Without admitting wrongdoing, the German pharmaceuticals and agrochemicals group said it has reached agreement with lawyers for 90% of the plaintiffs in all of the jurisdictions with significant volumes of cases, including the state of California Joint Council Coordinated Proceedings (JCCP) and Federal District Court for the Eastern District of Pennsylvania (EDPA). The provisions should cover all claims, it believes. Settling claimants will be required to dismiss their cases or not file.

The nearly 39,000 women who filed lawsuits beginning in 2014 – a year after Bayer acquired US-based contraceptive device manufacturer Conceptus for $1.1 billion – claim complications from the fallopian tube implant ranging from allergic reactions and chronic pelvic pain to forced hysterectomy or even death.

According to US press reports, the Food and Drug Administration (FDA) required Bayer to catalog all cases that extended to 53 deaths, 24 device malfunctions and 1,376 serious injuries.

Hit by restrictions, negative publicity and a 70% sales plunge, Bayer voluntarily withdrew Essure from the US market at the close of 2018, two years after the FDA in 2016 required warning labels about potentially serious side effects and subsequently obliged patients and their physicians to sign a statement that they were aware of the risks.

The Leverkusen-based group’s withdrawal of the device came a year after it had stopped selling the device in 20 other countries.  In all instances, Bayer said the decision to pull the product was based on declining sales and the conclusion that the Essure business was no longer sustainable.

 A lawyer for the plaintiffs told US media that the first trials had been due to get under way in March of this year, but were sidelined by the pandemic. Bayer’s decision to now settle these cases out of court will free up resources to focus on the $10.9 billion plan to resolve tens of thousands of lawsuits claiming that Monsanto’s glyphosate-based Roundup herbicides can cause non-Hodgkin lymphoma.

Bayer is dogged by more US lawsuits

Though the Roundup cases are the most prominent, and expensive, Bayer recently has had a rough ride in the US as regards litigation. In June, it agreed to pay $820 million to settle claims by California and other US west coast local governments that the former Monsanto – acquired by the German group in 2018 –  polluted waterways with PCBs more than four decades ago.

In yet another US legal challenge, Bayer has also tentatively agreed a $400 million payout to resolve crop damage claims related to its own dicamba-based herbicide portfolio. This settlement in part is contingent on an agreement with compatriot BASF, which is also being sued.

Author: Dede Williams, Freelance Journalist