In Philadelphia, a judge has ruled that a case brought by five women against Bayer Healthcare, claiming that they were harmed by company’s Essure sterilization coils, will continue.
The device is two metal coils that are inserted into the fallopian tubes.
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Bayer previously asked that the lawsuit be dismissed – but John Padova, U.S. District Judge in Philadelphia, has ruled that claims made by two particular women signify legitimate misleading advertising, essentially failing to provide information about certain risks.
A case like this isn’t really new for Bayer – it has encountered multiple somewhat similar cases previously, but the company wanted these specific cases thrown out because the FDA did give pre-marketing approval in 2002 for these devices. Technically, if a device is given regulatory status, it protects a product from liability lawsuits in state courts.
Essure has been criticized almost from day one, legally. Bayer inherited the device about a year after it hit the market when the drugmaker acquired Conceptus in a $1.1 billion deal in 2013.
In 2014, the FDA began an investigation of the device, and in 2015, the agency took a closer look when many women urged regulators to pull the product from the market.
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At this point the agency has ordered a clinical study to look at the risks with the product that has now been labeled with a black-box warning – which is due to a significant number of fetal deaths linked to the product.
Bayer has deep pockets, but that only goes so far. We’ll see how this plays out.