Sudafed Class Action Lawsuit Filed Over “Ineffective” Decongestant in Cold Medications

Following a determination made last week by a panel of scientific advisors to the U.S. government, which found that the decongestant phenylephrine is no more effective than a placebo, a Minnesota woman has filed a class action lawsuit against the makers of Sudafed.

The complaint (PDF) was brought by Miesha McIntyre in the U.S. District Court for the District of Minnesota on September 15, seeking class action status to pursue damages on behalf of all consumers from the drug maker Kenvue, Inc. and McNeil Consumer Healthcare as defendants.

Both companies were previously owned by Johnson & Johnson, and comprised its over-the-counter consumer medication division. They have since been spun off into Kenvue, which is now a separate company that owns McNeil.

Sudafed Decongestant Does Not Work

Earlier this month, an advisory committee to the U.S. Food and Drug Administration (FDA) determined that the decongestant phenylephrine is ineffective when taken orally. Even though its been on the market for decades in popular products like Sudafed, Mucinex and Tylenol Cold and Flu tablets and liquids, recent data indicates it is no more effective than a placebo.

The FDA must now decide whether it should be allowed to remain on the market.

However, McIntyre’s lawsuit points out that she and other paid premium prices for expensive cold medications for decades which did not alleviate their decongestion.

Her lawsuit specifically targets Sudafed PE, which she indicates she used as recently as this month, but failed to experience decongestion relief. The reason why only became apparent after the FDA advisory committee’s findings were announced.

“Had Plaintiff known that the phenylephrine-containing Products were entirely ineffective as a nasal decongestant, she would not have purchased them, or would have paid substantially less for them,” the lawsuit states. “Accordingly, Plaintiff, on behalf of herself and all other consumers of Defendants’ phenylephrine products, seeks to hold Defendants accountable for their deceptions, breaches of warranties, and violations of Minnesota consumer protection statutes.”

The Sudafed class action lawsuit seeks to represent all persons in Minnesota who purchased an oral nasal decongestant containing phenylephrine manufactured by the defendants.

McIntyre accuses the manufacturers of breach of warranty, unjust enrichment, fraud by omission, and violation of various Minnesota consumer protection laws.