This post is from the non-Reed Smith side of the blog.
When we last talked about Shuker v. Smith & Nephew PLC, No. 13-6158 (E.D. Pa.), it was with high praise for the court’s decision tossing out almost all claims as preempted and any non-preempted claims for being inadequately pleaded. Our post on that decision is here. The court gave plaintiff a second chance to re-plead the non-preempted claims, which he did. Defendant again moved to dismiss and this time it was granted with prejudice. Shuker, 2016 WL 5461900 (E.D. Pa. Sep. 29, 2016).
Plaintiff underwent hip replacement surgery. For that surgery, plaintiff’s surgeon opted to use defendant’s R3 hip replacement system, but also used a component, the metal liner, from defendant’s BHR hip resurfacing system. Admittedly, an off-label use. Plaintiff suffered complications that required multiple revision surgeries. Id. at *3.
In its original decision, the court’s leave to amend went only to parallel claims based on allegations of off-label promotion. Id. at *1. Those claims were for “tortious misconduct based on off-label promotion” and fraud. Id. at *4. Plaintiff cites to a single press release to support his allegation that defendant “actively marketed” the metal liner as an option for the R3 system “in a way that led” doctors to believe the liner was a component of the R3 system and safe to use with the R3 system. Id.
In assessing whether something is a viable parallel claim, there must be a traditional state-law duty – in this case negligence and fraud fit the bill – that parallels a duty imposed under federal law. Id. at *5. The federal duty on which plaintiff relies in this case is an alleged prohibition on off-label promotion. On this point, the court engages in a somewhat lengthy discussion of the split decisions on whether the FDCA prohibits all off-label promotion or only false and misleading off-label promotion. Id. at *6-7. But despite the rundown on the cases going each way, the court does not reach its own conclusion, finding it unnecessary to its decision. That’s because to state a parallel claim based on off-label promotion, “a plaintiff must plausibly allege the defendant affirmatively promoted the particular off-label use of the device in question that caused the plaintiff’s injuries.” Id. at *7. Plaintiff’s amended complaint missed the mark.
As mentioned, plaintiff relies exclusively on the press release, and a “selected reading of only a portion of the release” at that. Id. For instance, plaintiff focuses on the portion of the press release that says the metal liner is an “option” for the R3 system, but ignores the part that characterizes the R3 system for use in “hip replacement and resurfacing procedures.” Id. at *8. Because the system has multiple uses, the press release says nothing about the “particular use” for which the metal liner at issue is appropriate. Nowhere did the press release make any affirmative recommendations or suggest for which type of procedures the metal liner is or is not appropriate. In fact, when hip replacements are mentioned in the press release, it is in conjunction with other liner options, not the metal liner. Id.
All in all, when given the chance to re-plead his off-label promotion claims to meet TwIqbal pleading standards, plaintiff couldn’t do it. We’ve noted time and time again that when preemption strips plaintiffs down to only a possible off-label fraud or misrepresentation claim, plaintiffs are left with a fairly high hurdle to actually prove both the off-label promotion and a causal link to the doctor’s decision to use the device off-label. This may be a more extreme example of plaintiff grasping at straws, but the analysis and reasoning are strong and equally applicable in other situations.