Oakland, CAThe next twelve months will be critical for Mirena IUS (Intrauterine System) contraceptive plaintiffs currently engaged in a Multi-District Litigation lawsuit against Bayer alleging the hormone coated device leads to an intracranial condition with the potential to cause permanent blindness in some users.
“This is a very serious condition and for the most part we are talking about young women,” says Elise Sanguinetti. Sanguinetti represents a number of women in the MDL and is the managing attorney at Khorrami LLP in Oakland, California.
The Mirena IUS was held out by Bayer to be a safe and effective method of birth control but MDL claims filed by at least 200 against Bayer claim that they suffered pseudotumor cerebri (PTC), also known as intracranial hypertension (IH), after having the birth control device inserted into their uterus.
According to the peer-reviewed scientific evidence put forward, women using the IUS hormone coated device have experienced severe headaches and vision loss as a result of a buildup of spinal fluid. Other signs and symptoms include dizziness, blurred vision, neck stiffness, nausea or vomiting and ringing in the ears. Mirena users may also experience weight gain.
The Mirena intrauterine system was first approved by the FDA in 2000 and approved again for women with heavy menstrual periods in 2009. An estimated 2 million women in the US use the device and a further 15 million women around the world use the IUS as a birth control method.
The Mirena IUS’s potential connection to cause pseudotumors in the brain and intracranial hypertension is not consistently known to physicians. Although Bayer warns against the use of the Mirena IUS in women with respect to strokes, the label makes no mention of the non-stroke risks.
“We believe there are a lot more affected people out there. The connection between this device and the symptoms and diagnosis are not readily known by the public. We believe there are a significant number of potential plaintiffs that still exist,” she says.
“The science shows the Mirena IUS causes pseudo tumors which can lead to extreme headaches, vision problems and sometimes can lead to blindness,” says Sanguinetti. “There are treatments such as lumbar punctures to release the excess fluid in the spine that builds up or shunts can be placed in the brain to control the fluid. Those are among the most serious.
“We have clients who have experienced blindness with varying levels of permanency,” says Sanguinetti. “It depends on the individual. Once you have visual disturbance it does not necessarily lead to blindness but it can.”
The Mirena IUS is a T-shaped plastic device coated with the synthetic progestogen hormone known as levonorgestrel. It is inserted into the uterus by a physician and is expected to function as an effective birth control method for up to five years according to Bayer.
According to the statement of claim in the MDL “it is not known exactly how Mirena works, but Mirena may thicken cervical mucus, thin the uterine lining, inhibit sperm movement and reduce sperm survival to prevent pregnancy”.
Lawyers are now in the discovery phase of the case taking depositions from Bayer representatives with knowledge of the company’s Mirena IUS product. Hearings to qualify expert witnesses, known as Daubert Hearings, will follow early in 2018.
“There is a whole host of first-round depositions over the next month in Finland, London and New Jersey,” says Sanguinetti. “The judge has this MDL on a very aggressive track.”
Another Mirena MDL alleging the device could migrate leading to serious injury or cause ectopic pregnancy recently fell apart after the judge refused to accept the experts put forward to testify on behalf of the plaintiffs.
The MDL focus on the hormone coated device and its potential to cause pseudotumors and intracranial hypertension is a completely different lawsuit. It remains active and is moving forward.
Causes of action include gross negligence, defective design, failure to warn and fraudulent concealment.
MIRENA IUS LEVONORGESTREL-RELATED PRODUCTS
LIABILITY LITIGATION (NO. II) MDL No. 2767
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