Court: Useless decongestants shouldn’t be labeled ‘maximum strength’

Oral PE is present in products carrying brand names like Nyquil, Advil and Mucinex, and lawyers said studies starting in 2007 showed that it is ineffective. The litigation, involving almost 100 consolidated class actions, alleged drug-makers had sold $12 billion worth of ineffective nasal decongestants.

But even though research in 2016 said oral PE is “no more effective” than a placebo, the Food and Drug Administration has stuck to its existing labeling requirements that state it is effective. So claims over those drugs failed, the Second Circuit said, as preempted by the Food, Drug, and Cosmetic Act.

However, anything labeled “Maximum Strength” is not preempted, the Second Circuit held. That’s because consumers could possibly have been tricked into thinking those products work better than others.

“(W)e conclude that the FDCA does not require, nor has it blessed, Defendant Manufacturers’ inclusion of these phrases on their oral PE products’ labels,” Judge Denny Chin wrote.

“Defendant manufacturers therefore voluntarily and on their own accord placed these Maximum Strength statements on their products; they were not obligated to do so.”

Some of those products are Walgreens Daytime Severe Cold & Flu Maximum Strength, Vicks NyQuil Severe Maximum Strength and Mucinex Maximum Strength Sinus-Max. The Second Circuit pointed at a U.S. Supreme Court ruling allowing claims over an insecticide to proceed when, even though the label was compliant with federal rules, the manufacturer had voluntarily added warranties.

Firms including Lieff Cabraser, DiCello Levitt and Seeger Weiss are pursuing the litigation. Also revived for them were claims against drugs that went through the New Drug Application process, though “the record is unclear as to which drugs involved in this lawsuit are regulated through the NDA process,” Chin wrote.

When seeking NDA approval, manufacturers propose the labeling, and the FDA will approve the drug if it finds product is safe for use and suggested for treatment. Attorneys argue those manufacturers have a duty to update their labels to reflect new information on a drug’s efficacy.

But lost from the case are state-law claims over drugs that went through the “monograph” process, which allows makers of over-the-counter drugs to put their products on the market without FDA review if it and its label adhere to FDA regulations.

“We acknowledge that the limitations on Consumer Plaintiffs' state law remedies may appear unfair, particularly when the FDA's own agency review has confirmed that oral PE does not work as a decongestant and when studies have impugned oral PE's efficacy for twenty years,” Chin wrote.

“The fix, however, must flow not from litigation but from the FDA, which indeed has proposed an administrative order that would remove oral PE from the nasal decongestant monograph.”