Missouri Federal Court Rules Against Filshie Clip Plaintiffs

Plaintiffs filed a lawsuit for damages under Missouri law based on injuries they alleged to have sustained in connection with the use of Filshie Clips, a medical device used in tubal ligations. Plaintiff Kristin Bergdoll underwent a tubal ligation procedure in 2004 in which a Filshie Clip was utilized. Plaintiffs’ Complaint alleged claims based on design defect, manufacturing defect, failure to warn, strict liability negligence, violation of consumer protection laws, gross
negligence, and punitive damages against the Defendants. In general, Plaintiffs alleged the Filshie Clip migrated after the initial procedure causing injury and requiring surgical intervention. Plaintiffs further contended Defendants did not warn or adequately inform Plaintiffs or their healthcare providers about how frequent the migrations occurred, the severity and permanency of potential injuries, and their notice of adverse reports and injuries.

Over the years, Femcare has received patient complaints claiming symptoms related to migration of the Filshie Clip, sometimes called adverse event reports. Pursuant to FDA requirements, Femcare reviews each of these complaints to determine whether it meets the FDA defined threshold for reportability to the FDA. The FDA has reviewed and audited Femcare’s complaint-handling procedures and complaint files and has never found non-compliance with its reporting decisions on complaints of clip migration. The Plaintiffs do not dispute this fact. However, Plaintiffs claimed the FDA does not know about the vast number of “scientific articles” and “hundreds of adverse event reports” that Defendants have deemed not reportable. In essence, Plaintiffs contended Defendants are failing to report information to the FDA and if the FDA had this information Defendants would not be in found in compliance.

The United States District Court for the Western District of Missouri Southern Division issued an Order dated March 4, 2025 that stated, in part: “Here, Plaintiffs’ claims of manufacturing and design defect attempt to impose responsibilities on Defendants that are different from, or in addition to, the federal requirements. Plaintiffs do not allege, or provide evidence, that Defendants were manufacturing or designing the Filshie Clips in violation of what was required by the FDA’s authorization. The essence of each of Plaintiffs’ state law claims is that Defendants failed to comply with the FDA requirements or failed to disclose information to the FDA regarding the product. This is precisely the type of claim that is preempted. The MDA prohibits suits by private litigants for noncompliance with FDA requirements. This includes allegations that Defendants failed to report information to the FDA that would have changed their “approved” product. … It is undisputed that the Filshie Clip was studied and approved by the FDA through the PMA process, the Filshie Clip design was approved by the FDA, and the design has not deviated from that approval. Plaintiffs have not provided evidence of a deviation from the FDA design and have not provided expert testimony of any alleged failure to comply with the FDA’s requirements. As a result, the design defect claim is preempted.”

“Here, Plaintiffs do not allege that the Filshie Clip’s warnings deviated from the language approved by the FDA. By alleging that the Filshie Clip’s warnings were inadequate, even though the FDA approved those warnings, Plaintiffs seek to hold Defendants to standards that are different from, or in addition to, the federal requirements and any such claim is preempted. The FDA has approved the IFU and there is no evidence that Defendants have used language that was not approved or that they deviated from the FDA approved language.”

The District Court concluded: “Wherefore, for the reasons set forth herein, the Court finds Plaintiffs’ claims are preempted. The Court hereby GRANTS Defendants’ Motions for Summary Judgment (Docs. 117, 119, 121, and 123) on the issues of preemption as specifically stated herein.”

Source Bergdoll v. Coopersurgical, Inc., Case No. 6:22-cv-3018-MDH.

WE ARE CURRENTLY INVESTIGATING FILSHIE CLIP MIGRATION CLAIMS THROUGHOUT THE UNITED STATES.

If you or a loved one suffered injury or other harm from Filshie clip migration, or other Filshie clip issues, in the United States, you should promptly find a lawyer who may investigate your Filshie clip claim for you and who may represent you or your loved one in a Filshie clip case, if appropriate.

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