Meet Kimberly Dougherty, Esq. an attorney in Boston and has spent most of her legal career advocating for women’s’ health issues. Kimberly currently serves as the President of the Massachusetts Women’s Bar Association, where she works to increase gender equity in the legal profession. She is lead sponsor of the website BirthControlProblems.com.
For many mother’s birth control can be a controversial one for many reasons. There may be a clash of religious beliefs that causes an uproar with birth control, or there could be a new birth control product that creates a stir. In 2002, a company called Conceptus received FDA approval for its new birth control product called Essure. For 11 years, the product proved to be successful and popular. But that would change when the product was pushed into a bigger marketplace by a much bigger company.
In 2013, the Bayer Corporation bought Conceptus and took over the Essure product line. Almost immediately after taking over the Essure line, Bayer started to receive complaints about the product from thousands of women. In what seemed like an immediate whirlwind of activity, both Bayer and the FDA found themselves involved in lawsuits regarding Essure and the danger it poses to women.
What Is The Essure?
According to BirthControlProblems.com, Essure is a pair of metal coils that are implanted in a woman’s fallpian tubes using what is supposed to be a simple out-patient process. Over the span of one to three months, scar tissue forms around the metal coils and that blocks the tubes to the point where the woman can no longer conceive children.
Some of the initial complaints about Essure came from women who had become pregnant after their procedures, but those complaints were dismissed because Bayer explicitly warns against unprotected sex immediately after the implant. The manufacturer warns patients that it takes at least 90 days for the product to become effective. But when more serious health complaints started to reach Bayer, that is when the drug manufacturer knew it had an issue.
The Problems Being Reported
The problems with Essure can be broken down into health and legal issues. The health issues come from cases of women who have experienced serious medical issues because of Essure implants. BirthControlProblems.com lists 16 possible side effects linked to Essure including,severe abdominal pain, excessively heavy periods and bloating after getting the implants which some women have complained about after receiving the implant. There have also been reports of women who had to have emergency hysterectomies to get the implants removed because of the severe discomfort the product caused.
The legal issues with Essure revolve around the FDA approval in 2002 and the protections that it offers. Since the FDA approved Essure using a special process called pre-market approval, Bayer is shielded from being sued for any issues involving the product. Before Bayer can be sued, the FDA would have to agree to re-evaluate Essure and determine its new status.
Essure Lawsuit Updates
The Essure lawsuits filed against the FDA dealt with the approval process used for the product and the possibility that misinformation was used to rush Essure through the process. Patients trying to sue for their pain and discomfort due to Essure feel that the FDA should not only allow Bayer to be sued for the product, but that the FDA itself should assume responsibility for the system it used to approve what became to be a dangerous product to some patients.
In 2015, the FDA decided to take a form of action that many health advocates feel falls well short of what needs to be done. The FDA now requires that a black box warning be put on Essure packaging and includes a patient checklist that every doctor must go through with every patient before going through with the implants. The black box warning is the strongest warning label the FDA has, but the women suffering from Essure-associated pain feel that the measure is not enough.
A class action suit was filed against Bayer that demanded the company is held accountable for its negligent product. In March 2016, the United States District Court for the Eastern District of Pennsylvania threw out all but two counts in the pending class action lawsuit. There have been five lawsuits in total filed against Bayer (including the class action suit) based, in part, on 4,800 reports of adverse effects from the product from women all over the country. This recent ruling from a U.S. District Court will make it very difficult for any of those lawsuits to go forward.
With Bayer’s protection from litigation holding up in court, the victims of Essure are running out of options. While the Pennsylvania court’s decision did leave the opportunity to amend and refile the lawsuits against Bayer on the table, some legal observers are starting to wonder if the victims of Essure will ever get their day in court.