Essure Lawsuit

More than 12.5 million American women rely on permanent birth control devices to prevent unplanned pregnancy. Essure is a permanent, non-surgical birth control device on the market since 2002. Unlike pills, this birth control method doesn’t require the daily use of hormones. Patients believed it would be easier, safer, and cheaper than daily pill contraception, and just as effective. During the simple 10-minute in-office procedure, an OBGYN inserts the flexible metal coil device into the fallopian tubes, without incisions or anesthesia. Once in place, tissue grows in and around the device, creating a blockage that prevents the union of sperm and eggs.

The first Essure lawsuit was filed on behalf of plaintiff Heather Walsh in Philadelphia civil court in July 2014. The device migrated, leading to five hospitalizations, a hysterectomy, and chronic auto-immune disorders. According to the lawsuit, manufacturers failed to properly train doctors on how to insert the device and intentionally misled patients and regulators regarding the safety of their device. A year later, Essure lawsuits were filed at an accelerated pace, as awareness of Essure problems spread.

If you or a loved one has used Essure as a form of birth control and suffered sudden, adverse side effects like those mentioned, you need an experienced personal injury attorney to help you make your case. Bart Bernard of Lafayette and Baton Rouge, Louisiana has been assisting plaintiffs nationwide with their Essure lawsuits. His ranking among the Elite Lawyers of America and Multi-Million Dollar Advocates Forum puts him among the best in the nation. His extensive network includes medical experts who can help you substantiate your claims for compensation.

Bart Bernard Personal Injury Lawyers has been following this litigation from the beginning:

• November 2002: Essure is approved using the FDA’s Pre-Market Approval process.
• 2004-2013: More than 800 women file adverse event complaints with the FDA.
• 2011: The Essure label is updated with a warning about patients who experience nickel sensitivity.
• 2012: Labeling was updated to include information on pregnancies reported in the five-year follow-up.
• October 2013: ABC News investigates claims of adverse events reported by Essure patients, including one death.
• November 2013: Another label update warns of new risks, including chronic pain and device migration.
• October 2014: Official records reveal the makers of Essure knew patients were being harmed as early as 2004.
• May 2014: The AAGL highlights complications of Essure, including ectopic pregnancies and allergic reactions.
• June 2014: Essure patients testify before a Congressional Briefing in Washington D.C.
• July 2014: The first lawsuit is filed against Bayer/Conceptus Inc. in Philadelphia.
• January 2015: Seven women of the 13,700+ patients harmed by Essure meet with Congressional reps.
• March 2015: A federal judge dismissed all but two counts of injury, based on its Pre-Market Approval status.
• April 2015: More Essure advocates meet with FDA officials to discuss the possibility of a device recall.
• April 2015: A doctor describes a woman’s death during the Essure implant procedure.
• September 2015: The FDA holds a public hearing with government officials about Essure side effects.
• October 2015: A study published in the British Medical Journal found a 10-fold higher risk of needing re-operation within the next year due to complications than laparoscopic sterilization.
• November 2015: A bill is introduced to remove Essure from the market, but languished in Congress.
• March 2016: Labeling is updated a third time to include a black box warning and patient decision checklist.

Common Essure complaints filed with the FDA include:

• At least 150 cases of coils breaking or misfiring
• Even more repots of the device migrating or puncturing the fallopian tube
• Over 300 reports of miscarriages and ectopic pregnancies
• At least 91 reports of hysterectomies to remove the device

Nickel allergy sufferers have had wide-ranging symptoms, such as:

• Hair loss
• Abdominal swelling
• Chills and fever
• Skin rashes, hives, and severe itching
• Headaches and brain fog
• Severe mood disorders
• Chest pain and breathing difficulties
• Intestinal discomfort such as nausea, diarrhea, or vomiting

In one account, Becky Beesley of Gilbert, AZ told the local news her leg started to tremor and she threw up immediately after the procedure. Her pain was so bad that, within a few months, she had to quit her job as a teacher. The doctor removed the coils, but it was later discovered she had pieces of metal embedded in her uterus. She went through a hysterectomy to remove her reproductive organs. More stories can be found on a public Facebook page called “Essure Problems.”

Essure deaths have resulted due to:

• Infection post-procedure
• Uterine perforation during placement, and
• Air embolism during removal surgery

In March 2016, Federal Judge John R. Padova dismissed a group of claims based on allegations of fraudulent misrepresentation. However, he added that Essure’s premarket approval status did not prevent plaintiffs from filing claims of negligent misrepresentation.

In the summer of 2016, plaintiffs in several actions petitioned the Judicial Panel on Multidistrict Litigation to consolidate the cases into MDL No. 2739. Multi-District Litigation centralizes hearings before one common judge to “promote the just and efficient conduct, eliminate duplicative discovery, prevent inconsistent pretrial rulings, and conserve judicial resources.”

Plaintiffs withdrew their motion to centralize Essure birth control lawsuits after Judge Petrese B. Tucker of the Eastern District of Pennsylvania consolidated 18 Essure cases pending in the District Court to vacate proceedings. Judge Winifred Smith of Alameda County issued a case management order on Dec. 21, 2016 to streamline discovery proceedings from across the country. Lawyers are digging into what the device manufacturers knew and when. They hope to begin trials as early as 2018.

A federal MDL is still possible if a judge allows large numbers of consolidated lawsuits to proceed – that is, if an early class action settlement offer does not arise first. The company continues to stand by their product, despite the updated black box warning.

In order to qualify for compensation, plaintiffs must have suffered harm as the result of their Essure use.

Spouses may file additional claims for loss of companionship, lost income, loss of consortium – and, in the worst cases, wrongful death. In the event of death, dependent children can file for loss of support and guidance.

Most states have a statute of limitations determining how long you have to file, but the clock starts ticking from the time of discovery, not the time of insertion, so you may still be eligible to pursue legal action. Contact dangerous medical device attorney Bart Bernard for a free, no-obligation case review at 888-GET-BART.

1. FDA – Essure Permanent Birth Control Regulation History, https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452270.htm
2. News Channel 5 – Legislation Aims To Clear Way For Essure Lawsuits, http://www.newschannel5.com/news/newschannel-5-investigates/consumer-alert/legislation-aims-to-clear-way-for-essure-lawsuits
3. Gov Track – R. 3920 (114^th): E-Free Act, https://www.govtrack.us/congress/bills/114/hr3920
4. FDA – Essure Permanent Birth Control: Information for Health Care Providers, https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452252.htm
5. BMJ – Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study, http://www.bmj.com/content/351/bmj.h5162
6. The Huffington Post – Are Women Who Seek Compensation For Essure Side Effects Ever Going To Get Justice? http://www.huffingtonpost.com/toby-nwazor/are-women-who-seek-compen_1_b_11492282.html
7. Modern Healthcare – Essure problems cost Bayer $413 million last year alone, http://www.modernhealthcare.com/article/20170222/NEWS/170229972
8. The Legal Intelligencer – Court Narrows Claims Over Essure Birth Control Device, http://www.thelegalintelligencer.com/id=1202779713658/Court-Narrows-Claims-Over-Essure-Birth-Control-Device?slreturn=20170220095632

Last modified: June 07, 2019