16. April 2012 14:54
Bayer HealthCare has agreed to pay an average of $220,000 per patient to settle 500 lawsuits over the safety of its birth control pills Yaz and Yasmin (drospirenone).
The German company is accused of misleading patients and clinicians about the risk of venous thromboembolism (VTE), leading to cardiovascular events, to women taking the drug.
The settlement means Bayer will pay a minimum total charge of $110m – and if rolled out across all the current lawsuits, could cost the company over $2bn.
Safety reviews of drospirenone-containing birth control pills led to FDA’s decision to include VTE risk warnings in the product labels.
Bayer is currently facing more than 11,000 lawsuits in the US alleging harm caused by the use of Yaz, Yasmin or authorised generic equivalents.
Yaz is one of Bayer’s most successful brands, earning $1.1bn in 2011.
Rosemarie Yancosek, a spokesperson for Bayer, said: “Bayer HealthCare confirms that some cases pending in the current Yaz/Yasmin litigation in the US are being settled.”
Bayer’s settlement strategy contrasts with the more defensive approach taken by Johnson & Johnson over the marketing of its antipsychotic drug Risperdal.
1. June 2011 15:45
The FDA is to conduct a review of contraceptive pills that contain drospirenone, due to concerns they may cause an increased risk of venous thromboembolism (VTE).
The most well known of these medications are Bayer’s Yasmin and Yaz products.
Recent studies published in the BMJ claimed that the risk of VTE among women taking drospirenone is two to three times greater than in women taking a different progestin, levonorgestrel.
The FDA says that other studies show differing results, so it is “currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills”.
The manufacturer says that its own assessment of the available data, including up to 10 years of post-marketing studies, supports the safety of its products and that the risk of developing VTE is comparable across all oral contraceptives.