Yaz and Yasmin Birth Control Pill Injury Lawyers
Yaz, Yasmin and Ocella are birth control pills manufactured and marketed by Bayer Healthcare. They are combination oral contraceptives (“COCs”), meaning that they contain an estrogen component and a progestin component, which work together to prevent pregnancy. Yasmin and Yaz were approved by the FDA in 2001 and 2006, respectively.
The estrogen component in Yaz and Yasmin is known generically as ethinyl estradiol. The progestin component is known as drospirenone. Yasmin and Yaz differ from other combined hormonal birth control pills in that they contain drospirenone, a progestin that is unlike other progestins available in the United States and was never before marketed in the United States prior to its use in Yasmin and Yaz. No other birth control pills on the market contain drospirenone, except for the generic version of Yasmin and Yaz marketed under the trade name, Ocella.
Since drospirenone is new, there are not decades of data available regarding its safety. Studies conducted prior to FDA approval indicate that drospirenone is potentially more dangerous than other progestins, and therefore present additional health risks not associated with other birth control pills. Studies indicate that drospirenone has certain effects that are different from, and potentially more dangerous than those of traditional second generation progestins, such as an increase in potassium levels in the blood, which can lead to a condition known as hyperkalemia (elevated blood potassium level) if the potassium levels become too high. Hyperkalemia can cause heart rhythm disturbances, and can be fatal if left untreated. Moreover, if hyperkalemia disrupts the normal heart rhythms, the flow of blood through the heart can be slowed to the point that it causes blood clots to form, which can then lead to heart attacks, pulmonary embolisms or strokes. Additionally, drospirenone can cause gallbladder disease and kidney stone formation, which often requires women to undergo surgery.
Bayer’s overpromotion of Yasmin and Yaz has led the FDA to admonish the company on a number of occasions. In 2003, the FDA issued a warning letter to the company stating that the “FDA is not aware of substantial evidence of 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.” The FDA also admonished the company for failing “to communicate that the potential to increase potassium is a risk” or that “increased serum potassium can be dangerous.” In 2008, the FDA again issued a warning letter to Bayer Corporation for its misleading television ads. As a result of its misleading marketing and sales practices of Yasmin and Yaz, Bayer settled more than 20 claims with Attorneys Generals across the country in 2009. That litigation alleged that Bayer Corporation overemphasized the benefits of Yasmin and Yaz while minimizing the risks.
Bayer markets Yasmin and Yaz as being safe and effective as other birth control pills on the market. However, during the brief time that Yasmin and Yaz have been sold in the United States, hundreds of reports of injury and deaths have been reported to the FDA as a result of Bayer’s misleading advertisements. Some deaths reported occurred in women as young as 17 years old.
There are currently more than 75 federal lawsuits pending throughout the United States as a result of injuries sustained to women who ingested Yasmin, Yaz or Ocella. Accordingly, in October of 2009, a panel of judges ordered that all federal lawsuits against the manufacturers and sellers of Yaz and Yasmin birth control pills would be consolidated into an MDL (multidistrict litigation for pretrial proceedings in the Southern District of Illinois – MDL No. 2100, In re Yasmin and Yaz (Drospirenone) Marketing Sales Practices and Relevant Products Liability Litigation. The MDL process is designed to serve the convenience of the parties and witnesses involved in the litigation by avoiding duplicative discovery and inconsistent pretrial rulings on similar issues. Each lawsuit will still remain an individual lawsuit and each plaintiff will have the right to a trial to determine the amount of damages she is entitled to recover.
We currently represent more than 100 women across the country who have sustained devastating and life threatening injuries, such as deep vein thrombosis or DVT, pulmonary embolisms and gallbladder disease, as a result of ingesting Yaz, Yasmin or Ocella. If you or a loved one has suffered an injury as a result of ingesting Yaz, Yasmin or Ocella, please contact Cohen & Malad, LLP to speak with one of our products liability/personal injury attorneys to discuss your legal options. We are experienced trial lawyers and will help you seek the compensation you deserve.