Table of Contents
- 1 Tale of Contraceptive Clips
- 2 Evolution of Controversy
- 3 Escalation of Filshie Clips Lawsuits
- 4 Class Action Lawsuit for Filshie Clip
- 5 Medical Malpractice Lawsuits against Physicians
- 6 Filshie Clips Lawsuit Settlements
- 7 Key Allegations in the Filshie Clips Lawsuits
- 8 How to file a Filshie Clips lawsuit?
A woman’s choice of contraception is a personal and empowering decision, crucial in the pursuit of her dreams and goals. Whether she opts for contraceptive pills or devices like IUDs, Copper Ts, or clips, she puts her trust on these methods to be effective and safe. However, when these contraceptives fall short of their assurances, failing to protect her health, the consequences can be devastating, impacting her dreams, health, and career. This issue is not isolated to one method; for instance, Filshie clips, a form of contraceptive implant, have also been known to fail, trailing the path of other contraceptives.
Hannah Banet’s Filshie Clips lawsuit filed in January 2024 is the latest addition to the ongoing legal battle against Cooper Surgical’s Filshie Clips. The Filshie Clip birth control device migrated and embedded in organs, necessitating revision surgeries.
The story of Filshie Clips migration and perforation into other organs is not new. The history dates back to the time after its approval. Let’s plunge deep into the details of Filshie Clips and how it works to understand its adverse outcomes and the booming legal battle.
Tale of Contraceptive Clips
Fishie Clip was created by Marcus Filshie in the late 1970s. Designed, manufactured and marketed by the Cooper Companies (Cooper Surgical, Inc.), Utah Medical Products, Inc. and Femcare LTD, the Filshie Clips came to the market with pre-market approval (PMA) from the FDA in 1996.
This approval was given based on an evaluation of the safety and efficacy of the device needed for the Class III devices (devices come with potential risk of side effects or approved to sustain human lives).
What is a Filshie Clip?
Filshie clip is a silicone-rubber lined, titanium tubal occlusion device used to constrict the fallopian tubes from passing the ovum to the uterus. It is implanted in the fallopian tubes either during the caesarian or through a laparoscopic surgery. Once implanted, the Filshie Clips exerts continuous pressure on the fallopian tubes and terminates the blood supply to the constricted area. This leads to tissue necrosis and formation of fibrosis, which blocks the passage.
This “Filshie® Tubal Ligation System,” consists of a disposable Sterishot® II applicator (Filshie Clip Applicator), which is inserted into the women’s body to place the Filshie Clips on the fallopian tubes.
Since the approval, more than 12 million clips were implanted in women seeking permanent contraceptives. The Filshie Clip failure rate is probably 4.1-23.3/1000 procedures performed.
The Utah Medical Products claims the following as the special features of the Filshie Clips:
Evolution of Controversy
The cases of device migration and perforation into other organs started surfacing a few years after the approval of the Filshie Clips. While a few women faced issues soon after the device implant, many suffered for years without knowing the real culprit behind their trauma.
According to the Ulster Medical Society (UMJ) report published in the PubMed, two device migration cases were reported in 2005.
A 46 year old woman reported with a suprapubic discomfort for more than 4 months. Examinations couldn’t identify the cause of her symptoms. Her bladder had a 2cm nodule with mucosa in the cystoscopy, which could not be palpable. The following day one of her Filshie Clips came out through her urethra, which relieved of her symptoms.
A 45 year old woman reported of symptoms like appendicitis. During a laparotomy, it was discovered that one of her Filshie Clips migrated into the caecum causing inflammation. The clip was removed and her symptoms improved.
The British Medical Journal detailed a case of a 35 year old woman, who reported of left iliac fossa pain (pelvic pain) in 2006. One of her Filshie Clips migrated and was embedded in the peritoneum and was removed later.
As per the report published in the Annals of the Royal College of Surgeons, a 43 year old woman, who had her Filshie Clips in 2002, presented with recurrent peri-anal abscess (sepsis). A migrated Filshie Clip was found to be the cause of her suffering and was surgically removed in 2007.
The Journal of Medical Case Reports details the case of 56 year old woman with multiple groin hernias. A CT scan 21 years after her tubal ligation revealed that the migrated Filshie Clip was embedded in the right inguinal area and causing the hernia. The embedded clip was removed later relieving her of the issues.
A MAUDE Adverse Event Report registered on August 19, 2019 to the FDA noted that the 30 year old patient experienced abdominal pain, diarrhea, emotional changes, fever, hypersensitivity, rashes, urinary tract infection and abdominal distention due to her Filshie Clips. She had her tubal ligation surgery in 2014. She was allergic to nickel and the Filshie Clips had nickel in it, which resulted in her suffering as per her allergist report.
Aftermath of Filshie Clip Migration
The filshie clip migration symptoms include the following:
- Chronic abdominal or pelvic pain
- Device embedded in the lungs, abdominal wall, uterus, or groin
- Internal bleeding
- Organ damage
- Severe pain
- Tissue perforation
- Unwanted pregnancy
Though the reports of device migration and getting embedded into organs started arising before 2005, the defendants had not issued any Filshie Clips recall or taken any preventive measures like giving adequate warning to the consumers. Instead they promoted their product as the most safe and excellent form of contraception method among all the other available ones.
Escalation of Filshie Clips Lawsuits
Giovanna Bulox filed her Filshie Clips lawsuit against CooperSurgical and The Cooper Companies on July 16, 2021. Later she included the UTMD and Femcare too as defendants in her lawsuit. United States District Judge, Lynn N. Hughes, presided over this lawsuit.
Bulox had her Filshie Clips implanted in 2010 but they migrated below her intestinal wall. She underwent a revision surgery in 2019 to remove the device. Merlo, Bulox’s sister too received the implants in 2009, which gave her excruciating pain and the attempts to remove the clips became unsuccessful.
The lawsuit alleged that the Cooper Surgical had not warned about the high risk rate of device migration, which could have been a warning to the plaintiffs and influenced their decision in not choosing the device.
Brad James Rebando et al
Plaintiffs, Brad James Rebando, Shelby Marie Rebando, Brian James Hanse, Danielle Debra Hanse, Cassondra Caputo, Curtney Webbe, and Nakeia Webbe filed a personal injury lawsuit in the district court in the Middle district of Florida on January 28, 2022.
The Filshie Clips lawsuit claims-
- Design defect
- Manufacturing defect
- Strict liability
- Gross negligence
- Punitive damages
The Filshie Clip lawsuit 2022 lawsuit alleged that
The lawsuit also purported that the defendants had reported to the FDA at the time of PMA approval that Filshie Clip system had 0.13% of migration incidence. However, in reality it could cause around 25% of migration risk, which was higher than they claimed.
As per the latest update on January 19, 2024, Judge Carlos Eduardo Mendoza had issued a motion to continue this Filshie Clip lawsuit.
Plaintiff Amy Arnold filed a Filshie Clip migration lawsuit on July 10, 2023 in the District court of the Southern district of Ohio division. Judge Edmund A. Sargus, Jr, Magistrate Judge Elizabeth P. Deavers preside over this litigation.
Amy underwent a tubal ligation surgery with Filshie Clips in 2003. The consent, she received did not reveal that the device could migrate. Soon after the surgery in 2003, she started experiencing lower abdominal and pelvic pain. However, no one including her doctors suspected the clips as the cause of her pain.
Only in January 2022, nearly after 20 years of the surgery, it was detected that one of her Filshie Clips migrated and became the root cause of her suffering. Later she had a Filshie Clip tubal ligation reversal surgery to remove the clips.
The lawsuit alleged that
The allegations were made on
- Design Defect
- Manufacturing Defect
- Failure to warn
Jackie Dianna Mack
Jackie Dianna Mack and her husband Frankie Mack filed a Filshie Clips lawsuit in the district court for the middle district of Alabama southern division on January 27, 2022.
In 2017, Mrs. Mack had her tubal ligation surgery with Filshie Clips. Within a few months, she encountered adverse side effects of Filshie Clip migration. In August 2020, she had a surgery to remove the migrated Filshie Clips and one of her fallopian tubes. However, she had to undergo a complete hysterectomy as her symptoms did not resolve even after the device removal.
Her Filshie Clip lawsuit asserts as given below:
The motions filed by the defendants to dismiss the Macks claim were dismissed by the judge without prejudice on March 27, 2023.
Plaintiff Jessica Farson filed her Filshie Clips lawsuit on May 3, 2022 in the US District Court for the Northern District of Ohio. Judge James R. Knepp II was assigned to handle this case.
Jessica Farson had her tubal ligation surgery in 2008. She experienced adverse side effects of device migration. The CT scans and X-ray in September 2021 revealed that both of her Filshie Clips migrated and embedded – one in her pelvic artery and the other in her abdomen. The revision surgery became unsuccessful as removing the clips from their current positions were dangerous.
As of January 2023, there were 14 Filshie Clips lawsuits filed against the defendants. Out of which one was filed in the state court and the others were filed in the federal court. The lawsuit in the state court was filed in Utah with 50 plaintiffs and it was dismissed on August 29, 2023. Out of the 13 federal lawsuits, three were also dismissed.
As per the update on August 2023 by Accesswire, five lawsuits including 44 plaintiffs were dismissed and the other 12 lawsuits exist with 63 plaintiffs.
The Filshie Clips lawsuit filed by Christa Blevins-Ellington, Kimyania Smith, Amanda Jo Venenga & David Raymond Venenga on January 18, 2023. The defendants tried to move motions to dismiss the lawsuit on the grounds of personal jurisdiction and preemption. However, Judge Leigh Martin Mary denied the dismissal and affirmed that the case would continue to be trialed.
Jackie Jo Nedimyer, et al
Jackie Jo Nedimyer, Leo Joshua Nedimyer, Gloria Wilson, and Tabitha Wilson filed their Filshie Clips product liability lawsuit on September 7, 2023 in South Carolina.
Nedimyer’s Filshie Clips implanted in 2005 migrated and attached to her intestines. In 2021, she had undergone a hysterectomy to remove the migrated device.
Gloria Wilson, and Tabitha Wilson had their birth control device in 2012. Both of their devices migrated and injured them that they had to undergo revision surgeries to remove the migrated clips and heal the wounds.
The defendants moved motions to dismiss the cases on the grounds of lack of personal jurisdiction, unsuitable venue, and failure to state a valid claim. However, the court ruled that it had personal jurisdiction over the defendants and declared the venue as fitting.
Regarding the allegation of not stating a claim, it was determined that the plaintiffs had sufficiently articulated their allegations for the current stage of the legal process. The judge also noted that issues pertaining to preemption and the learned intermediary doctrine would be examined after the discovery phase of the claim.
Hannah Banet (January 2024 Update)
On January 2, 2024, Hannah Banet filed a Filshie clips lawsuit in the United States District Court for the District of Connecticut against its manufacturer, CooperSurgical, Inc., and others. She alleged that being advertised as the safest and reliable contraceptive methods, the Filshie Clips migrated, necessitating surgical removal. She accused that the manufacturers masked the 25% risk of device migration in patients to the FDA and the consumers.
This case was dismissed on January 19, 2024 by Judge Sarala V. Nagala as per the plaintiff’s notice of dismissal. The reasons for the dismissal was unclear.
Class Action Lawsuit for Filshie Clip
Around eleven women filed a class action lawsuit in the District Court in Connecticut in April 2023. The lawsuit filed by Kassandra Walsh and others alleged that the implant migrated and embedded in the other organs of the body, resulting in pain and necessitates correction surgery. Instead of creating fibrosis to block the fallopian tubes, the device dissolved the tubes and migrated from the implanted area.
The plaintiffs in this class action encountered severe pain, burning and throbbing sensation, cramps, broken clips, clips embedding in other organs and correction surgeries.
Medical Malpractice Lawsuits against Physicians
While product liability claims and personal injury lawsuits flood in the courts against the manufacturers, there were medical malpractice claims too being filed in the courts. The lawsuits alleged that the physicians failed to inform the plaintiffs of the health risks like device migration and other organ perforation injuries. Had the plaintiffs being warned of the risks, they would not have preferred the Filshie Clips for contraception.
Filshie Clips Lawsuit Settlements
Sandberg Law claims that they have settled two Filshie Clips wrongful pregnancy lawsuits for confidential settlements. In both the cases, the implanted Filshie Clips failed to perform as claimed leading to the plaintiffs getting pregnant while the clips were on. In both cases one of the Filshie Clips failed to perform as indented.
Key Allegations in the Filshie Clips Lawsuits
The Filshie Clips lawsuits hold the defendants liable based on the following grounds:
Failure to warn: The manufacturers failed to adequately warn patients or physicians about the high risk of device migration and other potential injuries.
Negligence: Manufacturers are negligent in producing a defective device. They knew or should have known that the device was designed and manufactured in way as to present an unreasonable risk of migration when used on the fallopian tubes.
Breach of duty of care: They breached their duty of care to follow prudent care during the development, design, testing, manufacturing, inspecting and marketing it.
Failed to do the pre and post market testing: They did not conduct adequate testing pre and post-marketing the device to ensure its safety.
Misrepresentation of clinical trial data: The lawsuit alleged that the manufacturers reported 0.13% migration incidents rate to the FDA, while the actual rates were much higher as 25%.
Surgical revision: The migration and embedding of Filshie Clips required surgical interventions to remove them, adding health risks and medical expenses to patients.
FDA regulation violations: The defendants masked the health risks to the FDA and thereby violated FDA requirements, compromising patient health for monetary benefits.
How to file a Filshie Clips lawsuit?
If you or someone close to you has been harmed by Filshie Clips, now may be the appropriate time to consider a legal action. Numerous attorneys specializing in Filshie Clips lawsuits are currently accepting new clients.
Evidence suggests that many women who experienced adverse effects from Filshie Clips were initially unaware that their symptoms were linked to these birth control devices. If you have been using Filshie Clips for an extended period and are experiencing any of the symptoms mentioned in this article, it is advisable to speak with your healthcare provider to determine if the Filshie Clips might be the source of your health issues.
Additionally, if you’re uncertain about the type of birth control device used in your treatment, but experiencing symptoms mentioned above, a consultation with your physician can confirm whether Filshie Clips were employed. This step is crucial for those considering legal action, as it establishes a direct connection between the product and potential health complications. Understanding the specifics of your situation is an essential first step in seeking legal redress.
Medical records can come in handy in proving your injuries from Filshie Clips migration. A thorough medical record review can unearth even minute details that can bolster your Filshie Clips lawsuits. It can project the sufferings you have encountered, the loss of work days and income, incurred medical expenses and the prolonged and extensive treatments like revision surgeries you would need in future. This will be helpful in establishing your damages and assert your eligibility in pursuing lawsuit against the defendants.
To wrap up,
Birth control choices are made by women trusting that it would provide what they are indented. When the negligence of manufacturers break that trust, it leads to never-ending woes and prolonged legal battles. Like most of the other defective contraceptive implants, Filshie Clips too have failed to offer what they promised.
Affected women should brace themselves to make the wrongdoers face the legal consequences for their negligence. Though some of the Filshie Clips lawsuits are dismissed, still it is promising for the eligible plaintiffs to move with their claims. Proceed with the assistance of an experienced Filshie Clip attorney to ensure recompense for your woes.
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