Dozens of women say that Bayer’s popular intrauterine device Mirena, marketed as safe contraception, led them to develop pseudotumor cerebri. More than 100 lawsuits have already been filed over the condition, which can lead to permanent vision loss if left untreated or misdiagnosed. Were you or a loved one injured? An experienced medical device attorney can help.
Dozens of women have filed lawsuits against Bayer, claiming that a hormone (levonorgestrel) in the company’s popular intrauterine device Mirena causes pseudotumor cerebri, a rare brain disorder that can lead to permanent vision loss. Contact our cancer misdiagnosis lawyers to learn more about filing a Mirena IUD lawsuit.
Were you or a loved one diagnosed with pseudotumor cerebri (intracranial hypertension) after receiving the Mirena IUD? Our experienced Mirena lawyers can help.
With more than four decades of trusted legal experience, our attorneys have guided hundreds of injured patients through complex, and often frustrating, legal terrain, providing compassionate representation with major results. We’ve secured millions in compensation for clients who were harmed by medical devices, allowing them to face the future with confidence.
Considerable financial compensation may be available. In pending Mirena lawsuits, women who developed pseudotumor cerebri, or intracranial hypertension as the condition is sometimes known, describe the devastating effects that this disorder has had on their lives. Many plaintiffs face hundreds of thousands of dollars in medical bills, but have been left unable to work as a result of severe chronic headaches and progressive vision problems.
More than 100 women who say they were diagnosed with pseudotumor cerebri have already filed Mirena lawsuits in federal courts across the country.
Recent developments suggest that the litigation could be moving quickly. On December 29, 2016, ten plaintiffs asked a panel of federal judges to transfer their lawsuits, along with 101 other cases, to the US District Court for the Southern District of Mississippi. An official decision has not yet been handed down, but if granted, the petition would create a Multi-District Litigation (MDL) for pseudotumor lawsuits, allowing plaintiffs’ attorneys to pool their intellectual resources. The creation of an MDL could speed up the pace of important pre-trial proceedings in considerable ways.
Over and above these potential developments, the time for filing new Mirena lawsuits may be limited. Every state has established a law, known as the statute of limitations, to restrict the amount of time injured patients have to file suit. Most states allow up to two years, beginning on the date that a plaintiff discovers their injuries, in cases that involve dangerous medical devices. But significant variations can apply and injured Mirena patients are urged to contact a local medical device attorney.
Mirena received approval from the US Food & Drug Administration as a contraceptive in 2000. Nine years later, the implant’s approval was extended to include cases of abnormally-heavy menstrual bleeding in women who have already chosen an intrauterine device as their primary method of contraception. By 2013, more than 2 million women had chosen to use Mirena.
Potential problems, however, had begun to surface. As an investigation by Detroit ABC affiliate WXYZ News discovered, the FDA received over 70,000 side effect reports between 2000 and 2013, linking Mirena to serious medical complications. While some of these reported risks were minor, many were not, the investigators say. In the five years between 2008 and 2013:
After beginning to suffer from debilitating symptoms, many women underwent surgical procedures to have the device removed. In fact, the first Mirena lawsuit ever filed came from a patient who was forced to undergo hysterectomy after the IUD perforated her uterus. That claim, logged in 2011, was soon filed by hundreds of other lawsuits, which accused Bayer of hiding risks from device migration to pseudotumor cerebri. Invariably, patients describe mounting medical expenses and life-altering consequences.
No. The Mirena intrauterine device has not been made subject to a recall and the device remains on the market. Bayer continues to claim that Mirena is both safe and effective as a long-term contraceptive, despite thousands of lawsuits that make allegations to the contrary.
While the US Food & Drug Administration has not yet advised physicians to stop using Mirena, the federal agency has warned healthcare professionals of severe significant risks and complications over the years.
In 2008, FDA regulators strengthened the device’s labeling on ectopic pregnancy, which can occur in up to 50% of pregnancies that occur while Mirena is implanted. In clinical trials, around 1 in every 1,000 patients with Mirena experienced an ectopic pregnancy, in which a fertilized egg implants somewhere other than inside the uterus. In severe cases, an ectopic pregnancy can lead to fallopian tube rupture, WebMD reports, but even minor cases will require at least pharmaceutical treatment, if not surgical intervention.
The FDA has not addressed the potential link between Mirena, the synthetic hormone levonorgestrel and cases of pseudotumor cerebri.
While Mirena pseudotumor cerebri lawsuits are big news, this isn’t the first time that Bayer has been hit with lawsuits over its popular hormonal intrauterine device.
New Jersey’s Supreme Court agreed to consolidate over 60 lawsuits in May of 2013, sending the cases to a central state court in Bergen County as part of a multi-county litigation.
The claims accuse Bayer of selling Mirena in an “unsafe, defective and inherently dangerous” condition, according to Law360. In their complaints, dozens of women say that the company swept serious side effects under the rug, including a potential for device migration, in which the Mirena IUD perforates the uterus and travels outside of the abdomen, threatening internal organs. Today, thousands of other patients have joined the mass tort, filing their own lawsuits for alleged perforation and migration injuries in New Jersey state court.
In 2016, Bayer won a substantial court victory when a New York federal judge decided to dismiss more than 1,200 Mirena lawsuits, which claimed the IUD could perforate the uterus after insertion. While the device’s warning label warns that uterine perforation is possible “during insertion” procedures, neither patient nor prescriber information said anything about post-insertion risks between 2008 and 2014, Law360 reports.
Thousands of women blamed the IUD for post-insertion injuries, along with resulting infections, in product liability lawsuits that were consolidated in the US District Court for the Southern District of New York. These claims were dealt a significant blow in March of 2016, when District Judge Cathy Seibel prohibited the plaintiffs from introducing expert testimony on the potential risk. Five months later, Judge Seibel concluded that, without expert testimony, the cases would not be able to proceed. “The court reaches this conclusion reluctantly, knowing that it will doom hundreds of cases,” Judge Seibel wrote in her opinion, “but in the court’s view it is compelled by law.”
While Judge Seibel’s decision was a major win for Bayer, it will have no effect on Mirena lawsuits that involve pseudotumor cerebri. Thousands of patients who were diagnosed with intracranial hypertension after receiving Mirena may be eligible to pursue justice. However, the time for doing so may be short. To learn more about your legal options, contact our experienced product liability attorneys today for a free consultation.