backOn August 27, 2024, King & Spalding secured final summary judgments for its clients Merck and Organon in the first two cases to be prepared for trial in a major nationwide pharmaceutical litigation. The litigation includes product claims by patients alleging injuries from use of the asthma and allergy medication, SINGULAIR®, as well as negligence claims under California law for “warning-label liability” by patients who used generic substitutes, which copy brand-name labels.
Judge Marilyn L. Huff of the U.S. District Court for the Southern District of California ruled against the two plaintiffs, who used generic substitutes, on several independent grounds. First, the plaintiffs failed in their attempt to show inadequacies in the warnings that the SINGULAIR® labeling provided prescribing physicians. Second, the plaintiffs failed to show that any difference between the labeling and their proposed changes was a substantial factor in causing their alleged injuries. Third, the federal Food, Drug, and Cosmetic Act preempted the plaintiffs’ warning-label claims. The plaintiffs failed to show that under the “changes being effected” (CBE) regulation, Merck could have changed the labeling to what the plaintiffs would have liked. Fourth, because one of the plaintiffs (despite California ties) was prescribed the medication in Florida (while living there), Florida law applied and barred his claims.
K&S partner Susan Vargas led the representation of Merck and Organon. She was joined in the representation by Alex Calfo, Paul Johnson, Meredith Redwine, Heather Howard, Brittany Litzinger, Stephanie Le, and Miranda Wheeler.