The preemption of state law claims against medical devices approved under the premarket approval (PMA) process is now an established principle of pharma law after Riegel v Medtronic, Inc., 552 U.S. 312 (2008). Most traditional product liability claims fail due to some combination of express preemption under the Medical Device Amendments of 1976 (MDA) and implied preemption. Courts have held claims under strict liability, negligence, warranty, and other theories expressly preempted because they seek to impose state law requirements "different from, or in addition to" the applicable federalrequirements. Wolicki-Gables a Arrow Int'1, Inc., 634 F.3d 1296 (11th Cir. 2011). Even if claims are "premised on a violation of FDA regulations," the claims mostly lack a "parallel" remedy under state law. Marmol v. St. Jude Medical Center, 132 F. Supp. 3d 1359 (M.D. Fla. 2015). At the same time, implied preemption operates as a further bar. See 21 U.S.C. 4337(a).

In response, enterprising plaintiffs' lawyers are resorting to more nuanced arguments in their search to circumvent prevention. Recent cases have involved attempts to use U.S. Food and Drug Administration (FDA) warning letters and formal performance standards to evade preemption. Brown a DePuy Orthopaedics, Inc., 978 F. Supp.,2d 1266 (M.D. Fla. 2013) (plaintiff failed to demonstrate the necessary nexus between her claims and an FDA warning letter); Kaiser a DePuy Spine, Inc., 944 F. Supp. 2d 1187 (M.D. Fla. 2013) (holding that the plaintiff failed to plead noncompliance with a formal performance standard established by FDA). For example, one appellate court has expressly rejected claims based on a flow-rate specification that was stated in PMA materials without a corresponding FDA-promulgated, device specific formal performance standard for the device involved. Walker v. Medtronic, Inc., 670 F.3d 569 (4th Cir. 2012).

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Previously published in For The Defense - Septembre 2016

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