Relevant Documents:
Barton Complaint
Coppock Complaint
JPML Transfer Order
FDA Advisory
The U.S. Judicial Panel on Multidistrict Litigation, or JPML, recently established a multidistrict litigation, or MDL, to centralize and coordinate claims against Kenvue’s Johnson & Johnson Consumer Inc., Procter & Gamble and other manufacturers of over-the-counter nasal decongestant medications that contain phenylephrine, or PE, as the active ingredient. Judge Brian M. Cogan will preside over the litigation in the U.S. District Court for the Eastern District of New York.
This fall, a flurry of cases emerged after an advisory panel for the U.S. Food and Drug Administration in September determined that oral PE products do not work as advertised to relieve nasal congestion. The FDA noted that neither it nor its advisory committee have raised any safety concerns about using oral PE.
The FDA has said that it will consider the advisory committee’s recommendation over oral PE but that the agency has final decision making authority on the matter. If the FDA determines such products to be ineffective, it indicated that it would “work closely with manufacturers to reformulate products as needed to help ensure availability of safe and effective products to treat symptoms of colds or allergies.”
The Dec. 6 JPML order notes that products at issue include Tylenol Cold & Flu, Sudafed PE and Benadryl produced by Kenvue, the consumer health division recently
spun off from Johnson & Johnson. Other oral phenylephrine products include Procter & Gamble’s Nyquil and Dayquil brands, GlaxoSmithKline’s Theraflu, Bayer’s Alka-Seltzer Plus, and Reckitt’s Mucinex. Additionally, the JPML order notes that products at issue also include store-brand versions offered by Albertsons, Amazon, CVS, Costco, Harris Teeter, Kroger, Publix, Rite-Aid, Target, Walgreens and Walmart.
The JPML’s initial order transferred 10 cases into the MDL. Plaintiffs in these suits accuse manufacturers of violating state consumer protection statutes, negligence, fraud and unjust enrichment. Additionally, the panel on Tuesday, Dec. 19, filed an order transferring another
65 tag-along actions to the MDL.
The proceedings are at an early stage, will likely take years to resolve and could be significantly affected by the FDA’s final decision on oral PE’s efficacy.
The newly established oral PE MDL does not center on personal injury claims, in contrast to the separate
acetaminophen products liability MDL involving Kenvue and numerous store-brand retailer defendants. In that proceeding, the plaintiffs allege that maternal prenatal use of Tylenol and other acetaminophen products led to autism spectrum disorder, or ASD, and attention deficit hyperactivity disorder, or ADHD, in children. Earlier this week, Kenvue and the other defendants received a
favorable ruling in that proceeding when the judge disqualified the plaintiffs’ general causation expert witnesses - a potentially fatal blow to the plaintiffs’ case.
Kenvue CFO Paul Ruh downplayed the oral PE risk during the company’s
Oct. 26 earnings call, noting that the FDA “routinely reviews ingredients'' and that the company would “work with the agency and our customers to ensure that we continue to offer a variety of options of both [over the counter] and behind the counter solutions.” Ruh also noted that Kenvue is “not the leader in the cold and flu category, with products containing PE across our portfolio representing just 2% of our global revenue and the US comprising about half of that.”
One of the recently transferred oral PE suits, a class action originally filed by Erin Barton against Kenvue, Reckitt, GSK, Procter & Gamble and Walgreens, asserts that in 2022 “nearly $1.8 billion in sales of phenylephrine-containing purported decongestants were made in the United States across more than 250 products.”
Additionally, the
Barton complaint cites a 2018 J&J study referenced by the FDA advisory committee that “suggest[ed] no beneficial effect [of phenylephrine] when compared with placebo.” The complaint further alleges that the manufacturers have possessed ample knowledge of oral phenylephrine’s ineffectiveness for some time.
The
Barton complaint seeks to disgorge profits made from sales of phenylephrine products, punitive damages and an order requiring the companies to fully disclose their knowledge surrounding the efficacy of their products.
The plaintiffs in
Barton propose nationwide classes for consumers who purchased products from each defendant company as well as multiple state-level subclasses. The plaintiffs also seek tolling of all applicable statutes of limitations, arguing that class members “had no way of knowing” about the defendants' “deception concerning their decongestant products.”
Another class action transferred to the MDL initially filed by plaintiff Kaycie Coppock points out that the FDA in 2018 issued new guidance on nasal decongestants which provided manufacturers with revised standards for evaluating their products’ efficacy. According to the
Coppock complaint, which names Procter & Gamble and Target as defendants, “the previous data under which the Products were approved … no longer supported efficacy” under the new 2018 standards. The complaint asserts that the manufacturers therefore “knew or should have known that their marketing claims regarding the Products’ efficacy were false and misleading” since September 2018.
Kenvue has also started to face legal blowback from its investors in light of the advisory committee’s statements on oral phenylephrine’s ostensible inefficacy. Shareholders have
alleged that Kenvue failed to disclose the risks to the commercial viability of Kenvue’s PE products prior to its initial public offering in May 2023.
In its most recent
10-Q, Kenvue noted that with respect to both the oral PE consumer claims and the shareholder litigation, “[a]t this stage in these proceedings, the Company is unable to reasonably estimate either the likelihood or the magnitude of its potential liability arising out [of] these claims and lawsuits.”