A B.C. Supreme Court judge has certified a lawsuit against the makers of Alesse birth control pills after they were found to have too little estrogen to be effective.
Two plaintiffs came before the court after becoming pregnant despite taking their Alesse birth control pills as instructed. Alesse is manufactured by Pfizer Canada Inc. and Wyeth Canada and comes in 21-pill packs or 28-pill packs. Each includes 21 “active” pills, with hormones. In the 28-pack, seven inactive pills are included to allow a break in hormones.
Taylor MacKinnon, said she had been taking the pills since 2014 in order to prevent pregnancy.
On Dec. 6, 2017, MacKinnon was notified by her pharmacist of a Health Canada advisory that found that two lots of Alesse contained an active pill that was half the proper size.
“Broken or smaller-than-normal birth control pills may deliver a smaller dose of the active drug ingredient, which could reduce its effectiveness in preventing pregnancy,” the advisory stated.
However, the advisory only warned against pills that were smaller or broken, not ones that looked normal. MacKinnon checked her 21-pack, which she had purchased on Oct. 22, 2017, but it was not from one of the lots noted in the advisory.
On Dec. 16, she took a pregnancy tests that came back positive. The next day, she went to a doctor and was told she was just over five weeks pregnant.
MacKinnon said despite phoning Health Canada and Pfizer, the makers of Alesse, she did not get any further information. She gave birth to her daughter on Aug. 4, 2018.
“Ms. McKinnon says she wished to have children someday but not at such a young age,” court documents stated. “She would have preferred that she and her partner were more established in their careers and financially stable before having children.”
MacKinnon has been unable to find work as a certified dental assistant following the birth of her daughter.
The second plaintiff, Alyssa McIntosh, said she had been taking the pills since January 2017 to prevent pregnancy. On about Oct. 21, 2017, McIntosh found out she was pregnant and had a miscarriage in late November or early December, when she was about eight or nine weeks along.
McIntosh’s 21-pack was one of the advisory lots and she purchased them on June 23, 2017.
Testing the pills
Two packs of pills from another woman, Jenelle Hamilton, were tested by Emery Pharma in the spring of 2019. Alesse pills are supposed to have 20 micrograms of estrogen, a hormone that prevents pregnancy. The first pack, which was expired by about six months, had between 18 and 19.2 micrograms of estrogen per pill. The second pack, which was not expired, had between 18 to 19.2 micrograms per pill.
“None of the pills tested contained 20 mcg of estrogen, as represented in the Alesse Product Monograph,” court documents state. Neither pack of pills had any broken and chipped pills.
Certifying the class-action lawsuit
To certify a class-action suit, a judge does not need to decide if the facts of the case are true. To be certified, a class action must satisfy five parts: a cause of action, a class of two or more individuals, a common issue, a decision that a class action is more appropriate than individual claims and a representative claimant.
Justice Karen Horsman certified a class-action lawsuit against the manufacturers of Alesse. The class in question includes any person who was prescribed Alesse and took the medication between Jan. 1, 2017, and April 30, 2019.
There are expected to be at least 138 potential claimants, based on the number of women who contacted Rice Harbut Elliott LLP, the law firm handling the class-action.
Thirty-eight women also submitted adverse reaction reports to Health Canada, though it’s unclear if these are the same women as went to the law firm.
Pfizer Canada Inc. and Wyeth Canada argued against the certification of the class action. They alleged the lawsuit was too broad because the class action includes all people who took Alesse between Jan. 1, 2017, and April 30, 2019, the date in the Health Canada advisory, but is not limited to those who took pills belonging to the lots identified in the advisory.
“The defendants further say that any proposed class should be limited to individuals who actually became pregnant as they are the only class members who actually suffered harm,” court documents state.
However, Horsman said that other negative effects of having taking the less-effective pills also constitute harm, including emotional distress and economic loss due to purchasing defective medication.