Using Highlights in Failure-to-Warn Preemption

Attorney James Beck (Reed Smith) says drug companies and their attorneys involved in failure-to-warn suits “should closely examine all allegations of ‘inadequate’ warnings to determine whether such claims would create inconsistencies with Highlights information [in the drug’s label], and adjust their preemption strategy accordingly.” Writing in a Washington Legal Foundation Legal Backgrounder, Beck reviews the history of the Highlights section, created as part of a 2006 FDA overhaul of labeling.

He writes that creation of the Highlights section directly affects preemption in prescription drug product labeling litigation. The Supreme Court in its October 2018 term reaffirmed that limits to the preemption of labeling claims for prescription drugs are “grounded in the availability of FDA’s changes being effected regulation, which defeats implied impossibility preemption by allowing certain unilateral label modifications.”

Since Highlights is to be a concise summary of the most important full prescribing information, Beck writes, it would be impossible to maintain it as a concise extract if plaintiffs could demand different or additional warnings in the full labeling that would diverge from what is contained in unmodified, FDA-approved highlights. “Thus,” he says, “plaintiffs should not be able to evade preemption by ignoring disparities with highlights and demanding only changes to the rest of a drug’s labeling. This need for consistency is analogous to the ‘sameness’ requirement that drives preemption in generic drug cases — for highlights to serve their intended function, they must convey the same information (in abbreviated form) as is found in the rest of a drug’s label.”

He concludes that preemption of explicit plaintiff demands for changes to the Highlights section of drug labeling is an easy argument to win, and has never been lost to date. “However,” he concludes, “now that Albrecht has clarified the standards for preemption, the broader argument should also be pursued, extending preemption to any informational claims that demand substantive changes that would necessarily require also modifying the language of the Highlights section.”