Mirena

  • Mirena

Mirena is a type of long-acting, reversible hormonal intrauterine device (IUD) manufactured by Bayer Pharmaceuticals. It is a small T-shaped flexible device that is placed into the uterus by a trained healthcare provider during a routine office visit. Once implanted, Mirena releases small amounts of progestin hormone called Levonorgestrel, locally into the uterus. It provides continuous, highly effective birth control.

It was approved in 2000 by the U.S Food and Drug Administration (FDA) and is one of two hormonal IUDs for use in the United States. In 2009, the FDA expanded Mirena's approval to treat heavy menstrual bleeding in women already using an IUD. It was also claimed to be more than 99 percent effective in controlling pregnancy for up to 5 years, after that the implant needed replacement.

Mirena is marketed as more convenient and effective than oral contraceptives because once implanted, women do not have to worry about taking a daily pill. Additionally, the removal of this device is also quick and hassle-free. However, there were incidences where the device got migrated outside the uterus or got lodged in the uterine wall, some females conceived in spite of the device placement and landed up in undue complications. All these evidence brought Mirena device in trouble.

Pseudotumor Cerebri Lawsuits: Pseudotumor Cerebri (PTC) or Idiopathic Intracranial Hypertension (IIH), is a condition caused by pressure on the brain from the buildup of cerebrospinal fluid, while on birth control like Mirena. This condition can lead to severe headaches, migraines, and vision loss/permanent blindness.

Serious Alleged Injuries may include:

  • Perforation of the uterus
  • Pelvic inflammatory disease
  • Ectopic pregnancy (pregnancy that occurs outside the uterus)
  • Displacement
  • Perforation of organs other than uterus
  • Menstrual Bleeding abnormalities
  • Abdominal/Pelvic Pain and Discomfort
  • Headache/Migraine

FDA Safety Warnings:

In 2009, the Food and Drug Administration sent Bayer two warnings about Mirena, including a warning that their television commercials were misleading and a warning that their internet advertisements were misleading.

Until June 30, 2012, US Food & Drug Administration (FDA) received over 45,000 reports of Mirena birth control side effects.

Legal Updates:

Lawsuits filed against Bayer Pharmaceuticals allege that the company is guilty of their failure to warn that the device is prone to spontaneous migration and perforation of the uterus. Plaintiffs accused Bayer of using misleading advertising, concealing the harmful side effects and misrepresenting the benefits of Mirena.

Mirena IUD Lawsuits were centralized at the state level in New Jersey Superior Court in Bergen County as part of an MCL, or Multicounty Litigation. At the federal level, all Mirena IUD injury lawsuits were centralized and consolidated for pretrial proceedings before the U.S. District Judge Cathy Seibel in the Southern District of New York as MDL 2434 In re Mirena IUD Products Liability Litigation with over 1800 cases.

In August 2016, Judge Seibel dismissed all federal Mirena IUD migration lawsuits, but the claims like pseudotumor cerebri remained unaffected.

Lawsuits are being filed by women who have developed PTC after taking birth control pills or using a birth control implant like Mirena,  (Yaz, Yasmin, Ocella, NuvaRing) and many others. According to the Mirena lawsuit allegations, the birth control implant warning label should indicate that use of Levonorgestrel alone, like with Mirena, suppresses the levels of sex hormone binding globulin (SHBG) in the body. When SHBG levels are lowered, it can cause stronger hormonal effects from LNG and similar hormones. This may increase the risk of IIH/PTC.

In January 2017, plaintiffs suffering from pseudotumor cerebri filed lawsuits and demanded creation of a new MDL specifically to address their claims separately.

In April 2017, MDL No. 2767, (In Re:  Mirena IUS Levonorgestrel-Related Products Liability Litigation [No. II], was established under Judge Paul A. Engelmayer in the U.S. District Court for the Southern District of New York. This centralized more than 150 Mirena intracranial hypertension lawsuits.

Important Lawsuit Time-lines

Dec 2020: Mirena MDL Over Idiopathic Intracranial Hypertension Tossed

The 2nd Circuit U.S. Court of Appeals dismissed the Mirena multidistrict litigation after finding that the plaintiffs lacked evidence over the allegations that the birth control device was the cause of idiopathic intracranial hypertension (IIH) in them.

The MDL consisted of more than 900 lawsuits, in which the plaintiffs linked the intrauterine device (IUD) to a disorder with similar symptoms to a brain tumor.

In October 2018, the district judge issued a 156-page opinion allowing Bayer's Daubert motion to exclude expert testimony. In June 2019, the manufacturer was granted summary judgment, and all the cases in the MDL were closed, ruling that the women failed to prove their allegations.

The plaintiffs appealed, stating that the district court focused too much on the conclusions instead of the methodologies and also argued the district court should have only excluded parts of the expert testimony.

In a recent opinion, the appellate panel upheld an award of summary judgment to Bayer, rejecting the plaintiffs' argument that the district court abused its discretion by stopping them from pursuing additional documents.

The panel noted that the rigorous analysis in the 156-page opinion undermined the women's assertion and said that the women did not identify which parts should have been included or how those parts would have shown the causation necessary for the suit to survive summary judgment.

June 2019IIH Allegations On Mirena Dismissed For Lack Of Proof

U.S. District Judge Paul Engelmayer passed a summary judgment motion in a suit that alleged Mirena causes idiopathic intracranial hypertension, or IIH, further stating clearly in the multidistrict litigation, Bayer AG cannot be held responsible for causing IIH as the plaintiffs failed to show there was any admissible evidence proving Mirena could cause IIH.

The ruling was a result of a lack of proof against the pharmaceutical giant. Around 920 women allege Mirena's use caused them to develop Idiopathic Intracranial Hypertension (IIH), which if left untreated, can cause headaches, vision problems, and, in extreme cases, blindness. The judge said there is no scientific literature reviewed by medical organizations, regulators, or peers that have found Mirena, or any contraceptive, to be a cause of IIH.

As per the statement released by Bayer, "Judge Engelmayer's decision on summary judgment is a significant ruling that dismisses all cases pending in the MDL." Three multidistrict litigations have been set up covering alleged 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 the United States District Courts; and NJ MCL No. 297 in New Jersey State Courts.

October 2019: Judge Outs Mirena Plaintiff Expert Witness Statements

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.

March 2018: PTC Symptoms Lead to Filing of Mirena IUD Lawsuit: 

An increasing number of product liability lawsuits are filed against Bayer Healthcare, the maker of the intrauterine birth control device Mirena. The lawsuits are filed by women who allege that the intrauterine device (IUD) maker failed to adequately warn the medical community and the end-users about the associated risks.

Recently, a lawsuit was filed in the U.S. District Court for the Southern District of New York by a woman who raised similar allegations that the side effects of Mirena IUD caused blurred vision, severe headaches, back pains, and other symptoms related to pseudotumor cerebri (PTC), or idiopathic intracranial hypertension (IIH) (a medical condition involving a dangerous build-up of fluid pressure around the brain) for which she had to be hospitalized and also undergo a diagnostic lumbar puncture.

A similar complaint was filed by a woman from Ohio in the U.S. District Court for the Southern District of New York, who claims the Mirena implant caused a dangerous build-up of fluid pressure on her optic nerves, resulting in papilledema, light sensitivity, blurred vision, headaches and other complications leaving her with a permanent injury.

This case will join the 200 plus centralized lawsuits involving pseudotumor cerebri or intracranial hypertension complications from Mirena IUDs filed against Bayer Healthcare as a part of MDL: 2767, established in April 2017, for coordinated pre-trial proceedings in the Southern District of New York, before Judge Paul A. Engelmayer.

Evidence:

  • Usage of Device in operative records.
  • Product identification (Implant sticker) in the medical records.
  • Proof of Injury in Medical Records.
  • Treatment provided for the injuries.

Medical Record Review and claim validation of Mirena case should take approximately 2 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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