Judge dismisses $14B MDL alleging ineffective decongestants

Decongestant lawsuits overview: 

• Who: A federal judge tossed a $14 billion consolidated class action lawsuit filed against companies such as Target and Bayer. 
• Why: The class action lawsuit claims companies sold ineffective over-the-counter decongestants. The judge ruled claims under New York state law were preempted and indirect purchasers lacked standing for federal racketeering claims. 
• Where: The decongestant lawsuits are in a multidistrict litigation in New York federal court.

A New York federal judge threw out a consolidated class action lawsuit claiming companies such as Target and Bayer made and sold ineffective over-the-counter decongestants. 

U.S. District Judge Brian M. Cogan determined claims brought under New York state law were all expressly preempted and that the proposed class lacked standing as indirect purchasers to assert claims under the Racketeer Influenced and Corrupt Organizations Act. 

The decision comes after a December 2023 order by the U.S. Judicial Panel on Multidistrict Litigation consolidated nearly 100 cases in New York federal court in May, Law360 reports. 

The plaintiffs reportedly sought around $14 billion in damages while arguing the defendant companies have been aware since at least 2016 that phenylephrine ingested orally has no more effect as a nasal decongestant than a placebo. 

Despite this, the plaintiffs argue the companies continued selling drugs with phenylephrine while touting the over-the-counter decongestants as effective, Law360 reports. 

The Food and Drug Administration seemingly confirmed this in September 2023 when revealing it found oral phenylephrine was ineffective as a nasal decongestant at the recommended dose.

Only FDA has authority to decide if ingredients effective, judge says

Judge Cogan also ruled that only the FDA has the authority to determine if an ingredient found in an over-the-counter medicine is effective. 

“The FDCA [Federal Food, Drug, and Cosmetic Act] generally commands that a drug’s label cannot be false or misleading and, in turn, vests authority in the FDA to determine whether a label is false or misleading,” the judge says. 

The over-the-counter nasal decongestants in question include Sudafed PE, Tylenol Cold and Flu, TheraFlu, Vicks Nyquil and Dayquil Severe Cold and Flu, Law360 reports. 

In addition to Target and Bayer, the defendants reportedly include Procter & Gamble Co., CVS Pharmacy Inc., Johnson & Johnson Consumer Inc. and Walgreen Co. 

Have you purchased an over-the-counter decongestant containing phenylephrine? Let us know in the comments.

The plaintiffs are represented by Melanie H. Muhlstock and Jason S. Goldstein of Parker Waichman LLP; Elizabeth J. Cabraser, Daniel R. Leathers, Jason L. Lichtman, Jonathan D. Selbin, David S. Stellings and Lexi J. Hazam of Lieff Cabraser Heimann & Bernstein LLP; Darren T. Kaplan of Kaplan Gore LLP; Andrew D. Bluth and Christopher R. Rodriguez of Singleton Schreiber LLP; George T. Williamson of Farr Law Firm PA; Conlee S. Whiteley and David J. Stanoch of Kanner & Whiteley LLC; Marlene J. Goldenberg of Nigh Goldenberg Raso & Vaughn PLLC; Bryan F. Aylstock and R. Jason Richards of Aylstock Witkin Kreis & Overholtz; Andrew D. Bizer of Bizer & DeReus LLC; and Ruben Honik of Honik LLC.

The decongestant lawsuits are In Re: Oral Phenylephrine Marketing and Sales Practices Litigation, Case No. 3089, before the U.S. Judicial panel on Multidistrict Litigation. 

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