In Kaiser v. Depuy Spine, Inc., --- F. Supp. 2d ---, 2013 WL 2006122 (M.D. Fla. May 14, 2013), the Court dismissed a complaint against a manufacturer of artificial spinal discs, finding the claims were preempted by federal law and not cognizable under the “parallel claims” exception to preemption.
Plaintiff brought negligence and strict liability claims after an artificial spinal disc allegedly failed and caused him bodily injury. Defendant argued that these claims were preempted under the Medical Device Amendments of 1976 (MDA), which generally preempt state law claims concerning medical devices subject to FDA’s rigorous pre-market approval (PMA) process. In an attempt to avoid preemption, however, plaintiff alleged that the discs violated FDA’s PMA requirements and argued that such allegations brought him within the “parallel claim” exception to preemption recognized in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).
Applying Eleventh Circuit precedent, the Court explained that “[p]arallel claims must be specifically stated in the initial pleadings.” Kaiser, 2013 WL 2006122, at *4. The Court then held that plaintiff failed to specify which federal regulations or requirements were violated, but instead had only pleaded in vague and general terms that defendant’s product violated PMA requirements.
Kaiser stands as a nice example of the intersection of the parallel claim exception and the pleading requirements of Twombly and Iqbal: to avoid preemption, plaintiffs must do more than simply invoke the “parallel claim” exception in general terms but must adequately plead the facts necessary to show that their claim is truly parallel.