123 F. Supp. 3d 733
D. Maryland2015Background
- Factual dispute centers on Smith & Nephew's BHR System, a Class III metal-on-metal hip implant approved via PMA by the FDA in 2006 under conditions of approval.
- Plaintiffs Williams allege ongoing FDA compliance failures and post-approval duties, including reporting and warnings, caused cobalt/chromium poisoning and permanent injury to Mr. Williams.
- BHR approval required adherence to PMA conditions; post-approval requirements included studies, training, adverse-event reporting, and labeling/warning obligations.
- Plaintiffs’ Maryland-law negligence and related claims are framed as parallel to federal PMA requirements, seeking damages for harm from deviations.
- Defendant Smith & Nephew moves to dismiss on express preemption under § 360k, implied preemption under Buckman, and Rule 8 sufficiency.
- Court will grant in part and deny in part, distinguishing which claims are preempted and which survive as parallel state-law claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether § 360k express preempts the claims | Claims parallel PMA requirements and state duties | Claims are preempted as ‘different from or in addition to’ federal requirements | Some claims preempted (design defect, implied warranty); others parallel and not preempted |
| Whether any claims are impliedly preempted under Buckman | Buckman applies to fraud-on-the-FDA-like theories | Buckman preempts the claims that conflict with FDA prosecution | Buckman does not broadly preempt most claims; some claims may survive if independently grounded in state law |
| Rule 8 sufficiency of the claims | Manufacturing defect, failure to warn, and warranties pleaded | Some claims lack plausible pleading | Manufacturing defect claim deficient and amenable to amendment; other claims pleads are plausible |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (PMA requirements establish device-specific safety standards; express preemption framework)
- Walker v. Medtronic, Inc., 670 F.3d 569 (4th Cir. 2012) (PMA; parallel vs. conflict with state-law duties; preemption analysis under 360k)
- Lohr v. Medtronic, Inc., 518 U.S. 470 (1996) (FDCA preemption and parallel state duties; foundational for MDA regime)
- Wyeth v. Levine, 555 U.S. 555 (2009) (Presumption against preemption; Congressional purpose governs)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (Fraud-on-the-FDA claims impliedly preempted; limits to preemption scope)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (Not all manufacturing defect claims preempted; depends on federal-law bases)
- Stengel v. Medtronic, Inc., 704 F.3d 1228 (9th Cir. 2013) (Governs whether state claims thread Buckman gap when predicated on federal duties)
- Gourdine v. Crews, 405 Md. 722, 955 A.2d 769 (2008) (Maryland duty to warn; parallel to PMA reporting duties)