Gross v. Stryker Corp.
858 F. Supp. 2d 466
W.D. Pa.2012Background
- Plaintiff Donald Gross sues Stryker Corporation and related entities over the Trident System hip prosthesis; he alleges a defective metal acetabular cup caused infection, pain, and a revision surgery.
- The Trident System is a ceramic-on-ceramic acetabular bearing with a metal shell and stem; the suit focuses on the allegedly defective metal acetabular cup.
- FDA-related events are part of the factual backdrop: a 2007 warning letter and a 2008 recall tied to manufacturing concerns at Stryker’s Mahwah facilities.
- Plaintiff asserts strict liability (manufacturing and marketing defects), negligence with res ipsa loquitur, and breach of implied and express warranties; punitive damages are also sought.
- Stryker removes to federal court and files a Rule 12(b)(6) motion arguing lack of proper party, express preemption under the MDA, and failure to plead viable parallel claims; the court later dismisses all claims with prejudice.
- The court does not convert the motion to summary judgment or allow discovery, and dismisses nonparty defendants for lack of service.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Stryker is a proper party to the suit | Gross alleges Stryker designed, manufactured, and marketed the Trident System | Howmedica Osteonics Corp. should be substituted as proper defendant and Stryker is not a proper party | Stryker is improper; case proceeds with its analysis on remaining issues |
| Whether strict liability is viable against a Class III PMA device under Pennsylvania law | Strict liability should apply despite PMA status | Comment k of Restatement 402A bars strict liability for unavoidably unsafe medical devices; Trident PMA device precludes liability | Counts I dismissed as preempted under MDA and barred by comment k |
| Whether Counts II (negligence and res ipsa loquitur) and III (breach of implied warranty) are expressly preempted or viable parallel claims | Claims are parallel to FDA regulations and thus survive preemption | Counts II and III are either preempted or inadequately pled parallel claims | Counts II and III dismissed as express preemption; parallel claims not adequately pled; dismissed with prejudice |
| Whether Count III (breach of express warranty) is pleaded with plausible specificity | Express warranty claim exists in Count III | No identifiable express warranty pleaded | Breach of express warranty dismissed for failure to plead elements with specificity |
| Whether punitive damages survive after dismissal of all claims | Punitive damages requested if gross negligence or malice proven | No viable claims remain to support punitive damages | Punitive damages dismissed with prejudice |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (express preemption framework for PMA devices; device-specific requirements)
- Lohr v. Medtronic, Inc., 518 U.S. 470 (U.S. 1996) (FDA approval processes; generic vs. device-specific requirements)
- Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (U.S. 2001) (implications of FDCA and preemption considerations)
- Creazzo v. Medtronic, Inc., 2006 PA Super 152, 903 A.2d 24 (Pa. Super. Ct. 2006) (Pennsylvania treatment of comment k and medical devices)
- Hahn v. Richter, 543 Pa. 558, 673 A.2d 888 (Pa. 1996) (application of comment k to prescription drugs; implications for devices)