The safety of yet another birth control device, Mirena, is the subject of scrutiny after a woman filed suit against its manufacturer, Bayer, in federal court. The woman is seeking at least $75,000 compensation from the manufacturer. She alleges that Bayer was negligent and also stated several claims related to medical product liability.
The product, like other types of birth control, gets placed in to a woman's uterus. From there, it releases a drug designed to prevent pregnancy, and it can be effective for up to five years.
The drug does come with warnings. Specifically, it states that the sudden onset of migraines, especially with blurry vision, is a sign that the drug may be cutting off blood supply to the woman's brain, increasing the risk of a debilitating stroke. Doctors are instructed to remove the device under such circumstances.
However, the manufacturer gave no such warning about so-called intracranial hypertension, which, according to the woman, is another condition the active ingredient in this device can cause. The woman was diagnosed with this condition after going through a battery of tests, and she will require additional medical treatment as a result.
Had it not been spotted when it was, the woman's condition could have blinded her.
This case is yet another example of how important it is that drug companies give adequate warnings about all the potential risks their product may entail. In some cases, it may even be better to forego the temptation to put a dangerous product on the market at all. When drug manufacturers do not take these precautionary steps, patients may be able to hold them legally accountable.