The sheer number of women filing Yaz lawsuits against Bayer HealthCare is considered by health groups to be proof enough to justify yanking the new breed of combined contraceptive formulations from the market. In particular, advocacy groups are targeting oral contraceptives that contain drospirenone, stating that there are safer alternatives. The Food and Drug Administration (FDA) did not agree; the products remain on the market.
While it seems foolhardy, the FDA maintains that with proper use, Yaz is a safe product. And indeed, targeting drospirenone-containing products is a bit of a puzzle. A significant number of the lawsuits filed refer to the formation of dangerous blood clots which caused the injury, and drospirenone is not the culprit in these cases. Estrogen, and in Yaz’s case a synthetic estrogen called ethinyl estradiol, is the component that affects blood coagulation, not drospirenone. So it would make sense to ban products that contain estrogen as well. That would take care of many of the new-generation contraceptive formulations.
The fact is, the problem with Yaz lies not in its formulation and attendant side effects, but the failure of Bayer HealthCare to post the proper warnings for existing and potential users. The product, while usually prescribed by a physician, is also available in some areas as an over-the-counter drug. Despite the black box warning, many users are more concerned with how the product was marketed than what the box and package insert, which is usually so closely printed that it is difficult to read aside from being couched in medical terms.
The failure of Bayer HealthCare to hold up its standard of care to its clients has cost the drug maker a mint of money. To date, settlements of 6,700 cases have totaled in excess of $1.4 Billion. The company can well afford it just out of its 2nd quarter earnings for 2013, but still it is a hefty sum. In the meantime, Yaz and similar products of Bayer continues to be available in the market, and many physicians continue to prescribe it to their female patients even as another half-dozen thousand Yaz lawsuits wait in the wings for their day in court.