Tenth Circuit Revives Herceptin Underfill Claims Against Genentech

Herceptin, a widely used breast cancer drug manufactured by Genentech, is sold in multi-dose vials labeled to contain 440 milligrams of trastuzumab at a concentration of 21 mg per mL. Cancer clinics and hospitals across the country purchase those vials to administer to patients. The problem, according to fourteen consolidated lawsuits centralized in the Northern District of Oklahoma, was that the vials routinely fell short of those figures.

The plaintiff providers, a group that included oncology practices, hospital systems, and state cancer treatment facilities, alleged that Genentech violated state law by shipping product that did not match its label. They brought claims for breach of express and implied warranties and unjust enrichment. The shortfall was not a rounding issue: clinics that trusted the label were, in effect, purchasing less drug than they paid for and less than patients needed, sometimes requiring additional purchases to make up the deficit.

Genentech moved for summary judgment on preemption grounds, and the Northern District of Oklahoma agreed, finding that both obstacle preemption and impossibility preemption barred the plaintiffs' state-law theories. The district court reasoned that federal drug-labeling regulations left Genentech no room to change its label unilaterally and that state-law duties conflicted with the federal scheme.

The Tenth Circuit reversed on May 29, 2020. The panel held that Herceptin qualifies as a 'liquid drug' under federal labeling regulations, which require the label to state the minimum quantity in each container. Because federal law itself demanded that the label be accurate about minimum content, state-law claims enforcing that same accuracy created no conflict. Neither impossibility preemption nor obstacle preemption applied. The dismissal was vacated and the cases were returned to the district court.

Matthew Sill of Fulmer Sill served as co-lead MDL counsel for the plaintiff providers, coordinating litigation strategy across the consolidated cases in Tulsa. The Tenth Circuit's ruling cleared the way for the plaintiffs to litigate their claims on the merits.