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Case Update December 2020: The U.S. Judicial Panel on Multidistrict Litigation has issued a transfer order to centralize Paragard lawsuits. Cases filed throughout the federal court system will be transferred to the Northern District of Georgia, and the MDL docket will be assigned to the U.S. District Judge Leigh Martin May.

A number of devices have been developed to provide women with the means to prevent pregnancy. One such invention is the intrauterine device (IUD) which is almost 100% effective. The popularity of this contraception method has significantly increased over the last 20 years. One popular brand is the Paragard IUD (T380, T380A, Tcu380A) manufactured by Teva Pharmaceuticals.

The Food and Drug Administration first approved Paragard in 1984. Since then, the FDA has given approval for its use even in women who have not had children yet. However, with the expanding number of women receiving IUD implants, there has also been an increase in reports of complications and unexpected side effects.

Patients who have suffered injuries from a Paragard IUD will be actively looking for a product liability law firm for legal representation. Broughton Partners connects personal injury law firms with Paragard lawsuit plaintiffs and other defective medical device plaintiffs. The retained plaintiffs we deliver to law firms are case-ready and pre-qualified. Your law firm can get signed Paragard claimants delivered with relevant case documents by contacting our team at (800) 949-8904 or fill out a quick online form for a free consultation.

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What Is A Paragard IUD?

Among the different types of medical devices that are offered as alternative methods to birth control pills is a small T-shaped device called an IUD.  An IUD is less than an inch and a half wide and similar in length. It consists of soft and flexible plastic with a copper wire wrapped tightly around the entire stem of the instrument.

No surgery is required to insert the IUD into a woman’s uterus and can be done by either a nurse or a doctor. According to Planned Parenthood, the apparatus is placed in the uterus by going through the cervix using a special inserter. The entire procedure can be completed within a matter of minutes but may result in pain or cramping.

The IUD is an effective means of preventing pregnancy. However, it offers no protection from sexually transmitted diseases. The Paragard IUD has a life expectancy of about ten years before it needs to be replaced, but a healthcare professional can remove it at any time. Paragard is marketed as the only IUD without hormones and Teva Pharmaceuticals claims it is 99% effective at preventing pregnancy. It does this by producing an inflammatory reaction in the uterus, which is toxic to eggs and sperm. This device can only be inserted and removed by a healthcare professional.

Paragard Linked to Serious Side Effects

A number of unexpected side effects have displayed themselves in women who have had a Paragard IUD implanted. 

 

Paragard Health Issues

  • Uterus perforation
  • Breakage of the device, requiring surgery
  • Device “stuck” in the uterus
  • Device migration
  • Copper wire remains in the body, resulting in injury or inflammation
  • Ectopic (tubal) pregnancy
  • Organ Damage
  • Scarring
  • Infections

Paragard Linked to Pseudotumor Cerebri

The medical term pseudotumor cerebri (PTC) means false brain tumor because the symptoms are similar to those caused by a brain tumor. With this condition, the level of pressure inside the skull elevates and can produce the same physical maladies that would occur with an actual brain tumor. However, no physical tumor exists. Some studies show a link between the use of Paragard IUD and PTC. 

Symptoms of PTC

  • Nausea, dizziness, vomiting
  • Problems with vision and blindness
  • Severe headaches originating behind the eyes
  • Whooshing sound inside the head, pulsing with heartbeat
  • Ringing in the ears
  • Light flashes
  • Neck, back or shoulder pain

Paragard IUD Lawsuit

Many women have safely and effectively used Paragard for years. However, reports of serious complications from its use have surfaced. These include severe issues such as pelvic inflammatory disease or even perforations that require expensive surgeries and cause tremendous pain.

Serious side effects have caused many women in the U.S. to contact attorneys for help in determining if the manufacturer of Paragard failed to produce a safe product and should have notified consumers of dangerous effects such as brain injury. Legal professionals are investigating claims against the manufacturers of Paragard IUD to determine if they:

  • Did not warn physicians, medical providers, and patients about possible risks.
  • Was aware of the risks, but did not redesign the IUD to be safer.

Paragard manufacturers facing lawsuits include:

  • Teva Pharmaceuticals USA, Inc.
  • Teva Women’s Health, Inc.
  • Teva Women’s Health, LLC
  • Teva Branded Pharmaceutical Products R&D, Inc.
  • The Cooper Companies, Inc.
  • CooperSurgical, Inc.

On December 16, 2020, the U.S. Judicial Panel on Multidistrict Litigation officially ordered 49 civil actions to be transferred to the Northern District of Georgia, where U.S. District Judge Leigh Martin May will preside over MDL No. 2974.

1984

The FDA approved Teva Women’s Health Pharmaceuticals’ copper IUD, Paragard.

2013

The FDA’s Medical Product Safety Network received a report stating that when a patient had a Paragard IUD removed there was moderated traction, the device was missing an arm, and the patient suffered some bleeding.

2014

A batch of Paragard T380A Intrauterine Copper Contraceptive devices was recalled due to a lack of assurance of sterility, according to the Food and Drug Administration.

2015

The FDA’s Medical Product Safety Network received a report stating that a part of a patient’s Paragard IUD was still inside her body after doctors removed it. The patient had the IUD for about 8.5 years and part of the copper coil was missing when it was removed.

2017

Researchers evaluated IUD devices that release levonorgestrel in patients with PTC. They found that women using these devices were over seven times more likely to develop PTC.

September 2020

Paragard plaintiffs filed a request to consolidate cases before one U.S. District Judge for coordinated pretrial proceedings.

December 2020

The U.S. Judicial Panel on Multidistrict Litigation issued a transfer order, confirming that establishing federal MDL is necessary, and decided that cases filed throughout the federal court system will all be transferred to the Northern District of Georgia and the U.S. District Judge Leigh Martin May will oversee the MDL.

References

Bliss Kaneshiro and Tod Aeby. “Long-term safety, efficacy, and patient acceptability of the intrauterine Copper T-380A contraceptive device”, International Journal of Women’s Health. Accessed February 24, 2020.

Cleveland Clinic. “ParaGard® (Copper IUD)”, Cleveland Clinic. Accessed February 24, 2020.

Mayo Clinic Staff. “Copper IUD (ParaGard)”, Mayo Clinic. Accessed February 24, 2020.

Mayo Clinic. “Pseudotumor cerebri”, Mayo Clinic. Accessed February 24, 2020. 

Planned Parenthood. “IUD”, Planned Parenthood. Accessed February 24, 2020.

Susan Wilson, et al. “Controversies in Family Planning: How to Manage a Fractured IUD.“, U.S. National Library of Medicine. Accessed February 24, 2020.

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