We talk a lot about preemption here. Click on the preemption topic on the side of our webpage (here) and you’ll get pages and pages of posts. That isn’t surprising. Preemption can end a litigation, and we all want to hit the game-winning home run.
But plaintiffs know that too. So, rather than taking preemption head on, we often find ourselves dealing instead with plaintiff’s attempts to get around it via “parallel violations” claims. Now, we have problems with the very existence of such claims. Among other things, they often appear to be improper attempts to bring private rights of action under the FDCA. But, unfortunately, they exist, and courts recognize them. Given that reality, however, we’d like courts to at least view them with a scrutinizing eye. The court in Cline v. Advanced Neuromodulation Sys., Inc., 2014 U.S. Dist. LEXIS 56669 (N.D. Ga. Mar. 31, 2014), did just that.
In Cline, the plaintiff had an opportunity for limited discovery (which we’ll discuss later) into the PMA specifications that came with the approval of an implantable pulse generator (“IPG”) implanted into plaintiff. Plaintiff then filed her third amended complaint in an attempt to state parallel violation claims related to the failure of her IPG. It didn’t go exceedingly well. The court lowered the microscope to look at those claims for what they really were, and almost all them did not survive.