U.S. District Judge Paul Engelmayer excluded statements given by plaintiffs' seven expert witnesses in a Mirena contraceptive lawsuit as the judge found the witnesses unqualified to opine on Mirena's role in causing intracranial hypertension or the opinions provided were unreliable.
Ever since its introduction in 2000, the U.S. FDA has received about 70,000 injury reports filed by individuals who used the Mirena contraceptive device. Bayer failed to adequately warn the public that the device must be used only up to five years after its placement and must be replaced after that. Thousands of women sued Bayer Healthcare for concealing its health risks; the allegations include a range of different side-effects, including Pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension (ITC), which causes a buildup of cerebrospinal fluid in the brain. This can lead to problems of vision changes, dizziness, nausea, memory problems, and Tinnitus (ringing in the ears).
There are three sets of multidistrict litigation covering side-effects of Mirena IUDs: MDL No. 2434 (In Re: Mirena IUD Products Liability Litigation (uterine perforation and migration) assigned to U.S. District Judge Cathy Seibel/and Judge Brian R. Martinotti of the Bergen County Superior Court; MDL No. 2767 (In Re:Mirena IUD Levonorgestrel-Related Products Liability Litigation (NO. II) ) in United States District Courts, and NJ MCL No. 297 in New Jersey State Courts. As of September 2018, there were 660 cases in the MDL No. 2767.
