Argument analysis: Gleaning the FDAs meaning for impossibility pre-emption

Much of the federal government may be in shutdown mode, but the Supreme Court is still open for business.

The Supreme Court opened its January session Monday morning with argument in Merck Sharp & Dohme Corp. v. Albrecht, a case about the workings of the Food & Drug Administration (still partially open) and when the agencys actions may insulate drug manufacturers from state tort suits through impossibility pre-emption. An important and often-used litigation defense for manufacturers, impossibility pre-emption doctrine shields manufacturers from state liability when it would be impossible for them to comply both with FDA regulations and with state-law duties to warn.

In this case, more than 1,000 patients sued drug manufacturer Merck for injuries allegedly arising from use of its FDA-approved prescription drug Fosamax. Merck raised impossibility pre-emption as a defense, arguing that the FDA had rejected Mercks proposal to add a new warning similar to the one plaintiffs allege was warranted. Opinions in the courts below and the parties and amicus briefs before the Supreme Court raised narrow technical questions about what the FDA meant in its official response letter rejecting Mercks proposal, as well as expansive questions about how to determine the FDAs meaning in pre-emption cases and who should resolve ambiguities about that meaning, a judge or jury. At Mondays argument, agency-process questions and hypotheticals featured prominently in the justices quest for the meaning behind the FDA letter and for interpretive principles to guide that quest.

All seemed to agree on the chronology: When reports surfaced of Fosamax users suffering a type of serious femur break called atypical femoral fracture, the FDA requested data from manufacturers. At that time, Merck also submitted a Prior Approval Supplement (PAS) to the FDA, seeking permission to add specific warnings to the Fosamax label, including one about stress fractures. The FDA sent a Complete Response Letter to Merck approving a new warning for one section of the label, but rejecting Mercks proposed stress fracture warning for the other section. After convening a task force to study the problem further, the FDA required all manufacturers of the drug to include a warning different from the one Merck originally proposed.

What the FDA meant in its letter and what context to consider in gleaning meaning divides the parties and, apparently, the justices. Merck argued first that the FDAs rejection of a manufacturers request to warn of a risk pre-empts state failure-to-warn claims based on that risk as a matter of law, owing to the statutory and regulatory framework. Merck focused on the portion of the statute requiring the FDA to initiate discussions to reach agreement with manufacturers on new warnings and the interpretive presumption of regularity, which assumes that the FDA follows its governing rules. Merck then argued that the absence of further revisions from the FDA until after its task-force report demonstrates that the FDA rejected Mercks proposed warning as unwarranted by the data at that time. The respondents, plaintiffs in the lawsuit against Merck, pointed to a different subsection in the same statute emphasizing that courts should not interpret the provisions to absolve manufacturers of their responsibility for the content of their labels. They also argued that the FDAs post-task-force rejection of the stress fracture terminology as insufficiently strong shows that the initial rejection was based on terminology.

Throughout the argument the justices expressed interest in how to frame the impossibility inquiry. Justice Elena Kagan distilled the inquiry down to what was [Mercks] proposal, what was [the FDAs] response, were you both talking about the same things? Pressed by the justices, Shay Dvoretzky, representing Merck, seemed to concede that the FDAs letter was not the strongest smoking gun of impossibility pre-emption. Had the letter explicitly stated that the FDA rejected Mercks proposed warning because there was insufficient proof for a warning, it would have pre-empted plaintiffs claims conclusively. On the other hand, had the letter explicitly stated that the FDA rejected Mercks proposed warning because Mercks terminology did not reflect the severity of the data, the plaintiffs claims would not have been pre-empted, just as conclusively.

Dvoretzky reiterated throughout his argument that the United States has told us the FDA understood [Mercks proposed] warning to be about atypical femoral fractures. One seemingly straightforward way to resolve ambiguity in what the FDA meant is to ask the FDA. To this end, the justices allotted argument time to Malcolm Stewart, the deputy solicitor general participating as amicus curiae supporting Mercks position. But the justices, with the possible exception of Chief Justice John Roberts, did not appear satisfied with taking the FDA at the solicitor generals word. Instead, Kagan, along with Justices Sonia Sotomayor and Neil Gorsuch, pressed Stewart for guidance on how to determine what FDA understands at any given moment and what are we to look to when we decide whether its impossible for Merck to change its label. Stewart admitted that the FDAs letter was ambiguous and that it would obviously have been better if [it] had stated without ambiguity the reason we are rejecting [the] proposed addition. The case therefore appears to turn on competing ideas of how to interpret that ambiguity in the context of impossibility pre-emption.

Direct discussion of the clear evidence standard used to resolve ambiguity in impossibility pre-emption, derived from the Supreme Courts decision in Wyeth v. Levine, was surprisingly absent from the argument. Though the justices and advocates vigorously debated what evidence to consider and how clearly that evidence illustrated the FDAs meaning, the argument did not touch on further articulation for the clear evidence standard or the appeals courts formulation of clear and convincing or highly probable, or even the presumption against pre-emption. Instead, the justices largely pressed the parties on the technical details of how the agency interacts with drug manufacturers over labeling, what the factual context most logically implies in this case, and whether the two pieces of the statute point to different conclusions.

Some of the justices also appeared concerned with the broader implications of the case for the functioning of the FDA. Kagan suggested that the idea that [FDA has] to look through all of your data in order to find out what the real risk is, [] and that if they dont manage to do that, youre exempt from suit seems to conflict with the statutory rule of construction that says that manufacturers have primary responsibility over their labels. Gorsuch wondered whether Mercks interpretation would create a moral hazard that encourages manufacturers to supply the FDA with a lot of information, overwhelming with data, and propose an inartfully drafted warning that it thinks is reasonably calculated to be refused so that it can avoid its own costs of negligence. Sotomayor expressed concern about the incentive for manufacturers to continue working expeditiously with the FDA to effect changes.

Justice Stephen Breyer, echoed at one point by Roberts, raised issues about the delicate balance involved in FDA judgments about under- versus over-warning. Breyer worried that going too far in allowing the tort jury to find mislabeling would hurt the vast majority of potential patients who can benefit from this medicine by deterring doctors from prescribing it. [O]n the other hand, he mused, the failure to include an important warning will hurt that minority of patients susceptible to that side-effect. This balance, Breyer suggested, is one best left to the FDAs scientific and public health expertise rather than 50 different states really giving different signals to the manufacturers about the right warnings.

These aspects of the how-to-decide question consumed nearly all of the argument time. Stewart had earlier noted that the Court ultimately should construe an ambiguous FDA letter. Justice Samuel Alito only raised the who-should-decide question near the end of the argument of David Frederick, who appeared on behalf of the respondents. Frederick agreed that the complete response letter back and forth was a legal document that a judge can interpret. But he added that the case also might raise factual issues about the meaning of the medical terms employed that judges could decide, but so can juries. When Breyer raised the possibility that this inquiry mixed issues of law and fact, Frederick refocused the attention on whether summary judgment was appropriate based on the uncontested facts alone: You can affirm and you can say what you want to say about jury issues deciding, but, here, our position is the complete response letter as a matter of law could not have made it impossible for Merck to update its labels. Frederick attributed this agnostic view on the judge/jury question to the extremely bizarre procedural route this multidistrict litigation case took from district court decision to appeal.

Although much of impossibility pre-emption case law to date has focused on predictions about whether the FDA would have rejected a hypothetical proposed warning, this case has prompted a existential-level debate about how to resolve ambiguity in what the FDA actually did. After argument, it appears that the justices views on the value of tort litigation and agency expertise will inform their decisions.

Editors Note: Analysis based on transcript of oral argument.