Health Law Daily Wrap Up, PREEMPTION OF STATE LAW—E.D. La.: State law claims against pharmaceutical companies were pre-empted by federal law in multidistrict failure-to-warn litigation, (Jan 23, 2026)

By Sara Cracau, J.D.

The court rule that the Taxotere failure-to-warn claims were pre-empted because the manufacturers had no newly acquired information to justify changing the drug’s label.

A district court in Louisiana granted the motions for summary judgment of several pharmaceutical companies in a multidistrict failure-to-warn litigation involving a chemotherapy drug which allegedly caused excessive tearing in cancer patients finding that the state law claims were pre-empted by federal law. The court concluded that the pharmaceutical companies did not have “newly acquired information” which would have rendered the changes-being-effected (CBE) regulation process available to them and, therefore, could not have unilaterally changed their labels (In re: Taxotere (Docetaxel) Eye Injury Products Liability Litigation, No. 3023 E.D. La Jan. 16, 2026)).

Patients who were administered a chemotherapy drug, Taxotere or docetaxel, brought a multidistrict action against several pharmaceutical companies alleging that the drug caused them to sustain injuries to their lacrimal systems, including various types of stenosis which resulted in excessive tearing, also known as epiphora. The pharmaceutical companies filed motions for summary judgment arguing that the patients’ state law failure-to-warn claims were pre-empted under the Federal Food, Drug, and Cosmetic Act (FDCA) and its corresponding regulations under the theory of “impossibility pre-emption.”

Impossibility pre-emption. In failure-to-warn cases, the central issue is whether a private party can comply with state law when federal law requires agency approval to act independently. The underlying question is whether a federal law or FDA action prohibited the drug manufacturers from adding any and all warnings to the drug label that would meet state law requirements. A state law challenge to FDA-approved warnings can proceed only when the defendant had unilateral ability to alter the labelling and, if not, the claim is pre-empted. The CBE regulation allows for a unilateral label change if there is newly acquired information for which there is evidence of a causal connection between the drug and the injury. Furthermore, if the CBE regulation is available, the claims are nonetheless pre-empted if a manufacturer can show clear evidence that the change would not have been approved. Here, the court found that there was no newly acquired information that would have allowed the manufacturer to unilaterally alter the label via the CBE process.

“Newly acquired information” after approval of the pharmaceutical companies’ Docetaxel. “Newly acquired information” is defined as ‘“data, analyses, or other information not previously submitted to the Agency,” including but not limited to “data derived from new clinical studies…”’ In the case of a name-brand manufacturer, courts assess whether the information is “newly acquired” by determining whether the information shows a “risk of a different type, or greater severity or frequency” than that of the preapproval literature. Here, in the pre-approval literature, the authors concluded that moderate to severe canalicular stenosis was found in about one-third of patients in the weekly group and in none of the patients in the every-three-weeks group.In the post-approval literature, the 2013 Chen Study, information was not found to determine that permanent stenosis, stenosis requiring surgery, or progressive stenosis occurred at a greater frequency than that reported in the pre-approval literature. Similarly, the post-approval literature did not show new or different risks but, rather, restated points that existed in the pre-approval literature. Nor did the literature show that the risks were more severe. Therefore, the court found that the pharmaceutical companies did not have newly acquired information and, could not, therefore avail themselves of the CBE regulation to unilaterally alter their labels. Although the patients challenged the pharmaceutical companies’ interpretations of “risks of a different type, or greater severity,” too narrowly, the court, nonetheless, rejected the patients’ arguments as the post-approval literature did not reflect any change as compared with the publicly available data. Therefore, the patients’ state law claims were pre-empted by federal law.

The case is MDL No. 3023.

Judge: Milazzo, J.

Attorneys: Karen Cannon Shanks (Hotze Runkle, PLLC) for Plaintiff. Douglas J. Moore (Irwin Fritchie Urquhart & Moore, LLC) for Defendant.

Companies: Accord Healthcare, Inc.; Sanofi Aventis U.S. LLC; Sanofi US Services Inc.; Sandoz, Inc.

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