A woman files a pseudotumor cerebri lawsuit against the manufacturers of Mirena PTC, Bayer Healthcare Pharmaceuticals, Inc. in New York federal court.

Plaintiff Nija J. filed the pseudotumor cerebri lawsuit on March 5, 2018, joining a growing multidistrict litigation (MDL) against the company.

According to the pseudotumor cerebri lawsuit, Njia is a citizen and resident of Burlington, N.C. She says that she became implanted with the Mirena IUS in February 2013. Nija claims that she relied on the manufacturer’s claims that the device was safe and effective for use.

On Feb. 4, 2015, she says that she underwent an MRI and MRV imaging procedure to check for intracranial abnormalities at UNC Medical Center in Chapel Hill, N.C. No confirmed diagnosis was made until she sought treatment for chronic headaches on March 6, 2015. It was then that she was diagnosed with pseudotumor cerebri by the physician at UNC Medical, she says.

The pseudotumor cerebri lawsuit was filed on multiple counts including negligence, design defect, failure to warn, strict liability, breach of implied warranty, breach of express warranty, negligent misrepresentation, fraudulent misrepresentation, fraud by suppression and concealment, and a request of punitive damages.

Nija requests a trial by jury.

Overview: Pseudotumor Cerebri Lawsuit

The Mirena IUD device is an intrauterine system with a t-shaped polyethylene frame. The device acts as a contraceptive device when it becomes inserted into a woman’s uterus. Once in place, the device can prevent pregnancy for up to five years. The intrauterine device releases a synthetic progestogen, also termed levonorgestrel into the woman’s uterus to prevent pregnancy.

The Mirena IUD was approved by the U.S. Food and Drug Administration (FDA) in December 2000. It provided women an alternative contraceptive method for the prevention of pregnancy.

However, Bayer Healthcare is facing a multitude of allegations against them. Some of the allegations accuse them of falsely advertising and representing the safety and efficacy of the Mirena IUD, and for leaving out the side effects and complications that are associated with the device. One of these side effects includes the development of pseudotumor cerebri.

According to the Mayo Clinic, pseudotumor cerebri is a condition that results when there is too much pressure, also known as intracranial pressure, inside the skull. Symptoms are very similar to that of a brain tumor. But with pseudotumor cerebri no tumor is present. What causes the increased pressure in the brain is the buildup of cerebrospinal fluid within the skull. With increased pressure, side effects can include partial vision loss and total blindness.

According to the Mayo Clinic, there are several symptoms of pseudotumor cerebri which include:

• Moderate to severe headaches
• Back, neck, and shoulder pain
• Vomiting, dizziness, or nausea
• Blurred or dimmed vision
• Double vision
• Difficulty seeing to the side
• Ringing in the ears that “pulses in time with your heartbeat”

The Pseudotumor Cerebri Lawsuit is Case No. 1:18-cv-01960-UA, in the U.S. District Court for the Southern District of New York. The Mirena Lawsuit is MDL No. 2767, in re: Mirena IUS Levonorgestrel-Related Products Liability Litigation (NO. II), in the U.S. District Court for the Southern District of New York.