Riegel v. Medtronic

In a case that could dramatically restrict the right of patients to sue medical manufacturers for faulty products, the Court will decide whether the federal scheme permitting the FDA to pre-approve some products insulates manufacturers from state tort suits.

The plaintiff in the case is Charles Riegel, who suffered severe complications when a coronary artery catheter burst during his angioplasty. Riegel sued the manufacturer, Medtronic, for negligence in the design, manufacture, and labeling of the device.

Medtronic argued that Riegel could not bring these state-law negligence claims because they were preempted by Section 360k(a) of the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act. The MDA establishes a federal regulatory process for ensuring the safety of medical devices, and it provides that no state may set requirements that differ from or add to the federal ones. The District Court dismissed Riegel's claims as preempted by the MDA.

The U.S. Court of Appeals for the Second Circuit agreed that the suits based on medical devices like the Evergreen Balloon Catheter are preempted by the MDA. The catheter had been through the exceptionally rigorous "premarket approval" (PMA) process, by which federal regulators ensured that it met federal requirements.

More than a decade ago, the Supreme Court ruled -- against the same manufacturer -- that patients could sue companies whose products entered the market after a far more lenient approval process. In that case, Medtronic v. Lohr, 518 U.S. 470 (1996), the Court specifically declined to say whether PMA-approved products would also be subject to state tort suits. In the intervening years, most of the circuit courts of appeal have concluded that the manufacturers need not defend against state suits when the federal government has already given the nod to their products.

To allow state common-law suits for PMA-approved devices, the court ruled, would be to add a state requirement to the regulatory process despite the MDA's preemption clause.

In a case that dramatically restricts the right of patients to sue medical manufacturers for faulty products, the Supreme Court ruled that the federal scheme permitting the FDA to pre-approve some products insulates manufacturers from state tort suits.

The plaintiff in the case is Charles Riegel, who suffered severe complications when a coronary artery catheter burst during his angioplasty. Riegel sued the manufacturer, Medtronic, for negligence in the design, manufacture, and labeling of the device.

Medtronic argued that Riegel could not bring these state-law negligence claims because they were preempted by Section 360k(a) of the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act. The MDA establishes a federal regulatory process for ensuring the safety of medical devices, and it provides that no state may set requirements that differ from or add to the federal ones. The District Court dismissed Riegel’s claims as preempted by the MDA.

The U.S. Court of Appeals for the Second Circuit agreed that the suits based on medical devices like the Evergreen Balloon Catheter are preempted by the MDA.

The catheter had been through the exceptionally rigorous “premarket approval” (PMA) process, by which federal regulators ensured that it met federal requirements.

More than a decade ago, the Supreme Court ruled -- against the same manufacturer -- that patients could sue companies whose products entered the market after a far more lenient approval process. In that case, Medtronic v. Lohr, 518 U.S. 470 (1996), the Court specifically declined to say whether PMA-approved products would also be subject to state tort suits. In the intervening years, most of the circuit courts of appeal have concluded that the manufacturers need not defend against state suits when the federal government has already given the nod to their products.

To allow state common-law suits for PMA-approved devices, the court ruled, would be to add a state requirement to the regulatory process despite the MDA’s preemption clause.

On Feb. 20, the Supreme Court upheld the Second Circuit decision.

“In the context of this legislation excluding common-law duties from the scope of pre-emption would make little sense,” Justice Antonin Scalia wrote for the majority. “State tort law that requires a manufacturer’s catheters to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than state regulatory law to the same effect.”

Justice John Paul Stevens joined the majority, but filed a concurring opinion disagreeing in part but agreeing with the overall judgment. Justice Ruth Bader Ginsburg dissented.

Justice Ginsburg said the majority had misinterpreted congressional intent.

Congress did not intend “to effect a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices,” she wrote.

Question presented: Whether federal law preempts state lawsuits against medical devices approved by the FDA.