Mirena IUD May Be Defective and Dangerous
November 10, 2015 | Pharmaceutical Litigation
Bayer Healthcare Pharmaceuticals is defending a series of lawsuits across the United States regarding the birth control device known as Mirena. The intrauterine device (IUD) is a reversible method of birth control that is intended to prevent pregnancy for a period of time up to five years. It does this by emitting hormones after it is implanted in the uterus. Mirena has been used in Europe since 1991. It was approved in the United States by the Food and Drug Administration (FDA) in 2000. More than 45,000 negative events related to Mirena usage have been reported by the FDA. These events include vaginal hemorrhage, IUD dislocation, and device expulsion. The Mirena IUD has also been the cause of serious complications including pelvic inflammatory disease, perforation of the wall of the uterus, and ectopic pregnancy (a pregnancy that happens outside of the uterus), which can be a life-threatening condition.
Grounds for Filing Suit
Many of the lawsuits filed by women against Bayer have accused Bayer of the following:
- Deceptive marketing
- Producing and selling a defective IUD
- Failing to disclose the dangerous side effects of Mirena
Lawsuits also allege that the device’s label did not warn consumers and doctors of the serious side effects. The plaintiffs in these lawsuits claim that the labels described the serious complications as uncommon even after many women had suffered from the named complications. Plaintiffs claim that Bayer designed a defective device, misrepresented Mirena’s benefits, did not warn about the serious side-effects (including device migration), downplayed the side-effects as “uncommon,” deliberately hid the harmful side-effects, and failed to give adequate instructions and provide proper warnings about the use of the device.
In 2009, Bayer received a warning letter from the FDA that it was in violation of the Federal Food, Drug, and Cosmetic Act. The FDA warned that Bayer was making certain false claims regarding the device and implying that Mirena would lead to women looking good and feeling well despite evidence that women using the product experienced back and breast pain, weight gain, and acne. The FDA also warned Bayer for failing to include risk information regarding complications caused by the device.
Plaintiffs in the Litigation
If you have used a Mirena IUD, you may have suffered from side-effects or complications that were unexpected. You may have even lost wages, incurred medical expenses, or experienced general pain and suffering related to these unexpected side-effects. These claims may be related to surgery required to remove the device, vaginal bleeding or miscarriage after removal of the device, infertility after removal of the device, or distress caused by any of these side-effects or complications.
If you or a loved one have suffered an injury related to the use of the Mirena IUD, the advice of an experienced personal injury lawyer who specializes in pharmaceutical litigation is crucial in navigating the complex personal injury laws in each state. Consult with the attorneys at Napoli Shkolnik PLLC today and get more information on your rights and the compensation to which you may be entitled. It can be difficult to know where to begin and how to proceed in these situations. Statutes of limitations are very important and may differ in each case, so it is imperative to seek counsel today if you have suffered from an injury. Call (212) 397-1000 to schedule your free consultation today.
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