Last Friday, a case was removed from the Circuit Court of Cook County, Illinois to the Illinois Northern District of Illinois. The case was filed against Mylan Pharmaceuticals, Mylan Technologies, Inc. and Walgreen Co. The case is regarding product liability involved with a birth control patch.
Xulane, the complaint said, is a transdermal birth control patch that contains two hormones, norelgestromin and ethinyl estradiol, which work “by preventing ovulation during a woman’s menstrual cycle. It also makes vaginal fluid thicker in order to help prevent a sperm from reaching an egg (fertilization) and changes the lining of the uterus to prevent the attachment of a fertilized egg.” The original application to the FDA for approval of Xulane was made under the auspices of its related sister product Ortho Evra, which later required a warning regarding the possibility of venous thromboembolism, leading to the manufacturer stopped making the product.
Prior to the patient taking Xulane, a study was requested of Mylan regarding the possibility of thromboembolism in patients taking Xulane. This study was reported by reports of adverse effects. The patient was prescribed Xulane, but no mention was made of the possibility of thromboembolism. The patient suffered from a thromboembolism during the time period of the requested study while the manufacturer was aware of possible bad events, but had not yet been required to post a warning by the FDA.