In Mack v. CooperSurgical, Inc., et. al., Case No. 1:22-cv-54-RAH, an Alabama federal judge has dismissed a Filshie Clips lawsuit against CooperSurgical Inc. and others, ruling that the claims are time-barred under the state’s two-year statute of limitations because the plaintiffs’ cause of action accrued by mid-2017, yet they did not file suit until January 2022. Here, CooperSurgical and Femcare denied the allegations, and argued that the claims are preempted by the Medical Device Amendments to the Food, Drug & Cosmetic Act, U.S. Food and Drug Administration regulations and federal laws under the Supremacy Clause of the U.S. Constitution.
On Oct. 4, Judge R. Austin Huffaker, Jr. of the U.S. District Court for the Middle District of Alabama found the limitations period was not tolled by fraudulent concealment because plaintiffs failed to show that defendants fraudulently concealed the risk of device migration from plaintiffs or their doctor. The Court noted that “[h]ere, there is no dispute that Ms. Mack’s Filshie Clips were implanted in February 2017 and that, within months, she began experiencing complications — and therefore injury — from her Filshie Clips, including severe pain, cramps and bleeding. Since she did not file this lawsuit until January 27, 2022, under straight up accrual principles based on the date of injury, the Macks’ claims appear to be time-barred.
The Court rejected plaintiffs’ fraudulent concealment tolling theory because there were no factual allegations “above and beyond the wrongdoing upon which the plaintiff’s claim is founded to keep a plaintiff from suing in time.” The Macks also invoked the doctrine of equitable tolling, which was likewise rejected because it was “thin” on facts. Jude Huffaker also granted summary judgment for defendants on the failures to warn and demoing defects claims based upon Federal pre-emption. Filshie Clips are silicone-lined titanium medical devices that work by exerting continuous pressure on the fallopian tubes, acting as a form of long-term birth control. Filshie Clips are designed to remain permanently attached.