Ten plaintiffs who have filed suit against Bayer over its Mirena hormone-coated birth control device have asked the Judicial Panel on Multi-District Litigation (JPMDL) to set up a new MDL focusing on injuries caused by increased intracranial pressure.
In November, the JPMDL reopened MDL 2434 in the Southern District of New York for product liability claims involving migration of the IUD in the uterus. It does not include any claims that the synthetic levonorgestrel hormone coating causes intracranial pressure or hypertension.
The new MDL No. 2767 would consolidate 166 “substantially similar” cases in 17 jurisdictions. The plaintiffs requested that US District Chief Judge Louis Guirola, Jr., of the Southern District of Mississippi, Southern Division, supervise the new MDL. The defendants include Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma AG and Bayer Oy.
IH in the skull
Medical literature identifies the condition by various names, such as Intracranial Hypertension (“IH”), Pseudotumor Cerebri (“IH”), Benign Intracranial Hypertension (“BIH”), Secondary Intracranial Hypertension (“SIH”), Medication-Induced Intracranial Hypertension (“MIH”), or Idiopathic Intracranial Hypertension (“IIH”).
IH is a condition that develops in the skull when a person’s cerebrospinal fluid level becomes elevated, causing increased intracranial pressure. Fluid builds up in the skull and is not released and absorbed at the proper rate.
Symptoms of IH include severe headache, nausea, ringing in the ears, blurred or dimmed vision, double vision, and neck, shoulder or back pain. This condition can also cause swelling of the optic nerves, leading to temporary or permanent blindness.
The FDA approved Mirena in 2000 and more than 15 million women worldwide have used Mirena. However, the association between IH and levonorgestrel has been known since 1991, when Wyeth began selling Norplant, a birth control system that released the same hormone. Norplant’s drug label warned about IH and added, “NORPLANT SYSTEM should be removed from patients experiencing this disorder.”
The plaintiff’s motion says, “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.”
“However, the product label for the Mirena® LNG-IUS has never contained any warning relating to the risk of IH. To this day, Bayer does not warn patients or physicians of the association between the Mirena® LNG-IUS and IH, despite the fact that another of its levonorgestrel-releasing contraceptive implants, Jadelle®, contains such a warning.”
Plaintiff attorney Trevor B. Rockstad of Davis & Crump, P.C. in Gulfport, Mississippi, said he expects to file more than 100 lawsuits for individuals injured by Mirena and is aware of several hundred more unfiled cases.