On January 2, 2024, a federal lawsuit was filed in the United States District Court for the District of Connecticut against CooperSurgical, Inc., The Cooper Companies, Inc., Femcare, Ltd. – UK subsidiary of Utah Medical Products, Inc., and Utah Medical Products, Inc. that alleges, in part:
Filshie Clips pose significant health risk, and the product has subjected untold thousands of women to significant injuries. These injuries stem from the simple fact that Filshie Clips have a propensity to migrate after being placed on the fallopian tubes. Migration of the clips following a normal application is estimated to occur over 25% of the time. The pathophysiology is related to the speed at which peritoneal-like tissue forms over the clip anchoring it to the fallopian tube.
The migration of the clip often requires surgical intervention to remove the Filshie Clips from the woman’s body. Defendants neither warned nor adequately informed patients nor their healthcare providers how frequently these migrations occur or the severity and permanency of the potential injuries even though Defendants had received adverse reports and knew or should have known Filshie Clips had a significant propensity to migrate.
Women and their doctors depend on Defendants, the manufacturers and distributors of products like Filshie Clips, to be forthcoming about the safety and risks of Filshie Clips. This reliance on Defendants was warranted. The regulatory scheme that governs Filshie Clips is premised on a system whereby the manufacturer is responsible for reporting relevant safety information to the public.
The onus is on the manufacturer to come forward with any safety risks because the public and the U.S. Food and Drug Administration (“FDA”) would otherwise have no insight of adverse events.
The Plaintiff has suffered as a result of Defendants’ failure to report adverse events involving the Filshie Clip. That failure violated requirements imposed by the FDA.
… during the premarket approval process, it was reported to the FDA that the Filshie Clip System had a migration incidence of .13%.
However, the risk of clip migration was significantly higher and continued to increase from year to year since the initial PMA. Despite these increases, Defendants failed to address the Filshie Clips safety issues, even though adverse event reports did or should have alerted them to a product defect causing the device to cause injuries.
Rather than inform of the risks, CooperSurgical, Femcare, Ltd., and Utah Medical Products touted the benefits of the Filshie Clip version of the bilateral tubal ligation procedure over other available procedures. As noted in the press release regarding the Femcare, Ltd. purchase, the Filshie Clip System was claimed to be “safer than electrocautery and the newer hysteroscopic devices” without mention Defendants had a duty to act as reasonable manufacturers and
distributors of medical devices. They had a duty to continually monitor their product, including, but not limited to, its design, manufacturing, testing, performance, safety profile, and labeling. They had a duty to continually test their product and ensure it was safe and would perform as intended. Yet Defendants breached their duties and, as a result, Plaintiffs were injured.
The Defendants’ knowledge regarding the migration issues involved with the Filshie Clip Systems not only triggers responsibility under Connecticut law for products liability, it also imposes parallel duties on the Defendants pursuant to the Food, Drug, and Cosmetic Act (FDCA) to accurately report and update the FDA of the same. These duties, both under Connecticut product liability law and the FDCA, are substantially similar. Connecticut products liability law does not impose a higher standard than the FDCA.
If Defendants had timely disclosed the propensity and severity of risks associated with use of the Filshie Clips, Plaintiffs’ injuries could have been avoided. Instead, Defendants did nothing, and for that, Plaintiffs here seek redress both to compensate them for their losses and to strongly deter future, similar misconduct.
Neither Plaintiff nor her healthcare providers were warned that Filshie Clips were unreasonably dangerous, even when used exactly as intended according to Defendants. To the contrary, Defendants promoted, marketed, and sold the Filshie Clip product implanted in Plaintiff (and thousands of women like Plaintiff) to healthcare providers as a safe alternative to other procedures that did not incorporate the Defendants’ products.
Banet v. The Cooper Companies, Inc., Case 3:24-cv-00001.
WE CONTINUE TO INVESTIGATE 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.
Visit our website or call us toll-free in the United States at 800-295-3959 to find Filshie clip attorneys who may assist you with your Filshie clip claim.
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