As we have discussed before on this blog, more than 11,300 Yaz / Yasmin lawsuits have been filed against Bayer, the drugs' manufacturer, typically alleging the drugs caused blood clots in legs or arms (deep vein thrombosis), blood clots in lungs (pulmonary embolism), or a stroke involving venous thrombotic event. Back in April, the Beyaz, Safyral, Yasmin and Yaz side effect warning labels were updated to reflect that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins.
Back in April, Bayer reported paying over $140 million in settlements for Yaz and Yasmin, at an average settlement amount of about $218,000 a case. Given the pace at which the cases are settling - normally in negotiated batches - that number could be $200 million by now. The lawsuits themselves are all on hold pending court-ordered mediation, which for the time being seems to be working in getting the cases resolved. As we mentioned in the prior posts here, the evidence against Bayer is quite strong, with the consolidated plaintiffs’ lawyers calling a former FDA Commissioner as an expert witness to testify his opinion that:
- "Bayer violated its duties under FDA regulations and state law by selectively presenting data as to thromboembolic events, which did not adequately inform FDA, doctors or consumers of the thromboembolic risks, from premarketing to the present";
- "Bayer engaged in extensive off-label promotion of Yasmin and YAZ for unapproved uses, in violation of FDA regulations, to increase sales"
- "[t]hat off-label promotion increased the risk of thromboembolic events in patients in violation of state law duties."
(That comes from the expert’s report.)
Further underscoring the problems with these medications - and, most pertinently, Bayer’s failure to warn patients about the risks - is a study just released in the New England Journal of Medicine (“Thrombotic Stroke and Myocardial Infarction with Hormonal Contraception“) which analyzed nearly two million Danish women without a prior history of heart disease. The researchers found:
Although the absolute risks of thrombotic stroke and myocardial infarction associated with the use of hormonal contraception were low, the risk was increased by a factor of 0.9 to 1.7 with oral contraceptives that included ethinyl estradiol at a dose of 20 μg and by a factor of 1.3 to 2.3 with those that included ethinyl estradiol at a dose of 30 to 40 μg, with relatively small differences in risk according to progestin type.
In layman’s terms, the study found that hormonal contraceptives that rely on estradiol and other progestins raised the risk of heart attacks and strokes by nearly 50%, and sometimes even doubled it.
If you suffered a blood clot injury, like venous thrombosis (whether DVT or pulmonary embolism), or a heart attack or stroke while taking Yaz or Yasmin, contact our dangerous drug lawyers for a free, no-obligation consultation. We've been representing injured patients for over 60 years, recovering over $2 billion in jury verdicts and settlements.