The latest in an eventful year for Bayer Pharmaceuticals is a $1.6 billion settlement to resolve claims against its Essure contraceptive device. The announcement comes just months after Bayer agreed to a $12.1 billion plan in June to settle various lawsuits it had inherited from its $63 billion acquisition of Monsanto. This most recent deal was reached to settle a portion of the 39,000 lawsuits, consolidated in California and Pennsylvania, alleging the Essure device caused excessive bleeding and pelvic pain as well as failing to prevent pregnancies. The defendants include Bayer and Conceptus, the original manufacturer of the device before Bayer’s acquisition of the company in 2013. The $1.6 billion amount will be used to settle approximately 90% of these suits, with an allowance for the additional outstanding claims. Whether the remainder of these suits will end in settlement is still a question to be answered in the upcoming months.
The Essure Contraceptive Device
First approved for contraceptive use in 2002, Essure is a device that is implanted through the cervix and into the fallopian tubes. The device consists of 2-inch-long metal coils, around which scar tissue builds to form a barrier to stop sperm from fertilizing eggs. The device, however, has a history of complications. Many women have complained that the coils became loose or pierced the walls of their fallopian tubes, causing pain and other serious side effects such as autoimmune conditions. In some cases, removal of the implant required a hysterectomy.
From 2002 through January 2018 (the year Bayer discontinued the sale of Essure devices), the U.S. Food and Drug Administration (FDA) received 26,272 adverse event reports about the device. In response, in February 2016, the FDA ordered Bayer to conduct a post-market safety study and add a warning on Essure’s product label. The FDA also required that a decision checklist be completed by new patients, confirming their knowledge of the device’s risks and benefits. After the FDA’s decision, Essure sales dropped by approximately 70% and a surge of lawsuits began to mount.
When Bayer decided to discontinue the sale of the device starting in 2018, the company cited issues regarding the overall declining use of birth control, the rise of long-acting reversible contraceptives, as well as “inaccurate and misleading publicity about the device.” Bayer’s official discontinuance of Essure also fell right before the premiere of a Netflix documentary, “The Bleeding Edge,” which investigates the medical device industry and features a group of women who had lobbied Congress for years regarding Essure’s dangers.
Around this time, in July 2018, CNN reported that from August 2013 through December 2017, Bayer paid 11,850 doctors $2.5 million related to Essure for consulting fees and similar services. Although the payments were legal, the report caused controversy due to the obvious concern of money unduly influencing a doctor’s recommendation of the device. According to the data, Dr. Cindy Basinski, an Indiana doctor who was paid $168,068 for consulting fees from August 2013 through 2017, was the second-highest-paid doctor in connection to Essure. Although the database only covered a five-year period, Basinski admitted that she also received payments from Bayer for about five years prior to 2013, making about $5,000 to $7,000 per year, according to her approximation. Basinski adamantly defended Essure and at the time of the report, stated that she would continue to implant the device in her patients until it went off the market. However, a number of Basinski’s patients, such as Christina Potts, described the doctor as “a cheerleader” for Essure. A year after Potts was implanted with the device, she developed headaches, joint pain, cramping, and fatigue, which resulted in a hysterectomy to remove the device.
Reported Injuries from Essure Usage
Women across the 39,000 lawsuits claimed similar injuries, with some still suffering from chronic pain and inflammation due to metal fragments of the device that could not be removed from their bodies. As one complaint filed in Pennsylvania alleges, Essure “migrates from the [fallopian] tubes, perforates organs, breaks into pieces, and/or corrodes wreaking havoc on the female body.” Remaining fragments and other materials left in the body are also alleged to have caused autoimmune conditions.
The complaints alleged that Bayer acted negligently in failing to properly train doctors on how to implant the device, relying on “Essure Simulator Training” rather than real, hands-on experience and that the completion of said training was never verified. Furthermore, the complaints alleged that Bayer encouraged unqualified doctors to sell the devices to patients, in exchange for fees, and that Bayer’s statements regarding the efficacy of Essure’s safety constituted a breach of express warranty.
The complaints also allege that Bayer failed to disclose to the FDA the thousands of complaints it had received regarding injuries stemming from the malfunction of its devices. David Kessler, a former FDA commissioner and expert witness for the plaintiffs, stated that “regulators may have demanded stricter labeling as early as 2006 if they’d been aware of all the problems patients claimed.” As Kessler explained in a 2019 report to the court, “[a] medical device company has a responsibility, independent of what FDA directs it to do, to alert physicians and patients to risks that were unknown to or poorly understood by FDA but were known to the company.”
Last month, a California state court judge unsealed thousands of documents filed as part of the litigation in Essure Products Cases, JCCP No. 4887, Superior Court for Alameda County, California. The documents, which included internal files of Conceptus and Bayer, are said to have “brought to public light” the dangers of Essure, according to the lead plaintiffs’ lawyer in California. Whether in response to the unsealing or just a coincidence, Bayer offered its settlement shortly thereafter.
The terms of the $1.6 billion settlement are mostly confidential, with negotiations still ongoing for the remaining 10% of suits that did not settle. The settlement includes all of the jurisdictions in which the majority of lawsuits were filed – the state of California Joint Council Coordinated Proceedings and the U.S. District Court for the Eastern District of Pennsylvania. According to Bayer, the company is not admitting any wrongdoing or liability but rather, offers the settlement to “distractions and uncertainties associated with this litigation.” The settlement does not have any impact on pending litigation in countries outside the United States.
The Future of Bayer
Essure is not the only product that has created legal troubles for Bayer. Since its June 2018 acquisition of agricultural giant, Monsanto, Bayer has also been embroiled in tens of thousands of lawsuits claiming that the company’s weedkiller, Roundup, causes cancer. After agreeing to an over $11 billion settlement of these claims in June, Bayer also announced to would settle for up to $400 million to settle lawsuits in relation to another Monsanto product, Dicamba. Unsurprisingly, Bayer stock has experienced decreases in value over the years, dropping close to 3% after the Roundup announcement. Bayer’s future is largely determined by their ability to settle these claims and more importantly, prevent additional lawsuits of such magnitude moving forward.