In 2013, a North Carolina woman made the choice to move forward with Essure because she wanted a permanent solution for birth control. However, the device didn’t work as she had hoped and instead caused her irreparable harm.
Lawsuit Filed Against Bayer After Traumatic Delivery
After Essure was implanted in her fallopian tubes, the plaintiff returned for rechecks, only to be told that the implant on her left side had only partially blocked the tube. She began to use additional birth control methods in addition to the Essure, which was upsetting enough since the entire point of receiving the implant was to be able to discontinue other forms of birth control.
Aside from that issue, everything appeared to go well until June 5th, 2015, when the plaintiff felt movement in her abdomen and she realized that despite all of her precautions, she had become pregnant. Within two days, she began to experience abdominal pain and then sudden bleeding, followed by her water breaking.
She was rushed to the hospital where she gave birth to a stillborn baby girl, estimated to be about 24 – 27 weeks. As if this wasn’t traumatic enough, she was informed that the Essure implant had completely eroded through the left fallopian tube and she required a total hysterectomy because of the extensive damage.
She was told that the reason for her early labor and the stillbirth of her child was because of placental abruption.
After taking some time to heal and mourn, she and her husband both filed lawsuits against Bayer, alleging four main points:
- Bayer failed to disclose to both the FDA and the medical community that numerous adverse events that had occurred to previous patients.
- Bayer failed to update its warning labels and marketing materials to reflect the risks associated with Essure.
- Essure was sold with manufacturing defects.
- Bayer failed to properly train doctors on how to properly insert the device.
They are hoping to recover compensation for the physical and emotional trauma that has been endured, as well as the death of their daughter. In addition to this, they hope to raise public awareness about the issues with Essure.
Lawsuit Also Filed Against Senior Sales Consultant
A second lawsuit has been filed by the couple against the senior sales consultant that covered their territory at the time the device was implanted. They allege that he “failed to provide information that was necessary for the medical and scientific community to protect each patient’s interest.”
Bayer Defense Argument Has Already Failed
In 2016, Bayer attempted to argue that Essure cases shouldn’t be allowed to proceed because the device was approved by a federal entity, the FDA. However, a California judge ruled that cases would be allowed to proceed because the company is still required to create safe products.
Many applauded this ruling, as it sends a message to medical device and drug manufacturers that they can’t expect the federal government to take the blame for any issues that arise because of their products.
18,000 Lawsuits Set To Move Forward Against Bayer
On December 31st, 2018, Bayer made the decision to pull Essure sales in the United States – however, this means that any physicians with the product in office will still be able to continue implanting the device for the next year. This means that thousands of women may join the 18,000 that have already filed a lawsuit against Bayer alleging that Essure caused them serious harm.
Although none of the cases have yet gone to trial, it is only a matter of time before the first cases are heard in court.
Has Bayer Settled Any Essure Cases?
No, at this time, Bayer has not settled any Essure cases. However, that doesn’t mean that they won’t in the future. Often, companies fight through the first few trials before considering the option to settle.