TORONTO – Doctors, pharmacists and their patients are scrambling in the wake of news that a batch of birth control pills that made its way across Canada has been recalled.
Some patients may have been in the dark for days before a Health Canada recall was issued on Monday. It noted that birth control pill Alysena 28 may contain two rows of placebos instead of one row, increasing the risk of unplanned pregnancy.
But it appears the manufacturing company Apotex, based in Toronto, knew of the mixup as early as April 3, when it issued an urgent recall to retailers and distributors but not to the public. The company says the issue applies to packages from Lot number LF 01899-A.
Apotex, on Tuesday afternoon, released a public advisory on its website saying it was “swift” to comply with Health Canada’s Type 1 classification that was issued on Monday.
It did not, however, respond to Global News’ request for comment, regarding the scope of the recall, how many people could be affected and why it didn’t inform the public on Friday when its urgent recall was sent to retailers.
Experts and the public are questioning why the recall wasn’t made public that same day and why patients were left in the dark for days.
“If you have defective birth control, you should have an ethical obligation to tell all users what their risk is,” Glenn Cohen, a Canadian and Harvard Law School professor, told Global News.
Health Canada says wholesalers, distributors and retailers of the pill are in British Columbia, New Brunswick, Newfoundland, Nova Scotia, Ontario, Prince Edward Island and Quebec.
In its recall notice, the hazard classification is a Type I and Type II. Health Canada says it conducted its own assessment on Monday morning and immediately posted its recall information on the federal agency’s website.
Type 1 situations require “reasonable probability” that the use of the drug will cause serious health consequences or death. Type 2 could lead to “temporary adverse health consequences,” Health Canada explains on its website.
Blossom Leung, a spokesperson for Health Canada, tells Global News that the classifications weren’t upgraded, contrary to other reports.
“The Type I is for certain populations who are under different drug regimentation where they should not get pregnant at all because the other types of drugs and medical issues they have could cause adverse reactions and adverse events for the fetus,” she told Global News.
Under the Food and Drugs Act, Health Canada says it’s the responsibility of companies to inform health system partners of any and all risks associated with its products.
“Pharmacists, as trained medical professionals, can interpret that information and respond as appropriate on behalf of their clients,” a statement from Health Canada said.
So far, Apotex has not responded to media requests for comment.
In the meantime, pharmacists across the country have been contacting women who may be affected by the recall.
Tammy Smitham, spokesperson for Shoppers Drug Mart, says the store’s pharmacists have been calling patients who may have taken the affected Alysena 28.
The affected batch goes as far back as December 2012, she said.
“We had planned on taking the extra step to contact patients even when the recall was just a Type II,” Smitham told Global News in an email.
West Coast company London Drugs scoured its database on Friday when it first heard of the recall, in an attempt to let patients know immediately that their medication has been recalled.
“When I sat back and looked at it, I thought it was prudent to contact the women in our database,” John Tse told Global News.
He spent the weekend working around the clock with information technology workers and about a dozen more pharmacists scouring their databases to find each patient who could be taking the recalled batch.
They were able to determine when shipments of the drug arrived and isolated a group of 350 women that could have been handed the product.
London Drugs blogged about the incident by Saturday.
Canadian and American experts weighing in say that it’s possible that women who get pregnant from taking the recalled pills could consider legal action.
Cohen says that courts in several Canadian provinces have already awarded people who have sued due to botched vasectomies, for example.
“There are cases in Canada holding manufacturers liable for these things,” he told Global News.
He says that the principles are the same in this case of mispackaged birth control.
“The short story is that people will very likely bring lawsuits in Canada against this manufacturer. They’ll have to show the mistake regarding the placebo caused them to be pregnant and had it not been one of these placebo pills, they would not have gotten pregnant,” he explained.
Matthew Baer, a class action lawyer with Siskinds LLP, says product mismanagement is key.
“Here’s a case where the manufacturer of the product has a duty of care to the person,” Baer said.
In January, the law firm moved onto its certification stage for a class action lawsuit against Bayer, the makers of birth control pills Yaz/Yasmin.
In that case, a collective group of women are arguing that they were not collectively warned about higher than normal risks for stroke, blood clotting and other side effects from taking the drug.
The court will provide its ruling on whether the case can proceed as a class action lawsuit or by other means.
In this instance, Baer says that precedence hasn’t been set yet. He says it’s certain that women can sue for product liability, but women would have to prove that pregnancies were caused by the mispackaged pills and that they were taking them properly.
“There are some tricky issues. The better question is could they win?”
Arthur Caplan, who is head of the division of medical ethics at New York University medical school, says that if a group of women taking this pill conceive, a class action lawsuit could be in the works.
“I can imagine there are law firms scurrying about looking to form these cases to turn them into class action suits,” he told Global News.
“The duty (the manufacturer) had wasn’t to be quiet but to announce the manufacturing error as soon as they knew. Unwanted pregnancy is a very, very serious matter and it clearly requires public notification promptly,” he said.
“It’s inexcusable to me that you could have an error like this affecting birth control and then not make a public notification.”