A federal judge in Philadelphia has determined that an Essure lawsuit filed against pharmaceutical giant Bayer has enough merit to proceed. Bayer had previously moved for the case to be dismissed.
The judge sided with Bayer on most of its motion. The plaintiffs had originally brought 12 claims against the company and, using an FDA provision specific to devices granted premarket approval, Bayer argued that Essure was effectively protected from any sort of liability action in a state court. However, when examining the plaintiffs’ claims as a whole, Judge John Padova determined that some of the claims asserted in the complaints should be allowed to be heard.
The first was that Bayer had misled the public through its advertising campaign for Essure. The second was that the company did not warn the public, be it consumers or prescribing physicians, about the dangers and risks associated with the use of Essure.
Judge Padova’s ruling also left open the possibility of “revisiting” five of the claims he’d dismissed; among them that the training offered to physicians on the implantation of the Essure device was inadequate and negligent and, in some cases, nonexistent.
Essure’s history in the American medical device market is as long as the list of women who have claimed to have been harmed while using it. Tens of thousands of complaints, ranging from intense pain and bleeding to device migration and organ perforation, have been filed with the Food and Drug Administration almost since its first day of availability. Women have been forced to undergo complicated surgeries to have the device removed, with some requiring full hysterectomies.
Essure may also soon bear the distinction of a black box warning; a measure taken only for those drugs and devices that the FDA believes pose a significant risk or danger to the public. And, as if that, the calls for a recall of the device, and an online community of alleged victims comprised of nearly 30,000 members isn’t enough; the device also faces possible action in the halls of the United States Congress. Representative Mike Fitzpatrick, responding to the hundreds of complaints received by his office, is author of the “E-Free Act.” The Act would specifically require the FDA to revoke its premarketing approval of Essure.
The very fact that Essure is still available may be a testament to the power of corporate influence in the medical device market. Many products see a recall before a black box warning is ever considered, yet Essure continues to be implanted in unknowing women – even in the face of federal legislative action.
The hopes of thousands lie with five women in a Philadelphia federal court as the outcome of this trial could serve as a bellwether for future Essure lawsuits. Two of twelve claims have been allowed to move forward on their own merits, with five more that can be revisited at a later date. In the meantime, revision surgeries, hysterectomies, unplanned pregnancies, and untold amounts of pain continue for women across the country who were sold on Essure as a safe, non-surgical alternative to surgical sterilization.