Over 3,600 lawsuits have been filed for women injured by Paragard breakage at the time of removal. Some of the injuries are so severe that women have undergone multiple surgeries and now experience fertility issues.
The multi-district litigation (MDL) of the Paragard intrauterine device (IUD) has been one of the most discussed cases in the complex medical device litigation, as of late. This T-shaped contraceptive, which is supposed to last up to ten years, has been the focus of thousands of lawsuits claiming that the device has a high likelihood of falling apart during removal, with serious medical consequences and requiring invasive surgeries[1].
To individuals who are operating within this legal environment, the essence of this argument lies in two main theories of law, namely ‘Failure to Warn’ and ‘Defective Design’. There are several court cases and expert testimonies that have come as a result of the use and dangerous effects of the Paragard intrauterine device.
The Silent Risk
- A claim on failure to warn relies on the allegation that a company was aware or must have been aware of a risk posed by a product, but the company did not give proper warnings or instructions on how to use the product to healthcare providers and patients[2].
- In the example of Paragard, some bellwether plaintiffs, whose cases would be put to the test in the greater litigation, will claim that when their devices were implanted, it was quite notable that the product labeling said nothing about the probability of breakage.
- Many of the plaintiffs, like Pauline Rickard, Melody Braxton, and Alisa Robere, had their implants installed between 2011 and 2014. The drug label at that time was reported to have no reference to device breakage in the Warnings, Adverse Reactions, or the Patient Information sections.
- Due to the absence of warning patients and their physicians believed the process of removal was going to be easy because of the lack of warning.
- When these patients attempted to get their IUDs removed, the devices failed, and their fragments remained attached in the uterus, which needed to be removed through surgery[3].
- Although some defense experts have claimed that the labels issued since 2005 were enough to warn of such risks. The court has however questioned such views, pointing out that most of the evidence that was relied upon to prove such cases was issued after the devices had actually been placed in the plaintiffs.
Have Engineering Flaws and Defective Designing Led to Breakages?
While the ‘failure to warn’ focuses on the lack of communication of the risk, ‘defective design’ claims focus on the integrity of the device itself.
According to Plaintiffs, the Paragard is defective in nature and unreasonably dangerous as a result of its material composition and physical construction.
Important witness accounts of polymer chemists point to several so-called design defects:
- Material Susceptibility: According to Dr. Mays, the materials used and even the process of manufacturing result in oxidative degradation, which makes the plastic base weak with time.
- Chemical Additives: There is a high concentration of barium sulfate in the T-shaped base that allows it to be seen in the X-rays. It has been recommended by experts that untreated barium sulfate may predispose the polyethylene base to snapping when subjected to mechanical forces of removal[4].
- Physical Geometry: The acute right angle of the “T” design is also mentioned as a structural defect that leads to the frequent occurrence of breaking of the device compared to other IUD designs[5].
- Safer Alternatives: A safer alternative is also a critical element in a design defect claim. Plaintiffs claim that it was not in line with international standards (including WHO standards) that would have significantly lowered the breakage rates.
The Legal Battleground: Preemption and Expert Challenges
The litigation process is now in a stage where the court is determining what expert opinions are to be heard by a jury and what claims have the capability to proceed. An example of this is the case of Federal Preemption that was recently adjudicated upon by the court. The defense contends that since the FDA approved the Paragard, state law claims are not allowed[6]. The court granted the manufacturers no summary judgment on failure-to-warn and some design-defect claims in a large Nunc Pro Tunc (now for then) order that permitted those fundamental matters to go to trial.
The court, however, has also curtailed particular expert testimony. Although Dr. Mays can give evidence on design defects, he cannot provide the jury with speculations on the motives of the manufacturers or make some kind of legal conclusions. On the same note, even defense experts such as Dr. Stephanie Benight were denied the right to testify to the existence of the so-called contraceptive effect of a broken IUD because it was not in her scientific expertise.
In the end, the Paragard lawsuit is a serious lesson on the significance of transparency in medical labelling and the need to conduct thorough materials testing over the long term in medical equipment. Everybody is concerned about whether the manufacturers care more about a ten-year-old design as opposed to the current safety practices and patient cautions.
Sources
[1] Sarver, Jordan, Melissa Cregan, and Daniel Cain. “Fractured copper intrauterine device (IUD) retained in the uterine wall leading to hysterectomy: a case report.” Case Reports in Women’s Health 29 (2021): e00287.
[2] Kraetschmer, Kurt K. “A Critical Appraisal of the Medical Eligibility Criteria.”
[3] Myo, Melissa G., and Brian T. Nguyen. “Intrauterine device complications and their management.” Current Obstetrics and Gynecology Reports 12, no. 2 (2023): 88-95.
[4] Specification, Prequalification. “The TCu380A Intrauterine Contraceptive Device (IUD).”
[5] La Saponara, Valeria, Shuhao Wan, Bhagyashree Nagarkar, Faress Zwain, and Mitchell D. Creinin. “Understanding the mechanical behavior of intrauterine devices during simulated removal.” Contraception 133 (2024): 110399.
[6] Cockey, Carolyn Davis. “ParaGard Gets Broader FDA Approval.” AWHONN Lifelines 9, no. 5 (2005): 368-368.
