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Essure is a type of permanent birth control that was manufactured by Conceptus, which was purchased by Bayer Healthcare in 2013.
Essure has allegedly been linked to serious adverse health effects, leading approximately 39,000 affected individuals to file Essure lawsuits. Bayer has entered into a settlement to resolve many of these lawsuits and also removed Essure from the market in 2019.
This Essure lawsuit update provides details on the current status of claims against Bayer related to complications caused by the permanent birth control as well as eligibility to file a product liability claim and obtain compensation.
What Are Essure Lawsuits?
Essure is a type of permanent birth control that consists of two flexible coils that are inserted into the fallopian tubes through the vagina and cervix.
After insertion by a physician, the coils are supposed to prevent the fertilization of eggs and stop eggs from reaching the uterus. Because Essure does not require a surgical incision, unlike tubal ligation, this non-surgical alternative was very popular, and more than 750,000 people used an Essure device.
Some of these individuals say they experienced complications. Between 2002 and 2017, the Food and Drug Administration received more than 26,700 complaints of adverse effects. The FDA subsequently required Bayer to conduct additional clinical trials in February 2016, and a “black box” warning of potential complications was placed on the product in November 2016.
Many of the individuals who experienced complications filed Essure lawsuits in order to seek compensation. The original drug manufacturer, Conceptus, was purchased in 2013 by Bayer Pharmaceuticals so the claims were filed against Bayer. The lawsuits alleged that Essure caused serious unexpected side effects and that Bayer had failed to disclose those side effects to either the FDA or to the public.
Complaints and Allegations in Essure Lawsuits
In a product liability claim, plaintiffs do not have to show negligence on the part of the drug manufacturer to obtain compensation. Strict liability rules apply and plaintiffs should be entitled to compensation if they can prove that the drug was defective and caused them harm when used as intended even if the manufacturer was not negligent.
One of the earliest Essure lawsuits alleged the company marketed and sold a device that “migrates from the (fallopian) tubes, perforates organs, breaks into pieces, and/or corrodes, wreaking havoc on the female body.” If true, this would indicate a defect in the product.
Many of the Essure lawsuits alleged negligence against Bayer, though. Specifically, Bayer was accused of:
- Violating the FDA’s conditional pre-market approval of Essure by failing to follow FDA guidelines
- Using non-conforming materials when manufacturing Essure devices
- Manufacturing Essure devices at unlicensed facilities
- Concealing complications of Essure and failing to report them to the FDA
- Failing to follow FDA guidelines when providing training to doctors on implanting Essure
- Negligently marketing Essure by overpromoting it
- Failing to properly train doctors by providing Essure simulator training instead of hands-on training
- Allowing doctors to implant devices without proper training
- Encouraging unqualified doctors to purchase and sell Essure kits to patients each month
- Asking doctors to use equipment without the proper qualifications.
Some plaintiffs also pursued claims against Bayer for express breach of warranty. This is a type of breach of contract claim that arises when a warrantor expressly or implicitly provides assurances about the quality of an item and those assurances are proved to be untrue.
What Injuries and Side Effects Are Linked to Essure Birth Control?
Essure allegedly causes many different types of complications for women after the birth control device is implanted. Some examples of problems that women have claimed Essure causes include:
- Adhesions
- Autoimmune disorders
- Chronic pelvic pain
- Coil eruption
- Ectopic pregnancies
- Hair loss
- Intestinal perforations
- Intestinal obstruction
- Migration of the coil that affects other organs
- Migraines
- Miscarriage
- Pain during sex
- Scarring
- Serious infections
- Stillbirths
- Uterine tears
- Uterine punctures
- Unplanned pregnancies
Some patients required hysterectomies as a result of Essure, while many others report ongoing pain even after the coil was removed.
Can I File an Essure Lawsuit?
You may be eligible to file an Essure lawsuit if you or a loved one had an Essure device implanted and you or they experienced serious complications including but not limited to pain, an unplanned pregnancy, perforated organs, stillbirth, ectopic pregnancy or the death of your loved one.
In order to be eligible to file an Essure lawsuit, you must have clear evidence of a condition related to the permanent birth control. You must also have supporting documentation showing the use of the device was likely the cause of the health complications.
How Long Do I Have to File an Essure Lawsuit?
In August 2020, Bayer entered into a $1.6 billion settlement to resolve most Essure claims. The settlement was expected to resolve around 90% of the 39,000 cases that had been filed at the time.
If you have not yet taken legal action and were not part of the settlement, it may not be too late to act. However, you will need to determine if your case is still within the statute of limitations.
The deadline when the statute of limitations runs out can vary depending on the type of claim you are bringing and where you live. For example, in many states, there is a two year statute of limitations for product liability claims so you must file your case within two years from the date of injury. If you do not file a case within the statute of limitations, your claim is time barred and you can no longer pursue legal action.
There are exceptions to this limit if you discover the injury later due to fraudulent concealment. It is possible that plaintiffs could allege that they were unaware Essure caused them harm due to Bayer hiding adverse event reports. Plaintiffs would need evidence that this fraudulent concealment impacted their ability to understand the cause of their injuries.
Because the rules vary, the best way to determine if you are still eligible to file an Essure lawsuit is to talk with an experienced product liability lawyer about your options.
Who Can I Sue for Essure Complications?
Conceptus was the original manufacturer of the drug. Bayer purchased Conceptus in 2013, which has resulted in Bayer Pharmaceuticals becoming liable for damages caused by Essure.
Can I Join an Essure Class Action Lawsuit?
Although there has never been an actual class action lawsuit over Essure, many women affected by Essure pursued their own independent lawsuits.
There is no current pending class action that you can join. Bayer settled the majority of the 39,000 pending claims against the company as part of a $1.6 billion settlement in 2020.
You may still be able to bring an individual case against Bayer if the statute of limitations has not yet expired in your case.
How Long Will My Essure Lawsuit Take?
The length of time an Essure lawsuit will take depends on many factors, including whether your case settles out of court or whether it proceeds to trial. The more complex the case, and the more severe the injuries, the longer it will take to resolve your claim.
Timeline of an Essure Lawsuit
When you file an Essure lawsuit, you will first file court paperwork called pleadings. Plaintiffs file a complaint, and the defendant will subsequently file an answer.
The discovery phase occurs after the pleadings and involves an exchange of information between parties. This is a fact-finding effort that allows both sides to see the evidence their opponents will be presenting. Interrogatories, or lists of questions sent to the opposing party, can also be used during discovery.
Typically, a pre-trial conference occurs next so the parties can meet and determine if a settlement can be reached. If no settlement is reached, then the case proceeds to the litigation phase. A trial occurs and can take several days or several weeks as each side presents evidence in support of their case.
If your Essure lawsuit proceeds to the litigation stage, you will get to present your case and Bayer will be eligible to raise defenses. Bayer has defended against Essure lawsuits by claiming the preemption provision prevented them from being held liable. Essentially, this means that Bayer argued the approval of Essure by the FDA protected the company against claims.
Essure Lawsuit Settlements
Lawsuits can be resolved if the involved parties agree to a settlement. They can also be resolved after a trial. If a case goes to trial, liability is determined and damages are awarded.
Bayer opted to settle many Essure cases, which means the company made an offer to pay a lump sum. Plaintiffs who agreed to the settlement were prohibited from pursuing their current and future claims against the company.
Bayer Settlement August 2020 Update
Bayer settled the majority of cases in August 2020. The company did not admit wrongdoing or liability, but indicated it was settling to avoid distractions from litigation and shift their focus to women’s health issues.
Appoximately 90% of cases were settled with the $1.6 billion payout from Bayer.
Essure Settlement Amounts
The approximate share per plaintiff from the Bayer settlement was $45,600. However, settlement amounts can vary depending on the extent of damage.
To determine if you could obtain compensation from an Essure lawsuit–and to get an accurate estimate of the likely amount of compensation that could be available–your best option is to speak with an experienced product liability lawyer. An attorney can help you to understand your rights if you were affected by Essure complications and can assist you with bringing a claim for compensation if that is an option in your situation.
Frequently Asked Questions (FAQs)
What’s happening with the Essure lawsuit?
Bayer settled most Essure lawsuits in August 2020. The company paid out $1.6 billion to settle approximately 90% of the 39,000 pending claims related to complications allegedly caused by the permanent birth control.
How much can you get in settlements from an Essure lawsuit?
Bayer settled Essure lawsuits for $1.6 billion. The approximate share of this settlement was $45,600 per plaintiff. However, plaintiffs who sustained more serious damage will receive more compensation.
Can you still file an Essure claim?
Most Essure cases were settled in August of 2020. Whether you can still file a claim or not will depend whether the statute of limitations has passed. The statute of limitations can vary by state and type of claim, but in most cases is two years from the time of injury.
How do I file a claim with Essure?
You can file a claim for Essure complications if you are within the statute of limitations and you have documentation that you experienced medical complications as a result of the permanent birth control. An experienced product liability lawyer can help you to determine if you can pursue a case against Bayer and can assist you in the process of filing your claim.
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