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Katherine Kern has filed a lawsuit against Bayer Healthcare Pharmaceuticals Inc., alleging that their product, Yaz (drospirenone and ethinyl estradiol), caused her to develop deep vein thrombosis (DVT).
According to her Yaz lawsuit, Kern began taking the birth control pill in August 2010. However, by November of that year, she was diagnosed with DVT and pulmonary embolism (PE). These are medical emergencies related to blood clot complications.
In DVT, a blood clot forms within the large blood vessels of the leg. Here, the clot can cause debilitating pain within the leg. However, the greater concern with Yaz DVT is that the blood clot can break away and lodge in other tissues of the body. Depending on the type of tissue in which the clot gets lodged, it can cause medical emergencies, including PE.
In PE, a blockage occurs in the large blood vessels leading from the heart to the lungs. This makes it harder for the body to absorb oxygen. The effects of a Yaz pulmonary embolism vary depending on the severity of the blockage. It can cause symptoms ranging from lightheadedness to sudden cardiac death.
The lawsuit alleges that Yaz caused these complications, and that the manufacturers were aware — or reasonably should have been aware — of the serious risks associated with the drug. To support this assertion, the Yaz lawsuit cites peer-reviewed studies that suggest there is a link between drugs like Yaz and an increased risk of blood clot-related medical emergencies like DVT and PE. Additionally, the Yaz lawsuit cites post-market surveillance reports, including those collected by the U.S. Food & Drug Administration (FDA), as a means Bayer could have used to find evidence of these risks, including the fact that the FDA received 50 reports of death associated with Yaz from 2004 to 2008.
Additionally, the Yaz lawsuit alleges that not only were the manufacturers aware of these risks, but that they continued to heavily promote the drug and downplay the risks, preventing patients like Kern and health care professionals from having all of the information they needed to make informed medical decisions.
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