Craft & Sheppard's Supreme Court Review

Preemption

In Riegel v. Medtronic, Inc., the Court held that the preemption clause in the 1976 Medical Device Amendments, 21 U.S.C. § 360k, barred an injured plaintiff’s state law tort and warranty claims suit challenging a medical device’s safety and effectiveness, which the Food & Drug Administration (FDA) had given premarket approval.  The Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301, requires FDA approval before a manufacturer markets new, complex medical devices [Class III devices].  The rigorous premarket approval process requires a manufacturer to submit a comprehensive application about a device’s safety and effectiveness, its components, ingredients, properties, and principles of operation.  After weighing the device’s benefits against risk, the FDA approves it only upon finding a “reasonable assurance” of the device’s safety and effectiveness.  The FDA reviews a device’s proposed labeling to ensure it is not false or misleading.  Under federal law, a state may not “establish or continue in effect” for a device intended for human use “any requirement …different from, or in addition to, any requirement” under federal law.  Here, a heart catheter [Class III device] received FDA premarket approval and was inserted into Riegel’s coronary artery, seriously injuring him.  Since state law sought to impose requirements different from or in addition to the FDA’s, the Court found that federal law preempted Riegel’s state law tort and warranty claims.
In Rowe v. N.H. Motor Transp. Ass'n, the Court found that federal law regulating motor carriers preempted Maine’s statute regulating delivery and sale of tobacco designed to prevent sales to minors. Federal law forbade states from enacting laws relating to rates, routes, or services.  State law required delivery of tobacco products only to licensed tobacco retailers, and the delivery service must verify the purchaser’s identity and age.  Preemption results even when the state law effect on rates, routes, or services is indirect or impliedly promotes public health.  If a state law may significantly impact deregulatory and preemption-related objectives, it conflicts with federal law purposes, and it is immaterial whether a state law is "consistent" or "inconsistent" with federal regulation.  Maine law focused on trucking services, which made up a substantial part of all delivery services and created a direct connection with motor carrier services. State law has a significant, adverse impact on federal law’s ability to achieve its objectives.  
A California statute, AB 1889, expressed employer-union neutrality, but prohibited employers who received state funds from using them “to assist, promote, or deter union organizing".  The law required employers who received $10,000 in state funds to allow unions access to their property, imposed onerous recordkeeping requirements, and gave a private action for violations. Federal law balanced protection, prohibition, and laissez-faire for organization, collective bargaining, and labor disputes.  Though the National Labor Relations Act does not expressly preempt the California-type law, the Court has long held that implied preemption forbids the NLRB and states to regulate conduct that Congress left unregulated, conduct for market forces to play out.  In Chamber of Commerce of the U.S. v. Brown, the Court preempted AB 1889:  it regulated a zone reserved for market freedom, the intersection of employee organizational rights and employer speech rights.  A state may not regulate directly non-coercive speech about unions or indirectly by spending restrictions on the use of state funds.