March 2008 Monthly Topic

Recent Developments in Federal Preemption
Under the Medical Device Amendments of 1976

The 1976 Medical Device Amendments (“MDA”), which was the landmark legislation that created the framework for the comprehensive regulatory scheme that exists today for the regulation of medical devices, included a provision that preempted certain state regulation of medical devices and authorized the Food and Drug Administration (“FDA” or “the agency”) to issue regulations to implement the preemption provision.(1) (2)  In essence, the idea was that under certain circumstances, federal requirements established for the regulation of medical devices would preempt state common law claims against a medical device manufacturer for injury resulting from use of the device.  However, the precise scope of this preemption provision remained ambiguous for nearly twenty years following its enactment.  This lack of clarity led to a split among the federal circuits about the precise meaning of the MDA’s preemption provision and FDA’s implementing regulations.  Some circuit courts interpreted the provision to mean that clearance of a device via the 510(k) premarket notification pathway preempted some or all state common law claims,(3) while other circuit courts construed the provision to preserve all state common law claims.(4)
To resolve this split among the federal circuit courts, the U.S. Supreme Court granted certiorari in 1995 in Medtronic v. Lohr.(5)  The issue presented was the precise scope of the MDA’s preemption provision.  Because the device in question was cleared by FDA through the 510(k) premarket notification process and was subject to continuing regulatory monitoring of its manufacture and labeling, Medtronic argued that state law remedies were preempted by the federal requirements.
The Court rejected Medtronic’s argument, concluding that the 510(k) process does not preempt state law claims.  Although this case resolved the issue of the scope of the preemption provision for state law claims regarding products cleared through the 510(k) process, the opinion expressly left open the question of whether premarket approval (“PMA”) would preempt state law claims.  After Lohr, a majority of the circuit courts of appeal concluded that state law claims regarding products approved through the exceptionally rigorous PMA process are preempted.(6)
 
Most recently, on February 20, 2008, the Supreme Court decided the case of Riegel v. Medtronic, Inc.(7)  Charles Riegel and his wife brought suit against Medtronic after Medtronic’s Evergreen Balloon Catheter, a class III, PMA-approved device, ruptured in Charles Riegel’s coronary artery during heart surgery.  The Riegels alleged that the device was manufactured, labeled, and designed in a manner that violated New York common law.  At issuewas whether PMA approval preempts state common law challenges to the safety and effectiveness of a medical device. 

In this case, the Court found in favor of Medtronic, concluding that the MDA’s preemption clause bars common law claims that challenge the safety and effectiveness of a medical device marketed in a form that received premarket approval from FDA.(8)  The Court’s decision was based on its findings that through the PMA approval process, the Federal Government has established “specific requirements applicable to a particular device,” within the meaning of the MDA’s preemption provision, and that the Reigel’s claims were based on state requirements, which were “different from and in addition to” those requirements imposed by FDA.(9) 

In distinguishing the PMA approval process at issue in Riegel from the 510(k) clearance process at issue in Lohr, the Court stated, “While §510(k) is ‘focused on equivalence, not safety,’ premarket approval is focused on safety, not equivalence.”(10)  The Court’s decision in Riegel decisively restricts the right of device users to sue medical device firms for products that have been approved through the PMA process, to the extent that the device complies with its FDA approved specifications.