A Winnipeg nurse is seeking class-action status for her lawsuit against several leading pharmaceutical companies, accusing them of profiting for decades from selling over-the-counter oral decongestants that contain an active ingredient that several studies have found to be ineffective.
Barb Eory’s lawsuit alleges nearly 50 years of allegedly misrepresenting the drug phenylephrine as an effective nasal decongestant in pill form, in violation of the Food and Drug Act and several consumer protection and/or business practice laws.
The companies named in the lawsuit, filed in Manitoba Court of King’s Bench on Nov. 10, are Johnson & Johnson, Pfizer Canada, Procter & Gamble and GlakoSmithKline Consumer Healthcare.
All four are linked to 24 over-the-counter drugs that contain phenylephrine as the sole active ingredient with an alleged decongestant effect, the suit says, including many commonly used cold medications such as Benyline, Neocitran and Tylenol.
None of the allegations have been proven in court. Defense statements were not submitted.
Phenylephrine became the main ingredient in over-the-counter decongestants in the US after the drug pseudoephedrine was banned in 2006 because it can be illegally converted into methamphetamine.
In September, a panel of 16 outside advisers to the US Food and Drug Administration unanimously voted 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 traces of the drug reach the nasal passages to relieve congestion when taken orally.
The drug appears to work better when administered nasally, either through 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 the original approval of phenylephrine. Regulators said those studies used statistical and research techniques that the agency no longer accepts.
The drugs currently sold in Canada as nasal congestion treatments listed in the suit are:
Benylin Extra Strength Cold & Sinus Day.
Benylin D for babies.
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.
Daiquil Cold & Flu and Sinus Liquicaps products.
NeoCitran produces Extra Strength Cold & Congestion and Extra Strength Total Cold.
Robitussin Complete Daytime.
Sudafed PE Extra Strength.
Triaminic Thin Strips products for colds and coughs, nasal congestion and nocturnal colds and coughs.
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 for nasal congestion and Sinek products for pressure and pain.
Eori, who worked as a nurse for 33 years, bought some of the listed drugs for herself and her family more than eight times a year under the impression that they would be enough to treat her stuffy nose, the lawsuit says.
“The defendants made billions of dollars selling phenylephrine drugs and marketing them as decongestants,” it said.
“None of those products have ever worked as a decongestant,” the lawsuit claims, citing the FDA’s September ruling. “She wouldn’t have bought these products if she knew they didn’t work when taken orally.”
Louis Sokolov, one of the lawyers for the suit, said some of the drugs are still being sold in Canada.
“Although the losses of individual consumers may be relatively modest, the scale of this case is large, given the popularity of the products and the time they were sold,” Sokolov said in a statement.
Over the years, several studies have questioned the benefits of phenylephrine, finding it no better than placebo in trials.
But the lawsuit alleges that through prominent claims displayed on packaging and public websites, the companies knowingly or recklessly led consumers, wholesalers, retailers and distributors to believe that phenylephrine worked as an oral decongestant.
That continued after the FDA announced its decision in September, which was information that consumers “could not reasonably have discovered” before then, according to the lawsuit.
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 that reflect its effectiveness as an oral decongestant and protect their reputations, the suit says.
Eori’s lawsuit seeks class action certification so that people in several Canadian provinces (the subclass is identified for every province except New Brunswick and Nova Scotia) can receive either all or part of the money they paid for the allegedly ineffective drugs, which are said to be the right for damages.
Representatives for Pfizer and GlakoSmithKline told CBC News that they have not sold the products since 2019, as both of their consumer health businesses folded into Haleon.
Halleon did not respond to requests for comment before publication.
Representatives of Johnson & Johnson and Procter & Gamble did not comment on the lawsuit.
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