JURIST Guest Columnist Darian Carrow, a staff writer for ConsumerSafety.org, discusses the potential uproar of lawsuits stemming from Bayer’s sterilization device…
From intrauterine device Mirena, to anticoagulant Xarelto, to gardening weed killer RoundUp, the German conglomerate Bayer has attempted to dip their feet into awe-inspiring advances in many sectors of the science field. Unfortunately, not all of the results have been ideal with the corporation now facing thousands of lawsuits from consumers over the past several years.
While Bayer has been under fire for many of their products, they are currently facing more than 18,000 lawsuits over their implantation method of female sterilization, Essure. Women all over the United States are suing the pharmaceutical giant for serious side effects that occurred as a result of the defective device.
Conceptus Inc, the original manufacturer of Essure, was obtained by Bayer in April of 2013. Around the same time, a slew of adverse events was reported to the U.S. Food and Drug Administration (FDA) regarding the permanent birth control device. Women have reported the development of autoimmune disorders, migrating devices, and unintended pregnancies. There is even evidence that suggests that the manufacturer failed to report many adverse events they knew about and altered records to show favorable information.
The marketing behind the product showed it as a quick, safe, and effective method of permanent birth control for women. But women complain about false marketing as many of the health risks that they experienced were not expressed by physicians before implantation.
Plaintiffs claim that the manufacturer failed to inform patients and physicians of possible dangerous side effects. Some women have been forced to have additional operations in an attempt to correct complications that the device caused. Women’s organs have been perforated, devices have broken inside fallopian tubes, and many women have endured years of pain and suffering.
Women are seeking several types of damages as a result of the pain and suffering from Essure, from compensatory damages for medical costs, to general damages for mental and emotional anguish. Consumers are also seeking punitive damages in order to punish Bayer for developing and selling a harmful product and to stop the company from making this negligent practice into a habit.
The FDA did step in several times over the years in an attempt to regulate the reports and lawsuits by restricting sales to women who reviewed a patient-decision checklist with their provider that discussed the possible risks of Essure. But the introduction of these new safety warnings also led to more lawsuits. Reports show that before the new safety warnings, Bayer faced 3,000 lawsuits, and after, they faced more than 16,000.
Bayer’s annual reports acknowledge the lawsuits and the claims from women, but they also defend their product’s effectiveness and safety. Bayer denies any problems with the product and claims that their benefit-risk profile still stands. They even stand by the original labeling, claiming that the FDA reports were false and some of the reports had to be from the same women. According to the company, they always properly disclosed side effects and believe that women should be wary of all birth control options because side effects are inevitable with every contraceptive method.
Even when the company voluntarily discontinued the product in the summer of 2018, they continued to back the effectiveness of the product, claiming the reasoning for halting sales was because there was no longer a marketin the United States for the product. But demand for the product started to fall when the reports of dangerous side effects and lawsuits were published.
In Bayer’s announcement to remove Essure from the market, they also claimed the decline in sales was due to “inaccurate and misleading publicity,” which some attribute to a recent Netflix documentary, “The Bleeding Edge.” The documentary dives into the medical device industry, following an Essure patient who suffered from severe adverse events as a result of the device. Though the documentary was quite damning for Bayer, the company did not address it in its announcement of discontinuation. With the release of the Netflix documentary, more lawsuits are expected to surface.
Women have also come together to form a Facebook group called “Essure Problems,” where they gather together to discuss the hardships they have endured because of the product, news regarding the device, and legal steps they are taking as a result of Essure.
Some say that Bayer’s decision to halt Essure sales could trigger an uproar of settlements, as the device will no longer be available, creating a possible deadline for when women can file cases against the company. However, there is currently a steady flow of cases coming in from women who have struggled for years as a result of the device.
Darian Carrow is a staff writer for ConsumerSafety.org who strives to inform consumers of harmful products they might encounter. With experience in editorial communications, Darian hopes to be a trusted source for the general public, journalists, and wellness enthusiasts and has received certification in CDC Health Literacy for Public Health Professionals.
Suggested citation: Darian Carrow, Female Filings: A Look Into the Current Essure Lawsuits, JURIST – Academic Commentary, Feb. 12, 2019, https://www.jurist.org/commentary/2019/02/Darian-Carrow-female-filings-a-look-into-the-current-essure-lawsuits/
This article was prepared for publication by Brittney Zeller, an Associate Editor for JURIST Commentary. Please direct any questions or comments to her at email@example.com