Bayer Rotten Score Breakdown

Bayer agreed in August 2020 to pay approximately $1.6 billion to resolve the majority of U.S. claims involving its Essure permanent birth-control device, after tens of thousands of women alleged that the implanted device caused serious injuries and complications. Essure was a permanent female sterilization device consisting of flexible metal inserts placed into the fallopian tubes. Scar tissue would develop around the inserts, creating a barrier intended to prevent pregnancy. Unlike traditional tubal ligation, implantation did not require a surgical incision. Bayer announced that settlement agreements would resolve approximately 90% of nearly 39,000 filed and unfiled U.S. Essure claims. The agreements covered jurisdictions with large volumes of litigation, including California and the federal court in the Eastern District of Pennsylvania. Bayer – $1.6 billion Essure claims resolution: https://www.bayer.com/media/en-us/bayer-announces-resolution-of-us-essuretm-claims/ Women bringing claims against Bayer alleged a range of device-related injuries and complications. Reported problems associated with Essure have included persistent pain, perforation of the uterus or fallopian tubes, migration of device components, abnormal bleeding, allergic or hypersensitivity reactions and the need for surgical removal. The U.S. Food and Drug Administration has maintained an extensive post-market surveillance programme for Essure and has received large numbers of medical-device reports concerning potential problems with the device. The FDA emphasizes that adverse-event reports do not by themselves establish that Essure caused the reported injury, because such reports can contain incomplete information and cannot establish incidence rates. FDA – Problems reported with Essure: https://www.fda.gov/medical-devices/essure-permanent-birth-control/problems-reported-essure FDA – Essure benefits and risks: https://www.fda.gov/medical-devices/essure-permanent-birth-control/essure-benefits-and-risks Regulatory scrutiny increased substantially before Essure disappeared from the U.S. market. In February 2016, the FDA ordered Bayer to conduct a post-market surveillance study designed to gather additional information about Essure's benefits and risks and announced that the product would receive stronger warnings. The FDA subsequently required a boxed warning and Patient Decision Checklist intended to make women considering Essure aware of important risks associated with the device. In April 2018, the FDA took the additional step of restricting the sale and distribution of Essure. Healthcare providers were required to review an FDA-approved patient-doctor discussion checklist with prospective patients and give them an opportunity to sign it before implantation. The FDA said the restriction was intended to ensure that women received adequate information about Essure's risks and benefits before deciding to use the device. FDA – Regulatory actions involving Essure: https://www.fda.gov/medical-devices/essure-permanent-birth-control/fda-activities-related-essure In July 2018, Bayer informed the FDA that it would stop selling and distributing Essure in the United States after December 31, 2018. The United States had been the final country where Bayer continued selling the device. By the end of 2019, unused Essure units were to have been returned and were no longer available for implantation in the United States. Bayer maintained that its decision to discontinue Essure was made for business reasons following declining sales, rather than because of a change in its assessment of the product's safety or effectiveness. Company response: Bayer has consistently defended Essure's safety and effectiveness and has denied wrongdoing. When announcing the $1.6 billion resolution in 2020, Bayer expressly stated that the settlement agreements contained no admission of wrongdoing or liability. Bayer said resolving the litigation would allow the company to avoid the distraction and uncertainties associated with continuing large-scale litigation. Settling claimants were required to dismiss their lawsuits or agree not to file them. Bayer has also stated that its decision to discontinue U.S. sales did not result from new safety concerns and that it continued to stand behind Essure's safety and efficacy. FDA – Current information for Essure patients: https://www.fda.gov/medical-devices/essure-permanent-birth-control/information-patients-and-health-care-providers-essure Importantly, the FDA has not recommended preventive removal of Essure for women who are using the device successfully. The agency says women who have been successfully using Essure for contraception can continue doing so, while women experiencing symptoms or who believe they may have device-related problems should consult their healthcare provider. Key facts: Bayer agreed to approximately $1.6 billion in settlements; the agreements were intended to resolve approximately 90% of nearly 39,000 filed and unfiled U.S. claims; women alleged serious injuries and complications associated with Essure; the FDA required additional post-market surveillance and strengthened warnings; Essure received a boxed warning and Patient Decision Checklist; in 2018 the FDA restricted its sale and distribution to strengthen informed consent; Bayer stopped U.S. sales after December 31, 2018; and Bayer denied wrongdoing and maintained that discontinuation resulted from declining sales rather than a change in its assessment of Essure's safety. The case is significant because of the extraordinary scale of the litigation and regulatory intervention surrounding a permanently implanted medical device. However, the evidence should be framed accurately: the $1.6 billion settlement did not constitute an admission by Bayer that Essure caused the injuries alleged by plaintiffs. The strongest established facts are the scale of the claims and settlement, the FDA's escalating regulatory actions and safety-information requirements, Bayer's eventual discontinuation of U.S. sales, and the continuing FDA post-market monitoring of women implanted with the device.