American women who were injured by a defective Essure birth control device may want an Essure Procedure lawsuit to claim payments for losses and personal injuries. Such lawsuits may come, but for now a federal preemption prevents women from suing Bayer, negligent maker and seller of Essure.
Yet that preemption is being challenged in a Philadelphia lawsuit. If it succeeds, Americans women will rightly be able to sue Bayer for its horrendous negligence in peddling an extremely dangerous device to unsuspecting and innocent women.
Another Essure lawsuit in Florida asserts that the federal preemption shouldn’t apply with Essure since Bayer misled the FDA about its effectiveness and safety, and it also gave doctors financial incentives to push the device on patients.
Also, the lawsuit holds that the FDA’s premarket “conditional” approval of Essure in 2002 should be invalid since Bayer did not comply with the FDA’s conditions. Those included a requirement that Bayer notify the FDA of any information it received which suggested reasonably that Essure might have caused or contributed to serious injuries.
Bayer also was required to be at all times “truthful, accurate and not misleading” in its representations and warranties about Essure’s effectiveness and safety. Yet Bayer failed to report and, in fact, actively concealed the fact that perforations in a woman’s body had occurred due to Essure. Bayer also used non-conforming materials in manufacturing Essure and did so at an unlicensed facility.
Such failures and non-compliance with FDA orders in its conditional approval — and concealment of that — should invalidate the approval, thus striking down federal preemption and enabling women to sue Bayer for damages.
What is Essure? It’s a permanent birth control device that’s been implanted in over 750,000 women across the globe. The 4-centimeter micro-insert is positioned in the fallopian tubes to stop pregnancy by causing severe inflammation to block the tubes permanently and completely.
How does this occur? The micro-inserts have an expanding coil. It’s composed of a stainless steel inner coil, a nickel titanium (nitinol) expanding outer coil and also polyethylene, or PET, fibers.
Following insertion in the fallopian tubes by a disposable delivery system, the micro-inserts expand and anchor there. Then their PET fibers produce inflammation, which makes scar tissue form over the coils and block fertilization. That occurs over the course of about three months. The nickel in the device is a metal to which some women — as many as 12 per cent, studies show — may be allergic, without being aware of it prior to implantation. Such women then may experience severe pain from the Essure implant.
Part of the problem also is that Essure is more difficult to implant that many physicians or gynecologists can handle. Sometimes several attempts are made, lodging more than one Essure device within the body. Bayer paid millions for an aggressive campaign of ads and marketing, claiming Essure was the “only non-surgical, permanent birth control available.”
For more information, read about the history of Essure Procedure.
Thousands of women throughout America have suffered debilitating chronic pain after receiving an Essure implant, or even have become pregnant, despite the fact that Essure was supposed to prevent that. As a matter of fact, Olympic skier and gold medal winner Picabo Street became pregnant despite having an Essure implant. She had been a spokesperson for the product, but isn’t anymore.
Other Essure side effects include women suffering fainting spells, fever and severe pain. Too, the micro-insert can migrate away from the fallopian tube and become lodged in or near the colon. Some women also have had to endure multiple hospitalizations, hysterectomy and adhesion and autoimmune disorders.
Women also have suffered such Essure side effects as rashes, excessive bleeding, chronic pelvic pain, bloating, ectopic pregnancies and miscarriages. Yet no Essure recall has yet been made, either voluntarily by Bayer or as ordered by the FDA. An Essure side effects lawsuit may help with financial compensation for your pain, suffering and medical treatments.
As for what is the federal preemption which currently blocks Essure lawsuits against Bayer, it involves the Medical Device Amendments Act of 1976. It has a preemption provision about state regulation of medical devices.
That preemption does not ban lawsuits based on state law tort claims, such as negligence or breach of warranty. Yet a 2008 U.S. Supreme Court ruling in Riegel v. Medtronic held that the provision prevents injured persons from filing lawsuits involving certain medical devices which got pre-market approval by the U.S. Food and Drug Administration.
That ruling is contradictory in the context of law, given the fact that lawsuits are allowed against makers of defective drugs or other medical devices which, similarly, had pre-market FDA approval. The New York Times reported that the 1976 law was not intended to prevent injured persons from suing negligent makers of defective medical devices. Also, the Times pointed out that FDA approval does not constitute a safety net for Bayer even under that interpretation of the law, since the FDA often approves medical devices based on questionable evidence.
In short, FDA approval should not represent a free pass for medical device manufacturers if their product turns out to be damaging. In fact, the Supreme Court itself has held that a medical device which got premarket approval must be made and sold with almost no deviations from the specifications in its FDA approval application. This has not been the case with Bayer, which owns Conceptus, Essure’s original designer.
Victims say Conceptus misled the FDA by failing to reveal negative Essure effects of at least one woman who was part of a clinical trial on which the FDA relied when it approved Essure. She told NBC News she suffered severe pain and had trouble breathing.
Despite legal hurdles, Essure lawsuits have started in which injured plaintiffs demand that Bayer is accountable for its negligence with Essure products. What’s needed is for a judge to rule that the pre-market FDA approval of Essure should be invalidated. Then victims of Essure can claim compensation via an Essure lawsuit against Bayer.
If you or someone in your family suffered an Essure injury and you are interested in exploring such an Essure lawsuit, contact the Willis Law Firm today. We stand ready to help you seek the payments you legally deserve. Such Essure lawsuit payments can include money for your pain, suffering, mental anguish, lost present and future salary and medical, hospital and rehabilitation bills stemming from your Essure injury.
If you had an Essure Procedure implanted and later suffered serious injuries, then call for a Free & Confidential Birth Defect Lawsuit Evaluation. All cases are taken on a contingency fee basis and the client is never charged an attorney fee or any legal case expenses, unless a recovery is obtained for them.
Trial Lawyer David Willis is a Board Certified Personal Injury Trial Lawyer and has been practicing for 30+ years. He has achieved Top Peer Review Rating and is licensed in Texas & New York.