Shuker v. Smith & Nephew PLC
211 F. Supp. 3d 695
E.D. Pa.2016Background
- S & N designed, manufactured, and marketed the R3 System hip replacement with an XLPE liner; R3 System received 510(k) clearance and the liner’s use with the R3 System was not approved in the U.S. for total hip replacements.
- S & N also marketed the Birmingham Hip Resurfacing (BHR) System, which had PMA approval; the R3 metal liner was part of that PMA-approved BHR system.
- Plaintiffs allege off-label promotion of the R3 metal liner for total hip replacement, citing a February 2009 press release promoting a metal liner option.
- Mr. Shuker underwent an off-label hip replacement in April 2009 using the R3 metal liner with the R3 System; later complications led to additional surgeries.
- The Court previously held that parallel state-law claims based on off-label promotion may survive preemption only if they plead conduct that parallels federal requirements; the Third Amended Complaint allegedly fails to plead affirmative off-label promotion by S & N.
- The Court granted dismissal with prejudice, concluding the Third Amended Complaint did not plausibly plead a parallel claim based on off-label promotion.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether off-label promotion claims can be a valid parallel claim to FDCA preemption | Shuker argues off-label promotion violates federal law and parallels state tort duties | S & N argues no plausible off-label promotion was pled and thus no parallel claim | No plausible parallel claim; dismissal granted |
| Whether the February 2009 press release constitutes off-label promotion for the R3 metal liner | Press release shows liner marketed as optional for R3 System | Release viewed in context does not prove off-label promotion of the liner for hip replacements | Not shown affirmative promotion for off-label use; fails plausibility for parallel claim |
| Whether labeling and warnings allegations render S & N liable under parallel tort theories | Claims include misleading statements and failure to warn about off-label use | Some alleged warnings relate to labeling separate from off-label promotion; not a single misrepresentation tying to off-label use | Claims fail to plead a single tort theory grounded in federal-law parallel conduct; dismissible |
| Whether the court should reconsider its preemption ruling given Huskey/Edwards decisions | Requests reconsideration of preemption scope | Rulings followed earlier controlling precedents; no basis for change | Court adheres to prior preemption framework; reiterates parallel-claim requirement |
Key Cases Cited
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. 1996) (establishes federal preemption framework for 510(k) devices)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (PMAs provide extensive federal safety/effectiveness review; preemption scope clarified)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (U.S. 2001) (implied preemption when claims exist solely by virtue of FDA disclosures)
- United States v. Caronia, 703 F.3d 149 (2d Cir. 2012) (off-label promotion First Amendment considerations; misbranding theory debated)
- Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015) (narrow view of labeling/adequate directions; parallel claims require traditional state tort grounding)