251 F. Supp. 3d 844
E.D. Pa.2017Background
- Gary Smith received a Stryker Gamma 3 Nail System implant in March 2015; the implant later fractured and treatment ultimately required a left total hip replacement and treatment for infection.
- Plaintiffs (Gary and Tamara Smith) sued Stryker and Howmedica asserting strict liability (design and manufacturing), negligence (manufacturing, design, failure to warn, failure to recall), breach of implied warranty of merchantability, and loss of consortium.
- Defendants moved to dismiss under Fed. R. Civ. P. 12(b)(6), arguing Pennsylvania law bars strict liability and implied-warranty claims for prescription medical devices and that Plaintiffs’ factual allegations are insufficient.
- The court treated the Gamma 3 Nail as an "unavoidably unsafe" product governed by Restatement (Second) § 402A Comment k, which limits strict liability for design defects and restricts failure-to-warn claims to negligence.
- The court predicted Pennsylvania would allow strict-liability claims based on manufacturing defects under Comment k, but held Plaintiffs failed to plead a negligence claim with sufficient factual detail.
- Result: design-defect strict liability and warranty theories dismissed; manufacturing-defect strict liability and corresponding warranty claim survive; negligence claim dismissed; loss-of-consortium claim allowed to remain (derivative of surviving tort claims).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Comment k bars all strict liability claims against prescription medical-device manufacturers | Smith: Comment k does not bar manufacturing-defect strict liability; only design/failure-to-warn are limited | Defs: Pennsylvania law precludes strict liability and implied-warranty claims for prescription devices (including manufacturing defects) | Court: Comment k precludes strict-liability design claims; court predicts PA Supreme Court would allow manufacturing-defect strict-liability claims to proceed |
| Sufficiency of pleadings for manufacturing-defect strict liability | Smith: implant fractured under normal use with no secondary cause, alleging manufacturing defect | Defs: allegations are insufficient to show defect/existence at time of sale/cause | Court: Allegations are sufficient to plausibly plead a manufacturing defect claim; claim survives dismissal |
| Sufficiency of negligence claims (manufacturing, design, failure-to-warn, recall) | Smith: negligence theories supported by product failure and harms | Defs: complaint lacks factual allegations about defendant conduct, knowledge, or manufacturing/design process | Court: Plaintiffs failed to plead the requisite factual detail for any negligence theory; negligence count dismissed |
| Breach of implied warranty of merchantability (relation to strict liability) | Smith: warranty claim available as to manufacturing defect | Defs: warranty coextensive with strict liability and thus barred where strict liability barred | Court: Warranty claim dismissed to the extent it asserts design-defect (barred by Comment k); survives to the extent it tracks the surviving manufacturing-defect strict-liability theory |
Key Cases Cited
- Ashcroft v. Iqbal, 556 U.S. 662 (pleading standard: plausibility required)
- Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (plausibility standard for complaints)
- Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014) (frames PA strict products-liability law and presumption favoring strict liability)
- Incollingo v. Ewing, 282 A.2d 206 (Pa. 1971) (Comment k limits strict liability for prescription drugs)
- Hahn v. Richter, 673 A.2d 888 (Pa. 1996) (failure-to-warn in Comment k cases limited to negligence)
- Lance v. Wyeth, 85 A.3d 434 (Pa. 2014) (discusses scope of Comment k and viability of negligence theories for prescription products)
- Riley v. Warren Mfg., Inc., 688 A.2d 221 (Pa. Super. Ct. 1997) (elements of strict-liability manufacturing-defect claim)