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Bayer has failed in an attempt to have a number of Essure lawsuits dismissed in Indiana, after a state appeals court ruled that dozens of claims brought by women who suffered injuries due to the birth control device will be allowed to proceed.
In an opinion (PDF) issued on December 31, the Court of Appeals of Indiana affirmed a decision by the lower court, which rejected Bayer’s motion for summary judgment on the pleadings in claims brought by more than 30 women, finding that sufficient allegations were identified upon which relief could be granted.
The Essure is a permanent form of birth control, involving flexible coils that are inserted into the fallopian tubes. The procedure is designed to cause scar tissue to develop that blocks the tubes and prevents insemination, but thousands of women have suffered painful and debilitating complications from the Essure device, including migration injuries, perforations, severe reactions and other problems.
Bayer currently faces more than 18,000 product liability lawsuits over Essure pending in state and federal courts nationwide, each raising similar allegations of design and manufacturing defects, claiming the manufacturer sold an unreasonably dangerous birth control device for years.
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 2018, amid mounting pressure and publicity about the injuries women were experiencing from the device.
In Indiana, Bayer tried to get the cases dismissed on the grounds that the claims were preempted by federal law and that some aspects of the complaints were deficient. A state court ruled against Bayer’s motion, which the company appealed to the appellate court, which again rejected Bayer’s arguments.
“We have concluded that the manufacturing-defect claim is viable. Thus, Bayer has not demonstrated that the complaint is devoid of allegations upon which relief could be granted,” the appeals court wrote. “Therefore, Bayer is not entitled to dismissal at this early stage of the proceedings.”
The appeals court noted that a jury could reasonably conclude that Bayer failed to comply with federal manufacturing standards, which led to the Essure device being defective and unreasonably dangerous.
FDA officials have reported that the agency received about 12,000 adverse event reports related to the Essure birth control implant in 2018. In April of that year, the FDA made changes to Essure’s premarket approval, requiring both doctors and patients to sign off on a checklist of potential Essure complications.
After the company decided to remove the birth control implants from the market, the FDA confirmed 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.