Yaz/Yasmin lawsuits on the increase

Yaz Lawsuits Heat Up – Is a Recall on the Horizon?
September 2, 2009

Several lawsuits have been filed against Bayer due to serous side effects associated with Yasmin / Yaz. Here we discuss the implications such a lawsuit would have on a potential recall.

Note: See earlier post on Yasmin Warnings (with reader comments)

Both the drugs are oral contraceptives that contain synthetic versions of the hormones estrogen and progestin, and are associated with side effects including stroke, heart attack, pulmonary embolism, deep vein thrombosis, gallbladder problems, and kidney problems. Some strongly suspect that Yasmin / Yaz will be recalled in the near future because of the attention now being brought to the serious risks involved in taking them.

The Drugs: Yaz and Yasmin
Both birth control drugs contain ethinylestradiol, a synthetic estrogen that has been in use in oral contraceptives since its approval by the Food and Drug Administration (FDA) in 1943. Ethinylestradiol can cause some minor side effects such as nausea, but has been used safely for decades. However, Yaz and Yasmin also contain 3 mg drospirenone, which is a relatively new synthetic progestin that is not used in other oral contraceptives. The health problems that result from taking the drugs may be caused by the drospirenone.

Drospirenone at 3mg (the amount found in Yaz and Yasmin) can potentially cause hyperkalemia in high-risk patients. Hyperkalemia is an elevated blood level of the electrolyte potassium. Extreme hyperkalemia is a medical emergency because it means there is a high risk of potentially fatal abnormal heart rhythms. These abnormal heart rhythms can then cause the slowing of blood to the heart, which often causes the formation of blood clots. Those clots can lead to heart attacks or can break off and travel to the lungs causing pulmonary embolism, or to the brain, causing a stroke.

The Yasmin and Yaz Lawsuits
On July 24, 2009, a petition was filed to consolidate the many lawsuits against Bayer over Yaz and Yasmin into a multidistrict litigation (MDL). There is a hearing scheduled for September 24, 2009 to decide whether or not they will be consolidated.

Andrew Gillin, an attorney handling several California Yaz lawsuits says the litigation is still in the early stages. “A petition has been filed to combine all of the federal lawsuits into a multi-district litigation (MDL) case. Later this month, a panel of federal judges will determine whether the cases involve sufficiently common questions of fact, and whether or not to consolidate,” explained Mr. Gillin.

Generally, consolidating a high volume of cases into an MDL saves money for both the plaintiffs and the defendants, and also removes some of the strain that so many cases would otherwise put on judicial resources. According to Mr. Gillin, the Yaz MDL stands a good chance at being approved because nearly all the complaints are with regard to blood clotting, making the factual issue in each case very similar.

A Possible Yasmin or Yaz Recall?
The alleged side effects of Yaz and Yasmin can be fatal. So if they are proved to be caused by these birth control drugs, it is certainly not a stretch of the imagination to think that Yaz and Yasmin will be recalled from the market. Yet the FDA has given no indication that it intends to do so. In the end, it is their decision whether or not to recall Yaz and Yasmin.

One might think that Yaz and Yasmin are sure to be recalled given the serious and fatal side effects some are associated with the widely popular birth control drugs, but as Gillin also points out, “We saw similar fatal side effects with the birth control patch, Ortho Evra, but we did not see an official FDA recall. It remains to be seen what will happen with Yaz and Yasmin.”

(see also FDA Sends Warning Letter to Makers of Yaz – Yasmin).