Lawsuit Against the Makers of Yasmin/Yaz/Ocella
Have you used the oral contraceptive drugs called Yasmin, Yaz, or the generic form of Yasmin marketed as Ocella? These contraceptive drugs have been linked to serious, life threatening injuries including, but not limited to, blood clots, strokes, pulmonary embolisms, heart attacks, and even death. Yasmin was approved for use in the United States in 2001, while Yaz, a lower dose version, was approved for use in 2006. Yasmin and Yaz, originally manufactured by Berlex Laboratories, are currently manufactured by Bayer Healthcare. A generic version of Yasmin, marketed as Ocella, has been on the market since 2008 and is marketed by Teva Pharmaceuticals.
Yasmin and Yaz are known as combination oral birth control drugs because they contain a combination of the hormones estrogen (ethinyl estradiol) and progestin (drospirenone). Yasmin and Yaz birth control are different from other contraceptive pills in that they contain the hormone drospirenone, which has never before been marketed in the United States. It is considered a fourth generation combination hormone birth control pill. This is compared to prior generation birth control containing desogestrel or oral contraceptives containing norgestrel, levonorgestrel or norethindrone.
The difference between Yasmin and Yaz is in the amount of the estrogen component, ethinyl estradiol. Yasmin contains 30 mcg ethinyl estradiol, while Yaz contains a lower dose of 20 mcg.
THE U.S. FEDERAL DRUG ADMINISTRATION (FDA) WARNINGS ABOUT YAZ AND YASMINE
In 2003, the FDA wrote a letter to Berlex Laboratories (the manufacturer of Yaz in 2003) requesting that it take Yasmin's television ad entitled "Goodbye Kiss," and all other promotional materials and activities for Yasmin that contain the same or similar violative presentations as "Goodbye Kiss," off the air because it was misleading.
According to the FDA's 2003 letter:
"The TV ad misleadingly overstates the efficacy and safety of Yasmin by suggesting that Yasmin is unique and therefore clinically superior to other birth control pills because it contains the chemically different progestin drospirenone. The unifying theme of the ad, typified by the tagline "Ask about Yasmin, and the difference a little chemistry can make" (emphasis added by FDA) suggests that Yasmin is better than other birth control pills because of drospirenone and the way in which it is metabolized in the body. This "chemistry" difference is presented as a product benefit. FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Yasmin is superior to other COCs or that the drospirenone in Yasmin is clinically beneficial. On the contrary, FDA is aware of the added clinical risks associated with drospirenone..."
Despite the above warning from the FDA, Bayer (who purchased Berlex Laboratories, and is the current manufacturer of Yasmin and Yaz) continued to mislead the public about the benefits and risks of the drugs. They were sent a warning letter by the FDA in 2008, this time about ads regarding Yaz.
Excerpts from the 2008 warning letter from the FDA:
"There are numerous warnings associated with the use of Yaz including, but not limited to, venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke), hepatic neoplasia, gallbladder disease, and hypertension. Moreover, Yaz has additional risks because it contains the progestin, drospirenone.
Drospirenone has antimineralocorticoid properties which can lead to hyperkalemia in high risk patients, which may result in potentially serious heart and health problems. Women taking Yaz must be concerned about the drug interactions that could increase potassium, in addition to the drug interactions common to all combination oral contraceptives...
The overall effect of the distracting visuals, graphics, concurrent supers and background music [in the ad] is to undermine the communication of important risk information, minimizing these risks and misleadingly suggesting that Yaz is safer than has been demonstrated by substantial evidence or substantial clinical experience."
Side effects of Yasmin, Yaz, or Ocella, should be immediately evaluated by a doctor because complications can cause serious injuries and be life-threatening.
Our attorneys at Wasserman, Comden, Casselman & Esensten, L.L.P. are evaluating claims on behalf of individuals throughout the United States who were prescribed Yazmine, Yaz or Ocella, and suffered serious side effects including blot clots, strokes, deep vein thrombosis, pulmonary embolism, heart attacks, kidney failure, gallbladder removal, pancreatic cancer, or death. If you would like us to review your information, please contact us as soon as possible to protect your legal rights.
