Mirena IUD Plaintiffs Seek a New MDLJan 26, 2017
The Bayer company is facing lawsuits concerning injuries allegedly caused by increased intracranial pressure in relation to the Mirena IUD (intrauterine device). Ten plaintiffs have asked the Judicial Panel on Multi-District Litigation (JPMDL) to set up a new MDL focusing on those injuries. An MDL is when lawsuits are consolidated when a number of cases have common allegations. MDLs make complex litigation more efficient as similar lawsuits are brought together in one court before one judge. This helps eliminate duplicate discovery and conserves resources.
New MDL Requested
In November 2016, the JPMDL reopened the MDL in the Southern District of New York citing product liability claims concerning migration of the IUD in the uterus. The claims did not include any allegations that the synthetic levonorgestrel hormone coating triggers intracranial pressure, or hypertension. Levonorgestrel is a progestin that may prevent pregnancy by inhibiting ovulation, altering transport of sperm or eggs to prevent fertilization, or altering the lining of the uterus to prevent implantation if fertilization should occur.
The new MDL would centralize "substantially similar" cases in 17 jurisdictions. The plaintiffs asked that U.S. District Chief Judge Louis Guirola, Jr., of the Southern District of Mississippi, Southern Division, oversee the new MDL. The companies that are cited include Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma AG, and Bayer Oy.
Personal injury attorneys at Parker Waichman LLP are actively reviewing potential lawsuits on behalf of individuals who have suffered injury from alleged defective medical devices, including intrauterine devices.
Intracranial Pressure in the Brain
Intracranial pressure is known by various names including: intracranial hypertension (IH), pseudotumor cerebri (IH), benign intracranial hypertension (BIH), secondary intracranial hypertension (SIH), medication-induced intracranial hypertension (MIH), or idiopathic intracranial hypertension (IIH).
Symptoms of pseudotumor cerebri mimic those of a brain tumor, but no tumor is present. Pseudotumor cerebri may occur in children and adults, but is most frequently observed in obese women of childbearing age.
IH may develop in the skull when the cerebrospinal fluid level becomes elevated, which may lead to a condition causing increased intracranial pressure. Fluid develops in the skull and is not released or absorbed at the correct rate.
IH symptoms include severe migraine or migraine-like headaches, nausea, blurred or dimmed vision, double vision, ringing in the ears (tinnitus), and neck, shoulder or back pain. The condition may also create swelling of the optic nerves, which may lead to temporary or permanent blindness.
Complications Regarding the Mirena IUD
The Mirena IUD was approved by the U.S. Food and Drug Administration (FDA) in the year 2000. Over 15 million women worldwide have opted for the Mirena long-term birth control method. The connection between IH and levonorgestrel has been known since 1991, when Wyeth-Aherst (original manufacturer of Norplant birth control system) started to sell Norplant, a birth control system that also released the levonorgestrel synthetic hormone. The drug label Norplant provided, warned about IH and added, "NORPLANT SYSTEM should be removed from patients experiencing this disorder."
Bayer maintains that the Mirena IUD is 99 percent effective in preventing pregnancy, however, women who have had a Mirena IUD inserted allege that the device is prone to migrating from its initial position in the uterus. The complaints regarding the Mirena device say the IUD has caused injuries and complications including pain, bleeding, miscarriages, ectopic pregnancies (pregnancy outside the uterus), uterine perforations, scarring, organ damage, and infertility. In case the IUD travels out of position, it may fail to prevent pregnancy.
The plaintiffs allege that Bayer should have known, or were aware of the link between levonorgestrel and IH at the time it made the Mirena IUD available to the public. It is also maintained by the plaintiffs that the product label for the Mirena LNG-IUS never carried any warning concerning the risk of IH. In addition, to this day, Bayer does not warn patients or doctors of the connection between the Mirena LNG-IUS and IH. This is despite the fact, that Janelle, another of its levonorgestrel-releasing contraceptive implants, does have such a warning.
It is maintained by numerous plaintiffs that had they been better informed of the potential complications and side effects of the Mirena IUD, they would not have opted for the Mirena IUD for their chosen form of long-term birth control.
Legal Information and Advice for Mirena IUD Recipients
Parker Waichman LLP has had years of experience representing clients in numerous allegedly defective medical device lawsuits. The firm offers free, no-obligation case evaluations to anyone with questions about filing a lawsuit over adverse effects from medical devices. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).