About 10,600 women who say Essure permanent birth control causes serious injuries including device emigration, organ perforation, autoimmune disorders, accidental pregnancies and hysterectomies. Litigation is ongoing, but so far there have been no settlements of jury verdicts.
If you had Essure Permanent Birth Control System inserted and you're suffering from one of the following complications, you may be entitled to compensation.
Number of Lawsuits 10,600
Plaintiff Injuries Organ perforation, pelvic pain, autoimmune disorders, inflammation, device migration, death
Defendants Bayer, Conceptus
Litigation Status Active
Main Courts Presiding Over Lawsuits Eastern District of Pennsylvania and Alameda County Superior Court in California
Women who filed Essure lawsuits claim Bayer’s permanent birth-control device caused serious injuries including pain or bleeding, device migration or fracture, damage to organs and children born with birth defects.
Bayer’s 2017 annual report revealed the company lost about $413 million in revenue in 2016 because of Essure lawsuits — though the medical giant has yet to offer any settlements.
So far, Bayer faces about 10,600 lawsuits in the U.S., as of October 2017.
The drug maker expects plaintiffs to continue to file.
Essure plaintiffs have had to face preemption laws that make it difficult for them to sue Bayer. But, so far, judges have been allowing lawsuits to continue for specific counts of negligence.
Despite preemption laws, judges have been allowing lawsuits to proceed, and thousands of Essure lawsuits are pending against Bayer. But, some judges dismissed cases because of preemption. They have also dismissed some cases for failing to meet judicial requirements.
For example, in January 2018, Missouri federal judge Stephen Limbaugh Jr. sided with Bayer and tossed 92 out of 95 plaintiffs from an Essure case. The judge said the out-of-state plaintiffs’ claims should not have been filed in Missouri even if Essure clinical trials took place there.
Despite some cases being dismissed, Essure litigation continues with individual lawsuits in various state courts. Some plaintiffs’ attorneys are also involved in trying to ban the device on behalf of their clients.
Examples of cases proceeding despite preemption:
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Currently, Drugwatch’s legal partners are accepting Essure cases for pain, bleeding, device migration, device fracture, organ perforation, Essure complications requiring surgery and children born with birth defects. But a number of lawsuits include additional injuries.
“Plaintiffs allege personal injuries from the use of Essure™, including hysterectomy, perforation, pain, bleeding, weight gain, nickel sensitivity, depression and unwanted pregnancy, and seek compensatory and punitive damages.”
- According to Bayer
Essure lawsuits claim Bayer failed to warn the public of the risks of the device and the company is guilty of negligence. They also allege Conceptus, the original manufacturer of Essure, falsified documents to obtain approval from the FDA. Women injured by the device turned to the legal system to hold Bayer accountable and to prevent Essure from injuring others.
Because many lawsuits are still pending, there are no publicized settlements or jury verdicts yet. So far, there have been no trials scheduled in any of the courts handling these claims.
There are currently no Essure class actions in the U.S. But in April 2017, two Canadian plaintiffs seeking class-action certification served Bayer with lawsuits.
Because there are over 10,000 Essure cases pending in multiple courts, plaintiffs may file a motion to consolidate the cases in multidistrict litigation (MDL). MDLs gather cases with similar injuries and causes of action against the same defendants together to make litigation more efficient. Unlike a class action, plaintiffs in an MDL retain their own lawyers and may accept a settlement or deny it and continue on to a jury trial.
Despite the number of complaints pouring in, preemption laws protect Bayer from Essure lawsuits. The law bars people from filing lawsuits against medical device makers with preemption status because the FDA supposedly puts the device through a rigorous process before approval. This ignited a battle against Bayer on social media.
Lawsuits against Bayer say the company lied to the FDA in its premarket application. The lawsuits that allege Conceptus violated the terms of the FDA’s premarket approval and committed fraud by withholding data from the agency. This could mean the company forfeited its protection under the preemption laws.
Lawsuits say Bayer “conspired to engage in…misconduct…for the purpose of enriching themselves and creating an injustice at the expense of plaintiffs” and their health. Some women lost marriages, family and even died after complications.
For many women, the Essure experience has been long and arduous. They incurred medical bills, scheduled multiple surgeries and suffered poor health for years before they filed lawsuits.
Tanya de la Paz
Tanya de la Paz filed her lawsuit against Bayer in September 2015. According to the lawsuit, in July 2012, de la Paz had her first Essure procedure. However, one of her fallopian tubes perforated during the procedure. She went to a hospital because of the bleeding. She returned in September 2012 for a second procedure. The doctor implanted the metal coils successfully, but she suffered constant daily pain. When she returned to her doctor three months later for a follow up, the examination revealed that coil in her right fallopian tube was broken.
Bayer advised de la Paz’s physician to surgically remove the right fallopian tube and the broken coil. The left coil remained implanted and continued to cause her constant daily pain and heavy bleeding. She also suffered weight gain, stomach issues and mental and emotional anguish. She scheduled surgery to remove the second metal coil in September 2015.
According to her lawsuit, “[Bayer] actively and fraudulently concealed adverse reports of migrations and perforations from the Plaintiff and from the FDA.”
Judge William Alsup granted Bayer’s Motion to Dismiss in February 2016, but allowed de la Paz to amend her complaint.
Heather Walsh filed suit against Bayer in 2015. In 2008, she went to her doctor’s office to have Essure implanted, according to her lawsuit. The doctor told her that a representative from Bayer would be there to supervise the procedure. The rep never showed, and the doctor attempted to implant the coils. The procedure failed. Walsh was forced to come back the following month and the doctor again tried several times to implant the coils without the presence of the Bayer rep. Finally, after several attempts, the inserts made it into the fallopian tubes.
After two years and four hospitalizations for severe pain, fainting and fever, she underwent a CT scan. It revealed one of the Essure coils had lodged behind her colon. There were three micro inserts and not two, as there should have been. She had to undergo a hysterectomy and an additional surgery to remove the coil in her colon. Now, she is left with a legacy of pain and autoimmune disorders. She said Bayer failed to warn her or train physicians properly.
“Defendant’s conduct was malicious, intentional, and outrageous, and constitutes a willful and wanton disregard for the rights and safety of Plaintiff and others,” Walsh’s lawsuit alleges.
In February 2017, Judge John R. Padova dismissed some claims against Bayer, but allowed the plaintiff to amend her complaint.
Stephanie Bailey’s husband, Bradley, filed a lawsuit on her behalf in 2016. After Stephanie received Essure in November 2010 she suffered numbness in her extremities, long-lasting migraines, joint pain and severe pelvic pain. She had to have a hysterectomy to remove Essure and subsequently died.
Her husband is seeking damages for loss of love, comfort, care, companionship, affection as well as emergency care, funeral expenses and medical bills.
Michelle Garcia had Essure implanted in April 2011 and again in May 2011. She suffered memory loss, numbness, severe pelvic pain, extreme menstrual changes and severe headaches. In order to remove Essure she had a bilateral salpingectomy.
Her lawsuit says Bayer, “actively and fraudulently concealed adverse reports of migrations and perforations from this Plaintiff but also from the FDA.”
Please seek the advice of a medical professional before making health care decisions.
Michelle Y. Llamas is a senior content writer. She is also the host of Drugwatch Podcast where she interviews medical experts as well as patients affected by drugs and medical devices. She has written medical and legal content for several years — including an article in The Journal of Palliative Medicine and an academic book review for Nova Science Publishers. With Drugwatch, she has developed relationships with legal and medical professionals as well as with several patients and support groups. Prior to writing for Drugwatch, she spent several years as a legal assistant for a personal injury law firm in Orlando. She obtained her English – Technical Communication degree from the University of Central Florida. She is a committee member with the American Medical Writers Association.
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