Narrative Opinion Summary
The case involves a dispute between the Missouri Board of Examiners for Hearing Instrument Specialists and Hearing Help Express, an Illinois-based company, over the sale of hearing aids in Missouri without adherence to the state's mandatory fitting and testing requirements. Missouri law mandates that hearing aids sold by mail must be fitted and tested by a licensed specialist, without allowing for consumer waivers, which Hearing Help Express argued was preempted by the Medical Devices Amendment (MDA) to the Federal Food, Drug, and Cosmetic Act. The district court initially ruled in favor of the Missouri Board, upholding the state statute and issuing an injunction against Hearing Help Express. However, on appeal, the court determined that the Missouri statute was preempted by the MDA as it imposed additional requirements not mandated by federal law and interfered with federal objectives concerning device safety and effectiveness. The court vacated the injunction and remanded the case, ruling in favor of Hearing Help Express, emphasizing the preemptive effect of federal law over state regulations in the field of medical devices.
Legal Issues Addressed
Dormant Commerce Clausesubscribe to see similar legal issues
Application: The Missouri statute was challenged as violating the dormant Commerce Clause by imposing undue burdens on interstate commerce, but the district court found it balanced consumer protection with state interests.
Reasoning: The district court ruled that the MDA did not preempt the Missouri law, citing that the state requirements for fitting were not covered by federal law, and determined that the Missouri statute effectively balanced consumer protection and state interests against the burdens on interstate commerce.
Express Preemption and State Regulation of Medical Devicessubscribe to see similar legal issues
Application: Federal law under Section 360k(a) of the MDA expressly preempts state laws that impose requirements differing from federal requirements on medical device safety and effectiveness.
Reasoning: The MDA’s Section 360k(a) establishes that state laws may be preempted if they impose requirements that differ from or add to federal requirements regarding device safety or effectiveness.
Preemption under the Medical Device Amendments (MDA)subscribe to see similar legal issues
Application: The Missouri statute mandating fitting and testing of hearing aids prior to sale is preempted by federal law under the MDA, as it imposes additional requirements beyond federal regulations.
Reasoning: The Missouri statute prohibits the sale of hearing instruments via mail without prior fitting and testing by a licensed hearing instrument specialist. This requirement is distinct and additional to federal regulations under the Medical Device Amendments (MDA)...