Mylan Pharmaceuticals, Mylan Technologies, Inc. and Walgreen Co. have been targeted in a lawsuit alleging that their transdermal birth control patch causes an increased risk of blood clots. The plaintiff, Erica Martinez, claims that she was prescribed Xulane, a birth control patch manufactured and distributed by the pharma companies. She later suffered a serious blood clot in her brain, which she alleges was caused by her use of the patch.

Xulane is a transdermal birth control patch that utilizes two hormones, a progestin (norelgestromin) and an estrogen (ethinyl estradiol). According to the complaint, the Xulane manufacturers deliberately ignored the risks presented by their products, including the fact that a related product was pulled from the shelves due to an increased risk of blood clots caused by the drug.

As explained by the plaintiff, Xulane was granted fast-tracked FDA approval based on prior FDA approval of a similar drug known as Ortho Evra. Following Ortho Evra’s original FDA approval in 2011, its label was changed several times to address the increased risk of blood clots associated with the use of the product. In October 2019, the manufacturer of Ortho Evra discontinued the product entirely, and the FDA approved a withdrawal of the drug’s approval.

According to the complaint, after Xulane was approved by the FDA in April 2014, the defendant pharma companies learned that norelgestromin and ethinyl estradiol transdermal patches were associated with a significantly increased risk of fatal and non-fatal venous thromboembolism (VTE) and arterial thromboembolism (blood clots in the veins and arteries). The FDA ordered the Xulane manufacturers to conduct post-marketing studies and clinical trials specifically to detect an increased risk of blood clots by users of the transdermal birth control patches.

The plaintiff alleges that she was prescribed Xulane in 2017 without any warning concerning her increased individual risk of developing blood clots. It wasn’t until April 2020, after the plaintiff had already suffered a venous thromboembolism, that the defendants changed the packaging, warning and prescribing information to reflect a warning about blood clots. Specifically, the updated warnings indicated that women with a Body Mass Index (BMI) of 30 kg/m² or more should not use Xulane due to an increased risk of developing blood clots. (Ms. Martinez’s BMI was 29.9 kg/m² at the time she was prescribed Xulane and was 28.32 kg/m² at the time she suffered her brain blood clot.)

The plaintiff claims that the product was defective as sold and defectively marketed due to the failure to warn her and other patients of the increased blood clot risk. She alleges that the pharma companies knew or should have known about the increased risk by the time she was prescribed the product, but neither the company, the marketing, the packaging, nor her prescribing doctor warned her about the blood clot risks. As alleged, she faces a lifetime of pain, suffering, and loss of life enjoyment, not to mention significant medical bills as a result of her injuries.