Class-action lawsuit involving Bayer IUDs gets certified in Canada
Canadians who used a certain intrauterine device (IUD) may be eligible to join a class-action lawsuit against the pharmaceutical company Bayer Inc.
On July 7, the Court of King’s Bench of Alberta approved a class-action lawsuit against Bayer regarding Mirena, an IUD inserted into the uterus. Considered a drug by Health Canada, Mirena releases a synthetic form of the female hormone progesterone called levonorgestrel.
It can be used as a form of contraception for several years and to treat heavy menstrual bleeding.
The allegations
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According to the court document, the lawsuit doesn’t question the safety of Mirena. Instead, Bayer is facing allegations that it failed to adequately warn users of the risks that the IUD could travel outside the uterus.
Health Canada defines a monograph as a “factual, scientific document on a drug product that describes the properties, claims, indications, and conditions for use of a drug.” It helps ensure that healthcare professionals and patients have the essential information. As a result, a monograph must also contain information required for “optimal, safe, and effective use of the drug, and warnings, precautions, [and] adverse reactions.”
Plaintiff Elizabeth Todd alleges that the Mirena product monograph that was used in Canada before the wording change in 2014, “failed to adequately disclose the risk of the Mirena device migrating from the uterus.”
“When a Mirena device migrates from the uterus, it can cause damage to organs in the abdomen and requires surgical removal,” reads the document. “The Proposed Representative Plaintiff asserts that Bayer’s failure to identify migration as a risk in the Mirena product monograph constitutes a breach of a duty to warn.”
Are you eligible?
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The court document doesn’t yet have a clear definition, but it does outline proposed eligibility requirements for class members.
According to the plaintiff, all women in Canada who used Mirena and experienced device migration during the class period should be included in the lawsuit against Bayer. As a result, they should be able to seek compensation.
Bayer argues that the class period should only start from 2008 until 2014 when “the Canadian Mirena product monograph was changed to address the risk of migration.” Daily Hive has reached out to Bayer for a statement regarding the allegations.
The case is set to go to trial in 24 months.