On Thursday, December 29th, a petition was filed requesting that the Judicial Panel on Multidistrict Litigation (JPML) create a single docket for more than 100 lawsuits against the contraceptive device Mirena—all claiming that use of the product has resulted in their development of pseudotumor cerebri (PTC) and that the drug manufacturer failed to warn doctors and consumers.
First approved by the FDA in 2000, the hormone-releasing intrauterine device (IUD) was touted by Bayer Healthcare Pharmaceuticals as the first of a “second generation” of IUDs—and Mirena sales skyrocketed accordingly. Soon after, serious issues started to emerge as users complained of pain-related side effects and other complications. By 2008, the FDA had received over 70,000 complaints from consumers—prompting the government agency to reevaluate their box label and add warnings of perforation, sepsis, ectopic pregnancy, ovarian cysts, and breast cancer.
The FDA’s intervention did not end there, though. In 2009, they issued a letter of warning to Bayer claiming that their current advertising for the IUD overstated the positives of the device while understating the negatives to the point that it was misleading to consumers. Specifically, the FDA requested that Bayer immediately take down several websites that failed to communicate any of the risks associated with IUDs while exaggerating the efficacy of the Mirena device.
Now the stakes have been raised as more and more women are stepping forward and claiming far more serious problems allegedly caused by the implanted device—yet, the FDA has failed to act in light of these more recent developments. New cases being filed against the pharmaceutical maker now claim that the Mirena device and the synthetic hormones it releases have caused a dangerous accumulation of cerebrospinal fluid and accompanying pressure in the skull. The syndrome is called pseudotumor cerebri, or PTC, and it can cause permanent damage to optic nerves and the brain. Sufferers often report migraines and issues with or loss of vision.
While several studies conducted during the past 20 years have shown a link between PTC and synthetic hormones, the FDA has yet to acknowledge such evidence with a revised box warning. Ironically, one study in 2015 attempted to quantify the risk of PTC while using the Mirena device by utilizing data from the FDA’s own Adverse Events Reporting System. The findings showed a higher than expected number of reports of PTC for those who had Mirena implanted.
In 2014, lawyers asked that a panel of federal judges centralize nine lawsuits pertaining to the possible link between Mirena and PTC. The multidistrict litigation was denied at the time, yet cases have continued to build. As mentioned earlier, a recent petition has requested that all pending and future Mirena cases be transferred to a federal judge in Mississippi based on the prevalence of PTC injuries as well as the promise that hundreds more cases are forthcoming.
As we wait to see how issues with Mirena might be handled by the FDA and the federal courts, it’s important for those who either now or in the past have had Mirena implanted in their uterus to be aware of all risks. If you’re concerned about PTC, you should be sure to watch for signs and contact your doctor immediately if you experience any of the following:
- Frequent headaches or migraines
- Pain that worsens with eye movement
- Blurry or loss of vision
- Ringing in the ears
- Nausea and vomiting
Derek T. Braslow is a partner of Pogust Braslow & Millrood, LLC. He is one of the first attorneys to file suit on behalf of families who lost a child, spouse or parent to suicide as a result of psychotropic medication and one of the first to file a suit against investigators, sponsors and institutional review boards for conducting unethical human clinical trials. Derek was voted by his colleagues as a Rising Star and SuperLawyer in the area of Pharmaceutical and Mass Tort litigation.