VIDEO: Birth control maker faces class-action lawsuit. Beatrice Politi reports.
TORONTO – At least 23 Canadian women who were taking the birth control pills Yaz or Yasmin are suspected of dying from potential adverse drug reactions, according to government records.
Health Canada told Global News that under its Canada Vigilance Program, about 15 patients taking Yasmin died, meanwhile another eight women who were prescribed Yaz died.
In some of these cases, more than one physician or pharmacist reported the fatality.
In total, Health Canada says it received more than 600 adverse drug reaction reports for both contraceptives – all documented on the federal agency’s database.
Health Canada notes that it’s not possible to determine if the bad reaction was a result of using a specific health product. The federal agency says that the benefits of Yaz and Yasmin “continue to outweigh the risks.”
“The risk of blood clots with these products is well known, and is included in the drug label. Health Canada has also communicated with healthcare professionals and the public regarding this risk,” a spokesperson said in a statement.
“No decision regarding product withdrawal is taken lightly. When the benefits associated with a product are determined to no longer outweigh its risks, the decision may be made to withdraw the product from the market,” the statement reads.
Bayer told Global News that it extends its “deepest sympathies to the women and their families” who have been affected by the birth control.
“It’s important to note that reported adverse events do not necessarily denote a direct causation with the product,” the company said in a statement to Global News.
“Bayer fully stands behind Yaz and Yasmin,” the company said. Read the company’s full statement here.
Video: Sabrina Lombardi, a class action lawyer with Siskinds, says their office has received calls from over 1300 women who have used Yasmin birth control and the majority suffering from issues listed in the lawsuit.
One of the deaths with a suspected link to Yaz and Yasmin includes Delta, B.C., 18-year-old Miranda Scott. Her mother, Chip McClaughry told Global News that Miranda died three years ago while working out in the gym on an elliptical trainer.
McClaughry said her teenage daughter had a wide smile, dimples and a positive attitude. She fell off the machine and collapsed, McClaughry said.
“She’s 18, she’s an athlete, she’s so healthy. What happened?” the mother told Global News. McClaughry said she and her husband worked together to try to piece together what happened. That’s when they learned their daughter was taking Yasmin – she was on the pill for only five weeks. In that time, her daughter had reported back pain and even trouble breathing.
“So we typed it into the computer and we said, ‘oh my gosh, this sounds just like Miranda,’” she said. Scott had died of blood clots that had formed in her blood vessels.
Right now, a class action lawsuit is looming against Bayer, the drug giant that makes Yaz and Yasmin.
In April, an Ontario judge gave the green light to a law firm to move ahead with its class action.
At the heart of the lawsuit are allegations that women across Canada were kept in the dark about the increased risk of blood clots, stroke, heart attack and gallbladder disease and other medical conditions they had from taking these contraceptives compared to other birth control pills.
London, Ont.-based law firm Siskinds LLP even suggests that this increased risk was known to drug giant Bayer and that the company chose not to reveal this information to consumers and the medical community.
So far, about 1,321 women from across Canada have joined the class action. Another eight people from outside of Canada have also asked to join the lawsuit, meanwhile another 250 women need to identify their province of residence to the lawyers.
Siskinds class action lawyer Sabrina Lombardi said that about 241 clients had a pulmonary embolism, another 281 had to have their gall bladders removed, 54 suffered a stroke and 85 had blood clotting.
“This is certainly higher so far than our experience with some other birth control products. It seems to be a very popular drug, especially among young women and that’s what we’re finding in the clientele that’s approaching us,” Lombardi told Global News.
She said the majority of the women contacting the lawyers tend to be in their 20s and even late teens, all reporting issues such as gall bladder disease and even removal.
Another 477 women have filed other complaints included in the lawsuit.
Siskinds launched a Facebook page called Taking Your Body Back in 2010. It already has 7,000 followers, with many leaving personal encounters of the side effects they encountered while taking Yaz or Yasmin.
The law firm calls the certification for a class action a success. If the judge hadn’t granted the lawsuit to proceed, the women would have to pursue their cases one by one, which would be a much more expensive route. As a class action, they have permission to move forward as a group.
Carrie Gibson, 25, had been taking Yaz for about four years. Last August, she felt a cramp in her leg, so strong, she told her boyfriend about it.
The next day, while grocery shopping, her breathing picked up rapidly, she began sweating and vomiting and she felt like she was going through a panic attack.
Ultimately, she experienced pulmonary embolism, a blockage in the arteries of your lungs caused by blood clots that travel to this vital organ in your body.
Some testing showed that the upper and lower lobes of both her lungs were covered in blood clotting.
Gibson said her doctors linked Yaz as the cause of her condition.
She now heads to hospital at least once a week for blood tests and relies on blood thinners taken through medication and injections to keep her healthy.
The residual effects of what’s happened to her are long-lasting, she said.
“It’s pretty scary what happened,” she told Global News.
“Everytime I lose my breath or if I have a cramp that’s a little different, immediately my mind goes back to wondering if this is happening again,” she explained.
Gibson now deals with fatigue and irregular breathing – issues she wouldn’t have encountered as a healthy 25-year-old.
Similar cases have already taken place in United States, and some have already resulted in settlements, Baer said.
In March, Bayer agreed to pay up to $24 million to settle gallbladder injury claims in Illinois, California, New Jersey and Pennsylvania.
Plaintiffs who suffered gallbladder injuries would receive $2,000 and those who had their gallbladders removed would receive $3,000, according to Reuters.
Another $1 billion will be doled out among 4,800 women who said the pill caused blood clots that resulted in heart attacks, strokes and other injuries.
A lawyer told the wire service that those who suffered from blood clots could get up to $100,000 in damages.
In the U.S., these cases were ultimately consolidated.
Bayer Canada told Global News in April that it was “very disappointed” in the judge’s decision to certify the class action case.
On Tuesday, Bayer said that it has filed a leave to appeal the decision to certify the class action.
“At Bayer we take the safety of our products very seriously and we continuously review the safety profiles of our products worldwide. Bayer investigates reports on side effects thoroughly and collaborates closely with Health Canada concerning the use, benefits and risks of all products, including YAZ® and Yasmin®. Bayer strongly encourages all patients and healthcare professionals to report adverse events to the company directly or to Health Canada,” the company said in a statement.
Bayer is scheduled to appear in court in Ontario on Sept. 4. Read the company’s full statement here.
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