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According to allegations raised in a lawsuit recently filed against Bayer Heathcare, the drug maker has misled the public about the impact side effects of the Mirena IUD birth control implant may have hormone levels, placing women at an increased risk of developing a dangerous build up of fluid pressure on the brain, known as pseudotumor cerebri (PTC) or idiopathic intracranial hypertension (IIH).
The complaint (PDF) was filed late last month by Maryssa Reese in the U.S. District Court for the District of New Jersey, indicating that the 28 year old was diagnosed with IIH/PTC about four years after a Mirena intrauterine device (IUD) was implanted by her doctor to provide long-term birth control.
Idiopathic intracranial hypertension (IIH) and pseudotumor cerebri (PTC) are medical terms used to describe complications caused by elevated levels of cerebrospinal fluid that cause increased pressure on the brain. This typically causes severe migraine headaches and potentially permanent vision problems as a result of pressure on the optic nerve.
The Mirena IUD is a T-shaped plastic device implanted in the uterus to prevent pregnancy for up to five years. The device releases the birth control hormone levonorgestrel (LNG), and is used by more than 2 million women in the U.S., and 15 million women worldwide.
While other birth control products that contain the progestin levonorgestrel without causing PTC/IIH side effects, Reese indicates that those drugs typically use other components that helps keep the hormonal effects low. However, the Mirena IUD uses levonorgestrel on its own, and despite claims by Bayer that these low levels are safe, it has been found to cause a much greater impact on the system, which increases the risk of PTC/IIH.
According to allegations raised in the complaint, Bayer failed to adequately warn women or the medical community about these potential side effects, instead pointing to low serum levels of levonorgestrel delivered by the implant as signs that it is safe.
“Because total LNG serum levels does not accurately reflect the propensity of LNG to cause or contribute to hormonal side effects, Mirena’s labeling is misleading, inadequate, and false,” the lawsuit states. “In addition to Defendant’s failure to describe the suppressive effects of LNG upon SHBG levels, Defendant’s description of systemic exposure to LNG are calculated in a manner which obfuscates and confuses healthcare practitioners and consumers who seek to compare hormonal exposure and systemic effects while on Mirena® with that of other hormonal contraceptives.”
Reese’s case joins a growing number of Mirena PTC/IIH lawsuits filed by women nationwide, each raising similar allegations that plaintiffs may have avoided severe and potentially life-long problems from permanent optic nerve damage if the drug maker had provided proper warnings.
Reese presents claims for negligence, failure to warn, design defect, strict liability, breach of warranty, negligent misrepresentation, fraudulent misrepresentation, fraud by suppression and concealment, and violation of trade practices. The lawsuit seeks punitive and compensatory damages.