A Winnipeg nurse is seeking class-action status in her lawsuit against several leading pharmaceutical companies, accusing them of profiting for decades by marketing over-the-counter oral decongestants containing an active ingredient that several studies have found to be ineffective.
Barb Eory’s lawsuit alleges nearly 50 years of allegedly negligently misrepresenting the drug phenylephrine as an effective nasal decongestant in violation of the Food and Drug Act and consumer protection and/or business practice laws.
Johnson & Johnson, Pfizer Canada, Procter & Gamble and GlaxoSmithKline Consumer Healthcare are named in the lawsuit, filed Nov. 10 in Manitoba’s King’s Court.
All four are linked to 24 over-the-counter medications that contain phenylephrine as the sole active ingredient, which has a purported decongestant effect, the lawsuit says, including many commonly used cold medications such as Benylin, NeoCitran and Tylenol.
None of the charges have been proven in court. No defense statements were submitted.
Phenylephrine became a staple in over-the-counter decongestants in the US after the drug pseudoephedrine was banned in 2006 because it can be illegally processed 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.
FDA experts came to that conclusion after finding that only trace levels 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 these products are not under review in the US.
The companies “earned billions”.
The September decision upheld 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 say those studies use statistical and research methods that are no longer accepted by the agency.
Medications currently marketed in Canada to treat nasal congestion include:
Benyline Extra Strength Cold and 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.
NeoCitran products Extra Strength Cold & Congestion and Extra Strength Total Cold.
Robitussin Full Daytime.
Sudafed PE Extra Strength.
Triaminic Thin Strips Cold & Cough, nasal congestion and nocturnal cold and 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, 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 they would be enough to treat nasal congestion, the lawsuit alleges.
“The defendants made billions of dollars selling drugs laced with phenylephrine and selling them as decongestants,” it said.
“None of these products have ever worked as a decongestant,” the lawsuit claims, referring to the FDA’s September ruling. “He wouldn’t have bought these products if he knew they didn’t work when taken orally.”
Louis Sokolow, one of the lawyers in the suit, said some of the drugs continue to be sold in Canada.
“While the losses to individual consumers may be relatively modest, the scale of this case is large given the popularity of the products and the amount of time they have been 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 on public websites, the companies knowingly or recklessly misled consumers, wholesalers, retailers and distributors that phenylephrine acted as an oral decongestant.
That continued after the FDA issued its September ruling, which was information that consumers “could not reasonably have discovered” before then, according to the suit.
The companies “actively, intentionally and fraudulently concealed the fact that phenylephrine does not act as an oral decongestant” in order to increase sales, continue to charge prices reflecting its effectiveness as an oral disinfectant, and protect their reputation.
Eori’s lawsuit seeks class action certification so that people in several Canadian provinces (with a subclass defined for each province, except for New Brunswick and Nova Scotia) can receive all or part of the money they paid for allegedly ineffective drugs that, according to him, they are. is entitled to damages.
Representatives for Pfizer and GlaxoSmithKline told CBC News that they have not sold the products since 2019 since their two consumer health care businesses were spun off from Haleon.
Haleon did not respond to requests for comment prior to publication.
Representatives for Johnson & Johnson and Procter & Gamble had no comment on the lawsuit.
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