Milberg Class Action Pushes Back on “Maximum Strength” Sudafed PE Claims

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September 18, 2023

by Brian Eckert

An FDA panel recently declared phenylephrine hydrochloride—a nasal decongestant used in some versions of the popular over-the-counter drug Sudafed—to be ineffective. Yet Johnson & Johnson markets its phenylephrine-based Sudafed PE products as “Maximum Strength,” which is misleading and damaging to consumers, alleges a Milberg class action lawsuit.

Sudafed, Pseudoephedrine, and Phenylephrine

The brand name “Sudafed” gained prominence as a decongestant by way of, as the name suggests, its use of the oral nasal decongestant pseudoephedrine. But not all Sudafed products contain the active ingredient pseudoephedrine. Some, including Sudafed PE: Sinus Pressure + Pain and Sudafed PE: Sinus Congestion, are made with phenylephrine.

Sudafed and other brands began replacing pseudoephedrine with phenylephrine after the FDA took action to limit pseudoephedrine because it can be processed to create methamphetamine. But since then, the FDA has cast doubt on the efficacy of phenylephrine.

Despite marketing Sudafed PE as “Maximum Strength,” J&J knew the active nasal decongestant ingredient in Sudafed PE, phenylephrine hydrochloride, was not as effective as a decongestant. Indeed, studies have shown phenylephrine hydrochloride is no more effective than a placebo.

In September, an FDA advisory committee declared by unanimous vote that phenylephrine is ineffective as a decongestant. According to the group of experts, phenylephrine is no more effective than a placebo pill.

More than one study supports this conclusion. The results of a clinical trial published in 2015 found that phenylephrine is “not more efficacious than placebo in relieving nasal congestion caused by allergic rhinitis” (hay fever).

Lawsuit: J&J Misrepresents Sudafed PE Products

Milberg’s lawsuit against J&J asserts that, as a leading manufacturer of phenylephrine decongestants, J&J was aware—or should have known—about the same phenylephrine scientific literature reviewed by the FDA. However, it represents its Sudafed PE products as “Maximum Strength.” This claim is misleading to consumers in the following ways:

  • J&J offers other Sudafed decongestants made with effective active ingredients, such as pseudoephedrine, which are not marketed as “Maximum Strength.”
  • Sudafed PE: Sinus Pressure + Pain contains 5 mg of phenylephrine per dose—half the dosage allowable by FDA and half of what’s found in J&J’s other phenylephrine Sudafed products. For example, Sudafed PE: Sinus Congestion offers 10 mg of phenylephrine per dose.
  • In addition, Sudafed PE: Sinus Pressure + Pain has 325 mg of the pain reliever acetaminophen—the equivalent of a “Regular Strength” Tylenol tablet.

J&J made these allegedly misleading claims about Sudafed PE products in order to appeal to consumer preferences for strong congestion, fever, and pain relief, states the lawsuit complaint.

Consumers lack the knowledge and means necessary to independently determine the veracity of these claims and rely on manufacturers like J&J to honestly disclose product strength and dosage, the complaint further claims.

Proposed Classes and Remedies

The lawsuit, filed in U.S. District Court for the Northern District of Illinois on behalf of lead plaintiff Tina Tuominen, cites breach of express warranty, breach of implied warranty, unjust enrichment, and violations of state consumer protection statutes. It seeks to establish three consumer classes:

  • Nationwide Class: All persons in the United States who purchased Sudafed PE in the United States for personal use and not for resale during the applicable statute of limitations period.
  • Multi-State Consumer Protection Class: All persons who purchased Sudafed PE in the State of Illinois or any state with similar laws (including California, Florida, Massachusetts, Michigan, Minnesota, New Jersey, New York, and Washington) within the applicable statute of limitations.
  • Illinois Subclass: All persons in the State of Illinois who purchased Sudafed PE in the State of Illinois for personal use and not for resale during the applicable statute of limitations period.

Qualifying class members could be in line to recover compensatory, punitive, and statutory damages, as well as attorneys’ fees and litigation costs. Milberg’s Gary Klinger, Nick Suciu, Erin Ruben, and Hunter Bryson are representing the class.

Since 1965, Milberg—the firm that pioneered class action litigation—has filed thousands of class actions, recovered billions of dollars for our clients, set groundbreaking legal precedents, and prompted meaningful corporate reforms.

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