Not too long ago, the Sixth Circuit – in an unpublished opinion in a below-the-radar case – held that a PMA medical device plaintiff had successfully threaded the preemption needle in Howard v. Sulzer Orthopedics, Inc., ___ Fed. Appx. ___, 2010 U.S. App. Lexis 12290, slip op. (6th Cir. June 16, 2010) (it’s also in our device preemption scorecard).  The one claim that the court held survived summary judgment was a negligence per se claim in the nature of a manufacturing defect claim based upon an FDA Good Manufacturing Practices regulation that the court admitted could be read two different ways.  Slip op. at 8 (“The provision, as we say and as the dissent illustrates, can reasonably be read either way”).  Based on some language it found in FDA “comments” and guidance documents, the court concluded that the plaintiff was interpreting the regulation in a way consistent with the FDA’s reading, and thus held that the regulatory-based claim survived preemption.  Id. at 7-8.
We don’t know enough about either the device or the regulatory history of the particular section that the plaintiff in Howard hung his hat on to say anything particularly useful.
What we’re interested in is where a defendant goes from here.  We were all set to pummel the defendant for ignoring the state-law based defenses to negligence per se that we’ve pontificated about at length when we noticed this in the Sixth Circuit’s opinion:

We also leave it to the district court to consider [the defendant’s] alternative ground for summary judgment: namely, whether Oklahoma law recognizes a negligence per se action based on violations of FDA regulations. All that we decide today, rather, is that [plaintiff’s] negligence per se claim for GMP violations is not preempted.

Slip op. at 9.  So it wasn’t the defendant’s fault.  If it was anyone’s, blame the court for reaching a constitutional issue when there were non-constitutional grounds available.Continue Reading PMA and Negligence Per Se Post Preemption – Then What?