Last year in October 2013, Bayer Pharmaceuticals issued an announcement stating that it had agreed to a settlement in response to at least 6,700 lawsuits related to the Yaz and Yasmin birth control products it manufactured and distributed. The total settlement is said to exceed $1.4 billion. As part of the settlement agreement, Bayer would not admit to any wrongdoing or assume any liability fo r the product which reportedly caused deep vein thrombosis pulmonary embolisms and any other, similar blood clot-related injuries in women who took it.
Outside of the $1.4 billion settlement, there are approximately 5,400 cases still pending. Nearly 2,700 allegedly involve similar blood-clot related injuries. The use of Yaz birth control pills has also been linked to diseases affecting the gallbladder, which result in the removal of the organ. In a separate settlement for gall-bladder injury claims, Bayer reportedly agreed to payments totaling over $24 million. The terms of that settlement include a $2,000 per-patient payment for the suffering of gallbladder injury as well as a $3,000 payment for those who had gall bladder removal.
Lawsuit Origins
Bayer’s brand-name birth control pills Yaz and Yasmin, containing drospirenone, were introduced to the market in 2006. Following a strong initial marketing campaign, Yaz and Yasmin both earned top spots among the top selling oral contraceptives in the US.
However, the trend reversed sharply in 2009 as patient injuries caused by the drugs’ side effects began raising serious concerns over both pills’ safety. Many Yaz and Yasmin users suffered from adverse side effects such as blood clots, strokes, and heart attacks. While over 10,000 women filed a class-action lawsuit against Bayer, neither Bayer nor the US Food and Drug Administration have ever issued a recall.
Among the more serious injury cases were instances of deep vein thrombosis, or blood clots that form in deep veins and can dislodge and travel to the heart, lungs, or brain, causing heart attacks, and pulmonary embolisms.
A study from 2011 report showed that Yaz and Yasmin users doubled the risk of clots as compared to other birth control drugs in the same category.
Claims Alleged Deceptive Marketing and Inadequate Product Testing
Many plaintiffs alleged that Bayer used deceptive marketing practices that focused on exaggerated potential benefits while the company simultaneously ignored the need to warn consumers of the serious side effects that could results from product use. A part of the Yaz lawsuits claimed that Bayer was also negligent in not fully studying the potentially serious and fatal side effects of taking Yaz or Yasmin. While Bayer did modify its general advertising strategy for the contraceptives, the affected consumers and the FDA considered the changes to be questionable and still misleading.
In 2010, the British Medical Journal and FDA published studies concluding that the hormone drospirenone can increase the risk of blood clots by as much as 74%. Many believe the FDA study is what prompted Bayer to begin taking the claims seriously. Since that time, the company began settling many of the 10,000s of suits filed and is continuing to compensate seriously injured consumers and patients. The recent October settlement agreement by Bayer is the company’s latest in response to a litany of still pending, unresolved claims.
References:
Med City News – https://medcitynews.com/2013/09/bayer-has-spent-1-4-billion-to-settle-lawsuits-over-yaz/
Drug Risk (.com) – https://www.drugrisk.com/yaz/recall
