A lawsuit filed in federal court in Connecticut alleges that the Filshie Clip birth control device can migrate after implantation, a risk that the manufacturers reportedly failed to disclose to the public and healthcare professionals. The plaintiff in this Filshie Clip lawsuit claims she was harmed by this movement of the clips.
The lawsuit, the first case filed in federal court in Connecticut in 2024, accuses the manufacturers of advertising the Filshie Clip as a safe and reliable method of preventing pregnancy. However, the suit alleges that these clips have a high tendency to move post-implantation, with occurrences estimated at over 25%. This migration often necessitates surgical removal.
March 2024 Filshie Clip Lawsuit Update
The US District Court for the District of Rhode Island ruled that the Medical Device Amendment to the Food Drug and Cosmetics Act preempted the claims related to defects. The distributor and the parent companies of CooperSurgical were also dismissed from the case.
But.. the claim will continue. The court found Rhode Island law does not preempt Franks’ allegations of failure to warn, as well as her strict liability and negligence claims based on the same accusations.
The Filshie Clip
The Filshie Clip is a medical device used for female sterilization. It is a key component of the “Filshie Clip system” used in laparoscopic tubal ligation, a procedure for permanent birth control.
Promoted as the “Filshie® Tubal Ligation System,” this medical procedure employs the use of titanium clips, which are coated with silicone rubber, to encircle each fallopian tube. The underlying principle is straightforward: by maintaining consistent pressure, these clips effectively obstruct the fallopian tubes, thereby hindering the passage of eggs to meet the sperm.
The design of the Filshie Clip allows it to exert continuous pressure on the fallopian tube, causing avascularization, which is the cutting off of blood supply to the enclosed area of the tube. Ideally, this results in necrosis (tissue death) in the targeted area of the tube and subsequent fibrosis, leading to permanent closure of the fallopian tube and thus preventing pregnancy.
The Filshie Clip system includes a disposable delivery system consisting of an applicator that is inserted into the woman’s body to place the Filshie Clip onto the fallopian tube. The method of application and the design of the clip are intended to ensure a minimally invasive procedure with high efficacy in preventing pregnancy.
The device received Conditional Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) in 1996. This approval was based on an evaluation of the safety and effectiveness of the device, as required for Class III medical devices, which are those that either present a potential unreasonable risk of illness or injury or are for a use in supporting or sustaining human life.
However, the lawsuit alleges that there are significant issues with the Filshie Clip, mainly concerning its propensity to migrate after implantation, a risk that is claimed to occur in over 25% of cases. This migration can lead to various complications, often requiring surgical intervention to remove the migrated clips from the body.
The plaintiff in the lawsuit contends that the defendants, who are involved in the manufacturing and distribution of the Filshie Clip, failed to adequately warn both patients and healthcare providers about this risk. Furthermore, it is alleged that the actual incidence of migration is much higher than what was reported to the FDA during the premarket approval process.
Specific Allegations in Plaintiff’s Lawsuit
Banet’s lawsuit asserts that the manufacturers did not adequately warn or inform patients and healthcare providers about the frequency and severity of potential injuries caused by clip migration, despite being aware of adverse reports. The defendants, The Cooper Companies Inc., CooperSurgical Inc., Femcare Ltd., and Utah Medical Products Inc., are accused of producing, testing, selling, and distributing Filshie Clips as an easy sterilization method. These companies are alleged to have promoted the device as a safe and reliable form of contraception. However, this Filshie Clips lawsuit contends that this is far from the truth, as the risks of migration were significantly understated, and the manufacturers were purportedly aware of these risks due to adverse reports.
The clip system was conditionally approved by the FDA, but the lawsuit claims that the manufacturers reported a significantly lower migration incidence rate (0.13%) than what is alleged. The suit argues that the manufacturers should have been more transparent about safety risks, as the FDA relies on them for information on adverse events.
Plaintiff alleges that her surgery in October 2019 led to injuries requiring further surgery and that she continues to experience pain and requires ongoing medical attention. She claims that had the risks been properly disclosed, she would not have chosen to use the Filshie Clips.
The Filshie Clip is alleged to have a high propensity to migrate after being placed on the fallopian tubes, often requiring surgical intervention for removal. The defendants are accused of failing to warn patients and healthcare providers about the frequency and severity of potential injuries caused by clip migration. The plaintiff also asserts that the defendants made false representations about the safety of the Filshie Clip, failing to disclose its risks.
The lawsuit seeks damages under the Connecticut Products Liability Act and punitive damages.
Key Points in the Filshie Clips Lawsuit
The lawsuit alleges several key points:
- Failure to Warn: The manufacturers did not adequately warn patients or healthcare providers about the risk of clip migration and the potential for subsequent injury.
- Misrepresentation of Safety Data: The lawsuit contends that the manufacturers reported a migration incidence rate of just 0.13% to the FDA, a figure starkly contrasted by the claim that actual occurrences are much higher.
- Requirement of Surgical Intervention: The migration of these clips often requires surgical procedures to remove them, posing additional health risks to patients.
- Violation of FDA Regulations: By failing to report adverse events adequately, the defendants allegedly violated FDA requirements, compromising patient safety and the integrity of medical device monitoring.
Migration Has Real Consequence for Women
Plaintiffs’ lawsuits – not just this case – allege that these clips have exhibited a tendency to dislodge and migrate within the body, akin to unpredictable hazards. This migration can result in the clips tearing bodily tissues, embedding themselves in organs, and leading to a range of internal injuries.
Such outcomes represent more than just technical failures; they signify a profound breach of trust. Women who opt for tubal ligation make a significant decision, expecting reliable birth control. Yet, if you buy into the allegations in the Filshie Chips lawsuit, this assurance transforms into a distressing uncertainty, leaving women to cope with chronic pain, the need for corrective surgeries, and the potential loss of reproductive organs.
The repercussions extend to every aspect of their lives, disrupting careers, family stability, and causing profound emotional distress. The magnitude of this personal impact is immense. So it is more thatn a malfunctioning medical device; it represents a narrative of failed promises and devastating consequences. It underscores the need for greater scrutiny and accountability, advocating for justice for the affected women and challenging the practices of prioritizing profit over safety.
October 2023 Litigation Update – Filshie Clips Suit to Continue
The case “Nedimyer v. CooperSurgical, Inc.” involved a products liability lawsuit against CooperSurgical, Inc., Femcare, Ltd, UK Subsidiary of Utah Medical Products, Inc., and Utah Medical Products, Inc. The plaintiffs filed claims for design defect, manufacturing defect, failure to warn, strict liability, negligence, violation of the South Carolina Unfair Trade Practices Act, gross negligence, and punitive damages.
The issue at the core of this case was the Filshie Clip which was alleged to have migrated from its intended position, causing harm to the plaintiffs. The plaintiffs claimed that the clips migrated and caused injuries, requiring surgical interventions for removal.
The defendants filed motions to dismiss for lack of personal jurisdiction, improper venue, and failure to state a claim. The court denied these motions. The judge ruled that the court had personal jurisdiction over the defendants, and that venue was proper. Regarding the failure to state a claim, the court found the plaintiffs had made sufficient allegations at this stage and that issues like preemption and the learned intermediary doctrine should be decided after discovery.
Filshie Clips Medical Malpractice Lawsuits
There have also been medical malpractice lawsuits involving Filshie Clips. For instance, two 30-year-old women filed separate lawsuits against a physician in Kingsport, Tennessee, for medical malpractice, medical battery, and breach of contract related to the physician’s use of Filshie clips. These lawsuits were filed because the physician allegedly did not advise the women of the risks associated with Filshie clips and did not obtain their consent for the permanent application of these medical devices.
These cases suggest that, in addition to product liability issues, there can be malpractice concerns if the medical professionals involved do not properly inform patients about the risks of using such devices or fail to obtain informed consent.
History of Complications with Contraceptives
Filshie Clips is not the first piece of litigation involving contraceptives. Drug and medical device companies have struggled to make contraceptives safe. Product liability litigation involving contraceptives has a significant history, often reflecting broader societal attitudes toward birth control, women’s health, and pharmaceutical regulation. Here’s a brief overview of some notable cases and trends in this area:
- Dalkon Shield IUD (1970s and 1980s): Perhaps the most infamous case in contraceptive product liability, the Dalkon Shield IUD was linked to severe health complications, including infections, infertility, and even death. Thousands of women filed lawsuits against the manufacturer, A.H. Robins Company, resulting in massive settlements and eventually leading to the company’s bankruptcy. This case also led to increased regulatory scrutiny of medical devices by the FDA.
- Oral Contraceptive Pills (1980s onwards): Various brands of oral contraceptive pills have been the subject of litigation due to their side effects, such as an increased risk of blood clots, stroke, and heart attack. Lawsuits have typically focused on whether pharmaceutical companies adequately warned users about these risks. Notable cases include litigation against the manufacturers of Yaz, Yasmin, and Ortho Evra.
- Norplant (1990s): Norplant, a long-acting contraceptive implant, faced lawsuits from women who claimed to have suffered from severe side effects, including excessive bleeding, headaches, and nausea. The litigation focused on whether the manufacturer, Wyeth Pharmaceuticals (now part of Pfizer), provided sufficient warnings about potential side effects.
- NuvaRing (2000s and 2010s): The NuvaRing, a vaginal contraceptive ring, was the subject of lawsuits claiming that it caused blood clots leading to serious health issues like deep vein thrombosis, pulmonary embolism, and stroke. These cases often centered on whether the manufacturer, Merck & Co., adequately disclosed the risks associated with its use.
- Mirena IUD (2010s): Litigation against Bayer, the manufacturer of the Mirena IUD, involved claims that the device could migrate from its original position after insertion, leading to perforation of the uterine wall and other complications.
- Essure (2010s): Essure, a permanent birth control device, was the subject of numerous lawsuits claiming severe side effects, including persistent pain, bleeding, and device migration. Bayer, the manufacturer, eventually discontinued the product in most countries amid mounting safety concerns and regulatory scrutiny.
- Paragard (2024): The litigation surrounding Paragard involves claims of physical injury caused by the device. Plaintiffs have alleged that the device is prone to break during removal, leading to serious complications, such as fragments of the device embedded in the uterine wall, migration of the device, or perforation of the uterus. The lawsuits typically claim that Teva Pharmaceuticals, the manufacturer of Paragard, failed to adequately warn patients and healthcare providers about the risks associated with the device’s removal. Plaintiffs have argued that they were not properly informed about the potential for the IUD to break and the subsequent complications that might require surgery.