Many women may one day choose to undergo permanent birth control procedures. Designed to safely and effectively prevent pregnancies, procedures should provide few complications. Unfortunately, some products don’t maintain these high standards of ethics and safety, such as Essure. Currently the subject of a major lawsuit against its manufacturer, the Essure lawsuit was levied by a number of women who have experienced a variety of negative effects as a result of using Essure. The proceedings took a positive turn for the plaintiffs last week as a judge denied a motion for summary judgment by opposing lawyers.
Justifying The Essure Lawsuit
Essure is a permanent birth control product that is advertised as a “non-hormonal” method with a low recovery time. According to its website, of women who undergo the Essure procedure, “75% return to normal activities within 2 days.” From its advertisement, Essure seems to be no more than a root canal, temporarily inconvenient, but no more than a weekend lost.
The method used for Essure’s birth control process is similarly appealing. Flexible inserts are surgically placed into the fallopian tubes and over time, these inserts will create a barrier using scar tissue. While the procedure is simple to explain, there are some risks and the Essure does mention the following potential side effects:
- Perforation of the uterus
- Perforation of the fallopian tubes
- Identification of inserts in the abdominal or pelvic cavity
- Persistent pain
- Allergic or hypersensitivity reactions
While these side effects are not insignificant, they again seem to downplay the true dangers. Members of the Essure lawsuit have reported more severe side effects. Some of these include internal bleeding, autoimmune problems, and pregnancy.
The U.S. Food and Drug Administration (FDA) seems to agree with at least some claims in the Essure lawsuit. On April 9, 2018, the FDA released a Press Announcement restricting the sale and use of Essure in the United States. The reasoning for this decision, according to FDA Commissioner Scott Gottlieb, M.D., was that
“based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option.”
After the decision to restrict the use of Essure, the FDA released a series of legally-binding requirements to Bayer to update their warnings and labels on Essure within the U.S. Instead, in December of 2018, Essure was removed from American markets. While no claims can be made to the goings on behind closed doors, it is likely that the withdrawal was due to irreconcilable differences between Bayer and the FDA about the proper warnings and notifications for Essure.
For more information about Essure, and potential class-action lawsuits against Bayer, visit our full Essure topic page here.
The Essure Lawsuit Motion Dismissal
On March 28, 2019, a Philadelphia judge denied a motion by Bayer’s legal team for summary judgment of 12 class action lawsuit members who were part of the Essure lawsuit. The argument that the Bayer legal team presented was that the women in question were not eligible to file suit against Bayer because they had filed after the statute of limitations allowed them too. The plaintiffs argued that the statute of limitations clock began not when they received the Essure implant, but at the time that a medical professional determined the Essure implant to be the cause of their complications.
After deliberation, the judge agreed with the plaintiffs and denied Bayer’s motion for summary judgment. Included in the 12 plaintiffs were 6 personal injury plaintiffs for issues of persistent pain, bleeding, and autoimmune complications, 3 breach-of-warranty plaintiffs, and 1 fraud plaintiff who argues that Bayer did not inform her that Essure was not guaranteed to prevent pregnancy. With this determination, the Essure lawsuit will continue to move forward with class-action proceedings.
How The Essure Lawsuit Affects Consumers
This Philadelphia judge’s determination that the statute of limitations clock began when the women’s doctored determined Essure was to blame for their complications and not from the time of implantation, is a very generous advantage for other potential plaintiffs that may wish to join in the Essure lawsuit following this judgment. If you or a loved one have suffered injuries, complications, or unexpected pregnancies following the implantation of the Essure birth control device, Parker Waichman LLP is here to help. With teams of experienced trial lawyers who have argued numerous medical device defect cases, Parker Waichman can get you the compensation that you and your family deserve. Contact Parker Waichman today for a free consultation.