Nasal Decongestant MDL Loses Steam in Wake of Preemption Ruling

WASHINGTON, D.C. — A New York federal judge has tossed an MDL for lawsuits alleging that phenylephrine (PE), the active ingredient in several over-the-counter oral decongestants, was a placebo that rendered them ineffective, finding the claims are preempted because they sought to change labeling that had been approved by the Food and Drug Administration.

In an Oct. 29 order, Judge Brian M. Cogan of the U.S. District Court for the Eastern District of New York explained that the FDA’s monograph for PE drugs does impose on manufacturers “a freestanding duty to update their indications in response to new scientific information.”