The first individual Yasmin lawsuit has been filed in Canada by the family of a 26-year-old woman who died after taking the birth control pills.
Vicky Caprice Mersereau died of a large pulmonary embolism in 2009 after ingesting Yasmin, which is manufactured by Bayer Inc., according to CBC News. Yasmin is one of Canada’s top-selling oral contraceptives and is described as a low-dose, so-called “fourth generation” hormonal contraceptive.
The lawsuit was launched in advance of the U.S. Food and Drug Administration’s (FDA) public hearings on the medication, scheduled for December 8 in Maryland, said CBC News. That hearing will consider not only Yasmin’s safety, but the controversial progestin used in the drug, drospirenone. As we’ve mentioned, the meeting is a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
Last month, the agency issued a warning concerning drospiernone-containing oral contraceptives—including Yasmin and Yaz—stating that the drugs increase blood clot risks by 74%, versus older birth control pills, said CBC News. Reports of health issues linked to Yasmin and Yaz use include stroke, deep vein thrombosis, pulmonary embolism, heart attack, and gall bladder disease. As we’ve written, a growing body of research has pointed to an increased risk of dangerous blood clots called venous thromboembolisms (VTEs) associated with the use of Yaz, Yasmin, and other drospirenone containing contraceptives.
CBC News said that, in the United States, over 10,400 individual lawsuits have been filed over Yasmin and Yaz. In Canada, at least one law firm filed a class-action lawsuit against Bayer concerning the use of Yasmin and Yaz in Canada that alleges that Bayer neglected to appropriately warn patients and doctors about increased health risks associated with the drugs, versus safer oral contraceptives. Thousands of these lawsuits have been consolidated in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) currently pending before the Honorable Judge David R. Herndon in the United States District Court for the Southern District of Illinois.
Documents provided by plaintiffs’ lawyers to Bloomberg News reveal that Juergen Dinger, lead author of the European Active Surveillance Study, which purportedly showed no increased risk of blood clots associated with Yasmin, was involved in the drug’s development when he was a Schering vice president. Plaintiffs claim that study downplayed the serious risks associated with drospirenone, the synthetic progestin contained in Yaz, among other conflict-of-interest issues.
Meanwhile, according to a CBC Marketplace investigation conducted this year, Bayer claimed its product was not any riskier than other currently approved oral contraceptives. We also recently wrote that a report on the matter revealed that Bayer AG may have considered marketing Yaz off-label and that internal Bayer emails provided to lawyers show company officials discussed promoting Yaz off-label. Company documents uncovered in the course of the lawsuits reveal that Bayer may have also misled women about the serious risks posed by Yaz’s precursor, Yasmin.
In 2008, the FDA cited Bayer for Yaz TV commercials that downplayed the drug’s serious risks, and forced it to spend millions on a corrective advertising campaign.