Yes, Justice Scalia, The Text Does Matter

At yesterday’s oral argument in the case Wyeth v. Levine, the Supreme Court considered a Vermont jury’s determination that pharmaceutical manufacturer Wyeth should be held liable for failure to properly warn of the dangers of intravenous “push” administration of its anti-nausea drug, Phenergan, which had been administered to the plaintiff, Diana Levine, to counteract nausea she was experiencing as a result of a migraine headache. Ms. Levine, a professional musician, was forced to have her arm amputated when she suffered gangrene caused by the manner in which Phenergan had been administered to her. The Vermont jury awarded Ms. Levine $6.7 million in damages for her injuries.

The Court appeared inclined to decide whether Ms. Levine’s state failure-to-warn claim was preempted based on a “new information” test: if the Vermont jury held Wyeth liable for failure to appropriately warn of the risks of “IV push” administration of Phenergan based on the same record of information that the FDA had used in approving the drug label, then Ms. Levine’s claims are preempted; if the jury was considering new, different, or additional information than what the FDA had considered, then her claims are not preempted. Most of the argument was devoted to a factual dispute over whether the jury had actually considered “new” information. This suggests that the Court may well decide the case based on “impossibility” preemption grounds. The federal government and Wyeth both argued that absent new information about the risks of Phenergan, the FDA would not allow Wyeth to change its label to warn more specifically about the risks of IV push administration of the drug.

From the Justices’ questions at oral argument, the Court appeared closely divided on whether the Vermont jury should have been allowed to decide whether the great risks of IV push administration of Phenergan—gangrene and amputation, as Justice Alito noted—outweighed the benefits to such an extent that the drug label should have been more strongly worded. While it is difficult to predict where the votes will fall, most commentators agree that whether the Court rules for Ms. Levine or for Wyeth, the decision is likely to cut a narrow path.

But there is potential for predictions of a “narrow” decision to be off the mark. At argument and in its brief, Wyeth suggested a much broader “objects and purposes” form of preemption that was not dependent at all upon whether or not Wyeth could have changed the label for Phenergan. At least one Justice—Justice Scalia—appeared sympathetic to this argument.

The problem is that this objects and purposes preemption entails, as noted by some members of the Court in previous opinions, “a freewheeling judicial inquiry” into how implied congressional purposes interact with state law. CAC submitted an amicus brief to the Court in Wyeth arguing that this “implied obstacle preemption” should be abandoned entirely, leaving state law preempted only when Congress has enacted an express preemption provision or when it is impossible to comply with both federal and state law.

An “objects and purposes” preemption ruling in Wyeth would be particularly remarkable in light of the Court’s ruling last Term in Riegel v. Medtronic. Writing for the majority in that case, Justice Scalia extolled the virtues of the approval process that medical devices must go through before the FDA approves them for the market. But he specifically noted that Congress had enacted an express provision preempting state common-law requirements concerning the safety of medical devices, whereas Congress did not enact such an express provision in the drug labeling context. Yesterday, both Wyeth and the United States sought to sweep away that distinction, arguing that the extensive preclearance process for drugs mirrors that described by Justice Scalia in Riegel in the medical devices context. Wyeth and the government seemed to be arguing that because the drug review process requires the same sort of expert balancing of risks and benefits, it should be accorded the same preemptive effect given to FDA decisions on medical devices. Despite Scalia’s oft-professed allegiance to statutory text—as he wrote in Riegel, “[i]t is not our job to speculate upon congressional motives”—he seemed receptive to this argument yesterday, suggesting that balancing risks and benefits is the expertise of the FDA, not a lay jury. It would be truly remarkable, under Scalia’s own jurisprudential philosophy, for the Court to achieve the same result as it did in Riegel, under virtually the same reasoning, but without the express congressional intent to preempt state law that is contained in the text of the statute at issue in Riegel.

However, we take Justice Scalia’s point to heart, even if he chooses not to—the text matters. Congress has never in the original FDCA or in its amendments to the drug review process expressed its intent to preempt state failure to warn claims as contrary to its “objectives and purposes” in protecting the nation’s health and safety. The Supreme Court should decline the invitation offered yesterday by Wyeth and the United States to push federal law beyond the bounds of the statute, disturbing the careful federal-state balance set forth in the Constitution and infringing the rights of consumers in the process.