A petition was filed last month urging the Judicial Panel on Multidistrict Litigation to create a centralized docket for 116 lawsuits from women who allege that they developed intracranial hypertension or pseudotumor cerebri (PTC) after using Bayer’s Mirena contraceptive device.


The plaintiffs who filed the Dec. 29 request are seeking a transfer of all pending and future cases against Bayer for similar injuries to a federal judge in the Southern District Court of Mississippi, which is a convenient and efficient venue, according to the petition.


When the contraceptive device was first approved by the U.S. Food and Drug Administration (FDA) in December 2000, it was billed as an easy, low-dose hormone option for women in need of reliable contraception. At the time, it had already been available for 10 years in Europe, but its arrival in the United States led to an explosion in popularity. An estimated 15 million women around the world have now used Mirena.


The controversial hormone-releasing intrauterine device has been the subject of hundreds of lawsuits from women over the years who say that Mirena has caused a variety of issues, including perforation and ovarian cysts.


Plaintiffs in 116 pending cases across 17 different jurisdictions all make a “substantially similar” claim that Mirena caused the development of PTC, which is sometimes known as intracranial hypertension (IH). This is a condition that develops when the pressure of cerebrospinal fluid within the skull becomes too high.


“Symptoms of IH include severe headache, nausea, ringing in the ears, blurred or dimmed vision, double vision, and neck, shoulder or back pain,” said the plaintiffs in the petition. “This condition can also cause swelling of the optic nerves, leading to temporary or permanent blindness. There is currently no treatment to reverse permanent injury to the optic nerves caused by increased intracranial pressure.”


The women say the potent synthetic progestogen called levonorgestrel that’s released directly into the uterus by Mirena is the reason why they developed IH. Bayer has ignored important information regarding the risks of levonorgestrel usage and negligently marketed the device to consumers and physicians, according to the petition.


Similar Devices to Mirena Carry IH Warnings


Levonorgestrel’s connection with intracranial hypertension is not a new phenomenon. In fact, the pharmaceutical industry has known about the link since at least the early 1990s when the FDA approved a similar levonorgestrel-releasing contraceptive device called Norplant in 1990.


Three years later, the manufacturer of the drug — before it was bought by Bayer — added a precaution to the physician labeling that users of Norplant have developed intracranial hypertension.


“In light of the pharmaceutical industry’s experience with the Norplant System, as well as Bayer’s specific involvement as the manufacturer of the Norplant System, Bayer knew or should have known of the association between levonorgestrel and IH at the time it put Mirena on the market,” plaintiffs said in the petition. “However, the product label for the Mirena LNG-IUS has never contained any warning relating to the risk of IH.”


Bayer also makes an updated version of the Norplant contraceptive called Jadelle. The new contraception, which is also a levonorgestrel-releasing implant, carries a warning that its users have reported cases of IH.


A June 2015 report on an epidemiological study supports the claim that exposure to Mirena was associated with intracranial hypertension. According to the study, women using the devices were nearly eight times more likely to develop IH.


Hundreds More Mirena IH Cases Expected


With millions of women having used Mirena over the past 16 years and the significant increase in the risk of IH in the study, plaintiffs anticipate significantly more cases to be filed in the coming months.
According to the petition, the Davis & Crump law firm expects to file more than a hundred additional lawsuits on behalf of individuals injured by Mirena and is aware of several hundred more cases that have yet to be filed.