PARAGARD IUD LAWSUITS DESCRIBE SERIOUS MEDICAL HARM

Paragard IUD lawsuits are now in the early stages of multidistrict litigation (MDL) consolidation in Philadelphia and more lawsuits are under investigation. Melissa Arias’s story about her experience with her Paragard T 380A is sadly commonplace.

A young woman, she wanted a reversible form of contraception so that she could have children later. But when she went to have her Paragard removed, it broke. The complications that followed ultimately required a total hysterectomy, thus ending her plans to have a family.

Other women claim that Teva Pharmaceuticals, Inc., the company that makes the Paragard IUD, did not warn them or their doctors about the risk of a long list of serious complications that could occur, especially on removal. In the last 30 years, the FDA has received more than 40,000 incident reports that detail adverse reactions to the Paragard device. These allegations include more than 15,500 serious complications and at least 15 deaths.  The agency received 7,273 reports in 2019 alone.

PARAGARD IUD SIDE EFFECTS UNDER SCRUTINY

Paragard IUDs were first approved by the FDA in 1984. Like the well-known Mirena device, the basic design of Paragard T 380A involves a T-shaped device that is implanted directly and non-surgically into the uterus. It can remain in place for up to 10 years. Removal is also intended to be a simple in-office procedure.  

Unlike Mirena, it is hormone-free. The T-shaped plastic frame is wrapped with copper wire coils, which produce an inflammatory reaction in the uterus that is toxic to sperm. It has an effective rate of well over 80 percent and has, thus, been seen as particularly appropriate for women who are interested in long-term contraception without the complications of hormone-based therapies.

It’s not trouble-free, however. Relatively minor complications include:

• Anemia;
• Backache;
• Pain during sexual intercourse;
• Complete or partial expulsion of the device;
• Prolonged menstrual flow;
• Menstrual spotting;
• Pain and cramping
• Vaginitis.

• Perforation or damage to the uterus on implantation, with resulting migration of the device or infection and scarring;
• Pelvic Inflammatory Disease, an infection of the uterus, tubes and nearby organs, which can often be treated with antibiotics, but may be fatal;
• Inflammation and injury from copper residue;
• Copper wire left behind in the body, causing inflammation and injury;
• Breakage on removal, which may necessitate additional surgery, including hysterectomy; and
• If pregnancy does occur, the patient faces an increased risk of ectopic pregnancy. 

Any of these can result in loss of reproductive health. In addition, questions remain about whether the Paragard device may also be linked, as Mirena has been, to pseudotumor cerebri, or idiopathic intracranial hypertension, the symptoms of which mirror a stroke.

FAILURE TO WARN ABOUT PARAGARD T 380A DANGERS

The plaintiff in a Paragard T 380A lawsuit may make one or more kinds of legal arguments about what Teva did wrong to cause her harm. Perhaps:

• The IUD’s labeling failed to warn about the risks, so that she and her doctor could not make an informed choice about the most appropriate form of contraception;
• The design of the T 380A was faulty or the manufacturing process produced a flawed product; or
• The manufacturer was otherwise negligent and failed to take adequate care that she was not harmed

These are generally the theories common to product liability lawsuits. In fact, most of the Paragard lawsuits to date have focused on the first argument – that Teva knew or had reason to know that the Paragard T 380A was dangerous to reproductive health, and yet kept that information from patients and medical professionals.

Most of the lawsuits are still in their early phases, though, and the process of discovery may still yield powerful arguments about what is going wrong that causes an apparently simple device to break and come apart in a patient’s body.

A study by the Open Journal of Clinical & Medical Case Reports that focused on the Paragard T 380A IUD found issues that included:

• 4 instances of embedded arms breaking during attempted removals;
• 1 case of ring holding strings breaking during removal;
• 1 embedded IUD with resistance on attempted removal; and
• 1 IUD breaking during removal in office.

PARAGARD T 380A LAWSUITS

In an early lawsuit from 2016, Stephanie Ideus argued that she and her doctor would not have chosen the Paragard T 380A had Teva adequately described the dangers of the product under standards set out in Nebraska law. She had the Paragard device placed in 2010. When doctors attempted removal in 2014, part of the IUD broke off and embedded in her uterus, necessitating additional surgery that put her at risk for reproductive health complications.

She relied on 24 reports that Teva had submitted to the FDA that detailed incidents in which the device had broken to argue that Teva knew about the dangers of the T 380A. The company nonetheless failed to update its warning label to include information about breakage.

The case was ultimately dismissed because of the court’s interpretation of Nebraska state law. Nonetheless, the lawsuit seems to have set the pattern of allegations for those that followed.

In her lawsuit against Teva for the permanent loss of her fertility, Melissa Arias seeks $50,000 in compensatory damages and an additional $50,000 in punitive damages. She claims that Teva was at fault for a manufacturing defect, design defect, failure to warn, negligence, common law fraud, breach of warranty, and violation of consumer protection laws.

Kathryn Reith and Laurie Halperin apparently had no problems with their Paragard T 380A IUDs from the time they were implanted (Ms. Reith in 2008 and Ms. Halperin in 2006) until they sought to have them removed.

In both instances, during the removal process, a part of the IUD broke off and remained embedded. Both plaintiffs later underwent additional surgery to remove the remaining fragment. Ms. Reith had her additional surgery in 2016 and Ms. Halperin in 2017. Each plaintiff alleges she suffered damages as a result of a defective ParaGard IUD “designed, researched, manufactured, promoted, marketed, labeled, packaged, and/or sold” by the defendants.

These are among many cases currently pending in the Philadelphia Court of Common Pleas, with information to be updated as the litigation in this and other jurisdictions continues to develop.
 

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Last updated on Jul-16-20