Bayer announced today that after thousands of reports of injuries from women and repeated safety restrictions by regulators said Friday that it will stop selling the device in the U.S.
What is the deal with these medical devices, and what is happening with the lawsuits in these cases?
The Essure Permanent Birth Control System was to provide women with a safer, less involved (and painful) tubal ligation alternative. This medical device was triumphantly marketed as the “[only] FDA-approved permanent form of birth control with a procedure that can be performed in an office setting without general anesthesia.” Unfortunately for the 750,000 women who have used this system since the Food & Drug Administration (FDA) approved it in 2002, both new scientific research and anecdotal evidence suggest that Essure has caused substantial injuries to thousands of patients, motivating calls among consumer advocates for the drug’s recall and spurring legal action.
This page was written many moons ago (2018 actually) but we do provide a 2023 Essure litigation update at the bottom of this page.
How Essure Works and Why the System Appeals to Women
The Essure system consists of two flexible coils that are inserted into the Fallopian tubes to produce permanent sterilization. Both patients and doctors have liked Essure, at least conceptually, because the system offers a less-invasive solution than tubal ligation and other birth control surgeries, ostensibly with shorter healing time and fewer side effects. Premarket studies tracked women’s pregnancies before and after Essure implantation, leading Bayer to assert that the device is 99.83 percent effective at preventing pregnancy and that “mild to moderate pain” and “spotting” are the most common side effects.
Alarming Studies and Anecdotes about Essure
Unfortunately, the facts may be more complicated than the product’s advocates will admit. For instance, a New York Times expose reported: “The F.D.A. approved Essure after a fast-track review process that prioritized the device because it offered the first alternative to surgical sterilization and promised a quick recovery…
Since then, the agency has received more than 4,000 reports of serious complications related to the device, including severe back and pelvic pain, heavy prolonged menstrual periods, and coils that pierced the fallopian tubes and lodged in other organs. According to a citizens’ petition filed with the F.D.A., an inspector was given records of 16,047 complaints made to the original manufacturer, Conceptus, between 2011 and 2013, when Bayer acquired a majority interest in the company.”
In light of these developments, many women have now filed lawsuits against Bayer, claiming that the system caused permanent pain and other damage. In September 2015, the FDA held a meeting to review the safety of this once-approved method of birth control – a meeting that was called after the agency realized it had received thousands of reports of adverse health effects from Essure.
Although Essure had been given conditional premarket approval (CPMA) by FDA, the CPMA was later invalidated, according to an Essure lawsuit filed in California. The lawsuit claims that the FDA invalidated the CPMA, rendering Essure “invalidated,” because Bayer failed to comply with two expressly stated conditions in the CPMA: that the company reports any adverse events within 10 days of learning about them, and that that company reports any information that the device had “caused or contributed to a serious injury.”
According to the FDA, Bayer failed to report eight separate cases of perforation that were brought to its attention. The FDA also alleged that the company failed to follow safety and regulatory procedures in the manufacture of the Essure system. The patient in the California case was forced to have a hysterectomy, suffering all its attendant side effects, after years of experiencing inflammation and burning pain which appeared to be the result of the Essure system she had implanted.
The legal language is an effort to get around preemption. Certainly, preemption is a complicated subject. But, simply put, Bayer is arguing that a key Supreme Court case has found that a law called the Medical Device Act prevents victims from bringing civil lawsuits involving medical devices that have received premarket approval from the FDA.
Plaintiffs’ lawyers are trying to get around this ridiculous interpretation of the law by arguing that Bayer’s approval was invalidated by the conditions of pre-market approval. Will this work? It remains to be seen. The fight for justice for women who have suffered from Essure is not over. The first big issue for the Essure litigation was whether federal preemption. Plaintiffs’ lawyers climbed over that hill in McLaughlin v. Bayer Corp where the court rejected Bayer’s asserting that preemption applies.
Last October, a California state court judge ordered that Essure lawsuits brought by almost 1,000 women were to be centralized in Alameda County Superior Court. This makes California state court a mini MDL class action lawsuit.
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Are Punitive Damages Possible Against Bayer?
Plaintiffs’ lawyers claim Bayer willfully hid the problems with Essure. How? The claim is that Bayer carefully manipulated its reports to the FDA and presented false and misleading information and did so to trick women and their doctors into believing that Essure was worth the risk.
The FDA was sleeping on Essure for a while but finally jumped in and required a black box warning for Essure. A black-box warning “is designed to call attention to serious or life-threatening risks.” So it is a big deal. (It is also important that the FDA wanted to place a black box warning because it shows the FDA thought the prior warnings were not strong enough.)
The FDA also required that every potential female Essure patient sign off on a checklist that explains all the risks. It is specifically tailored to the risks associated with the device. The checklist specifically warns of device migration and perforation of organs, side effects that Conceptus and Bayer had been cited for hiding from the FDA and the public for years.
If a jury believes these arguments, there could be both compensatory damages and punitive damages in the Essure lawsuits.
2023 Essure Lawsuit Update
Bayer ultimately paid $1.6 billion to resolve Essure lawsuits in 2020. Our law firm is no longer handling these claims in 2023.
On October 30, 2023, the FDA updated the status of the ongoing Essure implant post-market study, which follows women for three years post-implant. The update comes after the FDA last year criticized the study due to a high dropout rate of 47.4%, which compromised the data quality.
Despite the dropout rate now surpassing 51%, the agency has reclassified the study’s status from “inadequate” to “ongoing.” This change follows Bayer’s implementation of new strategies to improve study follow-up at the FDA’s behest. The FDA says it remains engaged in monitoring the study and plans to work with Bayer on additional measures, if needed to ensure the study’s integrity.