Mirena IUD Lawsuit Plaintiff Suffered from Headaches, Vision Problems. A new lawsuit has been filed against Bayer over the Mirena intrauterine device (IUD). The plaintiff is a Maryland woman who alleges that the birth control device caused pseudotumor cerebri, a condition that mimics the symptoms of a brain tumor when no tumor is present. According to the complaint, she was implanted with the Mirena IUD contraceptive in June 2005. In April 2009, she went to the doctor complaining of pressure headaches and vision problems.
The drug and medical device attorneys at Parker Waichman LLP have decades of experience representing clients in personal injury and product liability lawsuits. Additionally, the firm holds leadership roles in the Mirena IUD litigations. The firm continues to offer free legal consultations to individuals with questions about filing a Mirena IUD lawsuit.
According to court records, doctors diagnosed her with papillary edema, or optic nerve swelling. The plaintiff underwent brain imaging and a lumbar puncture, after which time she was diagnosed with pseudotumor cerebri, also known as idiopathic intracranial hypertension. Patients with pseudotumor cerebri suffer from increased pressure inside the skull. For example, an excess amount of cerebral spinal fluid (the fluid cushioning the brain and spinal cord) can cause pseudotumor cerebri. Symptoms may include vision problems (such as double vision, blurred vision, temporary blindness), nausea, vomiting and headaches.
The plaintiff alleges that Bayer knew Mirena IUD could increase the risk of pseudotumor cerebri but failed to warn patients and their doctors about the risk. In particular, the lawsuit says the labeling on Mirena fails to disclose information about pseudotumor cerebri or idiopathic intracranial hypertension.
Other Mirena IUD lawsuits have also been filed alleging pseudotumor cerebri. One Mirena IUD lawsuit was filed on behalf of a North Carolina woman who was implanted with the Mirena IUD in February 2007. According to her lawsuit, she did not suffer from any Mirena IUD complications during her first year. Starting in February 2008, she began to experience migraines, blurred vision and eye and neck pain. In January 2009, she was diagnosed with bilateral papillary edema. The Mirena IUD was removed in April 2009, without complications. The plaintiff underwent an MRI and lumbar puncture, according to the lawsuit. She was diagnosed with pseudotumor cerebri in January 2010. She alleges that Mirena IUD caused these complications and that Bayer failed to warn her or her physician about the risks.
Study Links Mirena IUD to Intracranial Hypertension
In 2015, the journal Therapeutic Advances in Drug Safety published a study analyzing the risk of intracranial hypertension with the Mirena IUD. To evaluate whether patients with Mirena had higher rates of intracranial hypertension, researchers gathered data using two separate databases. Authors used the U.S. Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) to study the association between Mirena IUD and intracranial hypertension. Another database was used to compare the risk of two oral contraceptives ethinyl estradiol (EE) with Mirena.
The study found that patients taking Mirena IUD had higher rates of intracranial hypertension than expected. “We found a higher than expected number of reports of ICH with Mirena® in the FAERS database. We also found a similar risk of ICH with Mirena® compared with the oral contraceptive EE-norgestimate. The higher risk of ICH with EE-norethindrone, another oral contraceptive should be further investigated.” authors concluded.
In a 1995 letter to the New England Journal of Medicine, physicians from the Oregon Health Services University in Portland, Oregon and the World Health Organization in Uppsala, Sweden noted cases of intracranial hypertension among women implanted with levonorgestrel (the same hormone released by Mirena). A review of data from three separate databases identified 56 cases of intracranial hypertension or disk edema associated with levonorgestrel. “Most cases were reported by physicians who believed the events may have been drug-related.” the doctors noted. The authors did not determine causality.
According to Mayo Clinic, symptoms of pseudotumor cerebri may include:
- Headaches that may originate behind the eyes and get worse with eye movement
- Ringing in the ears that pulses in time with your heartbeat (pulsatile tinnitus)
- Nausea, vomiting, dizziness
- Brief moments of blindness, lasting only a few seconds and affecting one or both eyes
- Difficulty seeing to the side
- Double vision (diplopia)
- Seeing light flashes (photopsia)
- Pain the neck, shoulder or back
Patients may suffer from pseudotumor cerebri when there is an excess amount of cerebrospinal fluid. This condition can worsen vision and cause blindness.
Mirena IUD Lawsuit Background
The FDA approved Mirena in 2000 as a long-term form of birth control. The device, an IUD, is a t-shaped contraceptive attached to two strings. Mirena IUD is placed inside the uterus by a healthcare professional. It releases the hormone levonorgestrel for up to five years to prevent pregnancy.
Mirena IUD lawsuits have been filed alleging various complications, in addition to pseudotumor cerebri. In fact, a multicounty litigation is underway in Bergen County, New Jersey. Additionally, a multidistrict litigation (MDL) has been established for Mirena IUD lawsuits in New York. Parker Waichman has served a leadership role in both litigations. Raymond C. Silverman, partner at Parker Waichman, has been appointed Co-Lead Counsel in the multicounty litigation centralized in Bergen and Matthew J. McCauley, Senior Litigation Counsel at Parker Waichman, has been appointed Co-Lead Counsel in the MDL. The firm continues to offer free legal consultations to individuals with questions about filing a Mirena IUD lawsuit.
According to the FDA, the most serious complications reported with the Mirena IUD include perforation of the uterine wall, embedment of the device in the uterine wall, intrauterine pregnancy, ectopic pregnancy, group A streptococcal sepsis and pelvic inflammatory disease (PID).
Some lawsuits filed over the Mirena IUD allege that the device caused injury when it migrated from its original position and perforated the uterine wall. Plaintiffs typically allege that they had to undergo laparoscopic surgery remove the IUD. Bayer allegedly knew about the risks but failed to warn patients or their physicians.