8 F. Supp. 3d 93
D. Conn.2014Background
- McConologue sues Smith & Nephew for injuries from a Ceramic Liner implanted in his right hip.
- Complaint asserts Connecticut product liability theories under §52-572m, including strict liability, negligence, warranties, and misrepresentation.
- Liner recall occurred after FDA-identified deviations in manufacturing process (titanium rings pressed with excessive force).
- Plaintiff’s surgery in Sept. 2012 revealed a fractured liner; revision surgery confirmed fracture.
- Defendant moves to dismiss under Rule 12(b)(6); court grants in part and denies in part, addressing preemption and pleading adequacy.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| MDA preemption scope for PMA device | Claims are parallel, not preempted; device not exempt from state law duties. | All claims preempted because PMA device controls safety standards. | Not wholly preempted; some parallel claims may proceed |
| Manufacturing defect claim viability | Manufacturing deviations from FDA specs caused defect; claim survives preemption. | Manufacturing defect claims are preempted if they relate to device safety post-PMA. | Manufacturing defect claim survives |
| Failure to warn claim viability | Failure to warn claims can parallel FDA requirements and survive if properly pled. | Failure to warn claims are preempted or insufficiently pled under Iqbal/Twombly. | Failure to warn claim GRANTED, dismissed without prejudice to repleading |
| Design defect claim viability | Manufacturing deviation, not the original FDA-approved design, supports design defect theory not preempted. | Design defect claim preempted as it relates to FDA-approved design. | Design defect claim GRANTED, without prejudice to repleading |
| Negligence claim viability | Negligence based on manufacturing defect survives as parallel claim; other negligence theories may be pled. | Some negligence allegations are conclusory and fail Twombly/Iqbal pleading standards. | Negligence claim survives to the extent tied to manufacturing defect; other negligent claims dismissed without prejudice |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (Supreme Court 2008) (PMA preemption; parallel claims survive when not contrary to federal standards)
- Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012) (parallel claims not preempted; pleading must show FDA violation)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (no special pleading for parallel manufacturing claims; standard plausibility applies)
- Gelber v. Stryker Corp., 788 F.Supp.2d 145 (S.D.N.Y. 2011) (manufacturing defect not preempted when alleging deviation from FDA standards)
- Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (failure to warn claims can be parallel to federal duties; not preempted)
- Horowitz v. Stryker Corp., 613 F.Supp.2d 271 (E.D.N.Y. 2009) (breach of warranty claims not automatically preempted when alleging FDA-related violations)