A Winnipeg nurse is seeking class-action status for her lawsuit against several leading drug companies, accusing them of profiting for decades by marketing over-the-counter oral decongestant medications that contain an active ingredient that several studies have found to be ineffective.
Barb Eori’s lawsuit claims nearly 50 years of alleged negligent misrepresentation of the drug phenylephrine as an effective nasal decongestant in pill form, violation of the Food and Drug Act and various consumer protection laws and/or trade practices .
The companies named in the suit, filed in the Manitoba Court of King’s Bench on November 10, are Johnson & Johnson, Pfizer Canada, Procter & Gamble and GlaxoSmithKline Consumer Healthcare.
All four are connected to 24 over-the-counter medications that contain phenylephrine as the only active ingredient with an alleged decongestant effect, the suit says — including several commonly used cold medications such as Benylin, NeoCitran and Tylenol.
None of the allegations have been proven in court. Statements of defense have not been filed.
Phenylephrine became the main ingredient in non-prescription decongestants in the United States after the drug pseudoephedrine was restricted in 2006 because it can be illegally turned 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 advisors came to this conclusion after finding that only trace levels of the drug reach the nasal passages to relieve congestion when taken orally.
The drug seems to work best when applied nasally, either through sprays or drops, and those products are not subject to review in the United States.
Businesses “make billions”: suit
The September decision supports 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 are 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 children.
The products Contac 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 Extra Strength Cold & Congestion and Extra Strength Total Cold products.
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.
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 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 suit says .
“The defendants made billions of dollars selling drugs with phenylephrine and marketing them as decongestants,” he says.
“None of these products have ever worked as a decongestant,” the suit says, referring to the FDA’s September decision. “I wouldn’t have bought these products if I knew they didn’t work when taken orally.”
Louis Sokolov, one of the suit’s lawyers, said some of the drugs continue to be sold in Canada.
“While the losses from 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, many 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 that phenylephrine works as a oral decongestant.
That continued after the FDA published its decision in September, which was information that consumers “could not reasonably have discovered” earlier, 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 that reflect its effectiveness as an oral decongestant, and protect their reputation, the suit says.
Eori’s lawsuit seeks class-action certification so that people in several Canadian provinces (a subclass is identified for each province except New Brunswick and Nova Scotia) can receive all or part of the money they paid for the alleged ineffective medications, which they say they are. the right to as damages.
Representatives from Pfizer and GlaxoSmithKline told CBC News that they have not sold the products in question since 2019, as their consumer health companies divested 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.
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