Yaz and Yasmin, manufactured by Bayer Corp. (along with the related entities of Bayer HealthCare Pharmaceuticals Inc.; Bayer Pharmaceuticals Corp.; and Bayer HealthCare LLC), are birth control pills that have been touted as being unique due to the use of the progestin drospirenone, which also has diuretic properties.
The complaints allege that Bayer Pharmaceuticals, which manufactures both Yaz and Yasmin, failed to adequately research their products, fraudulently concealed the risk of injury, negligently failed to warn about the degree of risk women faced and misrepresented the safety of the drugs in comparison to other available birth control pills.
The FDA issued warning letters to Berlex Laboratories, the predecessor manufacturer to Bayer, as early as 2003, ordering the Defendants to immediately discontinue a television advertisement that promoted Yasmin’s fourth generatio progestin, drospirenone, by stating, “Ask about Yasmin, and the difference a little chemistry can make.”
The FDA objected and stated “FDA is not aware of substantial evidence or clinical experience demonstrating that Yasmin is superior to other COC’s [combination oral contraceptives] 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 claims that Bayer used testing methods of the products that averaged out the test results as opposed to reporting results for each batch of the drug. Bayer had the batches shipped to the U.S. from its German plants between 2007 and 2009.
Yaz and Yasmin both contain a combination of ethinyl estradiol, which is used in many oral contraceptives, and drospirenone, a unique type of progestin that is only found in these drugs and a generic Yasmin version sold under the brand name Ocella. Drospirenone, or drsp, impacts the body’s normal mechanism of regulating a balance between salt and water, which could result in elevated potassium levels. This can cause a condition known as hyperckalemia, which is linked to potentially life-threatening heart problems and other health issues.
The FDA recently sent a warning letter to Bayer, which manufacturers Yaz and Yasmin that it has quality control problems at its German plant
The Food & Drug Administration has issued several notices to the manufacturer regarding improper advertising, and corrective advertisements are being televised currently in the United States. A recent British Medical Journal article noted that patients taking birth control pills that included drospirenone faced greater risks of developing blood clotting issues, including pulmonary emboli, deep vein thrombosis, heart attacks, and strokes. There are also concerns that patients taking Yaz and Yasmin face greater risk of developing gallbladder disease. As the litigation progresses, the plaintiffs will be seeking additional information regarding the development, sale and marketing of these drugs, as well as information as to when the German manufacturer knew of the special risks associated with Yaz and Yasmin and its efforts, if any, to communicate that vital safety information to prescribing physicians and patients.
It is anticipated that hundreds, if not thousands, of additional lawsuits will be filed in the coming months on behalf of girls and women who have suffered personal injuries or death as a result of their ingestion of Yaz and Yasmin. The Flynn Law Firm helps victims of defective drugs, and offers a free initial consultation and weekend appointments. The Flynn Law Firm only works on a contingency fee basis, and you will pay nothing if money is not recovered in your medication error case.