The Presumption of Regularity in Prescription Drug Cases

In products liability cases involving prescription medicines, defendants sometimes rely on a preemption defense that FDA would not have approved – or in some cases, already rejected – the warnings that plaintiffs argue were required by state law.  Where the evidence shows FDA considered and rejected plaintiffs’ proposed warnings, plaintiffs often argue that the Agency would have approved their proposed warnings were it not for some technical issue.  For example, that FDA rejected the warning because the manufacturer asked to put it in the wrong section of the label or FDA would have approved it had the manufacturer asked rather than some third party in a Citizen’s Petition.  In rejecting such arguments courts often point, explicitly or implicitly, to the presumption of regularity, which “presumes” government agencies have “properly discharged their official duties” unless “clear evidence” shows otherwise.  See United States v. Chem. Found., Inc., 272 U.S. 1, 14-15 (1926); see also Nat’l Archives & Recs Admin. v. Favish, 541 U.S. 157, 174 (2004) (requiring “meaningful evidentiary showing” to rebut presumption of regularity).

 In the context of prescription failure to warn cases, the rule requires courts to presume FDA properly discharged its statutory obligations under the FDCA to ensure prescription medicines are “safe for use under the conditions prescribed, recommended, or suggested” in their “labeling.”  21 U.S.C. § 355(d).  After initial approval of the labeling based on substantial evidence of the medicine’s safety and efficacy, the FDCA authorizes FDA to approve and even mandate label changes in response to evolving evidence.  And, under the 2007 amendments to the FDCA, FDA must act to initiate label changes if the Agency becomes aware of a new safety risk warranting a change.

FDA and manufacturer have a statutory obligation to work together to revise labeling to reflect new safety information.  Notwithstanding the spirit of teamwork embodied in these provisions, FDA has final say and can “order” the manufacturer to “make such a labeling change as the [Agency] deems appropriate.”  21 U.S.C. § 355(o)(4)(E).

The presumption of regularity, properly applied, requires courts to presume that FDA “properly discharged” these “official duties” unless there is a showing of “clear evidence” that the Agency negligently carried them out.  The presumption applies in several contexts, including disputes about what actually happened during the decision-making process and disputes about the motivation behind government action.  See, e.g., R. H. Stearns Co. v. United States, 291 U.S. 54 (1934), Chem. Found., Inc., supra.  The presumption applies to factual determinations and can be a powerful tool for resolving issues on summary judgment where the plaintiff has failed to rebut that presumption.  Although relatively few products liability cases involving prescription medicines refer explicitly to the presumption of regularity, and some apply the doctrine without a great deal of analysis, the presumption clearly affected the decision in a number of pharmaceutical failure to warn cases.

In Dolin v. GlaxoSmithKline, LLC, 901 F.3d 803 (7th Cir. 2018), plaintiff attempted to avoid the preemptive effect of FDA’s rejection of her proposed warnings by asking the court “to believe that the FDA—after deciding against an adult-suicidality warning based on its own analysis—rejected GSK’s warning only because GSK proposed putting it in the wrong place” of the label.  This argument rested on the premise that FDA was aware of new safety information that warranted a label change but failed to meet its statutory obligation to initiate a label change and instead, rejected the manufacturer’s proposal on a technical flaw relating to the “correct” location in the label.  The Seventh Circuit concluded this was “an unreasonable interpretation” of discussions between FDA and manufacturer, accepting FDA’s explanation that it rejected the proposed suicide warning in favor of class labeling for all SSRIs based on the Agency’s interpretation of the safety data.  While the opinion did not use the phrase “presumption of regularity,” it effectively applied a presumption of sorts that FDA properly discharged its statutory duty to ensure adequate labeling.

In Cerveny v. Aventis, Inc., 855 F.3d 1091 (10th Cir. 2017), the Tenth Circuit found plaintiffs’ claims preempted because FDA rejected Citizens’ Petitions based on the same theories and evidence that allegedly supported plaintiffs’ claims.  Plaintiffs “hypothesize[d] that the FDA would be more receptive to a manufacturer’s request to strengthen a warning than to a citizen’s effort to compel a stronger warning,” but because the same standard applied to either request and because “we do not presume that the FDA deviates from regulatory requirements,” the court declined to “assume that the FDA would have scuttled its own regulatory standard” because a private citizen requested the warning.

More recently, the presumption of regularity was raised in a case before the U.S. Supreme Court, Merck Sharp & Dohme Corp. v. Albrecht, No. 14-1900.  In that case, plaintiffs argued that Merck should have warned about a risk of atypical femoral fractures associated with its medication Fosamax.  The district court concluded the claim was preempted on the basis that there was clear evidence FDA would not have approved the warning proposed by plaintiffs – because FDA in fact refused to approve that warning.  The Third Circuit reversed, and Merck has argued in the Supreme Court, among other things, that this decision, based on speculation about what FDA might have done had Merck rephrased its proposed warning, necessarily assumed that FDA ignored its own legal responsibilities, contrary to the presumption of regularity.  The case has been argued and is awaiting decision.  It will be interesting to see how the Supreme Court addresses plaintiffs’ implicit, unsupported suggestion that the FDA elevated form over substance and thereby failed to do its job.