Sept. 5, 2016 – San Diego, CA — Another lawsuit against Bayer Healthcare regarding its permanent sterilization device Essure escaped federal preemption and is allowed to move forward on one claim, an Idaho federal judge ruled Aug. 30.
Chief U.S. District Judge B. Lynn Winmill decided the majority of claims alleged in the lawsuit were preempted by federal law, but kept the suit against Bayer alive by allowing one claim to move forward, Law360 reported Sept. 1.
The lawsuit was filed by Susan and Brian Richardson after the couple found out Susan was pregnant with twins one year after she was implanted in 2011 with Bayer’s supposed permanent birth control device Essure.
Judge Winmill reportedly allowed the couple’s suit to move forward on the claim that the company allegedly failed to warn about the risks of Essure.
The judge also allowed the couple to amend allegations the company failed to properly train implanting doctors and entrusted them with specialized equipment that was not regulated under the Food and Drug Administration’s Medical Device Amendments of 1976, Law360 reported.
Other claims made by the couple in the lawsuit were not able to proceed because they are preempted by federal law, a protection granted to Essure and other class III medical devices approved under the FDA’s Pre-Market Approval program.
Some of the claims quashed by federal preemption included allegations of manufacturing and design defects, negligent and fraudulent misrepresentation, and breach of implied and express warranty.
The Ninth Circuit Court of Appeals had reportedly ruled there was only a “narrow gap through which a state-law claim must fit to escape preemption” and the Richardson’s claim alleging Bayer’s failure to warn fit that narrow gap.
This is one of three relatively recent rulings regarding Essure claims and federal preemption. This past March, a federal judge in Philadelphia ruled two of 12 claims in a lawsuit filed by five women escaped preemption, while a judge in California came to a similar conclusion early last month and allowed the claims of 14 women to proceed.
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