Elliot Sheppard Tarloff


Medical Devices and Preemption: A Defense of Parallel Claims Based on Violations of Non-Device Specific FDA Regulations

Elliot Sheppard Tarloff

In Riegel v. Medtronic, Inc., the Supreme Court held that because the FDA
imposes device-specific requirements on the most sophisticated medical devices, tort
claims that would impose different or additional requirements on such devices are
preempted. The Court created an exception to this preemption rule for claims that
parallel federal requirements. However, it failed to define precisely what constitutes
a parallel claim. Lower courts have split on whether claims based on violations of
non–device specific, industry-wide federal regulations survive preemption. Several
courts, including the Eighth Circuit, and at least one scholarly article, have concluded
such claims are expressly and/or impliedly preempted. However, the Fifth
and Seventh Circuits, and a handful of district courts, have taken a more liberal
approach, holding that these claims should survive preemption. This Note explores
the split and argues that the liberal approach is preferable for doctrinal and public policy