In 2011, former FDA chief Dr. David Kessler publicly accused Bayer of making misleading Yaz marketing claims. Dr. Kessler also accused Bayer of advertising Yaz for unapproved or untested uses. His statement said, “By failing to disclose all thromboembolic event risk information and marketing Yaz and Yasmin off-label, Bayer needlessly exposed large numbers of women to risks of serious or fatal thromboembolic events.” By July 2012, Bayer paid more than $402 million in Yaz settlements for claims involving blood clot injuries.
Plaintiffs Allege They Were Unaware of Potential Yaz Blood Clot Risks
Many plaintiffs or their families claimed they were unaware of the drug’s potential dangers. That same year, the FDA issued a warning about potential Yaz risks. This warning also required Bayer to label Yaz a “black box” drug—the most dangerous level for prescription drugs.
Yaz Settlements Total Nearly $2 Billion To Date
Bayer paid Yaz settlements to more than 10,000 plaintiffs, totaling nearly $2 billion. The company is currently several thousand U.S. claims. Because Yaz is still on the market with the same health risks, it’s unlikely Bayer will stop paying Yaz settlements anytime soon.
The Case Against Yaz
In 2011, the U.S. Food and Drug Administration released the results of an extensive study on the possible dangerous side effects associated with the birth control pill, Yaz. Those results showed women taking Yaz were as much as 74% more likely to develop blood clots than they are when taking other forms of oral contraceptives. As one of the most popular forms of birth control, news of this study came as a disturbing and very real risk to millions to American women. Now, yet another lawsuit related to Yaz and blood clots is in the process of settling, and Yaz’s manufacturer is paying out tens of millions in damages.
The company has faced near-continuous Yaz litigation for over a decade due to increasing deep vein thrombosis reports. When blood clots break free and travel to your lungs or heart, they can cause heart attacks or strokes. Some cases may even be fatal. One lawsuit blamed Bayer for at least 50 deaths caused by Yaz.
Accusations of Misleading Marketing
In addition to Yaz side effects, Bayer is accused of misleading marketing practices. Though the FDA monitors drug safety, it doesn’t require new formulations of a current medication to undergo clinical safety trials. Bayer allegedly exploited this fact when initially marketing Yaz. Despite many independent international studies showing Yaz has higher safety risks, Bayer launched a massive $270 million campaign. Those ads touted Yaz as a safer, better birth control option. The marketing campaign was enormously effective, and Yaz became one of the most popular birth control pills of all time.
Lori Polemenakos is Director of Consumer Content and SEO strategist for LeadingResponse, a legal marketing company. An award-winning journalist, writer and editor based in Dallas, Texas, she's produced articles for major brands such as Match.com, Yahoo!, MSN, AOL, Xfinity, Mail.com, and edited several published books. Since 2016, she's published hundreds of articles about Social Security disability, workers' compensation, veterans' benefits, personal injury, mass tort, auto accident claims, bankruptcy, employment law and other related legal issues.