When patients sue medical device manufacturers for defective products, one of the most powerful defenses companies raise is federal preemption—the argument that FDA approval shields them from state law claims. Understanding preemption is essential for patients evaluating whether they can pursue legal claims for device injuries.
What Is Federal Preemption?
Federal preemption is a constitutional doctrine holding that federal law takes precedence over conflicting state laws. In medical device cases, manufacturers argue that FDA regulations "preempt" or override state product liability laws, meaning patients cannot sue under state law theories like design defect or failure to warn.
The Medical Device Amendments of 1976 contain an express preemption provision stating that states cannot establish requirements that are "different from, or in addition to" federal requirements for devices that have gone through FDA approval. Manufacturers interpret this to mean they cannot be sued for following FDA-approved designs and labeling.
The Supreme Court's Riegel Decision
In Riegel v. Medtronic (2008), the Supreme Court ruled that FDA premarket approval (PMA) preempts state law design defect and failure-to-warn claims. The Court reasoned that PMA involves rigorous FDA review establishing specific federal requirements for the device, and allowing state juries to second-guess those requirements would create conflicting obligations for manufacturers.
After Riegel, patients injured by PMA-approved devices face substantial barriers to filing product liability lawsuits based on claims that the device was defectively designed or that warnings were inadequate.
Exceptions to Preemption
Preemption does not completely bar all claims against device manufacturers. Several important exceptions exist:
Manufacturing defect claims may proceed because federal law requires devices to be manufactured according to FDA-approved specifications. When a specific device deviates from that specification, patients can argue the claim enforces rather than conflicts with federal requirements.
Parallel claims that are based on violations of FDA requirements may survive preemption. If a manufacturer violated FDA regulations—such as failing to report adverse events, making unauthorized design changes, or not following approved manufacturing processes—state law claims based on those same violations may proceed.
510(k)-cleared devices generally are not preempted under the Supreme Court's decision in Medtronic v. Lohr (1996), which held that 510(k) clearance does not establish device-specific federal requirements sufficient to trigger preemption. Most successful medical device lawsuits involve 510(k)-cleared products.
Fraud claims alleging that manufacturers deceived FDA during the approval process may overcome preemption, though such claims are difficult to prove and face procedural barriers.
Overcoming Preemption in Your Case
Patients with potential claims against PMA-approved devices should not assume preemption bars all legal options. An experienced medical device attorney can:
Research regulatory history to identify whether the manufacturer violated FDA requirements, made unauthorized changes, or failed to report adverse events—creating potential parallel claims.
Investigate manufacturing processes to determine whether your specific device was manufactured according to approved specifications or contained defects.
Analyze approval documents to understand exactly what FDA approved and whether the device as implanted matched those approvals.
The Ongoing Preemption Debate
Preemption remains controversial. Critics argue it unfairly shields manufacturers from accountability while leaving injured patients without recourse. Congress has periodically considered legislation to narrow preemption protections, and courts continue to refine the boundaries of what claims can proceed.
For patients injured by medical devices, consulting with an attorney experienced in navigating preemption issues is essential before concluding that no legal options exist.