dismissal. |
| Whether fraudulent misrepresentation claim is sufficiently pled under Rule 9(b) | Claim alleges misrepresentations and concealment; intermediaries relied upon for Plaintiff. | Count VI fails to plead who, what, when, where, how under Rule 9(b). | Amendment allowed; court will permit repleading before Rule 9(b) analysis. |
Key Cases Cited
- Reyes v. Wyeth Labs., 498 F.2d 1264 (5th Cir.1974) (Texas strict liability framework; supports Section 402A framework)
- Hackett v. G.D. Searle & Co., 246 F.Supp.2d 591 (W.D.Tex.2002) (Comment k applied to prescription drugs; can limit liability)
- Gerber v. Hoffmann-La Roche, Inc., 392 F.Supp.2d 907 (S.D.Tex.2005) (Comment k and unreasonableness in design defect analysis)
- Crest Constr. II, Inc. v. Doe, 660 F.3d 346 (8th Cir.2011) (Rule 9(b) pleading standards apply to fraud claims)
- Cont’l Cas. Co. v. Advance Terrazzo & Tile Co., Inc., 462 F.3d 1002 (8th Cir.2006) (When state law lacks answer, apply state high court would)