Preemption: The PMA "Shield"

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Medical device preemption refers to the legal principle that federal law can supersede or preempt state law in cases involving medical devices that have been approved by the Food and Drug Administration (FDA). This principle is rooted in the Medical Device Amendments (MDA) of 1976 to the Federal Food, Drug, and Cosmetic Act (FDCA), which gave the FDA authority to regulate medical devices.

Medical device preemption is based on the idea that once the FDA has reviewed and approved a medical device, states cannot impose additional requirements or regulations that differ from or add to federal standards. This ensures a consistent regulatory framework across the country and prevents a patchwork of state laws that could complicate compliance for device manufacturers.

Preemption has significant implications for litigation involving medical devices. If a device has gone through the FDA's premarket approval (PMA) process, manufacturers may be shielded from certain state law claims, such as those alleging design defects or failure to warn. Courts have often ruled that these claims are preempted because they would impose requirements different from or in addition to those approved by the FDA. A search in the FDA's MAUDE database may reveal thousands of allegations of injuries in PMA-approved products.

Not all claims are preempted. If a device manufacturer fails to comply with FDA regulations, they may still be liable under state law for negligence or breach of warranty.

Devices that have been cleared through the FDA's less rigorous 510(k) process may not be entitled to the same level of preemption protection as those that have undergone PMA.

Patients managing diabetes with medical devices choose between products cleared by 510(k) and products cleared by a new PMA or a supplement, from companies sheielded by preemption.

Facing severe cuts in the FDA's talented medical device review staff, perhaps now is the time to revise preemption, giving the state courts more power to resolve medical device injuries.