The Essure Permanent Birth Control System initially hit the United States market in 2002. In brief, Essure was intended to be a non-surgical sterilization procedure. It was developed by Concpetus, Inc., a subsidiary of Bayer AG. A certified doctor inserts the contraceptive into each of the recipient’s fallopian tubes. This insert then forms a barrier that keeps sperm from reaching the egg to prevent pregnancy. In 2004, the Food and Drug Administration (“FDA”) approved Essure. Per Bayer, there are currently about 750,000 of the contraceptives in use worldwide.
Today, however, there have been more than 4,000 reported adverse events with the Essure contraceptive. Various complications that Essure patients experience include, but are not limited to, fatigue, allergic reactions to nickel, severe pelvic pain, severe abdominal pain, painful intercourse, irregular periods, autoimmune disorders, device displacement and breakage, and weight fluctuation and bloating. In order to have Essure removed and end the complications, many patients were required to undergo hysterectomies. A trial found that, out of 518 women using Essure, 449 successfully relied on Essure. However, for the remaining 21 women, the contraceptive pieced their fallopian tubes and was pushed to other parts of the body.
The Lawsuits and Updates
Almost inevitably, lawsuits were filed against Bayer. Five Pennsylvania cases against Bayer Healthcare were filed and are now consolidated into one case, McLaughlin v. Bayer Corp et al, case number 2:14-cv-07315 in the U.S. District Court for the Eastern District of Pennsylvania. Upon the FDA’s approval of Essure, it was given pre-market approval. This shielded Essure from litigation. Yet, the plaintiffs argue that the FDA should never have approved Essure birth control. The plaintiffs allege that the original manufacturer of the device, Conceptus, breached its warranty and that Essure should no longer receive that protected status.
Bayer previously filed a motion for judgment on the pleadings, dismissing many claims either as preempted under the FDA or as not pled sufficiently. Recently, in March 2016, Pennsylvania federal judge John Padova granted Bayer’s motion. The judge ruled that most of the five plaintiffs’ claims were dismissed as being preempted by the FDA’s oversight of medical devices. Nevertheless, the judge also held that the five plaintiffs may proceed with their lawsuit regarding their remaining claims. In other words, the permanent approval status that protects Bayer and Essure from litigation did not prevent the plaintiffs from pursuing certain of their claims. The judge found, however, that the plaintiffs’ fraudulent misrepresentation claims, though not preempted, do not satisfy pleading requirements because they do not allege enough specific information. The judge thus spared the plaintiffs’ negligent misrepresentation claim and allowed them to re-file their lawsuits.
Take Action if Injured
If you or your loved one is an injured recipient of Essure, it is imperative that you hire an experienced attorney. Doing so will greatly increase your chances of adequate compensation. The experienced attorneys at Roberts Law Office are currently taking and reviewing product liability cases involving Essure. If you or a loved one have experienced complications from Essure like those listed above, we encourage you to seek legal counsel. Contact us for a FREE case consultation.