Medical device regulation
🔹 1. Introduction
Medical devices include a wide range of products—from simple bandages to complex pacemakers or surgical robots. Their regulation ensures that devices are:
Safe and effective
Properly tested and labeled
Manufactured under quality standards
Subject to monitoring post-approval
In the United States, the Food and Drug Administration (FDA) regulates devices under the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Medical Device Amendments (MDA) of 1976. Other countries have similar regulatory bodies (e.g., CDSCO in India, EMA in Europe).
🔹 2. Classification of Medical Devices (Under FDA – similar globally)
Devices are classified based on risk:
Class I: Low risk (e.g., tongue depressors)
Class II: Moderate risk (e.g., infusion pumps)
Class III: High risk (e.g., heart valves, pacemakers)
Each class has different regulatory requirements such as:
Premarket Notification (510(k))
Premarket Approval (PMA)
Quality System Regulation (QSR)
Labeling requirements
Post-market surveillance
🔹 3. Key Legal Doctrines
Preemption (Federal law may override state law)
Strict Liability for defective devices
Negligence in design, manufacturing, or warning
Failure to warn under product liability
Informed consent related to use of high-risk devices
🔹 4. Landmark Case Law on Medical Device Regulation
✅ 1. Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)
Facts:
Charles Riegel suffered injury due to the rupture of a balloon catheter. He and his wife sued Medtronic under state tort law.
Issue:
Does federal regulation of Class III devices under the FDA’s PMA process preempt state tort claims?
Judgment:
The U.S. Supreme Court held that state-law claims were preempted by the federal MDA.
Significance:
Established broad preemption for PMA-approved devices.
Individuals injured by Class III devices cannot sue under state law for design defects.
✅ 2. Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)
Facts:
Lohr was injured by a pacemaker that was cleared under the 510(k) premarket notification process.
Issue:
Does the 510(k) clearance trigger preemption of state law claims?
Judgment:
The Court held that 510(k) clearance does not preempt state law claims because it does not constitute a determination of device safety.
Significance:
Differentiated between 510(k) and PMA.
Allowed state tort claims to proceed for non-PMA devices.
✅ 3. Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001)
Facts:
Plaintiffs alleged that Buckman Co. defrauded the FDA in getting approval for bone screws used in spinal surgeries.
Issue:
Can plaintiffs sue for “fraud on the FDA” under state law?
Judgment:
The Court ruled that such claims are preempted, as they interfere with the FDA’s exclusive authority to police fraud on itself.
Significance:
Reinforced federal supremacy in regulatory enforcement.
Shut the door on private "fraud-on-FDA" lawsuits.
✅ 4. Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013)
Facts:
Stengel alleged Medtronic failed to report adverse events to the FDA about a pain pump.
Judgment:
The Ninth Circuit allowed the claim to proceed, holding that failure to report safety concerns to the FDA could support a parallel state law claim.
Significance:
Created an exception to preemption: parallel claims based on federal requirements may survive.
Encouraged manufacturers to comply strictly with post-market reporting obligations.
✅ 5. Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011)
Facts:
Patient was injured by a PMA-approved device and sued under state law for failure to comply with FDA standards.
Judgment:
The court held that “parallel claims” are not preempted if they do not impose additional requirements beyond federal law.
Significance:
Confirmed that PMA preemption isn’t absolute.
State claims mirroring federal duties can proceed.
✅ 6. Perez v. Nidek Co. Ltd., 711 F.3d 1109 (9th Cir. 2013)
Facts:
Plaintiffs alleged use of a laser eye surgery device not approved by the FDA.
Judgment:
The court dismissed the claim, ruling that only the FDA has authority to enforce regulatory violations.
Significance:
Prevented private enforcement of FDA rules.
Reinforced exclusive federal control over device approval compliance.
🔹 5. Summary of Legal Doctrines and Judicial Trends
| Legal Principle | Court Interpretation |
|---|---|
| Federal Preemption | PMA-approved devices generally shield manufacturers from state-law tort claims |
| Parallel Claims | Allowed if state claim mirrors a federal requirement |
| 510(k) Approval | Does NOT trigger preemption; state claims may proceed |
| Fraud-on-the-FDA | Claims preempted—FDA has exclusive power to enforce against regulatory fraud |
| Post-market Reporting | Failure to report adverse events can support liability under certain state claims |
| Private Enforcement Barred | Individuals cannot sue simply for violating FDA rules |
🔹 6. Conclusion
Medical device regulation balances innovation with patient safety. The judiciary has clarified that while federal oversight is dominant, state law liability still plays a role, especially where manufacturers fail to meet federal obligations. Courts closely scrutinize whether a claim imposes additional obligations or simply enforces existing federal duties.
This dynamic legal framework pushes manufacturers to stay compliant not just during premarket review, but throughout the device’s life cycle—including post-market monitoring and reporting.
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