A plaintiff who says she experienced intracranial Mirena IUD hypertension injuries filed a new lawsuit along with her spouse in federal court in New York.

Plaintiffs Kaitlin S. and her husband David S. are residents of Morrilton, Ark. Their Mirena IUD hypertension lawsuit joins Multidistrict Litigation (MDL) No. 2767, In re: Mirena IUD Levonorgestrel-related Products Liability Litigation, which is now in progress in federal court.

The defendants in this case are Bayer Healthcare Pharmaceuticals Inc., Bayer Pharma AG, and Bayer OY. These corporate entities developed, manufacture, promote, and distribute the Mirena Intrauterine Device (IUD) that contains the synthetic hormone levonorgestrel.

What is the History of the Mirena IUD?

The Mirena IUD is a contraceptive device designed to prevent pregnancy for up to five years from the date of insertion by releasing a daily 20 mg. dose of levonorgestrel.

The Mirena IUD new drug application (NDA) was approved by the U.S. Food and Drug Administration (FDA) in December 2009. Its ‘on-label’ use was specifically for contraception, but in 2009, according to the lawsuit’s documentation, it was additionally approved to help women troubled with excessive menstrual flow who also sought to prevent pregnancy.

It is used by two million women in the U.S. and 15 million women globally.

The Plaintiff’s Story

Plaintiff Kaitlin S. is 27 years old and was implanted with the Mirena IUD in August 2009. The procedure was done by Dr. Cole Andrew in Conway, Ark.

Kaitlin says the process was undertaken according to the defendants’ instructions and no immediate complications ensued. Moreover, Kaitlin was provided with a patient information booklet by her doctor.

However, Kaitlin says she began to experience unusual and painful headaches along with visual disturbances not long after having the Mirena IUD implanted.

In March 2010, the plaintiff visited an eye doctor at Baker Eye Institute in Conway for treatment of her visual symptoms which included seeing spots, unfocused vision with reduced acuity, and tunnel vision. She says she was diagnosed with intracranial hypertension.

Six months later, in September 2010, Kaitlin says she required a lumbar puncture to relieve some of the intracranial Mirena IUD hypertension issues allegedly caused by the overproduction of cerebral spinal fluid.

She claims it wasn’t until March 2013 that she was relieved of some of the Mirena IUD complications when the device spontaneously expelled itself from her uterus. She nevertheless claims permanent injury from the contraceptive method.

Kaitlin S. and her spouse David S. believe that the Mirena IUD is defective and dangerous. They bring the following actions against the defendants: 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 loss of consortium.

The couple are asking for an assessment of fair compensatory and punitive damages in light of evidence provided during a jury trial. They request consideration for all attorney and court fees as well as miscellaneous costs of litigation.

The Mirena IUD Hypertension Lawsuit is Case No. 1:18-cv-01810-UA, in the U.S. District Court for the Southern District of New York.