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Bayer failed to convince a federal judge to throw out all claims raised in Essure lawsuits filed by women who experienced problems with the controversial birth control coils, clearing the way for cases to move forward.
U.S. District Judge John R. Padova, in the U.S. District Court for the Eastern District of Pennsylvania, rejected a motion for summary judgment filed by the manufacturer, which sought to dismiss claims brought by 12 women, who Bayer argued failed to file their case before the statute of limitations expired.
In a memorandum (PDF) issued on March 27, the court concluded that the tort claims for six of the plaintiffs were time-barred, and that some of the warranty claims for nine of the 12 claims are time barred. However, Judge Padova determined that the remaining claims can proceed.
Bayer currently faces more than 18,000 product liability lawsuits filed nationwide, each involving similar allegations that side effects of Essure coils caused women to experience painful and debilitating complications after receiving the birth control device.
While there is no multi-district litigation (MDL) established for Essure claims in the federal court system, more than 1,000 plaintiffs are involved in a consolidated action pending in Judge Padova’s court.
Although Essure was recalled from the market in most countries in 2017, Bayer continued to sell the device in the United States until the end of last year. Amid mounting pressure and publicity about the injuries women were experiencing from Essure, the company announced in July 2018 that it was removing Essure from the US. market on December 31, 2018.
Following the decision, the FDA confirmed that Bayer would be required to extend a post-market surveillance study and take other measures to ensure long-term Essure oversight well after production and sales have ceased.
FDA officials have reported that the agency received about 12,000 adverse event reports related to the Essure birth control implant last year. In April, the FDA made changes to Essure’s premarket approval, requiring both doctors and patients to sign off on a checklist of potential Essure complications.
In November 2016, following controversial hearings in the U.S., where testimony was heard from large numbers of women and medical experts, the FDA decided not to recall Essure in the United States. However, the agency did require Essure black box warnings, which are the strongest that the FDA can require a medical device carry.
Approximately 750,000 women worldwide have been implanted with the device, and Bayer has previously estimated that 70% of those have been implanted in women in the U.S.
The manufacturer has reportedly spent about $413 million defending the litigation over the last year, and may face substantially greater liability at trial if Essure settlements or another resolution for the cases is not reached.