A federal judge in Philadelphia says that a lawsuit filed against Bayer for its Essure permanent contraceptive device can proceed, despite dismissing all but two claims filed by five women who allege they were harmed by the device.
U.S. District Judge John R. Padova said that the women's claims that Bayer used misleading advertising and failed to warn consumers about the risks of using Essure were reasonable. He dismissed 10 claims, while giving the plaintiffs the option to amend their complaint to restore five of the claims.
Essure was introduced in 2002 as an alternative to tubal ligation. The device is a small metal coil made of nickel and plastic fibers. Essure is inserted into each fallopian tube, resulting in inflammation and scarring that seals the tube, permanently preventing pregnancy.
In February 2016, the FDA ordered Bayer to add a “black box warning” to its Essure labels and include a patient information checklist highlighting the potential adverse events that could occur following implantation of the device, including persistent pain, perforation of the fallopian tubes or uterus, hypersensitivity reaction and device migration.
According to a FDA study, complaints about adverse events stemming from the use of Essure have quadrupled since late 2013. From 2002 until October 2013, the agency received 943 incident reports. Between October 2013 and May 2015, the FDA received 4,150 incident reports.
Pennsylvania Congressman Mike Fitzpatrick has introduced legislation called the “E-Free Act” that would require the FDA to revoke its approval of Essure.
The five Essure lawsuits have been consolidated in Philadelphia federal court and are among the first of hundreds of similar cases to proceed to the discovery phase of litigation. The first suit was filed in 2014 by a Florida woman who claims the Essure device migrated to her uterus, requiring a hysterectomy.
Showard Law Firm is Tucson's local law firm for defective drug and medical device claims. If you believe you or a loved one have been harmed by a medication or device, contact us for a free consultation.