A Vancouver lawyer is fighting to get a lawsuit approved as a class action, accusing the makers of popular cold and flu remedy Cold-FX of misleading consumers through false claims about the drug's effectiveness.
And they want a refund for every single bottle of the drug that was sold — plus interest.
But lawyers for embattled drug company Valeant are arguing that British Columbia's Supreme Court shouldn't the grant class action certification since the case has "no real complainants," even though a study shows that the drug is less effective than a sugar pill.
"We've known for a long time, at best, the supporting evidence [of Cold-FX] has been underwhelming," said University of Alberta health law professor Tim Caulfield, who's been following the controversy surrounding the drug for several years. "This lawsuit, what it's really about, is arguing that Cold-FX doesn't work, and more importantly, the company knew that it doesn't work and were advertising to the contrary despite that."
The company, on the other hand, is basically taking a 'no harm, no foul' defense — lawyer Alan D'Silva said certification shouldn't be granted since "class actions are intended to be for real people with real complaints," of which he said there are none, according to The Canadian Press.
"They are not intended to be manufactured by entrepreneurial counsel," he said.
Afexa Life Sciences Inc., which was bought by Valeant Pharmaceuticals in 2011, is the original license holder and manufacturer of the natural health product—the best-selling such product in the country, with a reported $117 million in sales in 2011.
"At the end of the day we'll argue that every box of Cold-FX that contained a material misrepresentation was part of the fraud."
Once one of Canada's most valuable companies, the Quebec-based Valeant is currently embroiled in controversy on several different fronts — allegations of price gouging, its relationship with mail-order pharmacy Philidor, and a lawsuit accusing Valeant and investor Bill Ackman of insider trading. Two weeks ago, it was announced that CEO Michael Pearson would be stepping down amid plunging share values.
D'Silva said in court that Ladysmith resident Don Harrison, who launched the initial complaint and would be the lead plaintiff in a class action, has never sworn an official court document explaining his decision to purchase the product, whether or not he took it, if he felt he was misled, or if he ever attempted to get a refund.
"One of the fundamental problems is that ... more than four years into this litigation, they still do not have a single person [who's] come forward to swear an affidavit and say these things. Not a single person," he continued.
According to the notice of civil claim, Harrison purchased Cold-FX after reviewing its package and watching TV ads about it, which both said taking a three-day dose of the product at the first sign of illness would result in immediate relief of his cold and flu symptoms.
But that never happened, Harrison claims.
"At all material times, the representations were exaggerations and/or were false or misleading in a material respect of the consumer transaction," the court documents state.
"At the end of the day we'll argue that every box of Cold-FX that contained a material misrepresentation was part of the fraud," Green wrote on Facebook. "We'll ask that the damage suffered by the class members correlate to what was ultimately paid by the consumer at [retailers] like Shoppers Drug Mart or Costco, multiplied by the number of bottles sold, adding on interest since it was sold."
Up until recently, packaging and advertising for the product claimed Cold-FX could "stop cold and flu in their tracks" and "help provide effective relief," although neither claim has been supported by scientific research, experts say.
While there has been research done that found Cold-FX to be effective as a preventative drug if taken for two to six months — a fact that the plaintiff doesn't dispute — the lawsuit takes issue with previous claims to consumers that it could offer "immediate relief" after symptoms have already appeared.
Green also cites a 2004 study conducted by the Capital Health Authority in Alberta, which apparently found the product to be less effective than a placebo. The results of that study, which he only came across when reviewing evidence submitted by the company, should have been made public, Green argues.
"They omitted to disclose research they commissioned, which showed that Cold-FX was not an effective treatment of a runny nose, stuffy nose, cough, or sore throat," he writes.
The study, which followed one group taking Cold-FX and another group taking a placebo for 14 days, starting right after their symptoms first appeared, found that symptoms for the first group lasted longer and were less severe for the placebo group.
But Valeant's lawyers are pushing back — D'Silva said in court that Green had cherry-picked "a chart out of one of the studies, which does not accurately reflect what we've put in the record."
The study, he pointed out, concluded that Cold-FX was in fact effective at treating a runny nose.
Green is seeking damages or restitution for deceit, fraud, or fraudulent misrepresentation. He's promised to contact anyone who wants to join the lawsuit with forms, allowing them to claim back some of the money they spent on Cold-FX, if it's successful.
Cold-FX has approval from Health Canada, which last reviewed it in November of last year and says it boosts the immune system, and thus helps reduce the frequency, severity and duration of cold and flu symptoms. The product works even better when combined with a flu shot, according its page on the federal health agency website.
"When it comes to natural health products, Health Canada has a lower standard when it comes to the assessment of efficacy," said Caulfield, adding that the current regulatory framework prioritizes safety and standardization over efficacy, enabling questionable products to enter the market.
Follow Tamara Khandaker on Twitter: @anima_tk
Photo credit: Flickr user Michael J