Los Angeles, CAJudges in Illinois and California recently ruled that Essure lawsuits can proceed in state courts, meaning that Bayer can no longer rely on a federal pre-emption law that would have protected the pharma giant (and other medical device manufacturers) from liability.
So the tides have turned on Bayer and the floodgates opened for Essure claims: A California judge in August 2016 ruled that 14 Essure lawsuits can proceed. Last month at least 50 petitions were filed on behalf of more than 900 California women to coordinate Essure lawsuits, its goal to ensure an efficient resolution of claims.
Hailed as the next generation of contraception, Essure consists of implantable coils that are permanently inserted via a catheter into a woman’s fallopian tubes to prevent pregnancy. It has been on the market since 2002.
Bayer is also getting pressured from Rep. Mike Fitzpatrick (R-PA), who is sponsoring a bill that would order FDA to revoke Essure's approval and remove it from the market. Specifically, the bill will “amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices”.
Perhaps Bayer won’t need to perform post-marketing studies to evaluate the safety and efficacy of the device after all, as ordered by the FDA in September 2016. Legislation has just less than seven years to pass the HR 5403 bill before the study’s deadline— September 2023! (The HR 5403 bill, also known as Ariel Grace’s Law, wants Essure removed from the market and Bayer held responsible for producing a defective medical device.)
Congressman Lou Barletta is the co-sponsor of the bill. "I don't think [Essure] is real safe considering the fact that there have been 5,000 complaints since this has been administered,” he told ABC - 16 WNEP (Wilkes Barre, Scranton, Pennsylvania) (Nov 14, 2016). The TV station also contacted a spokeswoman at the FDA, who said that, “on October 31, they finalized updates to the warnings on the box and the patient checklist when it comes to implants intended for sterilization, such as Essure, making sure women are as educated as they can be about the product.”
Although the FDA slapped a black box warning on Essure, this measure must seem to Essure victims like sticking a band-aid on a bullet wound. Women who have suffered serious Essure side effects (more than 25,000 women have joined Essure Problems Facebook page) have demanded its recall from the market since 2013.
For too many women suffering from Essure complications, the only way to find relief was through complete hysterectomies. Let’s hope they find financial relief through Essure lawsuits, and some gratification should the device be removed from the market.
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