Law

                In these movies, the writers/directors/actors give their spin on what happens after the war, after the disease, after the zombies.  In our DDL world, we sometimes have to ask what happens after preemption.  A lot of our posts are about what happens at the motion to dismiss stage, and our focus is on the claims that don't survive.  The ones that can't outrun the zombies.   But what about the survivors?  What about the plaintiff who manages to plead a parallel claim that doesn't get dismissed. 

               Well, much like Max Rockatansky and Imperator Furiosa, things aren't easy for post-preemption survivors either.

               To illustrate our point, we direct you to Swisher v. Stryker Corp., 2016 U.S. Dist. LEXIS 12726 (W.D. Okla. Feb. 3, 2016).  We know from a prior ruling in the case that the plaintiff claimed injury from a hip implant and that he was asserting a "parallel claim" -- an exception to Riegel preemption – based on alleged violations of PMA specifications and applicable Good Manufacturing Practices (GMPs).  When we originally covered the case it was dismissed as not satisfying TwIqbal pleading standards.  Somewhere in the ensuing years plaintiff must have amended his complaint with sufficient facts to maintain a parallel claim and the case proceeded. 

Now almost three years later, defendants have filed a Daubert challenge to plaintiff's engineering expert.  While the court found that plaintiff's expert was qualified to testify about the heat treatment used in the manufacturing process and the effect of that heat treatment on the metal used in the device that was where his expertise stopped.  Id. at *5-6.  But that's really not enough to make out a parallel claim.  A parallel claim is premised on an allegation that defendant violated a specific federal regulation.  Pleading that may get plaintiff around preemption, but then he's going to have to prove it.  And an expert engineer isn't competent to give the necessary testimony on the FDA scheme.  For instance, plaintiff's expert engineer in Swisher "does not have the expertise to express an expert opinion about . . . what the FDA may have viewed as complying or not complying" with manufacturing standards.  Id. at *6.  So plaintiffs are going to need more and varied experts if they are going to maintain their parallel violation claims.  This means the cases are more difficult and more expensive for plaintiffs.

    Not only was plaintiff's expert unqualified to offer the FDA-related opinions, the opinions he did offer turned out to be "inventive" and "wholly lack[ing] a reliable basis."  Central to plaintiff's case, his expert opined that the ASTM (American Society for Testing and Minerals) rule included an "inherent" or "implied" requirement that essentially barred heat treatment.  Id. at *7.  Not only could the court not find any evidence to support plaintiff's expert's interpretation of the rule, there was ample evidence that that was not the FDA's interpretation.  Id.   In a post-preemption survival world, plaintiff's experts have to give specific opinions.  As Swisher demonstrates, it often turns out that what plaintiff claims is "parallel" really involves regulatory interpretations that are much different than the FDA's.

Life isn't easy for PMA preemption survivors.  They may get farther down the road, but the road is dark, cold and mostly uphill.