Allison Zieve, arguing on behalf of the petitioner, began by discussing the PMA process and stressing what PMA is and what it isn't. Notably, Ms. Zieve argued, the FDA grants the PMA if the information submitted by the manufacturer meets the statutory standard of reasonable assurance of safety and effectiveness, but it is the manufacturer, not the FDA, that chooses the design, labeling, and manufacturing practices. Justice Kennedy expressed a concern that if state-law damages claims were not preempted, the jury, in determining if a device was unreasonably hazardous, would be asked to engage in the same balancing already undertaken by the FDA during the PMA process. Justice Scalia followed up on that point by stressing that in Lohr, unlike here, the jury was not simply revisiting the same inquiry already addressed by the FDA. Justice Ginsburg inquired how the PMA process for devices compares with FDA drug approval, to which Ms. Zieve responded that, for drugs, FDA approval is a defense on the merits but not preemptive of claims. Justice Scalia pressed on this point, and seemed skeptical of the assertion that the States would be free to enforce additional requirements on drugs beyond those of the FDA, so long as those requirements did not conflict with the federal requirements; Justice Scalia seemed to think that field preemption would prevent the States from enacting such requirements on drugs.

Turning to the question of when preemption would be found based on PMA, Justice Ginsburg posed a hypothetical situation in which a manufacturer sought to improve a device, but the FDA denied approval, and then someone brought suit based on the failure to make that improvement. Ms. Zieve agreed that, if 360k(a) ever preempts tort claims, that hypothetical would be such a situation. Chief Justice Roberts followed up by posing the question of what would happen if a manufacturer knew of a design that was superior to its already PMA-approved device, but would not be able to market the new improved device immediately (because it would need to first go through the PMA process itself) "“ would it then be negligent to continue selling the old device? If so, then the manufacturer would have to remove it from the market, which would injure patients because no device would be available in the interim.

Theodore Olson argued next on behalf of the respondent. Mr. Olson immediately returned to Justice Kennedy's line of questioning regarding the balancing that the FDA engages in when it weighs the safety and efficacy of a device against the public need for such a device. Mr. Olson stressed that Congress made the decision to trust this balancing to the expertise and the judgment of the FDA, and that further state-law requirements are preempted because they would make the process confusing and burdensome. Justice Ginsburg asserted that all of the same arguments could be made about new drugs, but Congress had failed to expressly preempt tort claims for drugs; accordingly, it could be argued that the preemption provision in 360k(a) was not meant to preempt tort suits, but rather state pre-market approval procedures that might conflict with the FDA process. Mr. Olson responded that regardless whether state requirements are created through a state pre-market approval process or through jury verdicts, the results would be the same and Congress's intent to allow the FDA to balance the interests would be thwarted. In response to questioning by Chief Justice Roberts about newly discovered safety concerns that were not before the FDA during the PMA process, Mr. Olson replied that the FDA PMA process is ongoing, with reporting requirements for the manufacturers and options for doctors to report problems as well. It is then up to the FDA to decide if the risks outweigh the benefits and, if so, they can revoke the PMA. Mr. Olson agreed that a negligent manufacture claim (such as when the claim is that the manufacturer failed to comply with PMA requirements) would not be preempted by 360k(a), but said that in this case that claim was dismissed on summary judgment for lack of evidence. Justice Ginsberg expressed concern that once manufacturers receive the PMA, there would be a lack of incentives to improve their devices. Mr. Olson responded that the market would always encourage manufacturers to seek to create better and safer devices.

Edwin Kneedler argued next for the United States. Mr. Kneedler began by imagining what the consequences would be if 360k(a) was not preemptive; he said that the States would be free to impose requirements that might be in direct conflict with the requirements of the FDA. Justice Ginsburg again wanted to know why, if it were so important, no such express preemption was needed for new drugs. While Mr. Kneedler tried to offer a justification based on the differences between medical devices and drugs, Justice Scalia offered the obvious response that these provisions were enacted by different Congresses. In response to questioning from Justice Kennedy about what remedies exist for a manufacturer who fails to notify the FDA of known safety problems that arise after the PMA process, Mr. Kneedler responded that criminal penalties for failure to comply with the FDA, along with important reputational interests in providing safe products, would serve to keep manufacturers from hiding problems.

In her rebuttal, Ms. Zieve was questioned by Justice Souter regarding where petitioner would draw the line for preemption under 360k(a). Ms. Zieve responded that the States cannot enact positive law that imposes requirements on medical devices, but that jury awards under state tort actions are not preempted.

Posted in Riegel v. Medtronic, Everything Else