A Winnipeg nurse is seeking class-action status for her lawsuit against several top drug companies, accusing them of profiting for decades by marketing non-prescription oral decongestant medications containing an active ingredient that several studies have found ineffective.
Barb Eori’s lawsuit claims nearly 50 years of alleged negligent misrepresentation of the drug phenylephrine as an effective pill-form nasal decongestant, breaching the Food and Drugs Act and several consumer protection and/or business practice laws.
The companies named in the suit, filed with Manitoba Court of King’s Bench on Nov. 10, are Johnson & Johnson, Pfizer Canada, Procter & Gamble and GlaxoSmithKline Consumer Healthcare.
All four are connected with 24 over-the-counter medications containing phenylephrine as the only active ingredient with an alleged decongesting effect, the suit says — including many commonly used cold medications like types of Benylin, NeoCitran and Tylenol.
None of the allegations have been proven in court. Statements of defence have not been filed.
Phenylephrine became the main ingredient in non-prescription decongestants in the U.S. after the drug pseudoephedrine was restricted in 2006 because it can be illegally processed into methamphetamine.
In September, a panel of 16 external advisers to the U.S. Food and Drug Administration voted unanimously that phenylephrine is ineffective as a decongestant when taken in pill form.
The FDA’s expert advisers came to that conclusion after finding that only trace levels of the drug reach nasal passages to relieve congestion when taken orally.
The drug appears to work better when applied nasally, whether by sprays or drops, and those products are not under review in the U.S.
Companies ‘made billions’: suit
The September decision supported the conclusions of an earlier FDA scientific review that found numerous flaws in studies from the 1960s and 1970s that supported phenylephrine’s original approval. Regulators said those studies used statistical and research techniques no longer accepted by the agency.
The medications currently marketed in Canada as nasal congestion treatments named in the suit are:
- Benylin Extra Strength Cold & Sinus Day.
- Benylin D For Infants.
- The Contac products Cold Nasal Congestion, Cold & Sinus Extra Strength, Cold & Sinus Hot Medicated Drink, Extra Strength Cold & Sinus Hot Medicated Drink and Super Strength Cold & Sinus Hot Medicated Drink.
- Dayquil Cold & Flu and Sinus Liquicaps products.
- The NeoCitran products Extra Strength Cold & Congestion and Extra Strength Total Cold.
- Robitussin Complete Daytime.
- Sudafed PE Extra Strength.
- Triaminic Thin Strips Cold & Cough, Nasal Congestion and Nighttime Cold & Cough products.
- Tylenol’s Cold and Flu Daytime, Cold Rapid Release, Extra Strength Cold Daytime, Extra Strength Flu Daytime, Extra Strength Sinus Daytime, Regular Strength Cold Daytime, Regular Strength Sinus Daytime and Sinus Liquicaps products.
- Vicks’s Custom Care Nasal Congestion and Sinex Pressure & Pain products.
Eori, who has worked as a nurse for 33 years, purchased some of the drugs mentioned for herself and her family more than eight times per year under the impression that they would be sufficient to treat nasal congestion, the suit says.
“The defendants have made billions of dollars selling drugs with phenylephrine and marketing them as decongestants,” it alleges.
“None of those products ever worked as a decongestant,” the suit claims, referring to the FDA’s September decision. “She would not have bought these products if she knew that they did not work when taken orally.”
Louis Sokolov, one of the lawyers for the suit, said some of the medications continue to be sold in Canada.
“While the losses by individual consumers may be relatively modest, the scale of this case is large, given the popularity of the products and the amount of time that they were sold for,” Sokolov said in a statement.
Over the years, several studies have questioned the benefits of phenylephrine, finding it no better than a placebo in trials.
But the suit says through prominent claims displayed on packaging and public websites, the companies knowingly or recklessly led consumers, wholesalers, retailers and distributors to believe phenylephrine works as an oral decongestant.
That continued after the FDA released its September decision, which was information that consumers “could not have reasonably discovered” before then, according to the suit.
The companies “actively, intentionally and fraudulently concealed the fact that phenylephrine does not work as an oral decongestant” in order to increase sales, continue to charge prices reflecting its efficacy as an oral decongestant, and protect their reputations, the suit says.
Eori’s lawsuit requests class-action certification so people in several Canadian provinces (a subclass is identified for each province except New Brunswick and Nova Scotia) can receive either all or part of the money they paid for the alleged ineffective medications, which it says they are entitled to as damages.
Representatives from Pfizer and GlaxoSmithKline told CBC News that they have not sold the mentioned products since 2019, as both of their consumer health-care businesses demerged into Haleon.
Haleon did not respond to requests for comment prior to publication.
Representatives for Johnson & Johnson and Procter & Gamble did not provide comment on the suit.