Bayer is one of the largest pharmaceutical and medical device manufacturers in the world today. Recently, a group of over 30 women filed a lawsuit against the company alleging that its Essure permanent birth control device resulted in serious and painful health problems. Common symptoms that the plaintiffs reported suffering from included menstrual bleeding, migraines, abdominal cramping, and abnormal bleeding. The complaint was filed on March 17 in St. Louis, Missouri.
The Essure birth control device consists of a metal coil inserted in the fallopian tubes using a catheter. Last year, the U.S. Food and Drug Administration reported that during the 13 years following approval of the device, it received thousands of complaints regarding physical complications that resulted after implantation. During the time between July 2015 and October 2015, the FDA received over 2,800 complaints alone.
In Fall 2015, the FDA’s Obstetrics and Gynecology Devices Panel convened to review clinical and scientific opinions regarding the safety of Essure in addition to receiving comments from patients who received the device. The FDA cataloged a number of other physical symptoms associated with Essure, including perforation of the fallopian tubes and/or uterus, intra-abdominal or pelvic migrations of the device, and hypersensitivity reactions. The agency has announced that it is mandating a new clinical study for the device as well as its intent to develop new guidance on how the Essure device should be used.
The plaintiffs’ lawsuit alleges that Bayer and the company who originally created Essure, Conceptus, was aware that the device posed serious physical risks to women and intentionally concealed evidence about the adverse effects in order to maintain sales of the product.
In general, to recover compensation from a medical device manufacturer, a plaintiff must demonstrate that the device is designed in an unreasonably unsafe manner and/or fails to include sufficient warnings and instructions regarding how the device should be used. A plaintiff can also recover damages on a product liability basis by showing that the specific unit of product that the plaintiff received suffered from a defect in the manufacturing process that rendered the product unreasonably dangerous. The plaintiff must also show that the dangerous nature of the device was the direct cause of his or her injuries while providing evidence supporting the amount of damages that he or she is seeking in the litigation.
If you or someone you love has suffered injuries as the result of a dangerous medical device, you may be entitled to compensation. At Moll Law Group, we have advised countless injury victims throughout the United States, including individuals in New York, California, and Texas, as well as our headquarters in Chicago. We offer a free consultation to help you learn about the rights and options available to you and do not collect any fees unless we obtain a settlement or judgment in your favor. Call us now at 312-462-1700 or contact us online to schedule your appointment today.