Yaz Lawsuits Pile Up, Could Eventually Number in the ThousandsDec 8, 2009 | Parker Waichman LLP
Yaz lawsuits continue to be filed by young women who claim the popular contraceptives caused them to suffer blood clots, heart attacks and strokes. According to a report in The Washington Times, some legal expert expect that thousands of Yaz lawsuits will eventually be filed against Bayer AG.
Yaz was approved by the Food & Drug Administration (FDA) as an oral contraceptive in March 2006, and as a treatment for the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in October 2006. Finally, in January 2007, Yaz was approved to treat moderate acne in women who desire an oral contraceptive for birth control.
Yaz contains a synthetic type of progestin called drospirenone. According to the FDA, drospirenone can lead to hyperkalemia, a condition caused by excessive amounts of potassium in the blood, in high risk patients. This condition may result in potentially serious heart and health problems. Because of this risk, women with conditions that predispose them to hyperkalemia (such as renal insufficiency, hepatic dysfunction and adrenal insufficiency) should not take YAZ. Women taking YAZ must also be concerned about the drug interactions that could increase potassium.
Yaz side effects reported to the FDA include heart arrhythmias, electrolyte imbalance, hyponatremis, hyperkalemia, hyperkalemic arrhythmias, atrial fibrillation, tachycardia, bradycardia, myocardial infarction, stroke, transient ischemic attack, blood clots, embolisms, and sudden death.
As we have reported previously, in October 2008, the FDA cited two Yaz commercials for deceptive claims. In a warning letter, the FDA faulted Bayer for overstating the benefits of Yaz. The FDA also criticized the ads for containing fast-moving images and background music that might be distracting to viewers. These elements were aired while information about potential Yaz side effects – including potentially life-threatening blood clots – was described. The FDA warning letter said the television commercials minimized the risks posed by Yaz.
Bayer ended up pulling the misleading ads. It also reached an agreement with the FDA and 27 state attorneys general to run new TV spots correcting the misinformation from the pulled commercials. They began running in early 2009.
Then in August, the FDA warned Bayer about quality control at a German plant that makes drospirenone for Yaz.
Lawyers for Yaz lawsuit plaintiffs told The Washington Times that most of their clients are young, and were healthy before they started taking Yaz. They also said that they are expecting a spike in the number of lawsuits filed on behalf of victims of Yaz and similar contraceptives, following publication of a study in the British Medical Journal over the summer that found higher risks of clots, heart attacks and strokes with Yaz and its predecessor, Yasmin, compared with other contraceptives. The study blamed the presence of drospirenone for the higher risk.