As of this writing, more than 17,000 personal injury lawsuits have been filed against Bayer Healthcare over Essure, a birth control device that features two metal coils that are implanted in the fallopian tubes. Some of the most common device risks include bleeding, severe pain, and organ damage.
Plaintiffs claim Bayer failed to warn patients of the potentially severe complications of using the device. In July 2018, the healthcare giant announced it would suspend all sales of the Essure birth control device by the end of the year.
But for the hundreds of thousands of women who have Essure, what can they do if they suffer a health complication? A possible solution is to file an Essure lawsuit with the assistance of a skilled product liability attorney. You can speak to one of our Essure lawyers at no cost or obligation to determine if you have a case.
Below is more information about Essure lawsuits and other important information about this potentially dangerous birth control device. If you think that you have been injured by the Essure device, you should be seen by a medical professional immediately to confirm the medical diagnosis. This action will be essential to a potentially successful Essure claim.
Why Women File Essure Lawsuits
While Bayer officials claim that the medical device is 99% effective to prevent pregnancies, women have sued Bayer because of several complications related to the Essure sterilization device. Complaints from plaintiffs have included broken devices, migration and sometimes expulsion of the birth control device.
Women have sought damages for their medical costs to deal with complications and symptoms of device malfunction, and other expenses. Many victims also have pursued non-economic damages, including pain and suffering, emotional and mental trauma, and even punitive damages against Bayer.
Some of the complications and side effects that lead to Essure lawsuits are:
- Additional surgeries
- Chronic fatigue
- Unwanted pregnancy
- Hair loss
- Autoimmune disorders
- Fetal death
- Scar tissue
- Brain fog
- Metal allergies
- Back pain
- Uterus perforation
- Problems with menstruation
- Weight gain
- Severe or chronic pain
Current Essure Litigation
Bayer’s latest financial reports reveal approximately 16,1000 lawsuits underway in federal and state courts across America. These Essure lawsuits are individual actions; there are not any class action lawsuits or multidistrict litigation (MDL) in motion.
However, in 2016, 28 plaintiffs in a group submitted a petition to court to transfer their individual cases using the MDL process. This process is overseen by the Judicial Panel on Multidistrict Litigation. But soon after this petition was submitted, the judge agreed to consolidate the cases in court. The MDL motion was pulled and the cases are still separate.
Some states, including California, have set up processes that coordinate Essure cases with processes similar to an MDL. But as of 2018, no more efforts have been tried to make a federal MDL. But as there are more Essure lawsuits being brought, it is possible that an MDL may be created in the near future.
In some of the individual lawsuits against Bayer, women claim a variety of serious charges:
- Design faulty product
- Willingly and knowingly hid Essure dangers from the public
- Did not train doctors properly with the right methods to use Essure
- Did not warn the public about risks that are related to Essure
- Breach of warranty – express and implied
Bayer has claimed that it is shielded from liability and negligence lawsuits because of preemption laws. These laws state that people may not sue a medical device manufacturer if the device was completely tested before FDA gave its approval. But many lawsuits are going forward against Bayer on the grounds the company violated the premarket approval process set by FDA. They claim that the company withheld important information from the agency and has lost its protection from lawsuits.
How to File Essure Lawsuit
Starting a dangerous device lawsuit is quite straightforward. To start the process, you need to contact a skilled Essure attorney who has the knowledge, skills, and resources to go to court against one of the largest pharmaceutical companies in the world.
If your attorney determines that your situation could result in a successful Essure lawsuit, he will request to review your medical records. These records will be important in determining the validity of your claim. The medical investigation is done by a licensed physician who will try to prove that your health condition was caused by the Essure device. Common problems are device migration and perforation of arteries and/or organs.
If the medical examination confirms your claims and shows your medical problems developed within the state’s statute of limitations, your personal injury lawyer will go ahead with the filing of your claim.
Your attorney will handle most of the responsibilities related to the legal claim. He will collect all of the documents, testimony and related evidence to fight the powerful lawyers that work to defend Bayer Healthcare.
It is important to file your Essure lawsuit as soon as you have a diagnosis of your condition from a doctor. Victims often delay the filing of their case and miss the statute of limitations for their state. These deadlines are unforgiving and strict. If you miss just one of the essential deadlines, your entire case could be thrown out.
Essure History with FDA
FDA originally approved Bayer’s product as a Class III medical device in 2002. After the approval, Bayer had to submit regular reports to the agency about the medical device’s efficacy and safety. It also was required to report all adverse events. Even with these requirements, Bayer was cited by the agency for violations of these rules. These violations led to several actions by FDA:
- April 2018: 26,700 Essure complaints were filed with the agency from 2002 to 2017. FDA restricted device sales in April 2018.
- November 2016: FDA mandated a black box warning on Essure to highlight health risks: perforation, abdominal pain, and allergy.
- February 2016: FDA ordered the healthcare company to perform a new clinical study. The purpose of the study was to determine if there were higher risks of using Essure for certain women.
- January 2011: Bayer was flagged by FDA for using unapproved materials in the device. This was a violation of the device’s premarket approval. The approval required the firm to obtain additional approvals for device changes.
- June 2008: FDA informed Bayer that it had found out the company had made the device in an unlicensed facility since 2005. The company also was cited in an FDA 483 for not properly documenting their medical device manufacturing procedures.
For women who have suffered injuries from Essure, the next step is to possibly file a lawsuit against Bayer Healthcare. You could be entitled to damages such as the cost of medical bills, lost wages, pain and suffering and more.
If you have been hurt by the Essure device and want to pursue legal action against defective device manufacturers, talk to one of our Essure lawyers today for a free consultation.
- Bayer Essure Suits Skyrocketed as FDA Pushed Stronger Warnings. (2018). Retrieved from,https://www.bloomberg.com/news/articles/2018-07-25/bayer-essure-suits-skyrocketed-as-fda-pushed-stronger-warnings
- Essure Lawsuits. (n.d.). Retrieved from https://www.drugwatch.com/essure/lawsuits/