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Women filed lawsuits against Bayer after suffering complications from Mirena, which is an intrauterine device (IUD). The contraceptive may cause organ perforation and ectopic pregnancy.
An estimated 8.5 percent of American women using contraception use a long-term, reversible method such as an intrauterine device (IUD). An IUD is intended to prevent pregnancy for up to five years by emitting hormones after implantation and can be a more convenient option for women who find it difficult to take oral contraceptives on a daily basis.
One IUD, marketed under the name Mirena and manufactured by Bayer Pharmaceuticals, has come under scrutiny for its dangerous side effects and has led to many lawsuits claiming the product is "defective and unreasonably dangerous." Among the many claims of negligence, Bayer is accused of intentionally selling a dangerous product, deceptive advertising and concealing the risk of complications.
The Mirena IUD has been in use in Europe since 1991 and was approved by the Food and Drug Administration (FDA) in 2000. According to FDA reports, there have been more than 45,000 adverse events reported, including device expulsion, device dislocation and vaginal hemorrhage.
The Mirena device consists of a small, T-shaped container of flexible plastic that releases continuous doses of a hormone, levonorgesterel, commonly found in oral contraceptives. The hormone thickens the wall of mucous lining the uterus and decreases the motility and survival rates of sperm entering the uterus, thus reducing the chances of pregnancy. Though, even Bayer claims that they are unsure of how Mirena really works.
In some women, Mirena can cause serious complications, including life-threatening ectopic pregnancy – pregnancy that occurs outside the uterus -- perforation of the uterine wall, and a serious condition known as pelvic inflammatory disease (PID). Women who have suffered after using Mirena are pursuing legal action against Bayer Pharmaceuticals, claiming the device is defective and seeking compensation for medical expenses, lost wages, and pain and suffering.
Lawsuits have been filed in New Jersey, and Bayer petitioned the state's Supreme Court to have the cases consolidated there. That request was denied in January 2013. Dozens of federal lawsuits filed against Bayer alleging that Mirena can perforate the uterus and migrate in the body were consolidated in multidistrict litigation in the Southern District of New York (In Re: Mirena IUD Products Liability Litigation, MDL Docket No. 2434, JPMDL). The judge assigned to the cases is U.S. Judge Cathy Seibel. The number of cases is approaching 500.
Lawsuits already filed accuse Bayer of misleading marketing, producing a defective product and failing to reveal the dangerous side effects of the device, such as spontaneous migration of the device and perforation of the uterus. Specifically, Mirena's label failed to warn doctors and consumers about these serious complications and described them as uncommon when a number of women have suffered from these adverse events. Plaintiffs who already filed lawsuits are also suing for punitive damages, claiming Bayer knowingly and willfully harmed them.
|Complaints allege that Bayer:|
|Misrepresented the benefits of Mirena.|
|Failed to warn about dangerous side effects, including spontaneous migration of the device.|
|Understated the product's complications as "uncommon."|
|Engaged in deceptive marketing.|
|Breached implied and express warranty.|
|Concealed the harmful side effects of Mirena.|
|Failed to provide adequate warnings and instructions.|
|Produced and knowingly sold and distributed a defective product.|
|Designed a defective product.|
Women who have experienced complications such as device migration or uterine perforations may consider filing a claim to receive compensation for medical expenses, as well as pain and suffering. An experienced Mirena attorney can provide advice on how to build a case, how to manage the process and what to expect from a claim.
A 24-year-old plaintiff filed a suit against Bayer for permanent physical injuries suffered as a result of the Mirena IUD. The plaintiff underwent surgery to remove the Mirena, but the device was no longer in her uterus. The device had migrated to her abdomen, and a separate surgery was required to remove it. She suffered painful side effects and incurred additional medical expenses because of the defective device. According to the complaint, the label on the product fails to warn that Mirena can spontaneously migrate in the body and falsely markets the device's benefits.
Desaree Nicole Lee Johnson filed a suit against Bayer after she suffered from a perforation of the uterus when the Mirena IUD moved from her uterus to the abdomen near the liver. She underwent surgery to remove it and shortly after she became pregnant. However, she subsequently sought treatment in the emergency room because of vaginal bleeding and a miscarriage. The plaintiff is distressed because she may now be infertile as a result of Mirena. In her complaint, Johnson accuses Bayer of knowingly releasing a defective and unsafe product.
In another suit filed in California by Melody and Ronail Williams, the plaintiffs allege that Bayer is guilty of several actions, including negligent misrepresentation, fraud and failure to warn consumers of dangerous side effects. Melody Williams suffered from abdominal cramping and pain less than a year after being implanted with Mirena. The first attempt to remove the IUD was unsuccessful, and when a second surgery was attempted, doctors found that the device had "migrated though the opening of the plaintiff's right fallopian tube." As a result of Mirena, Melody Williams suffered from pain, infection and had to undergo numerous procedures. She accuses Bayer of negligence and "wanton and reckless disregard for the public safety."
It can be difficult to prove a drug company produced a drug that is capable of injuring people.
Large companies like Bayer usually defend themselves by pointing to long lists of side effects and showing that they warned the public in advance. In the case of Mirena, having an experienced, qualified lawyer on your side can help you prove that you were not properly informed about device migration, organ perforation or other side effects that you endured.
Knowledgeable lawyers can also help explain each step of the legal process to you. They understand how drug companies work and can develop the best strategy for your circumstances and increase your chances of getting the compensation you deserve for injuries you suffered.
You should make sure you understand your legal options and rights. Drugwatch can help you understand how the complicated legal process works, so you can decide what options may be best for you.
Our Patient Advocates help people just like you every day who are dealing with dangerous drugs and medical devices. They are available seven days a week to speak with you one-on-one.
Mirena is at least 99 percent successful at preventing pregnancy, but it does not protect the user from sexually transmitted diseases (STDs). Despite some of the benefits of Mirena, there are also serious side effects that can occur in women who use it.
One of the biggest problems with Mirena is its tendency to move from the uterus, through the wall and into other parts of the body – usually the abdomen – and cause damage. Patients have reported incidences of perforation or penetration of the uterine wall after the implantation of Mirena. If the device penetrates the uterus, it can migrate into the intestinal cavity and cause further damage to internal organs, including abscesses, peritonitis, and obstructions or perforations of the intestines.
In studies, the IUD has been shown to migrate to the pelvis, and adhere to the internal layer of the uterine wall and even ovarian walls. What makes this dangerous is that the device is difficult to find and remove. Some women have had to undergo multiple surgeries to find and remove the device. Studies also found that the risk of uterine perforation is increased in women who use an IUD like Mirena up to 6 months after delivering a child.
Bayer has also had problems with the FDA regarding Mirena. In reviewing the manufacturer's script for advertising for the product, the FDA warned Bayer in a Dec. 30, 2009, letter that the company was in violation of the Federal Food, Drug, and Cosmetic Act. The agency further stated that the advertising included false or misleading presentations and misbranded the drug.
According to the FDA, Bayer made false claims that the use of Mirena will result in "increased levels of intimacy, romance and by implication emotional satisfaction" when there is no evidence for this claim. In addition, Bayer falsely insinuated that women who use Mirena will "look and feel great," even though women using the product may experience weight gain, back pain, breast pain and acne. The advertising also omits important instructions with regard to the use of the device. Bayer has also been warned for omitting risk information for complications.